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.
Indoor climate control is a wonder of modern engineering, but it can be extremely expensive and wasteful. Nearly 13% of the United State’s energy consumption comes from heating and cooling buildings. Instead of controlling the climate of entire buildings, a better solution may be to control the climate of individual spaces in buildings. Installing a personal climate control system at individual office desks puts each worker in control of their environment while helping businesses save energy and money on utility bills.
Personalized climate control systems in office buildings reduce the amount of heated or cooled air that needs to be supplied throughout the building because only certain areas need cooling at any given time. Cooling vents automatically switch off when a worker leaves their desk, eliminating unnecessary energy consumption. Studies show that providing temperature controls for individual desks can help cut down energy costs by half.
Benefits of Personal Climate Control Systems
Implementing personal climate control systems into workspaces provides a range of benefits to the company and to its employees. Some of the benefits include the following:
Enhanced Energy Efficiency and Reduced Costs
Energy consumption and its costs are a matter of concern for businesses. Personal ventilation systems can help cut costs by enhancing energy efficiency.
Improves Workforce Productivity
The comfort of workers is one of the major factors that improve productivity. People who work for long hours need solutions that enhance comfort. A personal climate control system allows personnel to customize their environment to their comfort level, thereby improving productivity.
Limits Air Borne Diseases Transmission
One of the major causes of the spread of airborne diseases is central HVAC systems. HVAC systems circulate the air throughout the premises, carrying with germs and bacteria with it which results in the spread of various airborne diseases. It has become critically important to limit this spread within facilities given today’s global health situation, and a personal climate control system can be an effective solution.
Nearly 60% of complaints regarding office environment are related to temperature. In any office space, there are diverse people of different sizes and gender with varying climate preferences. There is no perfect temperature to fit the needs of all of them. Providing workers with personal climate control makes it possible to optimize the workspace environment according to individual needs.
MyZone® System – Key Features and Benefits
MyZone® System is an innovative personal climate control solution that caters to the personal comfort of individual workers. This revolutionary personal climate control device is attached to the surfaces in personal workspaces, integrating lighting control, environmental control, and lift functions within a single unit. It comes with a non-fixed controller, which means you can position it anywhere on your desk without a problem. The MyZone system has a variety of features and benefits:
- Non-fixed user controller for user convenience
- Highly energy-efficient design
- Automatic integrated motion sensor for additional power savings. Following 10 minutes of inactivity, the system shuts off automatically.
- Variable options for cooling and heating
- Adjustable louvers allow you to direct air towards yourself
- Programmable for up to 15 users
- Integrated sit/stand desk leg lift control
- Adjustable generator for white noise
- Adjustable calendar and clock
- Task light dimmer
- Option of HEPA Filtration
Effectiveness of HEPA Office vs Desk Filtration
Along with climate control, MyZone® personal climate control system with optional HEPA filtration can also improve the air quality and provide better protection against airborne infectious diseases. This device can reduce particulate matter up to 94% in five minutes, directing quality air to the users.
Contact Our Experts for Custom Environmental Control Systems
MyZone® personal climate control systems provide a more comfortable, energy-efficient, and safe environment for employees. It offers unmatched flexibility, versatility, control, comfort, and user safety to maximize productivity and optimize the workplace environment.
Air Innovations specializes in designing and manufacturing remote and self-controlled packaged cooling systems. Our innovative designs provide precise temperature, filtration, and humidity control.
Contact us today to request a free quote for your custom personal climate control system!