INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.

  • Pharmaceutical companies face cost, complexity, and speed pressures. Inspection solutions support quality and compliance with fill detection, weighing, foreign body detection, and label verification.

  • Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.

  • A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).

  • Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.