We’re always looking for the next best practice.
Our commitment to quality is maintained through our development of over 150 Standard Operating Procedures (SOPs) that lead the biostorage and sample management industry. A full-time quality assurance team oversees procedures and monitors evolving industry regulations so we can easily adapt to meet new standards.
Quarterly independent and internal audits help ensure our operating procedures are fail-proof. Clients and prospects are also invited to conduct their own audits of our facilities. All sample storage units are equipped with ELPRO® and OCEASOFT temperature monitoring technology. Temperatures are continuously recorded every second and permanently logged every 10 minutes in a US FDA 21 CFR Part 11 compliant uneditable database.
Brooks maintains the following certifications, licenses, and memberships to ensure your biomaterials are handled, stored and shipped with full integrity and as mandated by regulations in your area:
ISO 9001:2015 Registered – Brooks is certified by DEKRA for our facilities in Indianapolis, IN, Bronx, NY, Fresno, CA, Quebec, Canada, Singapore, Beijing, China, Pfungstadt, Germany, and Griesheim, Germany. We provide short and long-term sample storage, wholesale distribution of pharmaceuticals and biologics, controlled-temperature logistics management of sample shipments, and basic lab services.
European Medicines Agency (EMA) – Certification of GMP Compliance of a Manufacturer, Brooks is EMA certified in Indianapolis, IN to store GMP working and master cell banks since 2016.
College of American Pathologists (CAP) Biorepository Accreditation — We received accreditation from the College of American Pathologists (CAP) Biorepository Accreditation Program in January 2013.cap accredited
National Quality Assurance (NQA ) Global Assurance Certificate (ISO 9001:2015 ) UK – Certificate number 16294/4 EAC Code 18 issued April 5, 2017 for Brooks Life Science Systems, Northbank, Irlam, Manchester M44 5AY, United Kingdom
National Quality Assurance (NQA ) Global Assurance Certificate (ISO 9001:2015 ) US – Certificate number 16294/4 EAC Code 18 issued April 5, 2017 for Brooks Life Science Systems, 15 Elizabeth Drive, Chelmsford MA 01824 US
GTP (Good Tissue Practices) — We’re registered by the FDA with a GTP license for the storage and distribution of human cells, tissues and cellular and tissue-based products (License #3004757032).
US FDA Title 21 CFR Part 11 Compliant — Both ELPRO® and our BioInventory informatics systems are validated and US FDA documentation compliant.
Qualtrax® Compliance Software — Our SOPs are maintained with Qualtrax, a quality assurance document management system.
Licensed Tissue Bank In These States— New York, California (License #CNC80754), Delaware, Illinois (License #0109), Maryland (License #TB1523) and Oregon
IATA (International Air Transport Association) and U.S. DOT (United States Department of Transportation) — Compliant shipper of radioactive goods and infectious substances
Nuclear Regulatory Commission (NRC) — Certified to store and transport radioactive materials License #13-32622-01
Certified Cargo Screening Facility — We are a US certified cargo screening facility as part of the Transportation and Safety Administration’s security program.
Certified as a Bekannter Versender — (known consignor) in Germany by the LBA (DE/KC/00901-01/0218)
Sterilization Practices: Brooks employs three labware sterilization practices to ensure products meet all client specifications and arrive ready-to-use:
|Methods:||Free from Pyrogens / DNA / RNA /RNase / DNase / Heavy metals / animal contaminants||Certified by case to a SAL of 10-6||Recommended for critical forensic applications (DNA amplification)||Modifies polypropylene|