In-process materials qualification and ancillary tests

Full client support for the in-process materials qualification and ancillary tests according to the last regulatory guidelines. An unique team of project managers is able to define the validation studies, issue the validation documentation and support clients until regulatory submission and audit. An expert team of laboratory technicians perform tests in GMP-oriented regime.

 

Main regulatory and technical references: Annex 1, USP <87>, USP <88>, USP <381>, USP <661.2>, USP <1663>, USP <1665>

 

Tests that we are able to perform on process and test filters are:

 

  • Compatibility test: to demonstrate that the manufacturing process and product does not alter the in-contact materials physical structure. The process material is exposed to the product for the process time applying simulated worst-case process conditions. The compatibility between product and material is evaluated in terms of leak test (if applicable), drop test (when applicable), visual inspection and main physical dimensions.
  • Extractables test: to demonstrate that the manufacturing process does not alter, under simulated worst-case process conditions, the quality of the drug product. Specific analytical techniques (GC/MS, Q-TOF and ICP/MS) are performed to evaluate the presence of extractables compounds potentially toxic for patients. Semi-quantitative analysis are applied to detect and quantify a wide range of extractables compounds. Following extractables results, specific toxicological assessment can be issued and, if needed, leachables test can be performed.
  • Adsorption test: to demonstrate that the in-contact material does not bind drug components affecting product specifications, e.g. API title decrease. Test is performed applying simulated specific process conditions.
  • Biological tests: to evaluate the biological reactivity of plastics and elastomers on cell culture and animals and classify plastics accordingly.
  • Physic chemical test: to perform specific tests that allow a well-characterization of the materials for pharmaceutical use, e.g. appearance of solution, acidity or alkalinity, absorbance, etc.
  • Sanitizing and disinfectant efficacy test: to assess the efficacy of sanitizing and/or disinfectant agents through the surface challenge tests on specific process materials (stainless steel, PVC, Silicone, Viton, etc.) using standard and/or specific test microorganisms.

For more information, please contact:

Manfredi