Autoclave Qualification & Sterilizer Qualification

 
  • Custom protocol consulting and development, or seamless execution of your own protocols.
  • Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.

 

Choose Masy for Accurate Calibration

Ensuring Compliance by Performing your Autoclave and Sterilizer Qualification

Masy BioServices supports a wide range of activities from installation and operational qualification as well as performance qualification (IQ / OQ / PQ). Masy supplies the calibrated test equipment (thermocouples and/or wireless data loggers, baths and standards) to do this testing as well as all the supporting devices to do the execution (e.g. biological indicators, flanges, validation clamps and gaskets).


Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Masy provides assistance with protocol generation, and our experts can demonstrate a written explanation describing how loads and products were selected for qualification testing. Prior to onsite execution, the test equipment is prepared and calibrated so when test execution is ready to commence, the testing can start immediately with no delays. Masy can perform the cycle development for the sterilizer so it satisfies the requirements of the guidelines and standards set for the industry, including EN 285, ISO 17665-1:2006, Choice Framework for local Policy and Procedures (CFPP) 01-01 part C, PDA Technical Report no. 1, and PDA Technical Report no. 48. Various European Directives, including Medical Device Directive (93/42/EEC and 2007/47/EEC) Class II a, Electromagnetic Compatibility Directive (2004/108/EEC), Low-voltage Directive (2006/95/EC), Pressure Equipment Directive (97/23/EEC) and the Machinery Directive (98/37/EEC and 2006/42/EEC) apply to sterilizers used in the pharmaceutical, biotechnology and medical devices industries as well and must be adhered to for compliance. We can work with you to create a custom protocol, or we will follow your Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols in accordance with US Food and Drug Administration, current good manufacturing practices (cGMP) and other cGxP guidelines. We can help you develop:

  • IQ Protocols: Establishes that the autoclave is properly and safely installed.
  • OQ Protocols: Verifies that the autoclave consistently meets operational specifications such as alarms, controls, and operates as intended.
  • PQ Protocols: Verifies that the autoclave consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols: Verifies that the autoclave consistently meets operational specifications while the autoclave is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.
  • Item Temperature Mapping: Verifies hardest-to-heat load items and locations within each load item for a reference to a worst-case, bracketed approach.
  • Cycle Development: Engineering data to support the development of your sterilization cycles

Contact Masy for Calibration

Choose Masy BioServices for your Autoclave and Sterilizer Qualification Needs

When you choose Masy for your autoclave or sterilizer qualification projects, you can enjoy the confidence that comes with knowing that your critical equipment is qualified to the highest possible standard, ensuring compliance with your SOPs and cGMP regulation – keeping your materials and products safe and effective.


Contact Masy BioServices today for your autoclave and sterilizer qualification needs.

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