Pharmacy Isolator Performance Evaluation

The United States Pharmacopeias (USP) has published USP Chapter 797-Pharmaceutical Compounding Sterile Preparations. The USP 797, enacted Jan 1, 2004 was written to improve the compounding of sterile products. It is the first official and enforceable requirement for compounded sterile preparation (CSP). Specific issues of USP 797 addresses the responsibility of compounding personnel to ensure that CSPs are prepared safely by the means of engineering control, which involves primary and secondary control. The primary control can be laminar flow, biosafety cabinet, or isolator, while the secondary control is the room requirement.

 

White Paper : HPI-4P1 Positive Pressure Compounding Aseptic Isolator Performance EvaluationAuthor: Yayi Nestiti and Alexander Atmadi

Positive pressure isolator is a Compounding Aseptic Isolator (CAI). Positive pressure inside work zone provides product protection and maintains sterility.  Safe and clean environment inside work zone are suitable for non-hazardous compounding applications, sterile drug preparations and IV admixtures in compliance with USP 797 criteria.

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White Paper : HPI-4N1 Negative Pressure Compounding Aseptic Isolator Performance EvaluationAuthor: Yayi Nestiti and Alexander Atmadi

Negative pressure isolator is a Compounding Aseptic Containment Isolator (CACI). Negative pressure inside work zone maintains operator and product protection. Barrier isolation system provide inherently superior sterility and suitable for compounding of hazardous drugs.

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HPI Testing


HPI Downflow Testing

HPI Filter Leak Testing

HPI Gauntlet Breach Air Velocity Testing

HPI Light Intensity Testing

HPI Microbiological Cross Contamination Testing

HPI Noise Level Testing

HPI Particle Count Testing

HPI Product Ingress and Egress Testing

HPI Recovery Time Testing

Recovery Visualization