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

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Specialized Cleanroom Services

B&V has developed specialized cleanroom services to optimize existing cleanrooms or build new controlled environments.

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Microbiological Solutions

B&V 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

B&V offers certification, repair and maintenance services for controlled environments, primary engineering controls, laboratory hoods and HEPA filtered equipment.

Testing Certification and Service Expertise

Your strategic partner in controlled environmental performance testing and compliance