CertAir offers an automated robotics platform that performs filter integrity, airflow velocity, and containment testing for terminal filters, biosafety cabinets, flow hoods, RABS, and isolators. Its dual‑probe system runs two tests concurrently, cutting cycle times by up to 75% while capturing all data electronically in a secure, ALCOA++‑compliant database and generating validated certification reports in real time. The solution ensures 100 % compliance with standards such as ISO 14644‑3, IEST 34.5, NSF 49, 21 CFR Part 11, and EU GMP Annex 11, reducing manual labor and operator injury risk.
Funding
Funding not disclosed
Founders
Product
Problem
Cleanroom and controlled environment testing for filter integrity, airflow, and containment often relies on manual procedures that are time‑consuming, prone to human error, and expose technicians to repetitive strain injuries. Inconsistent data capture and lack of automated compliance reporting increase the risk of regulatory non‑conformance for life‑science and microfabrication facilities.
Solution
CertAir provides an automated robotics platform that performs filter integrity, airflow velocity, and containment tests for terminal filters, biosafety cabinets, flow hoods, RABS, and isolators. Dual‑probe technology enables two robots to operate simultaneously, cutting test cycle times by up to 75% while maintaining 100 % adherence to standards such as ISO 14644‑3, IEST 34.5, NSF 49, 21 CFR Part 11, and EU GMP Annex 11. All measurements are captured electronically, encrypted, and stored in a secure, ALCOA++‑compliant database, generating validated certification reports in real time. The system’s kinematic verification and 2D scan layouts ensure precise, repeatable movements, reducing musculoskeletal strain on operators and improving overall workplace safety.
Target Audience
Primary customers are cleanroom operators, validation engineers, and quality‑assurance teams in life‑science manufacturing, pharmaceutical production, and microfabrication facilities that require certified testing of filters and containment systems.
Features
- Dual‑probe robotic system that runs two tests concurrently, halving scan time and reducing airflow/particle count test duration by 50%
- Automated filter integrity and airflow velocity testing for terminal filters, biosafety cabinets, flow hoods, RABS (open/closed) and isolators
- Custom 2D layout scanning with verified kinematic movements for each mounting point to ensure repeatable precision
- Secure, encrypted electronic data capture compliant with 21 CFR Part 11, EU GMP Annex 11, and ALCOA++ guidelines
- Real‑time generation of validated certification reports with built‑in traceability and audit trails
- Integrated compliance validation against ISO 14644‑3, IEST 34.5, NSF 49, and other industry standards
- Reduction of labor costs and hidden expenses related to technician turnover and workplace injuries