We follow cGMP and GDP procedures to manufacture Certified Challenge Sets (Defect Kits) of particulates and cosmetics defects for our clients in the pharmaceutical industry which they use in training of their employees and obtain a false reject baseline during manual inspection (Knapp Studies), qualifying their automated/semi-automated visual inspection machines and/or carrying out continuous improvement on their inspection process.
All our defect kit sets meet the requirements of all regulatory agencies. These kits are created under ISO 5 clean room conditions.
We have the follwoing capabilities:
Sterile filling capabilities to .5% accuracy from 2mL to 1L
Measuring particles from 50 microns and larger
Point and click on the top of the grid area below to watch video #1 then click the bottom area to watch video #2