Bettine Boltres Ph.D.

Manager, Technical Account, TCS

December 05, 2018

Why Every Extractables Study Should Be Tailor-Made

In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.

 Helium Leak Testing

To design a suitable study, a deep understanding of every material used in manufacture, storage, shipping and delivery of the drug/biologic product is necessary. Every material, whether polymer, glass, elastomer, metal or other, has unique characteristics and requirements when it comes to potential extractables and leachables. For example, glass consists of inorganic materials, which can best be addressed using aqueous solutions and detection of the extracted elements via Inductively Coupled Plasma (ICP). Polymers and elastomers can best be addressed using aqueous and organic solvents. However, there are significant differences that must be considered.

Considering polymers, BPOG (Biophorum Operations Group) has developed extractables methods for single-use manufacturing components and systems (SUS), for example silicone tubes, connectors, filters and plastic pouches. BPOG extractables studies, and the results produced from them, are specifically designed to address conditions of manufacturing, which can be wide-ranging and are not typical of storage and delivery. In particular, solvents used, such as 1% polysorbate and extreme pH values, can produce anomalies, require dilutions or mask some extractables. Further, 50% ethanol can produce interaction products.

To enable best correlation of extractable data to potential leachables, solvents employed should be stable, resistant to degrading or dissolving components and free of interferences. In other words, every extractable study should be tailor-made. Packaging component suppliers have the deepest knowledge about their materials and are best prepared to design such studies. West Analytical Laboratory services has the staff, expertise, and facilities to design and execute such studies. For more information, contact an Account Manager or Technical Customer Service representative.