503B, cGMP, FDA grade Compliance and Validation Services

Aseptic Enclosures, via it’s affiliation with Life Scientific, Inc. will now offer Mesa Laboratories’ Compliance and Validation Services to the 503B market segment. The agreement allows Aseptic Enclosures to provide FDA cGMP grade Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services to outsourcing 503B facilities.

Our validation Team has many years of experience providing IQ, OQ, PQ Qualifications, Calibration and Temperature Mapping services to the pharmaceutical production market.  They have expertise with equipment validations that include, Parenteral liquid fillers, Tablet presses, Cleanrooms, Sterilizers, Lyophilizers, Incubators, Freezers, Refrigerators, Autoclaves, Depyrogenation Ovens.  Cleanroom Qualifications via “in-house” Certified Microbiologist services(RM/NRCM), including viable and non-viable particulate monitoring and corrective action plan development. In addition to 503B, we can qualify to ISO, FDA and EU requirements. Final report packages are designed to meet your 503B/cGMP/GDP/GLP requirements. NIST Traceable calibrations are performed via Mesa’s ISO 17025 accredited laboratory. The team’s superior knowledge and experience in validation, calibration and compliance make them a trusted choice for 503B outsourcing facilities.

Aseptic Enclosures has been involved in parenteral production cGMP manufacturing facilities since 1992, and has had significant focus on equipment, supplies and services for Pharmacy USP797 and 800 compounding segments since their respective inceptions. Aseptic Enclosures has a broad range of expertise in training, cleanroom evaluations, microbiological and sterility testing supplies and services, equipment and design to help you build and operate a superior sterile preparation environment.

Please contact our main office in St. Louis, Missouri for detail.  800-418-9289

 

 

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