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.

Testing Available:

  • 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

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Testing, Certification & Services

The Certco team is NSF & CETA accredited and performs services to industry standards, guidelines & current Good Manufacturing Practices.

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Specialized Cleanroom Services

Certco has developed specialized cleanroom services to optimize existing cleanrooms or build new controlled environments.

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Microbiological Solutions

Certco offers a full suite of microbiological services: program development, analysis, and identification, through remediation to ensure sterility and compliance.

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Decontamination Solutions

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