ISO/IEC 17025:2017 calibration
Valid through April 30, 2027
**Two A2LA accreditations cover this service:** Allometrics Cert 2039.01 (ISO/IEC 17025 calibration) governs the sample-handling and field-deployment QC. Taylor Lake Laboratories Cert 7533.01 (ISO/IEC 17025 biological testing) governs the laboratory analysis itself. Same group; same accreditation chain.
Why monthly USP <797> environmental monitoring matters
USP <797> requires sterile compounding pharmacies to perform routine environmental monitoring of their PEC (Primary Engineering Controls) and SEC (Secondary Engineering Controls). The frequency: viable air sampling at least every 6 months in low-risk facilities, monthly in high-risk and Category 2 / Category 3 facilities.
If your monthly EM data shows out-of-spec viable counts and you cannot demonstrate corrective action, your batches go on hold. State boards of pharmacy and FDA inspectors review EM trend data as part of every inspection. The cost of a robust monthly EM program is small compared to the cost of a batch hold or a deficiency notice.
Allometrics' integrated cleanroom certification + viable air sampling team performs both certifications and EM in the same visit — under one accreditation chain, with one report deliverable.
What we deliver
- Viable air sampling — settle plates and active air sampling per USP <797>
- Surface sampling (RODAC and contact plates) — counter, floor, gloved fingertip
- Personnel monitoring — gloved fingertip and gowned-personnel sampling
- Identification of recovered isolates — to genus/species level for USP <797> Category 2/3 programs
- Trend analysis and reports — monthly trend reports formatted for state pharmacy board / FDA review
- Corrective action support — when EM data is out of spec, we help you investigate and document corrective action
- Combined certification + EM service — cleanroom recertification (CETA RCCP) and EM in the same visit