Our Accreditation
Taylor Lake Laboratories is formally accredited by A2LA to ISO/IEC 17025:2017 — the international gold standard for laboratory testing competence.
Taylor Lake Laboratories is formally accredited by A2LA to ISO/IEC 17025:2017 — the international gold standard for laboratory testing competence.
The American Association for Laboratory Accreditation (A2LA) is a nationally recognized accreditation body that evaluates and certifies laboratories against rigorous international standards. A2LA is a signatory to the ILAC Mutual Recognition Arrangement (MRA), meaning our accreditation is recognized worldwide.
ISO/IEC 17025:2017 is the international standard that specifies requirements for the competence, impartiality, and consistent operation of laboratories. Achieving accreditation to this standard requires an independent on-site assessment of our methods, equipment, personnel qualifications, quality management system, and facilities.
For compounding pharmacies, selecting an A2LA-accredited lab means your environmental monitoring results carry the weight of third-party verified competence — which is increasingly expected by state boards of pharmacy, accrediting bodies like PCAB, and regulatory agencies.
The following tests are included in our A2LA accreditation scope, valid for samples from cleanroom environments.
Sample Types: Air, surface, and gloved-fingertip samples from cleanroom environments; Media Fill Kits from cleanroom environments
| Test / Technology | Method | Sample Matrix |
|---|---|---|
| Microbial Enumeration | USP <797> | Air, surface, gloved-fingertip |
| Microbial Identification Microscopy and Biochemical Tests |
USP <797> | Air, surface, gloved-fingertip |
| Media Fill Kit Analysis | USP <797> | Media Fill Kits from cleanroom environments |
Source: A2LA Scope of Accreditation, Certificate No. 7533.01. For the most current scope, refer to the official A2LA directory at a2la.org.
State boards of pharmacy and accrediting bodies like PCAB increasingly require or prefer that environmental monitoring be performed by accredited laboratories. ISO 17025 reports provide documentation you can present with confidence during inspections.
Accreditation requires that our test methods are formally validated and documented. You can trust that our microbial enumeration and identification procedures follow a verified, consistent protocol — not an ad-hoc approach.
As an independent, accredited third-party laboratory, our results are free from conflicts of interest. A2LA's impartiality requirements ensure our testing is conducted objectively and our reports reflect true results.
A2LA is a signatory to the ILAC MRA, which means our accredited test reports are recognized by accreditation bodies in over 100 countries. This matters if your organization operates across state lines or under federal oversight.
ISO 17025 accreditation requires a robust quality management system covering document control, equipment calibration, proficiency testing, corrective actions, and more — ensuring consistent results over time.
Our accreditation verifies that personnel performing testing have the appropriate education, training, and demonstrated competency for the tests in our scope. You can trust that your samples are analyzed by qualified microbiologists.
USP General Chapter <797> — Pharmaceutical Compounding: Sterile Preparations — is the primary regulatory standard governing sterile compounding in the United States. Compliance is required or referenced by most state boards of pharmacy and is a foundational requirement for PCAB-accredited compounding pharmacies.
The revised edition of USP <797> significantly strengthened environmental monitoring requirements, including more frequent sampling, stricter action levels, and enhanced personnel qualification testing. Outsourcing your microbial testing to an accredited laboratory like Taylor Lake Laboratories helps you meet these requirements with documented, defensible results.
Regular air and surface sampling from ISO-classified areas (ISO 5, 7, and 8) at defined frequencies based on risk category.
Initial and ongoing gloved-fingertip and thumb sampling to verify aseptic technique for all personnel who compound sterile preparations.
Initial qualification and periodic re-qualification of compounding personnel and processes through media fill simulations.
When CFU counts exceed action levels, organisms must be identified to support root cause analysis and corrective action documentation.
Let Taylor Lake Laboratories' ISO 17025-accredited testing strengthen your USP <797> compliance program. Contact us to learn more or request a quote.