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Autoclave Validation Services
ENV
helps you meet steam sterilizer certification guidelines and document
conformance with your established manufacturing practices. Operational
qualification of steam sterilizers is an important component of an effective
process validation program. ENV’s validation services help you verify
that your autoclave is consistently performing within the limits of your
established process specifications.
ENV follows PDA guidelines in performing heat distribution, heat penetration and biological indicator studies that are necessary to document autoclave operating performance. Our validation studies provide you with heat-up and cool-down rates, calibrated chamber and jacket pressure readings, and data for the conditioning and exhaust cycles.
ENV’s state-of-the-art equipment provides the highest measurement accuracy available—better than twice cGMP requirements. Calibration records that demonstrate NIST traceable calibration are available on request.
Our
professionals can perform studies to validate your existing standard operating
procedures or help you develop validation protocols for new applications.
We conduct reproducibility studies to validate the consistency of our
results. We provide study results in a format tailored to meet your quality
assurance requirements.
ENV performs the following studies to meet your validation program needs:
Empty Chamber-Heat Distribution Studies to demonstrate the uniformity of temperature within the autoclave. Data is collected from up to 14 different points (inclusive of drain temperature) within the chamber. Temperature uniformity is considered acceptable if the deviation is less +/- 1 degree C of the mean chamber temperature. Temperature deviation that is greater than +/- 2.5 degree C of the mean chamber temperature may indicate equipment malfunction.
Container Cold Spot Studies (Container Mapping) to determine if the chamber has any identifiable cold spot and if the cold spot is consistent.
Loaded Chamber-Heat Distribution Studies to demonstrate that temperature distribution in the loaded chamber is acceptable and that the items within the chamber receive a uniform heat treatment.
Heat Penetration Studies to assure that the coolest container within a loading pattern will consistently be exposed to sufficient heat lethality. Heat Penetrations Studies can be performed with surrogate chamber loading or during actual routine production cycles.
Biological Indicator Studies to verify the process lethality provided by the sterilization cycle. Biological indicator data can supplement heat penetration data in assuring terminal sterilization (the probability of a microorganism surviving the sterilization process is less than 1 X 10 -6).
In addition to autoclave validation, ENV provides temperature/humidity mapping services for the following:
- Warehouses
- Incubators
- Environmental Chambers
- Tunnels
- Washers
- Dryers
