Blogs CCIT

23
Mar 2022

Parenteral Products Package Testing with E-Scan HVLDmc

Parenteral Products Package Testing with E-Scan HVLDmc

For parenteral administration, compounded sterile preparations are often made from manufactured sterile materials. As a means of drug delivery, patients commonly require the administration of parenteral formulations. When compared to other methods of drug delivery, this method has both advantages and disadvantages. Nowadays, the ways of administration of new drugs are increasing all over the world. The range of possibilities for drug delivery containers must be reviewed on a regular basis, with the objective of improving compliance and delivery accuracy.

The packaging around a drug product is critical when establishing a new drug product or even re-facing an old one. There has also been an increase in the number of packaging formats for parenteral over the last ten years. Liquid-filled containers such as vials, ampoules, syringes, blow-fill seals, and auto-injectors, as well as containers filled with lyophilized products, are common parenteral packaging methods. Parenteral drugs are directly injected into the human body. Therefore, it is necessary to ensure the product quality of parenteral throughout its shelf life. Highly sensitive and reliable test methods are required. In this blog, we will discuss about parenteral product leak testing.

Why Use E-Scan HVLDmc for Testing Parenteral Products Packages?

E-Scan 655 is a revolutionary deterministic offline micro leak test equipment that inspects vials, syringes, and other liquid-filled parenteral products for container closure integrity using a new class of HVLD technology. The technique utilizes a non-contact, non-invasive test procedure that does not need sample preparation. E-Scan 655 is compatible with a variety of liquid-based products, including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions, including vaccines. At high production rates, the offline E-Scan 655 approach may be converted from laboratory to 100 percent inline testing applications. The E-Scan 655 technology is a non-destructive MicroCurrent conductivity test technique for parenterals. This method exposes the packaging and product to a lower voltage than other conductivity-based solutions.

Using a series of electrode probes, the E-Scan tester scans a sealed non-conductive container. Glass, plastic, or poly laminate can be used to make the container. The liquid must be contained within the container or packet (minimum fill 30 percent). There is a resistance differential and a change in current flow if there is a pinhole, crack, or other flaw, indicating a container breach. The approximate position of the defect can be determined.

Benefits of E-Scan MicroCurrent technology

  • Non-destructive, non-invasive, and no sample preparation is required.
  • Greater accuracy and repeatability.
  • Lower voltage exposure eliminates risk to the product and environment.
  • Quick changeover and simple recipe set up to accommodate a wide range of products and applications.
  • E-Scan MicroCurrent technology is effective across all parenteral products, including extremely low conductivity liquids (WFI).
  • Listed in USP Chapter 1207> as a proposed methodology for parenteral liquid package inspection.
  • The inspection and validation process is simplified.

E-Scan HVLDmc is one of the highly effective CCI technologies for parenteral. It is applicable to pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. The technology has a rapid test cycle and is easy to use. PTI’s E-Scan 655 is a patent-pending technology that uses a unique mode of MicroCurrent HVLD technique that requires less than half of the voltage required by existing high voltage technologies. MicroCurrent HVLD technology can be applied from the R&D laboratory to automated 100% inline CCI inspection.

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microcurrent hvld, container closure integrity, parenteral product leak testing, container closure integrity testing, cci technologies
135
28
Feb 2022

How VeriPac 355 Ensures Quality and Integrity of Pharmaceutical Packages?

How VeriPac 355 Ensures Quality and Integrity of Pharmaceutical Packages?

The pharmaceutical packaging industry is constantly developing as pharmaceutical manufacturers require reliable and efficient packaging solutions that meet a variety of requirements. Packaging is essential for the safe storage and administration of pharmaceutical products. Packaging pharmaceuticals is important not only for storing and protecting products but is also helpful in identifying, marketing, and promoting different brands, and making pharmaceutical products easier to use. Vials, blister packs, bottles, syringes, ampoules, etc are the most common pharmaceutical packages. The packages must perform correctly to ensure that the drug product remains uncompromised throughout the distribution cycle and shelf life. These packages are later tested to guarantee their quality and integrity.

Testing Package Integrity Using VeriPac 355 Series

VeriPac 355 is a non-destructive micro leak detection device for testing container closure integrity and package integrity on a variety of products and packaging types. This system is specially designed to test containers for dry product gas leaks as well as liquid leaks. Since it is non-destructive and does not need sample preparation, the VeriPac 355 can be integrated into protocols at any step in the handling process. The VeriPac 355 is the ideal non-destructive quantitative test technique for various pharmaceutical and food applications, with the capacity to detect leak rates as low as 0.2 cc/min depending on package parameters. The VeriPac 355 core technology is based on the ASTM vacuum decay leak testing method (F2338-09), which is recognized by the FDA as a consensus standard for package integrity testing. VeriPac leak test instruments were used to develop this test method.

Technology Overview

The VeriPac 355 leak tester is connected to a test chamber intended to hold the package to be tested. The package is placed inside the vacuum-sealed test chamber. High-resolution absolute transducer technology is utilized to monitor the test chamber for, both the level of vacuum and the change in vacuum during a pre-defined test duration. This is capable of detecting both gross and micro leaks. The test cycle is only a few seconds long and the results are objective. The testing is non-destructive to both the product and the package.

The sensitivity of a test is determined by the sensitivity of the transducer, the package design, the package test fixture, and the crucial test parameters of time and pressure. Test systems can be configured to operate manually or semi-automatically. This method is suitable for offline laboratory testing and QA/QC statistical process control.

Advantages of VeriPac 355

  • Non-destructive, non-subjective, and no sample preparation is required
  • Deterministic, quantitative test method
  • Detection of defects down to 0.2 ccm (5 microns)
  • High sensitivity, repeatability, and accuracy
  • Operator receives a PASS/FAIL result within a short cycle time
  • Portable modular design with a small footprint
  • FDA standard and ASTM F2338 test method

VeriPac technology is the optimal non-destructive solution for determining container closure integrity in a variety of package configurations. The strategy for choosing the right VeriPac model is based on the package type and the required leak test sensitivity. Configurations can be optimized and customized to the needs of each application. The VeriPac Series will analyze a wide range of high-risk package applications and ensure that the product fulfills regulatory standards and customer requirements for integrity.

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container closure integrity testing, container closure integrity, vacuum decay leak testing, cci technologies, cci test
178
17
Feb 2022

Automation of Class III Medical Device Packaging

Automation of Class III Medical Device Packaging

Testing Container Closure Integrity (CCI) is crucial for ensuring the quality of Class III medical devices. Class III medical devices are sterile components that are designed to be inserted directly into the human body. These devices often sustain or support life, are implanted or pose an unreasonably high risk of disease or damage. A compromised package can serve as a vehicle for microbial transmission and compromised sterility, leaving patient safety at risk. When bacteria or other impurities enter the container, the device ceases to be a treatment and becomes a danger to the patient. Similarly, a breach of the seal affects the sterility of the device and may present a serious quality concern at a key point of usage.

Testing Challenges in the Medical Device Industry

There are three basic approaches to package integrity testing:

  • 100% in-line testing: All products in a batch are tested on a high-speed production line at an acceptable level of CCI assurance.
  • Small batch testing: Testing a statistically significant batch size for certain quality parameters and extrapolating to match the quality of the manufacturing lot.
  • Testing Offline: Operators test packages individually or in smaller batches.

Dye penetration is a technique for identifying defects in package body and seals that has a variable detection capacity. When carried out correctly, the approach can identify pinholes and channel defects as small as 20 microns. This method is only used to validate the packaging process and offers minimal value to in-process quality monitoring. The method is time-consuming to implement and provides limited information in the effort to ensure the quality of high-risk applications.

For CCI testing, the majority of medical device manufacturers use a 100% in-line manual visual inspection technique. Manual visual inspection has been proved to be one of the least reliable techniques for ensuring quality. The failure of manual visual inspection is caused by a number of factors. According to ASTM test method F1886, a manual visual inspection may detect 75-micron channel defects in a transparent seal 60-100% of the time. Although manual visual inspection can be applied as a 100% test method, performance on the task decreases significantly over time. This method is not applicable if the package format is not transparent or semi-transparent.

How Vacuum Decay and Airborne Ultrasound Technologies are Automated?

Vacuum Decay is a deterministic method proven to offer predictable and reliable results for CCI testing of high-risk package applications. This is an ideal solution for non-porous medical device applications. When the major focus of the inspection is the final seal of a porous package, Airborne Ultrasound is exceptionally efficient and reliable at detecting seal defects that are invisible to the manual visual inspector. Both approaches have shown to be reliable non-destructive testing methodologies, and one or the other can be used for inspection based on the unique features of the product and container.

The automation of each technology looks a little different. Vacuum Decay enables approximately 25 to 50 samples per minute, with low throughput detecting single-digit micron leak sizes. Airborne Ultrasound is a rapid-fire sensor that transmits 1000 pulses per second of sound through the seal. The final seal of Tyvek® pouches and other flexible packaging systems may be scanned at a rate of 20 inches per second (~40 cm/sec), with the capacity to detect the most frequent seal faults and seal quality concerns. Both methods enable a production line to ensure quality while reducing production throughput.

The Airborne Ultrasound technology offered by PTI can be automated in many ways. Basically, the technology can measure the quality of a quantitative seal in any way that the pouch seal can pass through the ultrasound inspection head. Ultrasound can be applied to the production flow, which captures seal quality when exiting a band-sealer or transferring pouches through a production line. Robotic handling may also be used to do a full 360-degree seal inspection on all pouch seals. Airborne Ultrasound has the flexibility to be deployed in a variety of production lines and has high reliability in detecting critical defects.

Vacuum decay is often utilized for both Tyvek® trays and non-porous container types. While a vacuum takes longer to do a test (about 5 seconds on a Tyvek tray), the sensitivity and stability of this technology make it perfect for low output applications with high sensitivity requirements. Robotic handling solutions can serve many test stations at the same time, allowing for increased product throughput without losing sensitivity.

Medical devices are packaged and delivered in a variety of ways, ranging from porous flexible packaging to non-porous rigid containers. The range of product types and packaging options create unique inspection challenges that must be overcome in order to assure seal strength, sterility, and quality. Airborne Ultrasound and Vacuum Decay offer 100% testing capabilities as well as an accurate inspection that includes quantitative test results and a pass/fail result. These new automated technologies, with more sensitive leak detection capabilities, inspect containers at a higher rate.

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airborne ultrasound, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci testing
158
08
Feb 2022

Understanding CCIT's Seal-Scan Technology

Understanding CCIT's Seal-Scan Technology

Package integrity leak test methods offered by CCIT such as Seal-Scan utilize non-contact Airborne Ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging. The method is applicable to pharmaceutical as well as medical device packaging.

Seal Quality Testing and Seal Analysis using Seal-Scan Technology

Seal-Scan® is a non-destructive offline inspection and analysis technique for pouch seals using Airborne Ultrasonic technology (ABUS). Seal-Scan® offers advanced digital imaging software tools for process control, including in-depth seal quality inspection. Seal-Scan system uses the non-destructive ASTM Test Method F3004-13 for "Evaluation of Seal Quality and Integrity Using Airborne Ultrasound Technology." This test method was approved using PTI's ABUS technology. Seal-Scan® is a deterministic, quantitative, high-resolution technology for inspecting pouch seals for defects and ensuring seal integrity.

Seal-Scan has two scanning modes:

  • Linear Scan (L-Scan) to simulate online defect identification (line graph)
  • C-Scan for detailed seal analysis, resulting in pixel-by-pixel seal evaluation (Opto-Acoustic image)

Technology Overview

The pouch seal or packaging material is scanned between two focused ultrasonic sensors. Ultrasonic waves travel through single or several layers of bonded materials. The reflection of sound waves caused by ultrasonic transmission via different materials reduces/eliminates signal intensity. The signal level that passes through the seal is a function of the seal's quality. Defects of various forms, such as leaking and non-leaking, process-related and random, can be detected. Seal-Scan® can provide Opto-Acoustic images as well as thorough statistical analysis using one of two scan modes (L-Scan and C-Scan).

An L-Scan is a single linear scan along the seal's X-axis that generates a line graph of seal integrity and replicates real-time inspection. C-Scan generates a series of scans (along the X and Y-axis of the seal region), that offers a high-resolution ultrasonic image of the seal structure. This technology, via the Seal-Sensor, can be integrated into a pouch production process for 100% online seal defect detection.

Benefits of Seal-Scan Technology

  • Deterministic inspection approach yielding quantitative results.
  • Works with any material and combination, independent of color, transparency, print, surface polish, or porosity.
  • Produces a high-resolution Opto-Acoustic seal image.
  • Characterizes the overall quality and consistency of the seal.

Seal-Scan® is a semi-automatic inspection system with an x-y drive that is used to identify seal defects, characterize seals, and analyze materials. This approach is non-invasive, non-destructive, and does not need any sample preparation. The ability of PTI to adapt this technology to diverse production restrictions and conditions makes it an effective solution for flexible packaging systems.

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seal quality inspection, airborne ultrasound, container closure integrity, cci technologies, package integrity test solutions
148
03
Feb 2022

Package Integrity Testing of Flexible Packages Using VeriPac FLEX Series

Package Integrity Testing of Flexible Packages Using VeriPac FLEX Series

The physical ability of a package to protect its contents with the necessary level of protection during a specific time is referred to as package integrity. Package integrity tests are performed to detect packaging issues that might affect the sterility of a medical device. Previously, microbial challenge or dye penetration testing was used to determine whether the product packaging has maintained its microbial barrier qualities. Due to technological advancements, VeriPac FLEX systems are currently being used for testing the package integrity of flexible packages.

VeriPac FLEX Systems to Ensure the Integrity of Flexible Packages

CCIT’s VeriPac FLEX systems are versatile non-destructive package inspection systems that are intended particularly for evaluating dry-filled pouches and flexible packaging. VeriPac FLEX systems are available in several configurations for both the leak test instrument and the test chamber capacity to accommodate various package specifications and test sensitivity requirements. VeriPac inspection systems provide a simple PASS or FAIL result, as well as quantitative test data. They offer unparalleled sensitivity, reliability, and practicality in testing a wide variety of flexible package formats and sizes, without changing settings or tools.

The ASTM technique for vacuum decay leak testing (F2338), which is specified in ISO 11607 and recognized by the FDA as a consensus standard for package integrity test solutions, is used by VeriPac FLEX Systems. As an alternative to destructive testing, they eliminate subjectivity while also reducing waste and cost. When compared to destructive techniques like water bath or blue dye leak test, vacuum decay leak testing technology has proven to provide a quick return on investment. The VeriPac test devices consistently detect significant packaging errors and provide useful packaging process information.

Technology Overview

On the basis of the package size, the VeriPac tester is initially attached to the appropriate FLEX chamber. The Integrated Flexible test Chamber (IFC) and Drawer Style test chamber (D-Series) are the two test chamber configurations available to connect with the VeriPac instrument depending on package specification and test sensitivity requirements. The Integrated Flexible test Chamber (IFC) is designed for low-headspace sachets or stick packs. Depending on the package size and requirements, the Drawer Style test chamber (D-Series) is available in 2 basic sizes: Small (D) and Large (DXL). Custom designs are possible for large packaging types and bulk products. The way the package is tested is what sets VeriPac FLEX systems apart. CCIT makes use of a flexible membrane that fits the shape and size of the package, preventing stress and damage to the film materials. In a single test cycle, several packages can be tested.

VeriPac FLEX System Advantages

  • Non-destructive, non-subjective, no sample preparation
  • Cost-effective with rapid return on investment
  • Accurate and repeatable results
  • USP< 1207> compliant
  • Supports sustainable packaging and zero waste initiatives
  • ASTM test method and FDA standard
  • Deterministic, quantitative test method
  • Simplifies the inspection and validation process

Manufacturers are still struggling with quality standards for flexible packaging. CCIT’s VeriPac FLEX has proven to minimize manufacturing waste and costs while boosting package quality assurance and brand value. It has high test sensitivity and is capable of identifying micro leaks down to the single digit micron range.

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package integrity, package integrity test solutions, cci technologies, ccit, container closure integrity
146
01
Feb 2022

Development and Validation of CCI Testing Method for Pre-filled Syringes

Development and Validation of CCI Testing Method for Pre-filled Syringes

Pre-filled syringes are becoming more popular as a preferred container closure system for biologics. Pre-filled syringes must offer an inherent barrier that maintains drug product stability and sterility throughout its entire shelf life as a primary container closure system. The ability of the system to retain its microbial barrier integrity must be checked and demonstrated by the drug manufacturers. In 2008, the FDA endorsed CCI testing as part of the sterile product stability protocol.

The pharmaceutical industry has witnessed substantial technical developments in CCI testing in response to rising regulatory demands. MicroCurrent HVLD, Vacuum Decay Leak Testing and Helium Leak Detection are examples of new technologies that have proven enhanced detection capabilities above traditional Dye and Microbial Ingress approaches. Many of the technologies have been employed for CCI testing of drug product stability.

CCI Testing Strategy for Development

Many CCI failure modes can occur throughout the life cycle of a syringe, from component production to drug product filling and sealing, device assembly and packaging, and finally distribution and storage. It is critical to create a comprehensive plan for conducting CCI testing across the whole syringe life cycle.

The creation of the CCI testing technique begins with a detailed study of the construction, design, and manufacturing procedures used in syringes. The failure modes and impacts associated with each aspect of CCI were identified first. The next step was to evaluate whether CCI testing is required, as well as the intended uses and testing frequencies, using a risk-based approach. Knowing that the needle shield compartment seal integrity had been verified by the component supplier, apply a non-routine CCI test to validate its seal integrity during drug product loading and sealing, as well as during device assembly. To ensure CCI was achieved and successfully maintained, implement a complete set of CCI tests across the entire product development cycle for the product-containing syringe barrel compartment.

Method Development and Method Validation

Method development consists of optimizing testing parameters and determining the appropriate pass/fail threshold.

  • Testing parameters optimization
  • Initially, several defect standards of known sizes were examined alongside undamaged samples using varied testing conditions. The relationships between key method parameters and instrument responses to intact and defect samples were comprehensively investigated, with the objective of determining a set of variables that give optimal separation between intact and defect samples. i.e. signal-to-noise ratio or SNR.

  • Pass/fail threshold determination
  • The improved method was utilized to evaluate different lots of filled intact syringes representing relevant product variations, such as drug product batches, and packaging locations and lines, in order to define the preliminary pass/fail threshold. For intact samples, the results of the tests were statistically assessed to determine the instrument baseline and variation (σ). Typically, the pass/fail threshold should be 10 σ higher than baseline. The pass/fail threshold was then further refined and verified by testing defect standards of known sizes.

CCI testing techniques were validated for the pharmaceutical product package. Since the drug product formulation and package design may change during the early development stages, a step-by-step approach was adopted to validate the methods in line with the product development stages. Once product design and packaging design are complete, the methods are fully validated to support CCI testing for initial consistency and process evaluation. The power of the additional long-term method may be further validated before this method is implemented in QC laboratories for routine testing.

During package and pharmaceutical product development and manufacturing, properly selected and verified methodologies are critical for demonstrating container closure integrity. It should be noted that existing CCI testing methods do not provide an optimal solution for all pre-filled syringe CCI testing requirements. To maintain total container closure integrity, an integrated solution involving CCI testing as well as additional engineering and administrative controls is required.

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parenteral product leak testing, container closure integrity, CCI testing, CCIT, vacuum decay leak testing
227
27
Jan 2022

A Quick Rundown on Package Inspection Guidelines for Sterile Medical Products

A Quick Rundown on Package Inspection Guidelines for Sterile Medical Products

Class III medical devices have a unique combination of criteria and package features that necessitate a comprehensive approach to determining the best inspection procedures. For medical package inspection, there are a variety of methods that require a thorough understanding to assure quality.

Manual visual inspection has been the most common form of inspection for medical device packaging. While an ASTM standard (ASTM F1886) covers this concept, it may not be applicable for all applications and has limitations. Even though a 75-micron channel defect can be detected by manual visual inspection, the ASTM method F1886 indicates that the chance of detection ranges from 60% to 100%. This vast range of uncertainty does not give the level of assurance required for the packaging of high-risk medical devices.

Although certain offline leak detection techniques can offer a quantitative evaluation of seal quality, they miss some of the most prevalent seal problems seen in Class III medical device packaging. Testing peel strength or utilizing other destructive methods will not reveal random seal problems. For class III medical devices, online non-destructive inspection procedures are excellent since they provide quality control with comprehensive manufacturing lot data.

All Class III medical devices must be sterile, however, container materials and design differ widely. A non-porous pouch or tray demands an entirely different technique than a porous pouch or tray. Tyvek® offers a sterile barrier, and the porosity of the material limits the leak test procedures that may be used on the package body. When it comes to porous packaging, the focus of online inspection moves away from leak detection and toward seal quality evaluation.

Technology Overview

Vacuum decay and Airborne ultrasound are the two main methods used by PTI/CCIT to inspect medical device packaging. Both methods are aimed at providing quantitative and deterministic test results in order to assess package quality. In terms of function and performance, the two technologies are entirely different. Package integrity and leak path detection are the main objectives of Vacuum decay. Meanwhile, Airborne ultrasound technology focuses on package seal inspection and seal quality. Both approaches aim to meet the basic requirements of being reliable and sensitive inspection procedures for Class III medical device applications.

Vacuum Decay (ASTM F2338)

Vacuum decay is the most practical and sensitive vacuum-based leak test method of CCI. When testing pouches, a versatile adjustable test chamber may be utilized to test pouches of various sizes. The package is then placed into the vacuum-sealed test chamber. The level of vacuum, as well as the change in vacuum during a pre-defined test duration, are both monitored during the short test cycle. The change in vacuum indicates the existence of leaks and defects within the package. Vacuum decay leak testing is a go-to standard for sterile products because of its sensitivity and dependability. The approach is ideal for laboratory offline testing and production applications for quality assurance process control, since test equipment may be developed for manual or automation operation.

The ASTM Vacuum decay leak test technique (F2338), which has been accepted by the FDA as a consensus standard for package integrity testing, was developed using PTI VeriPac technology. As a deterministic test technique for package integrity test solutions, Vacuum decay is mentioned in ISO 11607 and the new USP 1207 guideline document.

Airborne Ultrasound (ASTM F3004)

Airborne Ultrasound is an ASTM Test Method F3004-13 and is one of the most effective methods for non-destructive seal quality inspection of flexible packaging. It is mentioned in ISO 11607 and the new USP 1207 guidance document. Most inspection methods are challenged by the leaking nature of porous packaging, but Airborne ultrasound, with its non-destructive measure of seal quality, effectively overcomes those challenges.

The non-contact Airborne ultrasonic testing technique is used in both Seal-Scan (Offline) and Seal-Sensor (Online). Ultrasonic waves propagate through the material as a package seal passes through the sensor head, producing sound waves to be reflected. When defects are encountered, the signal intensity is reduced or eliminated. The larger the acoustic gap between mediums, the more sound is reflected and less sound is transferred through the seal.

The variety of package forms and materials makes inspecting the integrity of class III medical device packaging a challenge. CCIT's scientists and engineers have vast industry experience and can prove a complete solution, including test method development and equipment validation for Class III medical device packaging.

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package integrity test solutions, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci technologies
197
24
Jan 2022

A Simple Guide to CCIT Services

A Simple Guide to CCIT Services

The integrity of the container closure system is crucial for ensuring that all portions of pharmaceutical products stay sterile during transportation, storage, and usage. Product contamination occurs as a result of leaking containers or closures. A non-destructive packaging inspection technology used to keep an aseptic barrier against possible contaminants is called Container Closure Integrity Testing (CCIT), commonly known as leak detection. The sterility and product quality of sterile final pharmaceutical and biological products should be maintained throughout their shelf life using container closure systems.

Various CCI Services

For testing the integrity of many package formats, CCIT offers expertise for the application of the best deterministic inspection technologies and test methodologies.

Feasibility Studies for Testing Package Quality

The first stage in evaluating and determining the optimal CCI technology and test technique for a certain application is to conduct an experimental or a more extensive feasibility study. To evaluate if a proposed CCI solution works and establish optimal test circumstances and Limit of Detection (LoD) is the goal of a feasibility study. CCIT’s aim is to provide clients with deterministic package integrity test solutions and help them in the installation of comprehensive CCI systems. This process starts with a client's problem description and ends with a clear approach to ensuring container closure integrity. Feasibility studies by CCIT for package quality testing provide customers with a complete report on the quantitative test technique.

Test Method Development for CCI Testing

CCIT conducts feasibility studies and develops test methods for package quality testing, recommending test methods based on the customer's needs for a given package or container. CCIT's Test Method Development focuses on the package/product characteristics and the extent to which the package attributes must be challenged to ensure closure integrity. The Test Method Development comprises adjusting test parameter settings for a given test method, such as vacuum or high voltage, test cycle periods, and pass/fail criteria. The comprehensive report will include precise test processes and criteria, as well as test findings and leak rates that the customer may expect, along with conclusions and recommendations. Before being included in the final report, all of the worked-out test methods go through validation checks to verify that they are reproducible, accurate, specific, exact, and acceptable for their intended application.

Equipment and Application Support

CCIT offers analytical leak detection services as well as package integrity testing equipment and applications knowledge. We also provide demonstrations on equipment and application services.

At CCIT's laboratory, we have the following technological platforms:

  • VeriPac - Vacuum Decay applications
  • E-Scan - MicroCurrent High Voltage Leak Detection( MicroCurrent HVLD)
  • Seal-Scan®/Seal-Sensor - seal inspection through Airborne Ultrasound

CCIT also offers the following services:

  • Installation, training, and validation services for CCI applications
  • Calibration, technical assistance, and overall equipment maintenance
  • Navigating USP 1207/ASTM/ISO standards - CCIT and regulatory consultancy services

CCIT.s.a is Europe’s leading package testing equipment provider for pharmaceutical, medical device, food, and nutrition companies. We have expertise in Test Method Development & Feasibility Studies. We focus on non-destructive technologies like Vacuum Decay, MicroCurrent HVLD, Airborne Ultrasound, and Helium Leak Detection for package quality testing.

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container closure integrity testing, packaging integrity testing, container closure integrity, cci technologies, ccit
171
20
Jan 2022

MicroCurrent HVLD for Testing the Integrity of Ampoules

MicroCurrent HVLD for Testing the Integrity of Ampoules

Pharmaceutical package integrity testing has always been an important aspect of the quality control and manufacturing process. Container Closure Integrity is critical for protecting the product throughout its lifespan until it is delivered to the patient. CCIT uses non-destructive inspection technologies for ensuring container closure integrity of vials, ampoules, syringes, cartridges, and auto-injectors.

Ampoules must be properly sealed since any crack or defect might contaminate the sterile substance inside. Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if there is any breach in the package. Hence, container closure integrity is an essential stage in the lifecycle of a sterile pharmaceutical product. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause fatal side effects. CCI defects can cause oxidation, which can reduce a drug's potency and shelf life.

Integrity Testing of Ampoules using MicroCurrent HVLD

MicroCurrent HVLD technology detects leaks in nonporous, rigid, or flexible packaging such as ampoules that contains liquid products. This is a non-destructive High Voltage Leak Detection Technology that is highly effective across all parenteral products (vials, syringes, ampoules and BFS). The test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and many other defects by scanning a non-conductive container sealed with electrode probes. Any crack or other defect in the container can cause a resistance difference and a change in the current flow, which would indicate a breach. It is also possible to determine the approximate position of the defect.

When compared to conventional HVLD technologies, MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. At high production speeds, this HVLD method may be simply transitioned from offline to 100 percent inline testing applications. It is a cost-effective online container closure testing solution that requires only minor infrastructure changes. This method is non-invasive and does not need sample preparation. For all parenteral and biologic products, MicroCurrent HVLD is one of the most effective CCI methods.

MicroCurrent HVLD Benefits

  • Effective in all parenteral preparations, even liquids with extremely low conductivity.
  • At high production speeds, inspection can be done both offline and online.
  • Non-destructive, non-invasive, and requires no sample preparation.
  • High level of accuracy and repeatability.
  • Deterministic method for parenteral liquid package inspection.
  • A robust technique for a variety of product classes and packaging forms with an estimated 3x Signal-Noise-Ratio.

Ampoules are such little glass bottles containing a sterile pharmaceutical liquid for parenteral administration. Microbes or other harmful pollutants may enter the ampoules through capillary pores or microscopic breaks, or the contents may leak to the outside. This may result in contamination of the sterile contents as well as a deterioration of the appearance of the package. MicroCurrent HVLD technology offered by CCIT can be applied to a variety of pharmaceutical packing formats including ampoules for testing integrity.

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microcurrent hvld, package integrity, packaging integrity testing, container closure integrity, container closure integrity testing
204
02
Dec 2021

Assuring CCI in Parenteral Products

Assuring CCI in Parenteral Products

Container closure integrity (CCI) testing requirements and regulatory guidelines have been rising steadily in the pharmaceutical industry in recent years. Parenteral products are often packaged in a variety of ways. The most common packaging formats are - vials, ampoules, syringes, BFS, and autoinjectors.

Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if the packaging is breached. As a result, container closure integrity is an important part of the sterile medicine product's lifespan. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause catastrophic adverse effects. CCI defects might cause oxidation, hydrolysis, or a loss of vacuum, which would have a major influence on the drug's efficacy and shelf life.

MicroCurrent HVLD to assure CCI in parenteral products

The criteria and purpose of the test determine the optimal container closure integrity testing technique. The sensitivity and reliability of the test method, the material of the basic package, and the necessity for inline vs. offline testing are all considerations to consider when choosing the right CCI test method. CCI test procedures such as MicoCurrent HVLD can detect breaches before they become an issue with the product and ensure patient safety.

MicroCurrent HVLD is a non-destructive, highly sensitive technology for parenteral product leak testing. This test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other defects by scanning a non-conductive container sealed with electrode probes. A change in current flow indicates the presence of a leak, along with the approximate location of the defect in the container. This is a patent-pending high voltage leak detection technique that has been found to be extremely effective in a variety of applications, including pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. Being one of the most effective online CCI testing methods, MicroCurrent HVLD requires very minor infrastructure modifications. This method is non-invasive and does not need sample preparation. It is one of the most effective CCI methods.

What sets MicroCurrent HVLD apart from traditional HVLD technology?

MicroCurrent HVLD, as referenced in USP 1207, is a unique High Voltage Leak Detection Technology for container closure integrity testing. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. MicroCurrent HVLD is a non-invasive CCI technique that does not require sample preparation, and has a high degree of reproducibility and accuracy throughout. This ground-breaking technique can be applied to a wide range of liquid-filled products including low conductivity sterile water for injection (WFI) and highly proteinaceous pharmaceutical products within suspensions.

Any breach in the sterile packaging systems can cause environmental pollutants to grow, turning a life-saving medicine into a potentially fatal microbial soup. This technology is highly effective across all parenteral and biologic products. At high production speeds, the MicroCurrent HVLD technique is scalable and can easily migrate from offline to 100% inline testing applications. It is a cost-effective online container closure testing solution.

The rapidly increasing preference towards parenteral products continues to fuel innovation, but it also faces distinct challenges in terms of implementing a container closure integrity testing strategy. Parenteral product packaging can be as complicated as the products themselves. To ensure package integrity, CCI testing in accordance with current USP 1207 guidance and regulation is required.

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container closure integrity testing, container closure integrity, microcurrent hvld, parenteral product leak testing, cci technologies
314
30
Nov 2021

Evaluating Package Integrity Solutions for Vials

Evaluating Package Integrity Solutions for Vials

Sterile pharmaceutical products including vials are manufactured with extreme accuracy and zero tolerance for error. As a result, pharmaceutical manufacturers place a high value on their quality control procedures. This is to guarantee that the items meet the quality requirements for their intended application. Packaging is essential for maintaining product quality and providing protection from harmful external forces. Package integrity testing, in addition to selecting suitable packing material, is a crucial component in preserving product quality. It prevents external contamination that can have a negative influence on drug quality by ensuring that there are no leaks within the package.

An effective package integrity solution for vials will ensure:

  • The vial is well-protected from external factors that might affect its quality, such as light, oxygen, moisture, and temperature
  • It is safe from contamination

Various Container closure integrity testing (CCIT) technologies are available today. Helium leak detection is one of the leading methods used for testing the container closure integrity of vials.

Helium Leak Detection Technology for CCI testing of Vials

The process of detecting leaks in various enclosed or sealed systems by utilizing helium as a tracer gas and measuring its concentration as it leaves due to leakage is termed Helium leak testing. Simply say, a vial that consists of a container and an elastomeric closure is a good example for package system. The vial is filled with helium and evacuated. The quantity of helium that escapes from the package is quantified and expressed as a leak rate. A prefilled syringe, a foil pouch, or a cold form blister card are another example. Each of these package types is meant to keep the pharmaceutical product enclosed while keeping out potentially harmful environmental pollutants like germs, or even gases.

Helium gas has a number of qualities that make it the best choice for package leak testing

  • As helium gas is one of the smallest molecules, it may reliably and rapidly breach pathways.
  • It is an inert gas that won't react with the components being tested, therefore it's perfectly safe to use.
  • Because of its limited presence in the atmosphere (less than 5ppm), instrument noise from atmospheric helium is intrinsically minimal, resulting in very precise findings.

Following are the advantages of using helium leak detection technology for CCI testing

  • Highly sensitive leak test method for CCI
  • Specially designed for detecting extremely small leaks that other leak test methods failed to detect.
  • The leak test thresholds might be adjusted as low as 1 x 10 -10 cc/s using a high vacuum technique. This allows unique comparison amongst package components.

Sterility of vials is essential for reducing and preventing infection in patients when using the medicine. As a result, package integrity testing is essential for regulatory approval of sterile pharmaceutical products, and medical devices. When it comes to package integrity testing of vials, the terms packaging integrity and container-closure integrity are sometimes used interchangeably.

At CCIT, we provide a wide range of quality leak testing equipment for pharmaceuticals including vials. With our high-grade non-destructive testing equipment, you can ensure that your products meet stringent quality requirements.

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container closure integrity testing, container closure integrity, cci technologies, seal integrity testing, seal quality inspection
225
23
Nov 2021

Pre-filled Syringes Leak Detection with Vacuum Decay Vs MicroCurrent HVLD Test Methods

Pre-filled Syringes Leak Detection with Vacuum Decay Vs MicroCurrent HVLD Test Methods

Pre-filled syringes have a significant role in the injectable drugs market. Because of its convenience, efficiency, and patient safety, pre-filled syringes are now widely utilized in a variety of medical areas. Pre-filled syringes, which are rapidly replacing traditional syringes are frequently used to deliver vaccinations. Defects in pre-filled syringes are mostly determined by pharmaceutical product design and syringe process design. Patient-related concerns are also a regulatory concern. As a result, it is critical for manufacturers to have a thorough understanding of the various tests involved in order to assure patient safety.

Evaluating leak test using Vacuum Decay Vs MicroCurrent HVLD Test Methods

Manufacturers perform Container Closure Integrity testing to ensure that the product maintains sterility and microbiological quality until the point of use. Container closure integrity testing evaluates a container closure system's capacity to maintain a sterile barrier against contaminants that might affect the quality of the resulting pharmaceutical and biological products. Various test techniques may be used to challenge Container Closure Integrity (CCI), however, not all of them are equally capable of finding package leaks. Vacuum Decay and High Voltage Leak Detection (HVLD) are the two deterministic test techniques for CCI mentioned in USP 1207, that are frequently used for parenteral products.

Technologies Overview

Vacuum decay leak testing is a CCI test method that has been proven over decades and improved with new technology innovations. When compared to destructive testing techniques, non-destructive testing not only provides for a better knowledge of package quality but also minimizes waste. As a result of the waste reduction, the return on investment will be higher.

Vacuum Decay method operates by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using either single or dual vacuum transducer technology. The existence of leaks or flaws within the package is indicated by variations in an absolute and differential vacuum. The Vacuum Decay method for leak detection of pre-filled syringes have proven to be an effective method of testing.

Benefits of Vacuum Decay

  • ASTM Test Method F2338 and referenced in USP 1207 Guidelines
  • Deterministic, quantitative test method
  • Repeatable, rapid, and reliable testing
  • Non-destructive technology
  • Completely tool-less with no changeover to test different packaging formats

High Voltage Leak Detection (HVLD) is a deterministic CCI test method for package inspection of non-porous pharmaceutical and parenteral goods. This technique is based on the fundamental characteristic of electricity. MicroCurrent HVLD technique, the latest evolution of HVLD developed by PTI, promises to provide a high degree of CCI assurance throughout the whole range of parenteral goods.

This method operates by scanning the container which can be done offline in the laboratory or online in an automated robotic platform. On one side of the container, a high voltage is supplied, while the other side has a ground probe. If there is no leak in the package, the two container walls (high voltage and ground) offer complete electrical resistance, and no substantial current is measured passing through the vial. The break-down resistance is achieved when there is a micro-leak or fracture in one of the container walls, and the current passes through. HVLD is the only leak detection technique that does not require mass to flow through a defect location, instead of relying on electricity to pass through a crack.

Benefits of MicroCurrent HVLD

  • Non-destructive technology
  • Non-invasive, no sample preparation
  • High level of repeatability and accuracy
  • Offline and 100% online inspection at high production speeds
  • Low voltage exposure to product and environment

Pre-filled syringes have emerged as a practical and dependable source for unit dosage medication as the pharmaceutical industry continues to seek possibilities to create convenient drug delivery techniques. We, at CCIT put a lot of effort into developing customized handling solutions that guarantee that syringes are moved without touching their piston to minimize product loss.

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container closure integrity testing, container closure integrity, CCI test, microcurrent hvld, vacuum decay leak testing
361
18
Nov 2021

Importance of Testing and Inspection of Pharmaceutical Products

Importance of Testing and Inspection of Pharmaceutical Products

Prior to commercialization, the development of new pharmaceuticals, particularly combination treatments, was a complicated process involving extensive research. When it comes to packing pharmaceuticals for patient use, several things must be considered to ensure that they satisfy the highest quality requirements and are safe to use.

Nowadays, the challenge of adopting traditional glass or specialized polymers as combination products has become common. Similarly, the demand for scientific evidence to support regulatory requirements for the pharmaceutical industry has also become more prevalent. For effective development and commercialization of a pharmaceutical product, it is important to understand the compatibility and performance of the primary packaging system with both, the pharmaceutical product and the delivery systems, regardless of the material.

Container Closure Integrity (CCI)

Container closure integrity (CCI) testing is important when ensuring the quality of all packaged products, especially when it comes to parenteral drugs. To evaluate the CCI of the packaging system, a pharmaceutical manufacturer must calculate the Maximum Allowable Leakage Limit (MALL) for the pharmaceutical product. MALL is defined by USP<1207> Package Integrity Evaluation – Sterile Products as the highest leak rate that may be tolerated for a specific packaging method while posing no harm to the safety and quality of the pharmaceutical product over its shelf life. In comparison to probabilistic approaches, USP <1207> provides guidelines on how to assess CCI, including deterministic methods, which are strongly encouraged. Helium leak detection, MicroCurrent HVLD, and Vacuum decay- are deterministic techniques. For the given system, these techniques must be created and validated.

Test methods

MicroCurrent HVLD

MicroCurrent HVLD is a non-destructive technique for determining the integrity of container closures for a variety of parenteral liquid products, including ultra-low conductivity sterile water for injection (WFI). A non-conductive container is examined for pinholes, micro-cracks, plunger leakage, and non-visible crimping leaks, among other things, using an electrode probe. Whenever a defect is identified, it causes a change in current flow and resistance differential, which indicates a breach in the container. The MicroCurrent HVLD is a High Voltage Leak Detection method effective across all parenteral products.

Helium Leak Detection

Helium leak detection is a deterministic method used to detect leaks in pressure vessels and other enclosed systems. In this technique, helium is used as a tracer gas. The change in helium concentration as it escapes through the container is monitored. For helium-based leak detection systems, the Seal Integrity Monitoring System (SIMS) 1915+ is a perfect choice. Helium as a tracer gas delivers excellent levels of quantitative accuracy when compared to traditional vacuum bubble and dye penetration test techniques. Helium is an optimal solution for product quality monitoring across the product lifecycle.

Vacuum Decay

A non-destructive CCI test method for evaluating medical device package integrity. Non-destructive testing improves package quality while decreasing waste when compared to destructive testing. This testing also saves time and money while ensuring product quality. This method operates by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. A single or dual vacuum transducer is utilized in the test chamber to measure the level of vacuum as well as the change in vacuum over a pre-defined time period. The existence of leaks and defects is indicated by fluctuations in the package's absolute and differential vacuum.

Regardless of the pharmaceutical product, type of materials, devices used, developing a complete testing plan from initial compatibility to stability and release is critical. To assure the availability of scientific data that helps ensure optimal results for patients as well as rapid regulatory approval and delivery to the market, proper testing is required.

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container closure integrity testing, high voltage leak detection, container closure integrity, seal quality inspection, microcurrent hvld
302
16
Nov 2021

Vacuum Decay Technology for Quality Control Assurance of Parenteral Products

Vacuum Decay Technology for Quality Control Assurance of Parenteral Products

A significant challenge faced by the pharmaceutical industry is insuring the container closure integrity of parenteral products. Therefore, maintaining the quality of parenteral products is critical in order to make sure they are actually sterile and safe for delivery to patients. Parenteral products are often packaged in a variety of formats. Liquid-filled containers, such as ampoules, syringes, and vials are the most prevalent forms. Microbial infection, exposure to gases, and water vapor can all lead to product degradation if the packaging is breached. Pharmaceutical products that save lives might lose their effectiveness or even cause adverse effects. As a result, container closure integrity is an important factor of the lifetime of a sterile pharmaceutical product.

Ensuring quality control with Vacuum decay technology

Vacuum decay is a test technique for determining closed container integrity (CCI) for high-risk packaging applications that provides quantitative and deterministic quality assurance with rapid, consistent, and reliable test results. The Vacuum decay method provides non-destructive and non-invasive leak detection in hermetically sealed containers. This is actually a simple test method and it tests container integrity using basic physical characteristics. It entails drawing vacuum on a package inside a test chamber and checking for any deterioration in the vacuum level, which would indicate a leak. As a non-destructive alternative to the water bath leak test, the approach has gained popularity. It saves money by not wasting items during the leak test.

This technique is applicable to a wide range of packaging formats. The Food and Drug Administration (FDA) has designated the standard vacuum decay leak test technique (ASTM F2338) as a consensus standard for container closure integrity testing. The test technique is mentioned in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and is listed in ISO 11607.  It may be used to evaluate rigid or flexible packaging, as well as plastic, glass, or metal containers, making it useful in the pharmaceutical and food and beverage sectors.

Benefits of using Vacuum decay technology

  • Non-destructive, non-invasive, no sample preparation
  • Cost effective with rapid return on investment
  • ASTM test method and FDA standard
  • Pass/fail results backed by quantitative test data
  • Capability to test multiple packages in a single test cycle
  • Non-subjective, accurate and repeatable results

CCIT.s.a are leading providers of various CCI test methods including Vacuum Decay, MicroCurrent HVLD, and Helium Leak Detection, manufactured by our affiliate PTI Inspection Systems in the United States. We specialize in test method development for all container closure integrity of pharmaceuticals, medical device and nutritional products and package quality testing projects. Our aim is to provide customers with deterministic non-destructive technologies for container closure integrity and then provide full support in the complete implementation of CCI systems.

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container closure integrity testing, container closure integrity, CCI test, seal integrity testing, vacuum decay technology
286
21
Oct 2021

Evaluating Pharmaceutical Package Sterility with Vacuum Decay Technology

Evaluating Pharmaceutical Package Sterility with Vacuum Decay Technology

The ability to resist microbiological ingress and the entrance or escape of substances is necessary for the packaging of sterile pharmaceutical products to maintain their quality. Pharmaceutical package integrity standards are quite strict since any packaging defect might have a direct influence on the health and safety of patients. USP 1207 explains how to ensure the integrity of non-porous containers used to transport sterile pharmaceuticals. Syringes, cartridges, flexible bags or pouches, plastic or glass ampules, capped vials or bottles, and containers for drug/device combination products are examples of pharmaceutical packaging.

How to ensure pharmaceutical package sterility with Vacuum Decay Technology?

The most feasible and sensitive Container Closure Integrity test method has been proven to be vacuum decay. The test measurement yields a quantitative result that is both dependable and accurate, as well as a pass/fail determination. Vacuum Decay technique works by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using single or dual vacuum transducer technology. The existence of leaks and defects within the package is indicated by variations in absolute and differential vacuum.

As it is a non-destructive test method, it saves money by not wasting product during leak tests and produces a return on investment in under 6 months for most of the products. Vacuum Decay has shown to be a non-destructive alternative to the blue dye leak test. Vacuum Decay is an ASTM Test Method F2338, which is also recognized by the FDA as a Consensus Standard for Package Integrity Testing. It is referenced as a deterministic test method for container closure integrity testing in the new USP 1207 Chapter Guidance.

Advantages of Vacuum Decay Technology

  • Non-destructive, non-subjective, no sample preparation
  • Pass/fail results backed by quantitative test data
  • Cost effective with rapid return on investment
  • Deterministic, quantitative test method
  • Identifies which cavity is defective
  • ASTM test method and FDA standard
  • Repeatable, rapid and reliable testing

Package integrity must be evaluated as part of a sterility program in order to determine the risk of new leaks occurring during pharmaceutical storage. After understanding the mechanism and the rationale for guaranteeing no contamination, it is recommended that test techniques with detection ability as near as feasible to the maximum permitted leakage limit be utilized.

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pharmaceutical package integrity, container closure integrity, container closure integrity testing, pharmaceutical package testing, cci technologies
294
11
Aug 2021

How Automated CCI Testing Reduces Pharmaceutical Package Integrity Issues

How Automated CCI Testing Reduces Pharmaceutical Package Integrity Issues

Container Closure Integrity (CCI) is primarily intended to ensure parenteral bio-pharmaceutical sterility and product quality throughout its shelf-life and usage. Guidelines for initial qualification and standards for validation have been set out and are available in chapter 1207 of the US Pharmacopeia (USP<1207>) (1). Any common CCI testing (CCIT) approach can be used to obtain a method that is suitable for its intended application within an end-use cycle. the principles outlined in USAP<1207>. CCI is an integrative and comprehensive process.

Common challenges faced by the pharmaceutical packaging

Pharmaceutical packaging plays a very important role in ensuring protection and maintaining the quality of pharmaceutical products. As a result, a great number of challenges are faced by pharmaceutical packaging. Let us see some of the challenges.

1. Preserving the medical quality of products

The medicines may lose their therapeutic properties, which is one of the biggest challenges faced by the industry, owing to a continuous exposure to heat and moisture. Pharmaceutical materials must be carefully selected and must not be allowed to alter the product by external elements or the product may become totally waste.

2. Ensuring safe transportation of liquid medications and injections

The other big challenge faced by pharmaceutical packing involves ensuring the safe shipping of non-solid medications such as liquids medications and injections. Due to it’s fluid nature, these non-solid medications are considerably harder to handle, especially with glass packaging. There is a high chance of breaking down. In order to avoid this problem, modern technologies like foam packaging and roto molding cases are integrated into the pharmaceutical packaging industry so that the glass packaging does not break down.

3. Proper information of medicine and dosage

The specified dose consumption of medicine is very much important. Also the package must provide information on the required dose, and information about the medicine it is composed of, expiry date and the serial number in order to avoid any misunderstanding.

Role of CCI testing in reducing pharmaceutical package problems

CCI testing helps mitigate pharmaceutical package issues to a great extent. The capacity to describe elements and chemicals which are able to move through container closure system components and contaminate the therapeutic product is a crucial stage in knowing the biological safety and appropriateness of a container. The US Pharmacopeia (USP) and Food and Drug Administration (FDA) are the main forces behind the safety assessment of materials and container closure systems in the United States. These are complying with high Container Closure Integrity Testing criteria (CCIT).

Many damaging procedures were considered suitable to guarantee that container closures preserve the sterility of devices. Basically blue dye or water bath are the procedures. These procedures were actually time consuming, inaccurate and unreliable. Moreover, test operators may not be able to control some test aspects and the resultant findings may be subjective. As a result, the FDA led the industry to shift away from the probabilistic test techniques in favor of deterministic technologies that make it possible for variables to be checked better, performed in consistent circumstances and reliably detect major leakages. Until the emergence of new technologies such as Vacuum Decay and MicroCurrent HVLD, a proper balance between sensitivity and reliability was a difficult factor. These new technologies can successfully scan containers with a greater sensitive leak detection capacity at a much faster speed than ever before.

Vacuum Decay technology: A non-destructive Container Closure Integrity(CCI) testing method which measures leak by vacuum decay. This technology is usually used for sealed packages. In nonporous, stiff or flexible packaging the vacuum decay test identifies leaks. The vacuum decay leak test method is used to check the packages after they are filled to verify the integrity of the product. This method is mainly used by the food package manufacturer, beverages and pharmaceutical industries. This approach minimizes the number of precious completed medicines needed to evaluate stability because the test is not destructive of the samples. After the vacuum decay test, the same samples may be utilized for additional laboratory tests normally necessary for stability studies.

MicroCurrent HVLD technology: MicroCurrent HVLD is a non-invasive Container Closure Integrity(CCI) technology applicable for a broad variety of parenteral filled liquid goods, including exceptionally injecting low conductivity sterile water and protein-filled products. The test procedure assures CCI by scanning a container that is non-conductive and sealed with electrode samples to identify pinholes, micro cracks, leakage of stoppers/plungers, invisible leaks, etc. The resultant difference of resistance and change in current flow indicates a breakdown in the container. Thus a defect is detected with exact defect location.

In addition to offline laboratory systems for leak detection and package quality testing, CCIT offers configurations that provide the capability of fully automated inspection. These technologies do not compromise the reliability of test measurement and automatic inspections take the perfect time to manage and monitor expensive final goods. Automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technologies provide the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality.

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container closure integrity, vaccum decay technology, microcurrent hvld, pharmaceutical package testing, cci
323
08
Jul 2021

Evaluating Sterile Medical Device Package Integrity Solutions

Evaluating Sterile Medical Device Package Integrity Solutions

Package integrity testing of medical devices is important to ensure safety and security of the product throughout its shelf life. Medical device packaging aims to protect the product from physical damage, biological contamination, or any other external disturbance. Technological advancements have offered a wide range of sustainable as well as economical packaging materials and formats to the medical device industry. However, irrespective of whether the devices are packed in rigid thermoformed trays with Tyvek or film lids, or in pouches of porous or non-porous materials or sealed bottles or even blister packs, pharmaceutical package testing is critical to verify that their sterile barrier characteristics are not compromised. Today, the market offers a complete range of technologies that can non-destructively inspect medical device packages for container closure integrity.

Package Integrity Solutions for Sterile Medical Device

1. Airborne ultrasound Technology

Airborne Ultrasound technology is a seal quality testing method, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

Benefits of Airborne Ultrasound technology:

  • Deterministic seal quality inspection technique that assures quantitative and reliable results.
  • Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
  • Eliminates subjective manual inspection methods.
  • Non-destructive, non-subjective, no sample preparation
  • Technology can be integrated for 100% online defect detection of the final pouch seal.

2.Vacuum Decay Technology

Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

Benefits of Vacuum Decay technology:

  • Non-destructive, non-subjective, no sample preparation.
  • Capable of detecting defects down to 0.05 cm.
  • Accurate, reliable, repeatable results.
  • Supports sustainable packaging and zero waste initiatives.
  • FDA recognized standard for package integrity testing.
  • ASTM test method F2338.
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seal quality testing, pharmaceutical package testing, container closure integrity
374
02
Jul 2021

How has VeriPac Systems Raised Standards for Container Closure Integrity Testing

How has VeriPac Systems Raised Standards for Container Closure Integrity Testing

What is Container Closure Integrity Testing?

Container Closure Integrity Testing can be understood as a leak detection test conducted using non-destructive package inspection systems to ensure product stability throughout its shelf life. CCIT plays a major part in ensuring that the products are free from possible contamination. While there are multiple ways to conduct a CCI test, it can be broadly classified into probabilistic and deterministic test methods. Traditional test methods like bubble test, dye ingress and microbial challenge by immersion come under probabilistic test methods. However, upon realizing that such tests lacked accuracy and reliability, The United States Pharmacopeia released guidelines in 2016 stating that deterministic methods ae preferred over probabilistic test methods. Vacuum Decay technology and Airborne Ultrasound technology are among the most preferred deterministic test methods.

VeriPac Test Systems for Effective CCI Testing

The VeriPac test methods are non-destructive, non-invasive inspection system for CCI and package integrity testing. They utilize the ASTM approved patented vacuum decay leak test method recognized by the FDA as a consensus standard for package integrity testing.

This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines. Applications for VeriPac technology include stability studies, clinical trials, quality assurance testing and statistical process control (SPC). VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats. Leak detection of high-risk applications requires the highest level of test measurement reliability. The VeriPac series have redefined the reliability and accuracy of test measurement systems.

How do Veripac Test systems Operate?

VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package, making it an ideal choice for CCI inspection across industries.

Inspection Criteria

  • Seal quality testing of entire container or package
  • Measures and verifies container closure system integrity
  • Tests for gas leaks for dry products (lyophilized vials, powder filled)
  • Tests for liquid leaks (liquid filled vials, pre-filled syringes)
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seal quality inspection, vacuum decay technology, ccit, container closure integrity
545
19
Jun 2021

MicroCurrent HVLD Technology for Sensitive CCI Testing

MicroCurrent HVLD Technology for Sensitive CCI Testing

Container Closure Integrity Testing is a leak detection test conducted using non-destructive package inspection systems, to evaluate whether container closure systems can maintain sterile barriers against potential damages. CCIT plays a vital role in ensuring that the products are free from any possible contamination. Container closure systems are made up of primary packaging components and secondary packaging components. Components like glass, vials or syringes that are in direct contact with the product are called primary packaging components. Secondary packaging components include aluminum caps, cardboard boxes etc. that are not in direct contact with the product.

While there are multiple ways to conduct a Container Closure Integrity test, these methods can be broadly classified into probabilistic and deterministic test methods. Traditional methods like bubble tests, dye ingress and microbial challenge by immersion come under probabilistic test methods. Since it was found that such test results lacked accuracy and reliability, the United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. Let us now understand how Microcurrent HVLD technology ensures sensitive CCI testing across different industries and applications.

MicroCurent HVLD technology is a non-destructive test method capable of achieving high levels of CCI assurance across the entire range of parenteral products. It is an FDA recognized ASTM test method capable of detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. Additionally, MicroCurent HVLD technology is found to be effective in detecting leaks in a wide range of liquid- filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. A unique feature of Microcurrent HVLD technology is that it does not require mass to pass through a defect site, requiring only the passage of electricity through a crack.

How does MicroCurrent HVLD technology work?

MicroCurrent HVLD technology functions on the simple property of electrical current. The first step is to place container horizontally on the rotating stage. While rotating the container, high voltage is applied on one side of the container and a ground probe on the opposing side. In the presence of a micro-leak or crack in one of the container walls, break-down resistance is reached and the current passes through. On the other hand, if there is no leak, the two container walls (high voltage side and ground side) provide full electrical resistance and no significant current is measured passing through the package.

MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with other HVLD solutions. Reduced voltage exposure has twin benefits- limits any risk that the voltage may cause to the product, and greatly reduces production of ozone during operation. In fact, experiments have shown that MicroCurrent HVLD produces essentially no Ozone

Benefits MicroCurrent HVLD technology

  • Non-destructive, non-invasive, no sample preparation.
  • High level of repeatability and accuracy.
  • Effective across all parenteral products, including extremely low conductivity liquids (WFI).
  • Lower voltage exposure produces no ozone, eliminating risk to the product and environment.
  • Listed in USP Chapter as recommended method for parenteral liquid package inspection.
  • Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.
  • Simplifies the inspection and validation process.
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container closure integrity, CCI, Microcurrent HVLD
402
14
Jun 2021

VeriPac UBV for Blister Package Inspection

  VeriPac UBV for Blister Package Inspection

Blister packs are popular packaging options for pharmaceuticals and consumer goods. A wide range of pharmaceutical products are packed in blister packs, ranging from capsules and tablets to high-risk hormone-based drugs and steroidal treatments. Commonly made of thermoformed plastic, these are quite useful in guarding products against external factors like heat, moisture and humidity.

However, concerns over integrity of blister packaging have increased over the years. Even a minute breach in the packaging can result in compromised package integrity. Hence, pharmaceutical manufacturers concerned about quality and shelf life of their products make Container Closure Integrity testing a crucial part of their manufacturing process. There are several methods available to test blister packs, and each has its own merits and demerits. For instance, the most common method to test blister packs remain dye ingress. However, this method is subjective, probabilistic and lacked accuracy in test results. This encouraged manufacturers to use non-destructive CCI test methods, that were accurate and produced quantitative results with measurable result data.

Blister Package Inspection with VeriPac UBV Technology

The VeriPac UBV Leak Detection System is a deterministic, non-destructive technology designed specifically for multi-cavity blister packs. The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence and location of leaks. It is a rapid test requiring no changeover or sample preparation. Operators simply input the number of blister cavities, place the blister pack on the inspection plate and press the START button. Within seconds, the operator sees a definitive pass/fail result, along with a volumetric measurement reading. The location of the defective cavity is presented to the operator with an image of the tested package. The intuitive and simple method makes it a practical solution giving rapid feedback to production line operators.

The UBV technology can provide rapid detection of defects as small as 10 microns with a fast test time, averaging 10-30 seconds depending on blister cavity volume. Test system requires no tools or test parameter changes for different blister formats. This technology is particularly advantageous for small to tiny blister cavities that are notoriously difficult to detect with a standard Vacuum Decay technology due to the very low headspace.

Technology Overview

Under this method, the sample is first placed inside the hinged test chamber. After pressing the start button, vacuum is pulled to a defined level. The blisters expand under vacuum, driving air out of the blister through any leaks present. If there is a leak in the blister, the air escapes into the chamber leaving a collapsed blister package. During the dynamic vacuum test sequence, a volumetric measurement reading is taken which determines which blister cavities are defective.

Benefits of VeriPac UBV Technology

  • Non-destructive technology
  • Accurate and repeatable results
  • Pass/fail results backed by quantitative test data
  • Completely tool-less
  • No changeover to test different blister formats
  • Identifies which cavity is defective
  • Eliminates destructive, subjective testing methods
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container closure integrity, CCI, Vacuum Decay Technology, blister package testing
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May 2021

Airborne Ultrasound Technology for Efficient Medical Device Package Inspection

Airborne Ultrasound Technology for Efficient Medical Device Package Inspection

Medical device quality control inspection is considered to be highly significant in ensuring safe delivery of medical devices from their place of origin to the market. However, tremendous development in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging

Adding to that, drug contamination is a serious concern in any medical industry- specifically for Class III medical devices. Class III medical devices are understood as devices that sustain or support life and are implanted, or present potential unreasonable risk of illness or injury. Since these devices are directly placed into human bodies, proper packaging is required to ensure quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, causing major health risks. Hence, appropriate package integrity testing and seal quality inspection of Class III medical devices are required so as to ensure seal quality and sterile barrier integrity are maintained.

Initially, manufacturers heavily relied on visual inspection or other probabilistic test methods to inspect seal quality and integrity. However, such methods lacked accuracy and reliability in terms of test results. Hence, manufacturers are now shifting towards non-destructive method for evaluating seal quality and inspecting physical properties of a seal. One such technique that is increasingly becoming popular among medical device manufacturers is Airborne Ultrasound technology. It is an ASTM test method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. The test is conducted by transmitting high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can also be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced

Airborne Ultrasound technology variants, namely Seal-Scan® and Seal-Sensor provide both, offline and online inspection of packages and accommodate various package specifications, test sensitivity and package handling requirements. Seal-Scan® offline systems offer in-depth seal quality analysis and seal characterization. Seal-Sensor online inspection systems for automated 100% inline scanning of pouch seals can be integrated into pouch production or pouch handling line. They provide a quick analysis of the seal area without tampering with the packaging to identify defects, such as incomplete or missing seals, wrinkles, channel defects and so on.

Advantages of Seal Scan and Seal Sensor method

  • Deterministic seal quality inspection method that produces quantitative results.
  • This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
  • Non-destructive and non-subjective test method that requires no sample preparation.
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable, reproducible and reliable results for seal quality inspection.
  • Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.
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package integrity testing, seal quality inspection, container closure integrity, medical device package inspection
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