ISO/IEC 17025:2017 calibration + biological testing · Valid through 2027
The cGMP-meets-research vendor problem
Translational research and cell & gene therapy facilities live on the seam between research labs and clinical manufacturing. The same building often holds BSL-2 and BSL-3 research suites, cGMP cleanrooms making clinical product, biorepositories with ULT freezers and LN₂ tanks, vivariums, flow cytometry cores, and analytical labs — each governed by a different regulatory framework and inspected by a different surveyor.
Most regulated-services vendors specialize in one corner of this. The cleanroom certification vendor doesn't touch BSL-3 fume hoods. The calibration vendor doesn't touch viables. The TAB vendor doesn't have ISO/IEC 17025 anywhere on its credentials. The result is six vendors, six contracts, six escalation paths, and a head-of-quality role spent translating between them.
Allometrics consolidates the work into a single accreditation chain — A2LA Cert 2039.01 for calibration, A2LA Cert 7533.01 for biological testing through Taylor Lake Laboratories, NSF/ANSI 49 Field Certifier for BSCs, CETA RCCP for cleanrooms, NEBB for TAB through Precision Biotech Solutions. The same crew that calibrates a research lab's pipettes can recertify the cGMP cleanroom next door and recertify the BSL-3 fume hood down the hall.
Long-running relationships with major academic medical centers and research institutes across the Texas Medical Center — including cGMP cores supporting drug development, cell therapy, viral vector, and RNA work — anchor the program in actual cGMP-meets-research practice.
What we deliver to research and cGMP facilities
- cGMP equipment calibration — calibration under A2LA Cert 2039.01 directly satisfies 21 CFR 211.68. Pipettes, balances, thermometers, dataloggers, refrigerators, freezers, ULT freezers, LN₂ tanks, autoclaves, incubators, environmental sensors. The same calibration record system supports both bench research and cGMP product release.
- cGMP cleanroom certification — annual or semi-annual ISO Class 5/7/8 recertification for cell & gene therapy cores, viral vector manufacturing suites, sterile fill rooms, and translational research GMP labs. CETA RCCP and NSF Accredited Technicians.
- Biosafety cabinet certification — NSF/ANSI 49 Class I, II (A1/A2/B1/B2/C1), Class III for research labs, BSL-2 and BSL-3 suites, cell therapy cores. NSF/ANSI 49 Field Certifier credentialed.
- Fume hood and chemical hood certification — ANSI/ASSP Z9.5 ventilation verification for chemistry research labs, vivariums, and BSL-3 spaces.
- Accredited environmental monitoring — viable air, surface, gloved fingertip, media fill. Collection by Allometrics; A2LA Cert 7533.01 incubation and microbial ID by Taylor Lake Laboratories. The accredited viables capability research-cGMP cores ask for first.
- Temperature & humidity mapping — biorepository walk-ins, ULT freezers (with MKT calculation), stability chambers, controlled-temperature warehouses, vivarium environmental rooms. IQ/OQ/PQ qualification reports.
- Cleanroom commissioning for new and renovated facilities — Precision Biotech Solutions delivers IQ/OQ/PQ documentation, ISO 14644 classification, HEPA integrity, pressure cascade mapping, NEBB TAB. The same data record then transfers cleanly into the recurring recertification program.
- Air balancing & HVAC TAB — NEBB-credentialed TAB by Precision Biotech Solutions for cGMP HVAC balance, pressure cascades, BSL-2 / BSL-3 ventilation, and ASHRAE Standard 170 compliance where applicable.
- Vivarium enclosure certification — animal research enclosures, ventilated cage racks, and the controlled-environment work specific to vivarium operations.
Compliance frameworks we cover for research and cGMP facilities
- FDA 21 CFR 211 (cGMP for pharmaceutical manufacturing)
- FDA 21 CFR 211.68 (calibration and equipment qualification)
- FDA 21 CFR 1271 (HCT/Ps — human cells, tissues, and cellular & tissue-based products)
- FDA cGMP Phase 1 IND guidance (early-stage clinical product manufacturing)
- USP <797> sterile preparations (where used)
- USP <1043> ancillary materials for cell, gene, and tissue-engineered products
- USP <1046> cell & gene therapy products
- USP <1058> analytical instrument qualification
- ISO 14644 cleanroom classification
- ISO 13408 aseptic processing of healthcare products
- NSF/ANSI 49 (biosafety cabinets)
- BSL-2 / BSL-3 biocontainment (NIH BMBL 6th ed.)
- ANSI/ASSP Z9.5 (laboratory ventilation / fume hoods)
- ASHRAE Standard 170 (where research facilities are within healthcare envelope)
- ISO/IEC 17025 (the calibration accreditation chain underneath all of it)
Why research and cGMP facilities consolidate with Allometrics
Continuous data across the cleanroom lifecycle. When Precision Biotech Solutions commissions a new cGMP cleanroom, the commissioning data is on file with the same organization that performs the recurring recertification, calibrates the equipment, balances the HVAC, and analyzes the viables. Most cell & gene therapy programs split this across vendors who never share data; Allometrics keeps it in one place.
One accreditation chain across BSL-2, BSL-3, and cGMP. A2LA Cert 2039.01 covers calibration. A2LA Cert 7533.01 covers Taylor Lake Laboratories' biological testing. NSF/ANSI 49 covers BSC certification. CETA RCCP covers cleanroom certification. NEBB covers air balancing. The credentials match what each regulator and inspector expects in each space.
Texas Medical Center footprint. Long-running relationships with major academic medical centers, NCI-designated cancer centers, medical schools, and specialty research institutes across the Texas Medical Center — including cGMP cores supporting drug development, cell therapy, viral vector, and RNA work, plus BSL-3 enhanced research footprints.
Audit-time guarantee. If a calibration, certification, or qualification report we delivered is challenged in an FDA, IRB, IBC, or sponsor audit, we will address it. Records on IndySoft — 21 CFR Part 11–compliant electronic records.
50 years of regulated-environment experience. Founded 1976. 1,800+ accounts. Continuous through every revision of FDA cGMP, every NIH BMBL update, every USP cell & gene therapy chapter introduction.