“We are not in Kansas Anymore”, as stated by Dorothy in the 1939 classic film The Wizard of Oz, in many ways is applicable to the current state of USP Container Qualification testing. Over the past ten years, routine container testing has changed dramatically. Simple tests to quickly and easily evaluate plastic containers, glass bottle or vials and elastomeric closures have become more complicated and extensive. As outlined in a recent CS Analytical educational article, the number of USP chapters dedicated to the various containers and package systems now in use has grown extensively. Routine testing has become more complex, more confusing and in many cases more costly.
Over the past two years, the CS Analytical Team of Container Testing Experts has noticed a unique trend: we are spending more time with clients prior to the sample submission process helping to ensure that the testing being requested is the most applicable method specific to the regulatory requirements for that container or package system. This trend can be explained by the following factors that are all interrelated:
- The advancement in package system types now routinely used for the plethora of biologically based drug products being brought to market,
- The advancement of new qualification test procedures being implemented by regulatory bodies like the USP and EP,
- The industries lack of experience with both these new and advanced package systems and the new and complex USP and EP test requirements.
These factors play a key role in how an outsourced service provider like CS Analytical must operate to ensure a valued and needed service is delivered to the client. The consultative approach to each client engagement becomes of paramount importance. A mistake in application of a test method (or execution of the wrong test method) which leads to additional testing requirements is both a time and money waster. To address this market trend, CS Analytical has implemented a number of employee development programs to ensure our staff members are prepared to help clients meet the specific regulatory requirements a specific client may have. The basis of this program centers on key questions that all start with “What”….what is the package system?…what is the product?…what are the storage and use conditions?…what testing do you think is applicable? By taking the time to “question” the client, we can help to ensure that the most applicable regulatory tests are being implemented.
Many companies are in the process of implementing new and comprehensive test programs specific to the December 1, 2025 USP 661.1 and USP 661.2 requirements. For a company with many product presentations and a wide spectrum of package systems, this can be a daunting task. The value of understanding the program objectives, coupled with the experience that the CS Analytical team has, can be instrumental in helping a client devise a strategy and implement an effective plan to meet the new requirements in a clear and concise manner. For example, grouping various plastic components by their same materials of construction may prove to be a time and cost savings.
With regard to USP 1207 Container Closure Integrity Testing, the advisory aspect of the client engagement process is critical. To effectively define and prescribe a relevant method for the specific product and its package system requires a complex understanding of all key components. The entire chemical composition of the drug product and all package system materials is critical. The days of “one method works for all products and package systems” specific to CCIT are long gone.
To address more advanced client needs specific to defining strategies and programs for regulatory compliance, CS Analytical has developed an Advisory Services program that enables clients to call upon our experienced staff in a traditional consulting manner. In many cases, we have developed these advisory programs based upon a specific and common need. For example, development of a component baseline qualification program for all package system components or development of a container closure integrity test program across the product life cycle. This approach enables clients to address critical needs but yet have access to experience and knowledgeable operators in a fixed cost manner.
Regardless of the client need when it comes to routine container testing or advanced CCIT, working with outsource service providers that are committed to providing advice and direction are critical for success in this new regulatory environment.
As the only FDA regulated, cGMP contract laboratory that is solely focused and dedicated to container and package system qualification testing, the CS Analytical Team of Experts know and understand all of the testing required for the wide spectrum of container and package systems. In many cases, our team members have played an active role in helping to define these new and improved procedures and performed the bench work to ensure that the actual methods meet their intent in an effective and useful manner. As you work to qualify your current components, or develop new package systems, this article will provide a table of contents of which USP chapters may be relevant to ensure you meet the regulatory requirements. The CS Analytical Team is always standing by to help provide direction or confirmation when required.