Isolators are used in general industry as well as the compounding pharmacies. There are two types of isolators the positively pressurized aseptic isolators(CAI) and negative containment isolators (CACI), which are both are primary engineering controls. Both models are designed to meet the needs USP Standards <797> and <800> for the compounding pharmacy. We test and certify all isolators to manufacturers specifications, ISO classification, and CETA CAG-002-2.01.
HEPA filter integrity testing
Airflow velocity and/or volume
Chamber pressure testing
Work zone sterility testing
Product ingress/egress testing
Recovery time determination
Glove/sleeve breach testing
Glove port/sleeve push/pull testing
Interchange particle purge time determination
Particle containment integrity testing – CACI only
Volatile hazardous drug containment – CACI only
Interchange particle purge time determination – CACI only
Testing, Certification & Services
The Certco team is NSF & CETA accredited and performs services to industry standards, guidelines & current Good Manufacturing Practices.
Specialized Cleanroom Services
Certco has developed specialized cleanroom services to optimize existing cleanrooms or build new controlled environments.
Certco offers a full suite of microbiological services: program review, analysis, and identification, through remediation to ensure sterility and compliance.
Certco offers certification, repair and maintenance services for controlled environments, primary engineering controls, laboratory hoods and HEPA filtered equipment.
Cleanroom Certification and Complimentary Solutions
Your strategic partner in controlled environment performance testing and compliance