USP 797 is a standard for sterility that pharmaceutical compounding and preparation facilities must demonstrate. USP 797 is set by the United States Pharmacopeia and National Formulary (USP-NF) and ensures patient safety by protecting pharmaceuticals from contamination during preparation. Following USP 797 reduces infection, contamination, and improper dosage to maintain superior quality products in facilities such as pharmacies, operating rooms, chemotherapy units, hospital pharmacies, and nuclear pharmacies.
Meeting USP 797 Environmental Quality & Control Requirements
Meeting USP 797 standards is critical to the safety of pharmacy environments, as it ensures clean and sterile conditions for compounding and preparing pharmaceutical products. Sterile compounding pharmacy environments and other cleanrooms can demonstrate compliance by following USP 797 standards for monitoring and controlling airborne particles. It is necessary to follow USP 797 to comply with FDA and local regulations, protect against liability, and remain competitive.
USP 797 provides guidelines for the following:
- ACPH. Hazardous drug (HD) storage rooms require at least 12 air changes per hour (ACPH) for refrigerated, sterile, and nonsterile storage. Buffer rooms and anterooms with access to HDs require 30 ACPH, and anterooms without HD access require 20 ACPH. Buffer rooms with a redundant HEPA filtration system require 12 ACPH.
- Temperature. Cleanroom temperatures are dependent on the comfort of personnel. It can change relative to the necessary gowning or personal protective equipment (PPE). Sweat and shivering result in more particulate shedding by personnel, so temperatures must not be too low or too high. Uncomfortable temperatures can also encourage staff to shed gowning to cool down or wear unauthorized clothing for warmth.
- Humidity. Clean rooms must maintain an adequate humidity level to prevent personnel from sweating due to high humidity and static buildup in low humidity. Low humidity can also cause residual adhesives from labels to stick to surfaces like gloves. According to USP 797, relative humidity (RH) must be below 60% at all times.
- Pressure. Non-HD compounding pharmacies must maintain positive air pressure to keep airborne particulates, contaminants, and dirt from entering through doors, crevices, and ceiling tiles from outside the cleanroom. HD compounding pharmacies require a negative pressure buffer and positive pressure anteroom to prevent contamination and control HD particles.
- Air quality. Maintaining quality standards requires monitoring of airborne particles. Viable particles require monitoring every week, and non-viable particles require monitoring every six months.
Why Your Central HVAC System Won’t Help You Meet USP 797
Sterile compounding pharmacies within confined spaces often become a hotspot when using a standard building air conditioner that cannot keep up with the humidity. Relying on a standard HVAC system can often times result in a space above USP 797 humidity requirements. Maintaining USP 797 compliance requires an HVAC system designed for pharmaceutical applications. Air Innovations offers HVAC solutions to maintain USP 797 compliance.
Air Innovations HVAC Solutions
The HEPAir® Cleanroom HVAC Unit by Air Innovations is the ideal solution to maintaining USP 797 humidity, temperature, pressure, and air quality standards for sterile compounding pharmacies. The HEPAir unit operates independently of the building HVAC system, only serving isolation areas such as cleanrooms, pharmacies, and laboratories. Facilities can also implement several HEPAir units to provide additional air quality and climate control where necessary.
Contact Us for Environmental Control Solutions for Your Compounding Facility
Maintaining USP 797 requirements in your sterile compounding pharmacy space is crucial in delivering a safe product. Rely on Air Innovations’ HEPAir Cleanroom HVAC Unit to ensure USP 797 compliance. As a leader in designing and manufacturing environmental control solutions, we have the necessary knowledge and experience to deliver quality systems to help you abide by critical industry standards. For more information about our HEPAir Cleanroom HVAC Unit or other environmental control solutions, contact us today.