General Considerations

The importance of Extractables / Leachables testing for container closure systems (CCS) in the pharmaceutical industry has grown considerably in the last few years, driven both by an increase in global regulatory requirements as well as by well-documented incidents where impurities in the contained drug product – introduced by the container closure system via leaching – were found to be harmful to the patients. This has lead to a higher concern for potential interactions between the drug product and the CCS in general.

Over the last decade, a long list of new Guidances/Guidelines and recommendations in both the US and Europe have increased the level of scrutiny imposed on the primary packaging of drug products. Three of these Guidelines (The FDA Guidance “Container Closure Systems for Packaging Human Drugs and Biologics”; the EMEA “Guideline on Plastic Immediate Packaging Materials”; the PQRI-recommendations for OINDP’s) will be used on this website to describe the broad regulatory framework for different types of container closure systems. These documents were chosen because they either introduced extractable/leachable testing as a part of the documentation regarding the selected CCS in a marketing authorisation dossier/regulatory submission file, or they outlined a testing strategy to comply with the regulatory requirements.

Whether the pharmaceutical container is an Inhalation device for OINDP applications, a CCS for parenteral/injectable applications, an ophthalmic container, a container for non-solid oral or topical applications or disposable systems used in Bioproduction, Extractables / Leachables testing should be considered. However, every type of container closure system or device has its own approach and testing strategy ranging from basic compendial test information to an extremely high level of analytical development work.

The Nelson Labs Europe team has a vast experience with developing E/L-testing strategies for a wide variety of container systems used in the pharmaceutical industry. We can offer a tailored approach, based upon the regulatory requirements specific for your application or based upon the type of E/L-information you want to obtain when carrying out a specific testing programme.

If you would be interested to find out more about our services and testing programmes, please feel free to contact us at InfoEurope@nelsonlabs.com or call us at ++32 (0)16 400.484. 


Click image to download

Contact:


Dr. Piet Christiaens
Scientific Director

pchristiaens@nelsonlabs.com

Nelson Labs Europe | General Considerations