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.

Wide Range of Calibration Capabilities

Validator 2000, Premium Thermocouples, and Wireless Dataloggers

Based on your unique needs, we can use the gold-standard Kaye Validator 2000 with premium or ultra-premium thermocouples to perform your autoclave qualification, or we can use DataTrace wireless dataloggers. Both options offer accuracy and reliability for your temperature mapping projects.


Fast Calibration Turnaround Time

Post-Qualification Verification of Qualification Test Equipment Confirms Accuracy

All certified validation and calibration equipment used at our customer sites are verified upon return to our NVLAP-accredited metrology laboratory. This completes the physical execution of the qualification activity that took place at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable and repeatable.

Additionally, our own credentialed Quality Department will review all validation reports before delivery to ensure our final product to you meets our exacting standard. We also retain a digital copy of your completed report to assist you with future audit questions, should the need arise.


Contact Masy for Calibration

Quick Delivery of the Documentation Package

At the conclusion of your project, we will provide a clear, comprehensive validation report, confirming that your equipment is compliant to your standard operating procedures. Our validation reports contain all of the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurance practices, as well as cGMP and FDA requirements. 

Validation reports typically include:

  • Summary Report
  • Executed protocol
  • Real-time, hard copy, and soft copy of the raw data
  • Calibration certificates for all test equipment used, noting NIST traceability
  • Sensor calibration reports
  • Validation personnel detailed résumé
  • Electronic backup files for all studies

Contact Masy for Calibration

Fast Turnaround Time Keeps your Operations On-Schedule

We understand that your equipment being out-of-tolerance, or down for validation testing, can negatively impact your production schedules and capacity. We will supply enough personnel and equipment to complete the project within your specified timeframe.

 

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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