Lyophilizer/Freeze Dryer EQ&C

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    Lyophilizer/Freeze Dryer EQ&C

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Lyophilizer Equipment Qualification

When performing Installation, Operational, or Performance Qualifications on a Lyophilizer / Freeze Dryer it is essential that the protocols verify that the Lyophilizer / Freeze Dryer has been installed correctly (IQ), demonstrate that the Lyophilizer / Freeze Dryer is operating properly (OQ), and show that the Lyophilizer / Freeze Dryer production, cleaning and sterilization cycles are able to reproducibly meet your requirements (PQ).

Mesa’s Compliance and Validation Services Lyophilizer / Freeze Dryer Qualification protocols include:

  • Document the Lyophilizer / Freeze Dryer Information (Make, Model, Serial Number, etc.). (IQ)
  • Identification and Verification of the Critical Instruments used by the Lyophilizer / Freeze Dryer during production, cleaning or sterilization. (IQ)
  • Verification that the Lyophilizer / Freeze Dryer Controls and Alarms operate as required by the customer and per the manufacturer’s specifications. (OQ)
  • Verification that Standard Operating Procedures are available for the operation, maintenance, cleaning and/or sterilization of the Lyophilizer / Freeze Dryer.  (OQ)
  • Verification that the Lyophilizer / Freeze Dryer is able to achieve and maintain the required temperatures during production cycles to meet the requirements. (OQ/PQ)
  • Verification of the Clean in Place (CIP) cycle(s) to meet your needs for time, temperature, and the removal of residual product and/or the chemicals used in the cleaning process. (OQ/PQ)
  • Verification that the Sterilization in Place (SIP) cycles can reproducibly meet the requirements for time, temperature, pressure, and sterility assurance using biological indicators. (PQ)

By using Mesa’s Compliance and Validation Services to complete your Lyophilizer / Freeze Dryer qualifications, the completed IQ, OQ, or PQ protocols will provide a level of assurance that the Lyophilizer / Freeze Dryer has been installed properly, is operating correctly and is able to reproducibly meet your (the customer’s) production, cleaning and sterilization requirements.