Cleanrooms and controlled environments are utilized in order to control the levels of non-viable and viable particulates that medical devices and pharmaceutical products are exposed to during the manufacturing process. The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation or other personnel/equipment issues. CTS can provide you with the appropriate level of service that you need to ensure your manufacturing environment complies with FDA, USP 797 and ISO requirements.
Environmental monitoring services offered:
- Cleanroom and Hood routine air and surface bio-burden testing programs available for Medical Device manufactures, SOPs available for all customers
- CTS can help with establishment of action and alert limits with analysis of microbial and particulate trends
- Microorganism Fungal and Aerobic Gram Stain identification, CTS’s in house lab can auto conduct when Action levels are met.
- Cleanroom Start-up validation documentation and testing for IQ, OQ and PQ.
- Microorganism morphology identification for CAPA root cause investigations
- Monitoring of Non-viable particulates 0.5. 1.0 and 5.0 microns
- Passive and active viable air sampling with Biotest RCS or Climet high flow
- Room pressurization, temperature, and relative humidity air monitoring
- Compressed Dry Air Testing for Hydrocarbons, Dew Point, Non-viable and Viable particle count
CTS offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is ISO 9001:2008 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.
Contact us today at 1.951.894.6079 to schedule service.