Primary packaging for biopharma products has a vital role in assuring the drug product safety. Packaging must be a barrier to the external environment and maintain the sterility of its contents. It may also serve to shield the drug product from oxidation, light degradation, and moisture permeation. Fulfilling all of these functional requirements includes testing of a broad spectrum of components and materials (eg. plastic containers, metal springs, elastomeric valves and gaskets, adhesives, coatings ecc.).

Extractables and leachables testing is an essential component of the drug development process. With a proven track record of testing expertise, our services will ensure your products have a competitive edge for your regulatory success.

• Evaluation of the customer’s available data
  to check for integration for the E&L regulatory compliance
• Extractables study – From design to laboratory execution
  • Choice of the right components/materials to be tested
  • Extraction solvents to be applied in the extractables generation step
  • Extraction conditions (time and temperature to be used in the study)
  • Analytical techniques to be applied to cover all the potential released compounds
  • Definition of the correct reporting threshold (Analytical Evaluation threshold) to avoid both unfounded concerns and loss of alerts.
• Fingerprint approach - Extractables studies focused on specific items
  (e.g. the label which could be subjected to changes). This service is used in order to prevent the need to redo another extractables study.
• Leachables studies – comprehensive study to meet regulatory requirements
  • Targeted leachables screening - to search for specific compounds with potential toxicological concerns
  • Non targeted leachables screening – to screen for potential compounds missed in the extractables step (this is a mandatory requirement from FDA)
  • Limit Test method validation
  • Full method validation (ICH Q2R1 and Q2R2)
• Detection of unidentified impurities