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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.

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.

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.

Testing the integrity of package seals helps ensure that nutritional packaging provides required product protection. Maintaining the reliability of package seals is critical for product quality and food safety. Airborne Ultrasound and Vacuum Decay technology can be used for testing package and seal integrity of nutritional packages. These CCI technologies produce quantitative, and repeatable results, due to their deterministic nature. The primary purpose of implementing these testing methods is to ensure the safety of consumers.

Overview of Nutritional Packaging Inspection

Nutritional packaging plays a significant role in securely delivering the product. The majority of nutritional products are shelf-stable in nature, therefore package performance is typically a concern. Chemical reactions occur naturally in all nutritional products. Any break in the nutritional packing might lead to the products deteriorating due to air, moisture, and microbial exposure. Fats and other nutrients for infants might become rancid and inactive. The quality and safety of the contents that reach the customer are determined by nutritional packaging.

Package and seal integrity techniques have great expertise in the packaging industry, which helps in inspecting nutritional packages in the most efficient method in order to preserve package and product quality. For the food and nutritional packaging industries, CCIT provides a variety of technologies and solutions. The two most common nutritional package inspection technologies are vacuum decay and airborne ultrasound. While vacuum decay is utilized for applications such as filled and sealed rigid containers, dry products in pouches, and flexible packaging. Retort pouch final seal inspection can be achieved using non-destructive with airborne ultrasound technology.

Technologies to Assure Package and Seal Integrity

Vacuum Decay Technology

Vacuum decay is a package test method for vacuum-based leak detection. It is considered one of the most practical and sensitive test methods used in nutritional package inspection. When compared to destructive test procedures, this technology not only provides for a better understanding of package quality but also minimizes waste. As a result of the waste reduction, the return on investment is higher, and the operation is closer to green initiatives.

The Vacuum Decay leak testing method operates by enclosing package samples in an 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 pre-defined test duration using single or dual vacuum transducer technology. The existence of leaks and defects within the package is indicated by variations in an absolute and differential vacuum. Test systems can be designed to be operated manually or fully automated.

Airborne Ultrasound Technology

Pouches are the common form of packaging for most nutritional products. Hence, it is necessary to ensure the package integrity of such pouches. Airborne Ultrasound is a non-destructive and non-invasive method of inspecting seal quality. In this method, ultrasound waves are permitted to pass through the package seal, causing sound waves to be reflected. The fluctuation in the reflected signal intensity is used to detect defects.

Airborne Ultrasound technology is available in both online and offline solution options. It has been proven to be one of the most successful non-destructive testing procedures for flexible package seals. According to ASTM F3004-13, this is the standard test technique for evaluating seal quality and integrity using airborne ultrasound. This method has high applicability in the food and nutrition industry.

Vacuum Decay technology and Airborne Ultrasound technology are both ASTM test methods and also FDA consensus standards for package integrity and seal quality inspection of nutritional products. An appropriate testing method for inspecting nutritional packages is selected based on the nature of the product and its package.