Environmental Monitoring in Irvine, CA
Most Industries concerned with viable microorganisms have published standards and/or use current Good Manufacturing Practices (cGMP) to help with environemntal monitoring in Irvine, CA by Cleanroom Facility Services.
These Industry practices are continuously evaluated, confirmed or negated through OQ and IQ. The viable action and alert levels are determined and set via the original design and work in progress using company developed standard operating procedures (SOP) for which validation is performed for the product manufacturing process. This validating system allows the company to determine their own risk assessment of the manufacturing process based on the product being manufactured, the design of their cleanrooms, the gowning techniques, products used and the amount of people working in the rooms. All cleanroom design conditions, environmental conditions, manufacturing and personnel conditions are different and vary not only by industries, but within the same industries and same products manufactured. For example a company making X vaccine may have different SOPs or validation results than a competitor company making the same product, yet they are both successful Most Product non-conformities or high microbial levels in the production environment have resulted from improper human behavior, facility compromises or improper cleaning and disinfecting. Zero cfu are common when following validated gowning, cleaning and disinfecting SOPs.
Epidemics of disease of of contamination of pharmaceuticals don't appear to happen when the SOP are followed.
• Room Surface Testing
• Air Sampling
• Detail Report
• Incubate and Count
• Testing Design Plan
• Isolates Identified to Gross Morphology and Gram Staining
• Species Identification
• Continuous and Periodic Validation (IQ, OQ, and PQ)