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