Blogs CCIT

23
Jul 2021

CCIT for Pharmaceutical Package Integrity

CCIT for Pharmaceutical Package Integrity

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufactures. For this reason, drug product manufacturers give at most importance to their quality control procedures as well as package integrity tests. All packaging forms, whether pouches constructed of porous or nonporous material, rigid thermoformed trays with Tyvek or film lids, bottles with induction-welded seals, or blister packs, need verification that their sterile-barrier characteristics are not compromised. Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasized the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI).

Relevance of CCIT in pharmaceutical package testing

Container Closure Integrity Testing is an assay to evaluate whether container closure systems can maintain sterile barriers against potential damage. Even a minute defect in the container can cause external elements to enter the product, thereby reducing its shelf life. Common threats that can pass through a defected container closure system include microorganisms, reactive gases, and other substances. Considering the ability of such threat to deteriorate product quality, undertaking appropriate CCI tests are beyond crucial. However, it should be noted that CCI is not a one-time process, rather an integral and comprehensive approach. It is evaluated throughout the manufacturing lifecycle of a sterile drug product -from primary package development until the products are dispatched.

Container closure systems are made up of primary packaging components and secondary packaging components. Components like vials or syringes that are in direct contact with the product are called primary packaging components. Although there are multiple CCI techniques available in the market today, regulatory guidelines have broadly classified methods into probabilistic and deterministic test methods. Under a probabilistic test method, results are generated through a series of events, each with a respective probability distribution. Thus, the accuracy of the results cannot be assured. In contrast to a probabilistic method, deterministic test methods assure quantitative results with higher level of accuracy and reliability. The United States Pharmacopeia in 2016 issued new guidelines stating that deterministic methods are preferred over probabilistic test methods. Container closure integrity testing can be performed in many different ways. All the testing methods have pros and cons. Given below is a list of non-destructive Container Closure Integrity test methods:

  • Airborne Ultrasound technology
  • Vacuum Decay technology
  • Microcurrent HVLD technology
  • Helium Leak Detection
  • Pressure Decay leak testing
  • Force Decay leak testing
Readmore...
pharmaceutical package testing, container closure integrity testing, Vacuum Decay Technology, Airborne Ultrasound technology
46
15
Jul 2021

Vacuum Decay Technology Raising Standards for Pharmaceutical Package Testing

Vacuum Decay Technology Raising Standards for Pharmaceutical Package Testing

Right from clinical trials to drug packaging, all aspects for pharmaceutical industry are subject to strict quality control regulations. The process of selecting and validating appropriate packaging for pharmaceutical products takes a significant effort. Pharmaceutical package testing is conducted to ensure the suitability of drug packaging for its intended use. It included all components containing the product, even if they are in direct contact with the drug or not. As such, containers should be capable of retaining the healing properties of the drug product throughout its shelf life or until it is administered. Even a minute breach in container closure integrity can compromise the safety and effectiveness of the drug product. This realization has prompted pharmaceutical product manufacturers to conduct appropriate container closure integrity tests to ensure product sterility throughout its lifecycle.

Why use Vacuum Decay technology for pharmaceutical package testing?

PTI’s Vacuum Decay technology is a non-destructive container closure integrity testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Non-destructive testing provides a greater understanding of package quality while also reducing waste. Waste reduction delivers a fast return on investment and brings operations closer to green initiatives. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology can identify leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. 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. Vacuum Decay technology is a practical alternative and significant improvement to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of PTI’s Vacuum Decay Test System

  • Better process control - reliable and sensitive leak detection of quality critical defects.
  • The advantage of test results that are both qualitative (pass/fail) and quantitative (Statistical data with each test result).
  • Repeatable test results demonstrate the reliability of the instrument and test data.
  • Cost savings - Eliminates product loss, waste and mess of both packaging and coffee that results from using destructive testing methods
  • Using a non-destructive leak test method allows an increase in the number of products samples tested.
  • Rapid test cycle and minimal training required to operate tester.
  • Rapid ROI due to substantial cost savings and elimination of product loss.
Readmore...
container closure integrity testing, pharmaceutical package testing, vacuum decay technology
60
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.
Readmore...
seal quality testing, pharmaceutical package testing, container closure integrity
79
23
Jun 2021

Evaluating Package Inspection Solutions for Pre-filled Syringes

Evaluating Package Inspection Solutions for Pre-filled Syringes

Did you know that majority of defects in high-risk pharmaceuticals including pre-filled syringes are caused by seal defects, attributed to both process and personnel error? While micro leaks pose a risk, the primary causes of defects are larger seal related quality deviations.

As the pharmaceutical industry is constantly seeking opportunities to develop convenient drug delivery methods, pre-filled syringes have come up as practical and reliable source for unit dose medication. The demand for glass syringes faded as the industry moved towards plastic and disposable syringes. Pre-filled syringes are applied across a wide range of medical sector including vaccines, blood stimulants, and therapeutic proteins.

Convenience in use and reduced dosage errors are the primary benefits associated with pre-filled syringes. They make injections easier and safer for both doctors and patients. In addition, pharmaceutical companies are able to minimize drug waste and increase product life span- which are important factors, particularly with costly biopharmaceuticals. However, considering the fact that pre-filled syringes are complicated combination products, manufacturers face a number of challenges in terms of quality control and stability concerns. Therefore, pharmaceutical package testing demands sound knowledge of various CCI testing methods. In this blog, we will understand how Microcurrent HVLD technology offers reliable seal quality testing of pre-filled syringes.

MicroCurrent HVLD Technology for CCI testing of pre-filled syringes.

High voltage leak detection (HVLD) has been a common technology in the market for decades. The latest evolution of HVLD, MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of parenteral products. High voltage leak detection is a method included in USP 1207 as a deterministic test methodology and is an established and reliable solution for all liquid filled parenteral products.

HVLD operates on the simple property of electrical current. The package barrier must be non-conductive and would resist voltage from passing through, while the package contents should generally be able to carry voltage. Liquid products with a conductivity of 5 microsiemens and greater meet the requirement for PTI’s MicroCurrent HVLD

The E-Scan 655 is a Microcurrent HVLD technology-based leak test instrument used to inspect vials, syringes, and other liquid filled parenteral products. It is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions. The technology uses a non-contact and non-invasive test method that requires no sample preparation. E-Scan 655 can be used with a wide range of liquid-based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

Benefits of 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.
Readmore...
pharmaceutical package testing, seal quality testing, CCI, Microcurrent HVLD
108
21
May 2021

Pharma Package Testing CCI of High-Risk Pharmaceuticals

Pharma package testing

The pharmaceutical industry is the backbone of our health care system. As the industry is continuously progressing, the requirement for package integrity while being stored and shipped across the world is also increasing. Pharma package testing now has become an integral part of pharmaceutical industry especially when it comes to high-risk pharmaceuticals.

High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals. High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals?

Container Closure Integrity of Pharmaceuticals

The United States Food and Drug Administration recommends container closure integrity testing as part of the stability protocol for sterile biological products, human and animal drugs and medical devices. Traditionally, dye immersion, bubble test and other probabilistic and destructive test methods were used. In 2016, United Stated Pharmacopeia (USP) released a guidance stating that deterministic methods are preferred over the probabilistic methods.

The container closure integrity testing landscape has advances drastically. The USP Chapter <1207> on integrity testing have recommended different deterministic and non-destructive container closure integrity technologies throughout their specific product package life cycle.

The different deterministic pharma package testing technologies include the following:

Vacuum Decay Technology

Vacuum decay is considered as one of the most sensitive, practical and reliable vacuum-based leak detection method. This method gives repeatable and accurate quantitative data result with a pass or fail determination and can be used effectively for different kinds of nonporous, rigid or flexible packages. Vacuum decay technology is referenced in USP 1207 chapter guidance and is also listed in 11607. The vacuum decay method developed by PTI’s VeriPac instruments is capable of detecting microleaks in the range of single digit micron. In this method, the package to be tested is placed inside the test chamber to which vacuum is applied. The changes in absolute and differential vacuum is monitored over period of predetermined test time & is used to detect the presence of leaks within the package.

Benefits of Vacuum Decay Technology:

  • Non-destructive & no sample preparation
  • Deterministic test method
  • Repeatable and quantitative test results
  • Can be deployed in a robotic automated platform
  • Highly sensitive & non- subjective

Microcurrent HVLD

Microcurrent HVLD Technology, the new breakthrough in the field of pharmaceutical package testing & highly effective for all parenteral and biological products. The microcurrent HVLD exposes the product and environment to less voltage and has transformed the conventional HVLD technology. It capable of detecting small pinholes, micro cracks and seal defects in applications that include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology:

  • Non-destructive & requires no sample preparation
  • Deterministic & non-invasive
  • Higher levels of accuracy, reliability & sensitivity in test results
  • Offline and 100% online inspection at high production speeds
  • Can be deployed in a robotic automated platform
Readmore...
Pharma package testing, pharmaceutical package testing, CCI of high-risk pharmaceuticals, container closure integrity of pharmaceuticals
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