Why CAI certification matters
Compounding Aseptic Isolators provide a higher level of sterile assurance than open-bench LAFWs by sealing the aseptic compounding environment. State pharmacy boards expect annual CAI certification per CAG-002 and ongoing pressure-decay testing to demonstrate sealed-envelope integrity. A failed CAI certification halts sterile compounding until remediation and recertification.
The cost of a certification program isn't measured against itself — it's measured against the cost of a failed inspection, a hold on a batch, or a deficiency notice from a state pharmacy board or FDA inspector.
Allometrics has been performing controlled environment testing and certification since the early days of the discipline. Our certificates pass FDA, USP, and Joint Commission review.
Why Allometrics for CAI certification
CETA-certified technicians. The Controlled Environment Testing Association is the trade body that defines this discipline. Our team holds the credentials regulated buyers expect.
NSF/ANSI 49 Field Certifiers. Required by every regulated buyer of biosafety enclosure work. Our team is field-certified.
Replace 3–5 vendors with one accredited partner. Calibration, cleanroom certification, biosafety, fume hood, decontamination, and viables — all delivered by the same Allometrics team under one accreditation chain. Allometrics' integrated compliance service team ensures compliance and helps you pass your audits.
50 years of regulated-environment experience. Founded 1976. The team has lived every USP revision, every FDA cGMP guidance update, every Joint Commission standards change.
Audit-ready certificates that pass FDA, USP, and Joint Commission review
Designed to pass FDA, USP, and Joint Commission audits on first review. Every Allometrics CAI certification produces a signed certificate built to survive inspection. Each certificate includes:
- Equipment / room ID, serial number, manufacturer, model, customer asset tag
- Date of certification, technician (with credential), next-due date
- Standard the work was performed to (CAG-002, USP <797>, ISO 14644-3)
- Test results at every measured location — face velocity, pressure differential, particle counts, smoke pattern, integrity, etc.
- Pass/fail determination against the standard
- CETA / NSF certifier credential reference
Certificate format is designed for FDA inspections, USP <797>/<800>/<825> reviews by state pharmacy boards, Joint Commission MM/EC chapter reviews, ISO 9001 audits, and the operational-control requirements of every customer QMS we've worked under.
If your Quality team needs custom IQ/OQ/PQ documentation for equipment qualification, we deliver it.
What we test and certify
- CAG-002 certification — annual recertification of sealed CAIs for non-hazardous USP <797> sterile compounding
- HEPA integrity — DOP/PAO challenge of the supply HEPA filter
- Pressure-decay testing — sealed-envelope leak rate verification
- Glove integrity — pinhole and tear inspection of compounding gloves
- Particle count classification — ISO 5 / Class 100 verification inside the work zone
- Airflow pattern (smoke study) — visual verification of unidirectional flow
All certifications result in a signed report formatted to satisfy USP <797> Category 1, 2, and 3 compounding review.
Service modes
Onsite field service — best for active facilities. Our CETA-credentialed technicians arrive with HEPA challenge equipment, pressure-decay test rigs, calibrated particle counters, and smoke generation gear. CAI certifications are performed onsite during a coordinated outage window so the pharmacy can resume sterile compounding immediately after.
Recurring certification programs — best for multi-site customers. Most CAI certifications are required at intervals defined by the standard (annually for most BSC / LAFW / CAI / CACI; semi-annually for some). Allometrics manages multi-site recurring program calendars with one consolidated report deliverable.
Combined certification + viables — best for USP <797> and USP <800> programs. Allometrics' sister entity Taylor Lake Laboratories performs the viable air sampling and surface monitoring under A2LA Cert 7533.01. We can deliver certification and EM in a single coordinated visit — one team, one accreditation chain, one report.