ISO/IEC 17025:2017 calibration + biological testing · Valid through 2027
The coordination problem most hospital systems live with
A six-hospital system runs six pharmacies, fifty-plus biosafety cabinets, a dozen cleanrooms, dozens of OR suites with engineered ventilation, AIIR rooms across every campus, sterile processing departments, oncology infusion suites, and (often) a cell therapy or research facility. Each space has its own regulatory framework. Each has its own surveyor question set. Each has its own certification cadence.
Most hospital quality teams manage this across half a dozen separate vendors — one for cleanroom certification, one for BSC recertification, one for fume hoods, one for TAB and air balancing, one for calibration, one for viables, sometimes another for cleanroom commissioning when new construction comes online. Six vendors means six contracts, six report formats, six escalation paths, six visit schedules to coordinate, and six different stories the system's accreditation team has to translate when Joint Commission arrives.
Allometrics consolidates this into a single integrated relationship. The same field-service team that certifies your cleanrooms also recertifies your biosafety cabinets, calibrates your pharmacy equipment, and collects your viable samples. Sister entities Taylor Lake Laboratories and Precision Biotech Solutions handle the accredited microbiology and the commissioning / TAB work — under one Allometrics Group umbrella with one shared data set.
"The hospital ensures the medications it prepares are sterile when patient care requires sterility. The hospital plans the storage, preparation, and dispensing of medications according to applicable laws and regulations and standards of practice."
— The Joint Commission, Medication Management chapter
What we deliver to hospital systems
Every service below sits under the same A2LA accreditation chain and the same field-service team. Click through to the service page for scope, deliverables, and credentials.
- USP <797> / <800> / <825> compounding pharmacy compliance — recurring environmental monitoring, primary engineering control certification, audit-ready documentation. Microbiology by Taylor Lake Laboratories under A2LA Cert 7533.01.
- Joint Commission Environment of Care & TAB documentation — OR positive pressure, AIIR negative pressure, Protective Environment positive pressure, bronchoscopy room ventilation, decontamination / sterile processing balance, IV room balance. NEBB-credentialed Precision Biotech Solutions technicians.
- Cleanroom certification across the hospital footprint — ISO Class 5/7/8 pharmacy buffer rooms, ante-rooms, hazardous drug suites, sterile compounding workstations. CETA RCCP and NSF Accredited Technicians.
- Biosafety cabinet, LAFW, CAI, and CACI certification — NSF/ANSI 49 Class I, II (A1/A2/B1/B2/C1), Class III. IEST RP-CC002 LAFWs. CAI / CACI under USP <800>.
- NIST-traceable equipment calibration — pharmacy balances, pipettes, thermometers, refrigerators, freezers (pharmaceutical and ULT), incubators, autoclaves, pressure gauges. Satisfies FDA 21 CFR 211.68 for hospital pharmacies under cGMP rules.
- Accredited viables & microbial environmental monitoring — viable air, surface, gloved fingertip, media fill. Collection by Allometrics; A2LA Cert 7533.01 incubation and microbial ID by Taylor Lake Laboratories.
- Cleanroom commissioning for new and renovated facilities — Precision Biotech Solutions delivers IQ/OQ/PQ on new pharmacy spaces, surgical suites, isolation rooms, research areas. ISO 14644 classification verification, HEPA integrity, pressure mapping, NEBB TAB.
- Temperature & humidity mapping — pharmacy storage rooms, vaccine cold storage, ULT freezers, biorepository walk-ins. IQ/OQ/PQ qualification reports formatted for Joint Commission medication management surveys.
Multi-facility coordination — what changes for systems with 3+ campuses
For hospital systems running cleanrooms, pharmacies, and engineered ventilation across multiple campuses, Allometrics manages the program as a single contract:
- Centralized scheduling — recertifications coordinated so no campus loses too much capacity at once.
- Consistent documentation formats across every site — your accreditation team gets a single deliverable for Joint Commission, FDA, and state board reviews.
- One technician team trained across the full equipment footprint — the same field-service personnel who certify Campus A's IV room are familiar with Campus B's.
- Single point of escalation for action-level findings — deficiencies route through a defined workflow rather than requiring central quality to translate between vendors.
- Centralized procurement alignment — Allometrics aligns with the system's master service agreement and centralized purchasing structure common to multi-facility hospital systems.
Hospital types we serve
- Academic medical centers — major teaching hospitals with research operations and complex compliance footprints
- Multi-hospital health systems — integrated delivery networks running compliance programs across multiple campuses
- Community hospitals and regional health systems — smaller systems where consolidated vendor management is operationally critical
- Specialty and surgical hospitals — cardiac, orthopedic, oncology, pediatric, surgical centers with focused compliance scope
- Children's hospitals — pediatric-specific compounding, pharmacy, and research compliance
- Hospital-based 503B outsourcing facilities — internal sterile compounding programs operating under FDA cGMP rules
Compliance frameworks we cover for hospital systems
- USP <797> sterile compounding (Categories 1, 2, 3)
- USP <800> hazardous drug compounding
- USP <825> radiopharmaceutical compounding (where applicable)
- FDA 21 CFR 211.68 (calibration and equipment qualification under cGMP)
- FDA 21 CFR 1271 (HCT/Ps — for cell and gene therapy)
- The Joint Commission Medication Management chapter
- The Joint Commission Environment of Care chapter (EC.02.06.01 ventilation)
- The Joint Commission Life Safety chapter
- ASHRAE Standard 170 (ventilation of healthcare facilities)
- ISO 14644 cleanroom standards
- NSF/ANSI 49 (biosafety cabinets)
- ANSI/ASSP Z9.5 (laboratory ventilation / fume hoods)
- BSL-2 / BSL-3 biocontainment (NIH BMBL)
- ISO/IEC 17025 (the accreditation chain underlying the calibration certs)
Why hospital systems consolidate with Allometrics
One accreditation chain across every service. A2LA Cert 2039.01 covers calibration. A2LA Cert 7533.01 covers Taylor Lake Laboratories' biological testing. NSF/ANSI 49 Field Certifier credentials cover BSC certification. CETA RCCP and NSF Accredited Technicians cover cleanroom certification. NEBB credentials cover air balancing. The credentialing matches the regulator's expectation for every regulated space in your facility.
Continuous data record across the cleanroom lifecycle. When Precision Biotech Solutions commissions a new 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 hospital systems split this across vendors who never share data; Allometrics keeps it in one place.
Operational fit for multi-campus systems. Centralized scheduling, consistent reports, alignment with the system's centralized procurement structure, single escalation path. Reduces the operational burden on the system's accreditation and quality team.
50 years of regulated-environment experience. Founded 1976. 1,800+ customer accounts. Continuous through every USP revision, every Joint Commission standard update, every FDA cGMP guidance refresh. The team has seen the regulatory environment evolve and adapted continuously.
Audit-time guarantee. If a calibration, certification, or qualification report we delivered is challenged in a Joint Commission, FDA, USP, CAP/CLIA, or state board audit, we will address it.