ISO/IEC 17025:2017 calibration + biological testing · Valid through 2027
ISO 14644 is the framework for cleanrooms across every regulated industry
ISO 14644 is the international cleanroom standards family. ISO 14644-1 defines classification by airborne particle concentration. ISO 14644-2 defines monitoring and recertification frequency. ISO 14644-3 defines test methods. ISO 14644-4 covers design and construction. Together they define what makes a cleanroom a cleanroom and how to keep it qualified over its operational life.
Pharmaceutical compounding facilities reference ISO 14644 through USP <797>'s Category-specific air quality requirements. cGMP manufacturing references ISO 14644 through FDA's expectation of ISO Class 5 / 7 / 8 designations for aseptic processing. Cell and gene therapy facilities reference ISO 14644 through ICH and FDA cGMP expectations on ISO Grade A / B / C / D classifications. BSL-3 research labs reference it through HEPA exhaust integrity and pressure cascade requirements.
One framework. Multiple regulator-recognition contexts.
"Cleanrooms and clean zones shall be classified by airborne particle concentration. Classification testing shall be performed in the Built, At-rest, or Operational state, at sampling locations and frequencies prescribed by the standard."
— ISO 14644-1:2015, Section 5 (paraphrased)
ISO 14644 classification at a glance
| ISO Class | Particle limit (≥0.5 µm/m³) | Typical use |
|---|---|---|
| ISO Class 5 | 3,520 | USP <797> primary engineering controls; cGMP aseptic processing (Grade A / B); sterile fill |
| ISO Class 6 | 35,200 | Specialized aseptic processing |
| ISO Class 7 | 352,000 | USP <797> buffer rooms; cGMP Grade C; cell & gene therapy production |
| ISO Class 8 | 3,520,000 | USP <797> ante-rooms; cGMP Grade D; bulk pharmaceutical compounding |
| ISO Class 9 | 35,200,000 | Less-stringent controlled environments |
Classification testing is performed in the Built, At-rest, or Operational state per the qualification protocol. Allometrics and Precision Biotech Solutions report multiple states where the protocol calls for it.
The ISO 14644 services map
| Service | What it covers | Spoke page |
|---|---|---|
| Cleanroom commissioning | Initial ISO 14644-1 classification verification, IQ/OQ/PQ documentation, NEBB-credentialed TAB, HEPA integrity, pressure cascade. Delivered by Precision Biotech Solutions. | Cleanroom commissioning → |
| Cleanroom certification | ISO 14644-2 recertification (every 6 months for ISO Class 5; every 12 months for Class 7-9). Particle counts, air change rates, pressure mapping, recovery testing, T/RH verification, dynamic smoke studies. | Cleanroom certification → |
| HEPA integrity testing | DOP / PAO leak testing per IEST-RP-CC034 of supply HEPAs and exhaust HEPAs (covered as part of commissioning + certification). | HEPA filter certification → |
| Particle counting | ISO 14644-1 classification verification testing (covered as part of commissioning + certification). | → section of cleanroom certification |
| Biosafety cabinet certification | NSF/ANSI 49 — separate from ISO 14644 but commonly required in conjunction. | BSC certification → |
| Air balancing (TAB) | NEBB-credentialed TAB by Precision Biotech Solutions for cleanroom HVAC balance and pressure cascade adjustment. | Air balancing / TAB → |
| Airflow visualization | Dynamic smoke studies for unidirectional flow verification — required by USP <797> and useful for ISO 14644 commissioning. | Airflow visualization → |
Why an integrated commissioning + certification provider matters under ISO 14644
ISO 14644-2 explicitly requires that recertification reference the original classification. A cleanroom certified at ISO Class 7 at commissioning must continue to demonstrate ISO Class 7 at every recertification. Where the recertification vendor doesn't have access to the original commissioning data, the comparison is less robust — the recertification confirms the room meets ISO Class 7 today, but cannot directly demonstrate continuity from the original qualification.
The Allometrics Group integrated stack — Precision Biotech Solutions commissioning + Allometrics ongoing recertification — solves this by keeping the data in one organization. The recurring recertification report references the original commissioning baseline, demonstrates continuity of classification, and provides the documentation continuity ISO 14644-2 anticipates.
For facilities where commissioning was performed by another agent, Allometrics establishes a baseline at the first recertification cycle and tracks drift from that baseline forward.
Audit-time guarantee. If a cleanroom certification or commissioning report we delivered is challenged in an FDA, USP, Joint Commission, ISO 9001, or sponsor audit, we will address it.
Industries we serve under ISO 14644
ISO 14644 cleanrooms exist across:
- Pharmaceutical compounding (USP <797> alignment)
- Pharmaceutical manufacturing (cGMP Grade A/B/C/D alignment)
- Cell and gene therapy CDMOs (ICH and FDA cGMP)
- Hospital pharmacies (USP <797> Category-specific)
- Hospital surgical suites (where cleanroom design applies)
- Research operations (university research cleanrooms, BSL-2 / BSL-3 facilities)
- Biotech R&D operations
- Industrial cleanrooms (semiconductor, medical device, aerospace components)
- Government / VA / academic research