extractables and leachables

ExtractablesAndLeachables_Blog2-1.jpgAssessment of extractable and leachable compounds is an analytical imperative, one that ensures the overall quality of the drug product is not impacted by its container or closure. Alcami understands this fundamental course of testing and analysis is an important aspect of any new drug product or device submission and an important milestone on the critical path to drug commercialization.

Federal regulators prescribe their guidance in 21CFR211.94(a): “Drug product container and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity beyond the official or established requirements.” Similarly, 21CFR600.11(h) “All final containers and closures shall be made of material that will not hasten the deterioration of the product or otherwise render it less suitable for the intended use.”

Our scientists have a thorough working knowledge of plastics, rubber and elastomeric materials, those compounds most frequently used in today’s pharmaceutical manufacturing, packaging and delivery technologies. Equipped with a wide range of compliant qualified instrumentation and working under cGMP guidelines, Alcami’s analysts are able to perform timely, efficient trace analysis necessary to support our customer’s applications and speed them to market.

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A proper assessment includes studies to not only understand which compounds have the ability to leach into the drug product, but also studies to identify which compounds the drug product may extract from the surfaces it contacts. Innovation in this space is arriving quickly and there are many new drug delivery devices and primary packaging materials to be considered and consequently assessed for their risk:

  • Metered Dose Inhalers
  • Dry Powdered Inhalers
  • Nasal Spray pumps
  • Pre-filled syringes
  • Parenteral solutions in bags and vials
  • Lyophilized products
  • Liquid oral products
  • Ophthalmic products
  • Surfaces contacted during manufacture including piping, tubing, flanges and connectors, filters, valves and single-use disposable bags and containers.

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