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Autoclaves: Calibrations and
Sterility Assurance

Facilities operating under the FDA’s GLP (good laboratory practice) for non-clinical lab studies must follow the guidelines set forth. This is the CFR Title 21 part 58. Equipment used for generalization, measurement or assessment of data must be calibrated and maintained.

Avant Garde performs this equipment maintenance and keeps electronic files of all quarterly preventive maintenance equipment checks. All remedial service records are filed per your equipment’s individual ID. The cage washers and autoclaves all have temperature measurement and controlling devices that must be calibrated at least yearly. These calibrations are carried out within the FDA guidelines, and using NIST traceable testing apparatus.

For facilities using autoclaves for decontaminating general lab waste, we can perform the sterility assurance measures to qualify the autoclave cycles used. This test involves load runs with lethality indicators. These tests can assure that your loads are completely biologically inactivated.

You can find helpful information on the FDA’s website following this link.

[CFR - Code of Federal Regulations Title 21]

[Contact us to set up calibration full service]


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