Thermal qualification (performance)

Thermal qualification consists of demonstrating, through documentary evidence, that any thermal equipment actually achieves the expected results according to the manufacturer’s specifications and complies with applicable current regulations.

The services and reports prepared by MGC Life Science are in accordance with the technical specifications of the following standards:

ABNT NBR 16328:2023 – Sterilization of health products — Test procedure for measuring temperature, pressure and humidity in equipment;
ABNT NBR ISO 17665-1:2010 – Sterilization of health products — Steam Part 1: Requirements for the development, validation and routine control of sterilization processes for health products;
ABNT ISO/TS 17665-2:2013 – Sterilization of health products — Steam Part 2: Application guide for ABNT NBR ISO 17665-1; ANVISA – RDC No. 658, of March 30, 2022 – Establishes Good Manufacturing Practices for Medicines;
ANVISA – RDC No. 430, of October 8, 2020 – Establishes Good Distribution, Storage and Transportation Practices for Medicines;
ANVISA – RDC No. 653, of March 30, 2022 – Establishes Good Distribution, Storage and Transportation Practices for Medicines;
USP 36 [1079] Good Storage and Shipping Practices/General Information;
WHO Technical Report Series, No. 961, 2011;
FDA Regulation 21 CFR Part 11.

Aseptic Barrier

High Containment

Vial and product transfer system

Aseptic Barrier

High Containment

Vial and product transfer system

Thermal qualification (performance)

Among the areas of thermal qualification, we can assist you with:

Thermal qualification of equipment

Thermal mapping and qualification of areas

Transport thermal qualification (Route qualification)

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