BioMetrix
Services for the Life Sciences



Our Glass Washer Validation Services Include:
  • Protocols aimed at robust compliance
  • Cycle development geared toward quality, cleanliness and efficiency
  • Performance Qualification testing to detect problem areas in the rack, spindles or load items
  • Cleaning Validation testing using proven soiling methods, extraction techniques and testing methodology
  • An audit-ready final document package

Glass Washer Validation
Biometrix can validate your glass washer to the strictest of requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211 or ISO-13485

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

We include our clients in the review, edit and approval cycles of all testing protocols

We identify our clients’ critical soils, whether Active Pharmaceutical ingredients (APIs) detergent residues, or other critical soils

Cycle development and validation protocols include riboflavin testing, soiling methodologies, soil concentrations, residue detection methodology, minimum detection levels, acceptance criteria, hand-washing protocols, and pre-soak and pre-wash cycles. Load configurations are representative of actual usage patterns for open racks and spindle racks, glassware, plastics, ceramics, 316 stainless, 316L stainless, 316LVM stainless, Ti6Al4V and medical devices

Occasionally, a NIST-traceable Kaye Validator and an array of calibrated high-accuracy premium thermocouples is required to demonstrate temperature uniformity of test loads

Your audit-ready documentation package includes a summary report, completed protocol and detailed data with all requisite statistical calculations. Attachments, including calibration certificates, Material Safety Data Sheets on soils and detergents, soil and detergent concentration documentation and residual soil test result documentation 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

Let’s get started today! A quick call to our toll-free number1-800-890-8909 will reach one of our experienced engineers with informative answers to your questions and same-day pricing (24 hours or less)

We look forward to being of service!

 

   7X®, Blue Gold®, Branson®, CIP®, Contrad®, Detergent 8®, LiquinoxTM, Solujet®, DetojetTM, Citrajet®, Alcojet®, Tergajet®, Luminox®, Tergazyme®, P3-Cosa®, Deconex®, Extran®, FL-70®, Haemo-sol®, Lab Solution®, Micro 90®, Neodisher®, Neutrad®, RBS®, Sparkleen®, Versa-clean®. Extran® is Reg. Trademark of E M Industries, Labtone® is Reg. Trademark of Scientific Holdings Corp, RBS-35® is Reg. Trademark of Chemical Products R. Borghraef, Micro-90® is Reg. Trademark of International Products Corp., LabSolutions® is Reg. Trademark of Labconco, Versaclean®, FL70®, Jet-Clean®, and Sparkleen® are Reg. Trademarks of Fisher Scientific, Contrad®, Descal®, Neutrad®, and Dri-contrad® are Reg. Trademarks of Decon Laboratories, Deconex® is Reg. Trademark of Borer Chemie, Acationox® is Reg. Trademark of Sherwood Medical, Haemo-sol® is Reg. Trademark of Haemo-sol Inc., CIP 100®, CIP150®, and CIP 220® are Reg. Trademarks of Steris Corp., Blue Gold® is Reg. Trademark of Modern Chemical, 7X® is a Reg. Trademark of ICN, Neodisher® is Reg. Trademark of Dr Weiggert, Heikol® is Reg. Trademark of Hotpack Corp, Branson® is Reg. Trademark of Branson, P3-Cosa® is a of Henkel. Unless otherwise indicated, all other trademarks in these reference materials are the respective property of their owners. No sponsorship or affiliation is claimed with these companies or their trademarks.

Examples of critical soils include Chlorhexidine Gluconate (CHG), Silver Sulfadiazine (AGSD), Polyvinyl Alcohol (PVA), Titanium Dioxide (TiO2), Hydrochloric Acid (HCL), Nitric Acid (HNO3)

 



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