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A contract development and manufacturing organization (CDMO) is a company that provides drug development and manufacturing services. Pharmaceutical companies collaborate with CDMOs to outsource drug development and manufacturing. CDMOs can handle the entire process of medication research and production, and they also deal with clients who want to outsource specific steps in their workflow and manufacturing.

Pharmaceutical businesses increasingly depend on CDMOs to handle the complicated requirements of drug research and production. Having a CDMO partner can be a great resource with many advantages for pharmaceutical companies to focus their efforts and resources on initiatives that move their company forward, whether it's navigating the highly regulated drug development framework required by the FDA or scaling production to meet deadlines and demand.

Quality assurance is a key concern for prospective clients when choosing a CDMO because strict quality control procedures are what makes the difference when it comes to protecting a product on its journey to the patient.

The packaging of a drug is a crucial element in preserving its quality since it protects both the product and the manufacturer's commitment to patient safety throughout the product's life cycle till delivery. Container closure integrity testing (CCIT), in accordance with USP 1207>, provides confirmation of a package's capacity to prevent loss and maintain product sterility. ¹ However, a lack of knowledge of CCIT could put a CDMO at a disadvantage when compared to rivals that have adopted advanced CCIT solutions that cater to the particular needs of the goods of their clients. As a result, it's critical that CDMOs have a thorough understanding of CCIT.

Container Closure Integrity Testing Methods Offered by PTI.

Pharmaceutical packaging innovation has paved the way for a diverse range of advanced technologies and materials that enable drug manufacturers to design container and closure systems based on the unique properties of their products.

Traditional leak testing methods, such as the dye ingress leak test and the water bath, have been commonly used methods, but their test results are highly subjective. Since some items, like cell and gene therapy treatments, are only produced in small amounts, manufacturers cannot take the chance of the dye ingress leak test being detrimental to the product itself.

Probabilistic methods rely on a series of sequential and/or simultaneous events, each associated with uncertainties, yielding random outcomes described by probability distributions. On the other hand, deterministic approaches produce objective quantitative data by following a predetermined course of events, and leakage is detected using physiochemical technologies that are simple to regulate and monitor. PTI offers a wide range of non-destructive container closure integrity test methods applicable across a wide range of industries.

PTI's goal is to help our clients succeed by delivering on the promise of science through exceptional CCIT solutions. Life-changing products rely on dependable, high-quality delivery systems that can withstand the rigors of the journey from the lab to the patient.

That is why our experts are committed to providing strong CCIT through exceptional engineering and an organizational drive to achieve our own purpose and mission. We recognize the importance of our role in delivering safe and effective products and are excited about the opportunity to collaborate with you to advance the future of medicine.

Apart from validating the functionality and design of medical devices, ensuring package integrity is crucial to make sure that the product reaches the end-user intact. Packaging and delivery formats available for medical devices range from porous flexible packaging to non-porous rigid containers. Each packaging format has a unique set of characteristics and requirements, which necessitates a comprehensive approach while selecting an appropriate inspection technique.

With increasing innovations in packaging formats and materials, packaging challenges have also increased. Among other medical devices, Class III medical devices pose the highest level of risk associated with ensuring package integrity. Such devices sustain or support life and are implanted. Examples of Class III devices include pacemakers, cardiovascular stents, respiratory ventilators and breast implants. Since these devices are directly placed into human bodies, even a minute breach in the packaging can pose significant risk to patient safety. Hence testing container closure integrity (CCI) of medical devices is crucial.

Vacuum Decay is a non-destructive Container Closure Integrity test (CCIT) 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.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating wide range of high-risk package applications. It can be efficiently incorporated into the packaging process to ensure quality, reduce waste and allow operators to have a proper understanding of package integrity. Multiple vacuum supply types along with single or dual high-resolution transducers configuration enables the VeriPac series to provide fast and reliable test results that are quantitative and deterministic. It is an ideal solution for medical device manufacturers to ensure that the product meets regulatory standards. Based on packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

PTI has revolutionized Vacuum Decay technology with the development of next generation PERMA-VAC technology, that offers increased test sensitivity and repeatable results. The technology is capable of detecting leaks in the MALL range for parenteral packaging and can accommodate a variety of flexible and semi-flexible package formats. The advancements in PERMA-VAC technology has made the VeriPac series the most reliable and practical vacuum-based leak test method available today.

Benefits of Vacuum Decay technology:

• Non-destructive, non-subjective, no sample preparation
• Capable of detecting defects down to 0.05 ccm
• Accurate, reliable, repeatable results
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing
• ASTM test method F2338