In February 2016, the US Pharmacopeial Convention (USP), a non-profit organization that sets health care activity standards enforceable by the Food and Drug Administration (FDA) and State Pharmacy Boards, adopted a new regulation to address concerns over the handling of non-hazardous and hazardous drugs. The regulation, (USP<795>, USP <797> and USP <800>) respectfully, seeks to “identify the requirements for receipt, storage, compounding, dispensing, and administration of drugs to protect the patient, healthcare personnel, and the environment.
Filtration Technology can provide the guidance and proper recommendations for your Compounding Room Requirements.
Listed below are three Basic Variations of USP Compliant Room Layouts. Other variations of Room Layouts are available, but not shown.
USP <795>-Compliant Non-Sterile Non-Hazardous and Hazardous Drug Compounding Layout. Neutral or Positive pressure differential to adjacent areas.
USP <797>-Compliant Sterile Non-Hazardous Drug Compounding Layout. Min 30 ACPH, Min 0.02” water column positive pressure differential to adjacent areas.
USP <800>-Compliant Non-Sterile Hazardous Drug Compounding Layout. Min 12 ACPH. Between 0.01” and 0.03” water column negative to adjacent areas. Externally vented.
USP <800>-Compliant Sterile HD Compounding Layout. Buffer Room: Min 30 ACPH, Between 0.01” and 0.03” water column negative to adjacent areas. Externally vented. Ante-room: Min 30 ACPH, positive pressure with respect to Buffer Room.
The USP documents reference the ISO Global Cleanroom Standards; specifically, ISO 14644 series of standards. The ISO Standard for Barrier Isolators is addressed in ISO 14644-7.
A Choice between a Cleanroom and a Barrier Isolator must be determined based on your process. Controlled clean environments commonly referred to as Cleanrooms can be expensive spaces. A self-contained, controlled, clean environment enclosure, such as a Barrier Isolator, around a critical care process area can be an economical alternative to a Cleanroom.
Since 1971, Filtration Technology Inc. stands as one of the most experienced sources for Separative Devices such as Barrier Isolators and other Laminar Air Flow Equipment. Our principal, Richard A. Matthews, was the World Chairman for the International Standards Organization (ISO) Technical Committee for Global Cleanroom Standards and Associated Controlled Environments for 12 years.
Simplicity and efficiency are necessary features of a specialized Separative Device that requires professional attention to your functional process.
A well-designed positive pressure Barrier Isolator supported by adequate procedures for maintenance, monitoring, and control may be an acceptable alternative to Laminar Air Flow Devices and a Cleanroom.
BARRIER ISOLATOR COMPLIANCE
Under the revised USP Chapter 797 regulation, all compounding pharmacies are required to protect their products by utilizing a Barrier Isolator or a Laminar Flow workbench within a Cleanroom. Greater care and cleaner facilities are now required for Compounded Sterile Preparations (CSPs).
Our team of professionals can assist you in determining your requirements. We can provide you with a no-cost audit that consists of a site survey, particle counts, and a written report.
Our commitment to high-quality standards has created reliable specialty filtration and contamination control systems that bring the advantages of our technology to your facility. Our team of professionals will work with you to determine your applications specific needs, considering both your immediate and long-term goals.
Our experience with sterile compounding facilities in hospital pharmacies, home infusion pharmacies, and retail pharmacies will help you determine your requirements.