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Our Autoclave Equipment Qualification and Cycle Validation Services Include:

  • Protocols with robust acceptance criteria intended to satisfy FDA general equipment qualification requirements, USP 1229 compliance, and FFDCA Sections 503A or 503B for compounding pharmacies
  • Cycle development balancing quality, cleanliness and efficiency
  • NIST-traceable calibrated Kaye Validators with premium thermocouple sensors and biological indicators (BIs)
  • Performance Qualification testing aimed at assessing heat penetration and heat distribution
  • An Audit-ready final document package

Autoclave Validation
Biometrix can validate your autoclave to the strictest requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211, ISO-13485, Regulated Medical Waste (RME) licensure requirements, Joint Commission Standards, and USP 1229 Sterility Assurance and Sterilization, and FFDCA Sections 503A or 503B for compounding pharmacies

Each of our Validation Engineers has over ten years of field-service experience in executing FDA-compliant protocols, coupled with extensive training in current Good Manufacturing Practices (cGMP) and safety protocols

Our Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols reflect a customized approach aimed at delivering robust and efficient regulatory compliance coupled with the desired degree of confidence

Our clients are always invited to participate in the review, edit and final approval cycles of all testing protocols

An array of high-performance premium calibrated thermocouples and custom-matched biological indicators are used to demonstrate heat penetration and heat distribution of liquid, solid, glassware, and waste test loads. All test equipment is calibrated before and after your validation, using NIST-traceable standards, to ensure the utmost accuracy

Your audit-ready documentation package includes a summary report, completed protocol and detailed data with all requisite statistical and lethality calculations. Attachments, including calibration certificates, media testing certificates, and Biological Indicator (BI) certificates of analysis are included

Our competitive pricing reflects our many years of experience coupled with our extensive library of hundreds of executed protocols, which we reference to expedite new document packages. This time-savings approach is gladly passed on to you as lower pricing. We also structure our hours on-site to not interfere with your peak activity periods, thus minimizing equipment down-time

We look forward to being of service! A quick call right now to our toll-free number 1-800-890-8909 will reach one of our experienced engineers with informative answers to your questions and same-day pricing (24 hours or less)

"Serving the continental United States since 1994"

1BIs produced by Mesa Labs with the brand name of EZTEST®, SterilAmp II®, and MagnaAmp® (or equivalent produced for steam sterilization testing and liquid load testing, respectively) Each vial contains Geobacillus stearothermophilus with an initial heat-shocked population of greater than 1.0 x 10⁶ spores/unit and D-Value exceeding 1.5 for all cycles at 121°C to demonstrate that each Autoclave cycle successfully reduces the Geobacillus stearothermophilus population by a 6-log reduction and thereby demonstrates that each Autoclave cycle has successfully delivered the desired level of sterility to the load-items.


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