Our Automated Filling Machine Qualification Services Include:
- Protocols with robust acceptance criteria intended to satisfy FDA general equipment qualification requirements, and FFDCA Sections 503A or 503B for compounding pharmacies, with a minimum of representative configurations
- Use of NIST-traceable test equipment
- Performance Qualification testing aimed at characterizing optimum washing, filling, capping, sealing, and labeling capabilities
- An audit-ready final document package
Automated Filling Machine Validation
Biometrix can validate your automated filling machine to the strictest of requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211, ISO-13485, 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 test equipment standards are used to qualify the operation and performance of your filling machine. All test equipment is calibrated to NIST-traceable standards before and after your equipment qualification to ensure the utmost accuracy
Your audit-ready documentation package includes a summary report, completed protocol and detailed data with all requisite statistical calculations and attachments including calibration certificates
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"
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
Back
Schedule a Callback Now