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Services Extractables & Leachables

The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers, such as plastic or elastomers (rubber), rather than metal or glass. Polymers offer more versatility, since they are light-weight, flexible and much more durable than their traditional counterparts. Additives can be incorporated into polymers to give them clarity that rivals that of glass, or to add color to the materials, or that can give the polymer a desired physical property. However, given all of the positive attributes that polymers possess, there are also some negatives to consider when working with them in medical applications. In the presence of heat, light, oxygen and various external influences, such as sterilization, polymers can degrade over time if not properly stabilized. This degradation can manifest itself as cracking, discoloration, or surface blooming/exudation and can severely impact the mechanical properties of the polymers. Stabilizers, and other additives, are often incorporated into polymers to prevent this degradation. Yet this results in a more complex formulation than typical metal and glass, and makes materials such as plastic and rubber much more prone to leaching unwanted chemicals into the drug product formulation when they are used in applications such as manufacturing, drug delivery devices, or packaging. The experts at Impact Analytical have the experience and resources to perform Extractables and Leachables studies that mitigate the risk associated with using these materials and ensure a safe and compliant product.

Our extensive plastics characterization experience is the backbone of our Extractables & Leachables testing regiment. This knowledge serves as a solid foundation for our experts to quickly and efficiently characterize container closure systems for leachables. We follow Product Quality Research Institute (PQRI) best practices to ensure all studies are thorough and compliant. While a proven testing process is the starting point, each project benefits from our scientific experience and ability to customize methods and develop the best testing solutions.

Extractables & Leachables Process

1. Evaluate
   – Initial materials assessment
   – Primary contacting components
   – Secondary contacting components
   – Associated closure and packaging systems
      > Associated components

2. Controlled Extraction Studies
   – Material extraction
   – Analysis of the extracts 
      > Multiple separation and detection techniques to identify volatiles, semi-volatiles, non-volatiles and inorganics
      > Establishment of leachables threshold limits

3. Leachables Method Development and Validation
  – Leachables testing
  – Correlation establishment
  – Evaluation of leachable profile
      > Toxicology evaluation

4. Ongoing Testing
    – Release testing  
    – Lot Testing 

Impact Analytical is a cGMP compliant laboratory that has been recently audited by the FDA, with no 483’s issued. All study design and E&L testing is performed according to the latest industry recognized “best practices” including the United States Pharmacopeia (USP), Product Quality Research Institute (PQRI), Bio-Process Systems Alliance (BPSA), and ISO-10993.

Whitepapers/Case Studies

Extractables and Leachables Testing for Medical Applications
July 25, 2014
By: Michael Ruberto, Ph.D.

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