Pharmaceutical companies are challenged by the need to ensure the highest quality in parenteral products, therefore, requiring manual, semi-automatic, or automatic inspection to detect and reject product with contaminants or defects.
Process and machinery both have to be validated to comply with FDA regulations and to ensure that they are performing as intended. Test Standards (aka control sets) are used to measure the efficiency of the inspection process, whether manual, semi-automatic, or automatic. They can also be used to perform routine challenges to verify that the process maintains its validated state, or to perform Knapp statistical studies, and can also be used to train inspectors for a manual inspection process.
Our validation professional have experience with inspection machinery having validated over 165 automatic inspection machines worldwide, including development of inspection recipes. We know how to best fabricate the test set so that it performs at its best on your machine, since we have experience with most brands of inspection machines. We prepare the sets in ISO Class 5 (209E Class 100) laminar flow hoods, located in an ISO Class 7 cleanroom (ISO 14644-1; Fed Std 209E Class 10,000).
We use particulate matter created from our customers own containers to represent the type of particulate that could be encountered at the production area. Particles are measured and classified, then seeded into the containers with Water for Injection, or product solution. Cosmetic defects are created manually, measured and identified for size and location. We work with a variety of vials, ampoules, cartridges, and syringes in different sizes.
All test standard sets are delivered with a Certificate of Conformance. We can produce a photographic record with individual description and measurements for each particulate in the set.