Biological contamination is of special concern to those with aseptic operations.
CMI SALES offers a complete line of microbial air sampling instruments that help manufacturers meet regulatory requirements such as EC-GMP Annex I and FDA Sterile guidelines 2004. Air collection products are designed to maximize collection efficiency for microbial particles of interest and are validated in accordance with ISO 14698-1.
Biological efficiency is guaranteed by ensuring optimal impaction velocity also giving statistical control over false positive results. The impaction heads are fully autoclavable and the instruments can be readily sanitized.
All products we sell are compliant with cGMP, GAMP®, and 21 CFR Part 11 regulatory requirements.