Our Depyrogenation Oven Equipment Qualification and Cycle Validation Services Include:
- Protocols with robust acceptance criteria intended to satisfy FDA general equipment qualification requirements, USP 37 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 Endotoxin Unit (EU) Challenge Vials
- Performance Qualification testing aimed at assessing heat penetration, heat distribution, and sterility
- An Audit-ready final document package
Depyrogenation Oven Qualification and Validation
Biometrix can validate your depyrogenation oven to the strictest requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211, ISO-13485, USP 37 Dry Heat Sterilization guidelines, and FFDCA Sections 503A or 503B for compounding pharmaciesEach 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 EUs 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 Endotoxin Unit (EU) 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-saving 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"
1EU vials produced by Charles River Laboratories with the brand name of Endosafe® EVV10K (or equivalent produced for endotoxin challenge testing) containing approximately 1,000 ng of lipopolysaccharide (derived from E. coli Strain 055:B5) with the biological activity of approximately 10,000 Endotoxin Units (EU) of lipopolysaccharide per EU vial to demonstrate that each Depyrogenation Oven cycle successfully reduces the Endotoxin Level by a 3-log reduction and thereby demonstrates that each Depyrogenation Oven cycle has successfully deliver the desired level of sterility to the load-items
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