BioMetrix
Services for the Life Sciences



Our Lyophilizer (Freeze Dryer) Equipment 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
  • Use of NIST-traceable vacuum sensors and Kaye Validators with three-point premium temperature sensor calibration prior to qualification activities and verification after qualification is complete
  • Performance Qualification testing aimed at assessing product temperatures as well as shelf temperature distribution
  • SIP qualification using heat distribution and biological indicator testing geared toward quality, sterility and efficiency
  • An audit-ready final document package
Lyophilizer Validation

Biometrix can validate your lyophilizer to the strictest of requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211 or 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, premium calibrated thermocouples and vacuum standards are used to qualify the operation and performance of your lyophilizer. All test equipment is calibrated to NIST-traceable standards before and after your validation 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-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”

Back



  • Biometrix Corporation
  • 301 Edgewater Place, Suite 100
  • Wakefield, MA 01880
  • www.biometrix.com
  • Tel: (978) 338-5263