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Services / Container Closure System Development

Kamat Pharmatech conducts extractables-and-leachables testing of single-use bioreactores, IV bags, filters, syringes, BFS ampules elastomeric closures, cardboard boxes, overwraps, lables, and others.

We help clients achieve the following:

  • Establish appropriate E/L Testing approach
  • Identify and develop a profile of extractables using appropriate methods
  • Quantify the level of extractables that will be studied as leachables
  • Develop a program to monitor leachables during product stability
  • Establish specifications and acceptance criteria and prepare CTD sections

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