Validating an autoclave what is the best dating service

When compared with the previous steam document, the new 17665 also has more information on product and process characterization, sterilizing agent characterization, installation qualification/IQ, and operational qualification/OQ.

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For this article, the general requirements for an overkill cycle PQ will be reviewed.

While many activities are required to complete the PQ, the primary goal for the commonly employed overkill validation is this: the user needs to complete three consecutive successful halfcycles in order to qualify their proposed fullcycle exposure for routine processing of sterilization loads.

The product definition and process definition sections of the new document list things such as product specifications, product families, packaging, re-sterilizationissues, package moisture, stability and potency of container products, re-usablecontainer systems, process challenge devices/PCDs, sterility assurance level/SAL, BIs and CIs, and bioburden determination if necessary.

PCDs are described asproducts or items that provide a known resistance to the sterilization process.

For small chambers, as few as five or six BIs and temperature loggers may be needed. Large, multi-pallet-sized chambers may require many more samples per run.

The sterilizer is programmed for one-half of the proposed full-cycle exposure time.

The new 17665 document also has more information on IQ and OQ.

It defines IQ as “obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification.” Autoclave installations commonly document items such as the sterilizer identification numbers, location, line voltage and amperage, water supply piping and pressure limits, steam line requirements, filtration, chamber size, structure and support, piping materials, software certification, manuals, drawings and documentation, and calibrations (temperature, pressure, and timer).

For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing, cleanroom, and laboratory processes for the medical device, pharmaceutical, biologics, and human tissue/HCTP industries.

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