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VHP Sterilization Validation

The client is the largest gene engineering pharmaceutical company in China and the largest manufacturer of recombinant human growth hormone in Asia, whose space sterilization method was found to have deficiencies during an inspection by the provincial drug administration. VHP concentration was not monitored, the cooling area of the tunnel oven was not considered for space sterilization, and there was a lack of parameter development and validation (CD/CV) processes.

AUSTAR Solution

• Using the STERIS Victory vaporized hydrogen peroxide sterilizer, providing effective process monitoring and control, including temperature, relative humidity, hydrogen peroxide concentration, etc., ensuring the consistency and repeatability of validation. • The cooling area of the tunnel oven can achieve a 6log sterilization effect, and it has passed sterilization challenges for three consecutive batches. • AUSTAR's professional VHP engineers, with rich execution experience, collaborate with CCS contamination control subject experts to develop a comprehensive parameter development and validation solution.

AUSTAR Value & Client Benefits

• New Approach - Solving the problem of long equipment procurement cycles in a short time, and a one-stop service to assist in completing VHP sterilization validation, helping the client to timely close the deficiency items within the specified time. • Cooperation - Close communication with client, actively respond to demands, solve pain points, and have received praise from the client.

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