Polymeric Materials

The United States FDA recently announced a new Guidance For Industry on Container Closure Systems for Packaging Human Drugs and Biologics. The FDA has also expressed concerns (see 21CFR201.323) regarding aluminum levels in parenterals; as a result, the cleanliness of plastics used for medical applications is under increasing regulatory scrutiny.

In response to these challenges, CANTEST has developed procedures for characterizing and quantifying the presence of leachable additives, such as calcium or zinc stearate and phthalates, from plastic products in a variety of matrices used in the biotechnology industry. 

Trace contaminants are introduced into polymers from a variety of sources including the following:

• The use of “re-grind” in batch manufacture
• Impurities in pigments and stabilizers such as TiO2
• Inadequate cleaning and handling procedures and
• Mold release agents

Therefore, a variety of techniques are required in order to successfully cover all contamination possibilities. For example, to assist in identifying unwanted extractable components in leachates of plastic materials, a NIST traceable library is employed to simplify complex GC-MS spectra. While this technique is best-suited for the determination of volatile species, LC-MS can be used to analyze these leachates and characterize the non-volatile extractable components. 

For elemental impurities/ additives and characterization of plastic materials, both laser ablation-ICPMS and high-pressure microwave digestion followed by conventional ICPMS analyses are used. Laser ablation is particularly well-suited for detecting elements such as boron, aluminium and silicon which are often difficult to recover with wet chemical techniques.