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.
HVAC systems are essential components in the functionality and appeal of all modern buildings. Well-designed and efficient HVAC systems go well beyond ensuring comfortable temperatures and fresh air for facilities. They also play a key role in the production and testing processes of a broad spectrum of industries.
HVAC systems play a crucial role in pharmaceutical engineering and manufacturing because they have a direct impact on the production environment. Optimized HVAC units can help pharmaceutical companies Mining and Drilling, pass inspections, and remain CGMP-compliant, and more.
All You Need to Know About Specialized HVAC Systems
What is a Specialized HVAC System?
The acronym HVAC stands for heating, ventilation, and air conditioning. Specialized HVAC systems control the temperature, humidity level, and air quality in a space to ensure the required specifications for your application are met.
Types of HVAC Systems We Design & Manufacture
We specialize in the design and manufacture of advanced HVAC systems for the precise control of temperature, humidity, filtration, and pressurization for equipment and processes. The three main configurations of HVAC systems we manufacture are integrated, mounted, and standalone in standard or custom solutions.
Integrated solutions are designed to fit seamlessly within existing equipment structure, allowing for a smaller size and footprint, greater system efficiency, and lower installation cost.
ECUs that are mounted to an existing system can be designed to meet system weight constraints, provide a reduced ECU footprint, and offer close proximity to the process.
Standalone units can be placed in the space surrounding your equipment and offer maximum flexibility in system location, installation, configuration, and performance capability.
Less common but no less critical, explosion-proof HVAC systems are an essential aspect of many industrial applications. For example, ore mining/processing facilities can make use of these units to prevent an explosion of coal dust particles in the air.
Other industries that utilize explosion-proof HVAC systems include:
Nowadays, many off-the-shelf explosion-proof units are available. However, companies that require explosion-proof environmental control units often need to ensure that their HVAC systems supplier has the capability to provide a tailored solution for their particular application.
Industries and Applications
Industries ranging from homeland security to aerospace use specialized HVAC solutions as an essential part of their daily operations. The following are some examples of specific industries and applications that utilize HVAC systems.
Aerospace applications require strict environmental control in everything from research and development to launch areas. At Air Innovations, we’ve supported a variety of unique aerospace projects, such as clean room filtration, environmentally controlled transportation of aerospace components, and strict environmental control of launch areas.
For example, one rocket’s fueling system demanded a dry dew point of -22° C just before launch. Any remaining moisture would condense and transform into ice on the rocket’s piping, creating a dangerous situation. The solution to this quandary was an in-line desiccant dryer surrounded by two tailored environmental control units used to eliminate moisture and maintain tight temperature tolerances.
Durable HVAC units assist in temperature and humidity maintenance at airport terminals, including security checkpoints and baggage claim areas. Additionally, explosives detection devices (EDDs) at airports demand strict internal control of temperature and humidity variables in order to function properly.As such, the Homeland Security Department relies on specialized HVAC units for these applications.
Mining and drilling companies use environmental control units to keep electrical cabinets of centrifuge machines cool. Centrifuges eliminate slurry during drilling operations, and are therefore an indispensable component of the overall extraction process. ECUs that keep their cabinets cool help prevent overheating, fires, explosions, and other dangerous circumstances.
Biotech and pharmaceutical companies frequently employ specialized HVAC units for strict control over temperature, humidity, and dew point, especially when handling sensitive equipment, or performing processes that require certain environmental conditions to succeed.
Computer rooms, laboratories, hospitals, and process isolators often make use of cleanrooms. HVAC units designed for cleanroom use often come with features such as positive/negative pressure control, once-through or recirculating air flow, and alarms triggered by the slightest variance from set tolerances.
The Pharmaceutical Industry and HVAC Systems
The Importance of HVAC Systems for the Pharmaceutical Industry
Why are well-functioning HVAC systems so important to the pharmaceutical industry today? While there are many factors involved, but here are just two of the reasons they are so essential:
Modern diagnostic machines need to operate within very strict temperature and humidity tolerances so that the integrity of powdered and fluid reagents is not comprised. The consequences of a misdiagnosis or false reading from the introduction of unanticipated moisture, for example, could be serious for both patient and medical provider alike. Customized HVAC units that ensure stable environmental conditions—whether cold, hot, or dry—and integrate well into often limited space, are key pieces of an effective diagnostic process.
Moisture can be one of the worst enemies of modern medicine production. In every phase of production—from milling to compounding to coating—excess moisture can cause manufacturing inefficiencies, weaken the medicine’s effect, or in the worst-case scenario, completely ruin an entire batch of product. Specialized HVAC units that enforce a specified dew point based on the application all but guarantee that there will be no excess moisture from the air to cause production issues.
There are several design considerations that engineers must apply to HVAC systems intended for pharmaceutical applications. Ideally, architectural components should dovetail with HVAC design factors, such as pressure differential cascades and cross-contamination control. Adequate ventilation and filtration are important considerations for laboratory testing areas and cleanrooms.
Additionally, HVAC engineers must implement systems that ensure strict control over temperature, relative humidity and/or dew point, without interfering with the actual pharmaceutical manufacturing process.
Operational HVAC Optimization in Pharmaceutical Facilities
After HVAC room requirements have been established, there are ways to optimize HVAC system operations to keep costs low and efficiencies high. Some optimization measures could include:
The reduction of air-change rates
Optimized temperature and humidity limits
Improved control sequences for use of floating set-points and dead-band control
Changeover to a two-port variable volume system
The addition of airflow meters and air volume control components
Efficient and Custom HVAC Solutions at Air Innovations
Air Innovations provides several HVAC products specifically designed for use in the pharmaceutical industry. These include:
In another case, a client needed a chemical process control unit that would hold set temperature and humidity levels in widely varying conditions all over the globe, while also operating on a continuous, year-round basis. Air Innovations provided an HVAC unit that depends on two independent cooling coils, along with process fans that alternate operation time. Various sensor inputs help to manage switch-over intervals. As a result, the cooling coils continue running without defrost interruptions, even in sub-zero temperatures.
HVAC systems are an essential aspect of pharmaceutical manufacturing. If you’d like to learn more about how Air Innovations can provide a workable, highly-customized, and efficient HVAC solution for your manufacturing needs, reach out to us today.