ISO/IEC 17025:2017 calibration + biological testing · Valid through 2027
The biotech vendor problem
A growing biotech operator runs everything from a research bench to a clinical product line out of the same building. The pipette that ran the discovery assay is the same pipette that loaded the IND-enabling experiment. The biosafety cabinet that processed cell material in research is the same BSC under USP <800> controls in clinical manufacturing. The ULT freezer that holds the discovery material is the same freezer holding the cGMP master cell bank.
Most biotech operators come to us with three or four vendors covering this — a calibration vendor for pipettes and balances, a separate vendor for BSC certification, a third for cleanroom recertification, and (often) a fourth for environmental monitoring or freezer mapping. None of them share data. All of them charge minimum visit fees. Each one's documentation reads differently to your QMS reviewer.
Allometrics consolidates the regulated-equipment work for biotech under one program — A2LA Cert 2039.01 calibration, A2LA Cert 7533.01 biological testing through Taylor Lake Laboratories, NSF/ANSI 49 BSC certification, CETA RCCP cleanroom certification, NEBB TAB through Precision Biotech Solutions. The same field-service crew that calibrates the bench pipettes can recertify the BSC, map the −80 freezer, and draw the viables — all on one workorder.
What we deliver to biotech operators
- Bench instrument calibration — pipettes, balances, thermometers, dataloggers, pH meters, spectrophotometers, centrifuges, mixers, shakers, environmental monitors, dataloggers. A2LA Cert 2039.01.
- Pipette & liquid handler calibration — single-channel, multi-channel, electronic, and bench-mounted handler programs. ISO 8655 gravimetric method.
- Lab centrifuges, mixers, shakers, incubators — RPM, RCF (g-force), temperature, time. Onsite or in our Webster lab.
- ULT freezer, biorepository, and stability chamber mapping — IQ/OQ/PQ qualification reports with mean kinetic temperature (MKT) calculation. The mapping deliverable cell & gene therapy auditors actually open.
- Biosafety cabinet certification — NSF/ANSI 49 Class I, II (A1/A2/B1/B2/C1), Class III. NSF/ANSI 49 Field Certifier credentialed.
- Cleanroom certification — ISO Class 5/7/8 recertification for cGMP manufacturing suites, fill-finish rooms, and translational labs. CETA RCCP and NSF Accredited Technicians.
- Accredited environmental monitoring — viable air, surface, gloved fingertip, media fill. A2LA Cert 7533.01 incubation and microbial ID by Taylor Lake Laboratories.
- Cleanroom commissioning — Precision Biotech Solutions delivers IQ/OQ/PQ for new biotech manufacturing space. ISO 14644 classification, HEPA integrity, NEBB TAB.
- Fume hood certification — ANSI/ASSP Z9.5 ventilation verification for chemistry and BSL-2 spaces.
- Analytical / pH / spectrophotometry calibration — for the QC bench instruments biotech operators run alongside their main workflows.
Compliance frameworks we cover for biotech operators
- FDA 21 CFR 211 (cGMP — for clinical product manufacturing)
- FDA 21 CFR 211.68 (calibration and equipment qualification)
- FDA 21 CFR 1271 (HCT/Ps — cell and tissue products)
- USP <1058> analytical instrument qualification (the chapter most QC reviewers cite)
- USP <1043> ancillary materials for cell, gene, and tissue-engineered products
- USP <1046> cell & gene therapy products
- USP <1079> good storage and distribution practices
- ISO 14644 cleanroom classification
- ISO 13408 aseptic processing of healthcare products
- ISO 8655 (volume / pipette calibration)
- ICH Q7 (active pharmaceutical ingredient cGMP)
- NSF/ANSI 49 (biosafety cabinets)
- BSL-2 / BSL-3 biocontainment (NIH BMBL 6th ed.)
- ANSI/ASSP Z9.5 (laboratory ventilation)
- ISO/IEC 17025 (the calibration accreditation chain)
Why biotech operators consolidate with Allometrics
One accreditation chain that scales with you. Most calibration vendors lose value as a biotech operator moves from research-only to clinical manufacturing — the small-shop vendor doesn't carry A2LA accreditation, the cGMP-only vendor doesn't want the bench work. Allometrics serves bench biotech with the same accreditation chain that supports cGMP manufacturing — so the program scales with your stage.
One Group across commissioning, recertification, calibration, viables, and mapping. When Precision Biotech Solutions commissions a new cleanroom, the data is on file with the same organization that performs the recurring recertification, calibrates the equipment, and analyzes the viables. Most biotechs split this across vendors who never share data; Allometrics keeps it in one place.
Houston life-sciences cluster fluency. 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. We know the inspectors, the QMS templates, and the IRB / IBC review cycles your biotech is moving through.
Audit-time guarantee. If a calibration, certification, or qualification report we delivered is challenged in an FDA, sponsor, IBC, or partner 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+ customer accounts. A team that has seen biotech evolve from monoclonal antibodies to mRNA platforms.
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Services we deliver to biotech operators
- Calibration (cGMP / pharma)
- Pipette / liquid handler calibration
- Centrifuges & mixers calibration
- Temperature & humidity mapping (ULT, biorepository)
- Biosafety cabinet certification
- Cleanroom certification
- Cleanroom commissioning (PBS)
- Fume hood certification
- Microbial testing services
- Air balancing / TAB (PBS)
- Analytical / pH calibration