Pharmaceutical refers to drug and medicinal products and these industries are defined as the discovery, development and manufacture of drugs and medications. It is widespread including research, chemicals, regulations and the involvement of government agencies. In this article we learn about the HVAC design for the pharmaceutical industry.
In the Pharmaceutical industry, the strictest environments are reserved for compounding rooms. Per the U.S.Pharmacopeia (USP), compounding includes the preparation, mixing, assembly, alteration, packaging and labeling of non hazardous and hazardous drugs, Anterooms about compounding rooms and are used to prevent contaminants from spreading to unwanted areas or rooms. Three sets of standards that the USP developed and dictate proper preparation conditions for compounded drugs and these three standards cover four permutations of hazard level and sterility compounded sterile preparations (CSPs) and compounded nonsterile preparations (CNSPs) of both non hazardous and hazardous drugs. The Hazard level and sterility requirements of compounded drugs directly affect the air cleanliness level, space pressurization, and air changes per hour required in the compounding room.
Design Aspects for HVAC System :
In Pharmaceutical Industry, HVAC s system performs four basic functions :-
- Maintain Space Temperature: Temperature can affect production directly or indirectly by promoting the growth of microbial contaminants on workers.
- Maintain Room Pressure (delta P) : HVAC system helps to maintain the room pressure by providing more air into the “cleaner” space than is mechanically removed from that space. Areas that must remain “cleaner” than surrounding areas must be kept under a “positive pressurization” meaning that air flow must be from the “cleaner” area towards the adjoining space to reduce the chance of airborne contamination.
- Maintain Humidity: With the help of HVAC systems, Humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers and it can affect the efficacy and stability of drugs and is sometimes important to effectively mould the tablets.
- Control airborne Particles, dust and microorganisms : Through air Filtration using high efficiency particulate air (HEPA) filters. Solids present in the air are called airborne particles. They are very minute in size and measured in microns. Sometimes , these airborne particles are also called contaminants or bacteria based on their structure and biology.
These are the main four factors of HVAC systems in the pharmaceutical industry.
Each of the above parameters are controlled and educated in light of its potentials to impact product quality.
The other factors that contribute to the efficiency of HVAC systems are –
- Air Flow Pattern.
- Design of Ducting.
- Building and construction layout.
- Heat Load
- Location of Filtration assembly installation.
- Commissioning an HVAC systems ,
- Releasing the system for commercial applications.
Validation of HVAC :
Without validation , HVAC systems can’t be used for commercial manufacturing. Validation provides documentary evidence that the system is designed, installed and works as intended. With a protocol or strategy challenging each design aspect of the system. All the documentary evidences such as RH, Temperature Mapping, Pressure Mapping, and other controlled parameters are recorded and archived. HVAC systems can be used for commercial manufacturing operations once the PQ report is released.
Conclusion:
With so many factors and points we see the HVAC designs for pharmaceutical industries. The high airflow and pressure can result in higher capacity for HVAC systems and maintaining sufficient differential pressure across the different classes of rooms is key to prevent product contamination