Clean Room Engineering (CRE)

Clean Room Certification in Compliance with FDA

Dynatec Clean Room Engineering staff are trained in the Certification of your Clean Room.

The CRE can evaluate your Clean Room regarding its Installation Qualification (IQ) continue with the Operational Qualification (OQ) and completing the Certification with the Performance Qualification (PQ).

Dynatec Complies with ISO 14644:2015 “Cleanrooms and Associated Controlled Environments.”

In addition, Dynatec is experienced in the Certification of your oil-free compressor for Class Zero Certification for clean room application in compliance with ISO Standard 8573:2010 “Compressed Air.”

Dynatec’s CRE Team serve the Pharmaceutical Compounding Clean Room in accordance with USP Monograph <797> “Pharmaceutical Compounding – Sterile Preparations.” Dynatec CRE Team function as an international service group, and can conduct and certify your facility Clean Room based on Dynatec’s ISO/IEC 17025:2017 “General Requirements for the Competence of Testing and Calibration Laboratories.”

The CRE team will utilize Dynatec Microbiological Department to isolate and identify resistant microorganisms in your manufacturing/ compounding clean room. In addition the CRE Team utilizes conventional microbiological methods during the Clean Room Validations or monitoring to isolate microbiological contaminants with Standard Forensic Methods. These isolates are identified with the latest fatty acid (FAME) methodology or our select data base DNA system.

A Clean Room should have, as a minimum design specification, the following:

 

A Clean Room or controlled environment will perform under dynamic conditions. Those attributes should be monitored and statistically evaluated to understand the efficacy and standardize your specific alert and action limits.

Dynatec can certify your clean room, conduct investigations, or develop monitoring programs. Call 915-849-1322 or email dynatec@dynateclabs.com

 

References:

 

Key factors in controlling contamination:

 

Indirect Processes

 


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