The pharmaceutical industry is a vital sector producing and distributing life-saving drugs, medicines, and vaccines. This sector has strict standards and regulations to ensure the quality and efficiency of the drugs and the safety of employees and patients. The importance of high-quality pharmaceutical products in maintaining health and preventing diseases underscores the need for an efficient HVAC system to control temperature, humidity, and pressure in pharmaceutical facilities, including production, laboratories, and storage areas.
Table of Content
- Using HVAC in the pharmaceutical industry
- Choosing the right pharmaceutical HVAC system
- Top HVAC manufacturers on Venwiz
Using HVAC in the pharmaceutical industry
HVAC (heating, ventilation, and air conditioning) systems are vital in the pharmaceutical sector. It ensures smooth operation during various manufacturing processes, safeguards product quality and creates a controlled environment for various operations. Let us delve into some of how HVAC helps:
Temperature control
Pharmaceutical products show varying degrees of temperature sensitivity. Temperature fluctuations can impact product stability and potency and start product degradation. HVAC systems use temperature sensors and control mechanisms to maintain temperature within a designated range. Common temperature control mechanisms include
- On-off method is a simple temperature control technique. It operates by using the full heating or cooling capacity until the desired temperature is reached. Once the set temperature is reached, the power supply shuts off.
- Proportional-integral-derivative (PID) control is a closed-loop temperature control method. This system continuously monitors temperature deviations and adjusts the temperature as required.
Humidity control
Similar to temperature control, humidity is another crucial part of HVAC systems. Increased humidity can promote bacterial and mold growth, and affect product stability. HVAC systems employ desiccant dehumidifiers or chilled water coils to regulate humidity levels within specified ranges.
Air filtration
Pharmaceutical HVAC systems regulate the airflow pattern within the cleanroom to ensure a sterile environment. HVAC systems use HEPA (high-efficiency particulate air) filters or ULPA (ultra-low particulate air) filters to remove contaminants like dust particles and microorganisms. This minimises the risk of product contamination and helps maintain standards within the cleanroom.
HEPA filters (High-efficiency particulate air filters) can remove 99.97% of dust, pollen, mould, germs, and other airborne particles that are 0.3 microns or larger. These filters work by pushing air through a narrow mesh to capture tiny, dangerous particles.
ULPA filters (Ultra-Low Particulate Air) filters are designed to remove extremely small particles from the air. They are considered to be more efficient than HEPA filters.
MERV is a rating system that measures the effectiveness of air filters in trapping particles of different sizes. It ranges from 1 to 20, with higher ratings indicating better filtration capabilities. Filters with higher MERV ratings are thicker and more densely woven, designed to catch smaller particles.
Airflow management
Pharmaceutical HVAC regulates airflow within a designated area to ensure uniform airflow, as unregulated airflow can cause dust particles and foreign particles to enter the air stream. The blower maintains airflow, with input parameters fed into the main control unit of the HVAC system. Sensors monitor the airflow, and a signal is sent to the controller if any change is detected. The controller calculates any deviation and regulates the blowers using a variable frequency drive (VFD). We can adjust airflow by opening or closing air dampers.
Air Change Rates: The HVAC system should be designed to provide an adequate air change rate per hour (ACH) to maintain the required cleanroom conditions and remove contamination effectively. The ACH may vary based on the cleanroom class and the nature of the process.
Pressure Regulation
HVAC systems help establish and maintain pressure differences in different areas of the pharmaceutical facility. For instance, cleanrooms usually maintain a positive pressure relative to surrounding areas. This pressure gradient ensures air flows from clean to less clean zones, preventing cross-contamination between different processes.
Energy Efficiency
Pharmaceutical companies must balance environmental control with energy conservation. Modern pharmaceutical HVAC systems incorporate energy-efficient technologies, such as VFD for fan motors and optimising coil design.
HVAC systems can constitute up to 35% of the energy used in manufacturing facilities. These systems are rated with SEER or Seasonal Energy Efficiency and usually range from 13 to 23. Higher ratings denote a more efficient system.
Regulatory compliances
The pharmaceutical industry is highly regulated and established by agencies. Systems must be designed, operated, and maintained to meet these stringent guidelines, ensuring consistent performance and adherence to established quality standards. Regular monitoring and maintenance of these systems are crucial for maintaining compliance.
- WHO Good Manufacturing Practices (GMP): These guidelines from the World Health Organization offer recommendations for facility design and operation, including HVAC systems. This ensures proper air quality to prevent contamination of pharmaceutical products.
- ISO 14644 Cleanroom Standards: These international standards define the cleanliness levels for controlled environments like pharmaceutical cleanrooms. They specify the maximum allowable airborne particles in different cleanroom classifications.
- Schedule M of the Drugs and Cosmetics Act: This regulation outlines Good Manufacturing Practices (GMP) for pharmaceutical products in India. It emphasises maintaining suitable environmental conditions in manufacturing areas, which relies heavily on proper HVAC systems.
- US FDA Guidelines: For companies exporting to the United States, the US Food and Drug Administration (FDA) sets guidelines that include HVAC system requirements. These guidelines ensure appropriate environmental conditions within manufacturing facilities.
- European Union Good Manufacturing Practice (EU GMP) Guidelines: Similar to the US FDA, companies exporting to the European Union may need to comply with EU GMP guidelines. These guidelines also have specific requirements for HVAC systems to guarantee product quality and safety.
- Pharmacopoeial Standards: Additional guidance on HVAC systems and environmental controls can be found in pharmacopoeial standards. These include the Indian Pharmacopoeia (IP), the United States Pharmacopoeia (USP), and the European Pharmacopoeia (Ph. Eur.).
Process specifications
Certain pharmaceutical processes (crystallisation or drying) require a specific reaction or product formation. HVAC systems are provided with heating or cooling systems to meet these requirements.
Cleanrooms in the pharmaceutical industry
Cleanrooms are essential in pharmaceutical manufacturing, providing a sterile environment where temperature, pressure, and humidity are tightly controlled. They are crucial for meeting regulatory standards and ensuring product quality and safety.
HVAC systems help maintain cleanrooms by:
- Control airflow and prevent contaminants
- Maintain pressure differential
- Temperature and humidity control
Cleanrooms are classified based on the level of particulate cleanliness in the cleanroom. ISO 14644 regulate the level of air cleanliness in the cleanroom. The classification ranges from ISO 1( the cleanest) to ISO 9 (the least clean). Pharmaceutical companies typically require ISO 5 or higher cleanliness levels in their cleanrooms, and HVAC systems are indispensable in achieving and maintaining these standards.
Choosing the right pharmaceutical HVAC system
Given the intricate requirements of pharmaceutical manufacturing, selecting the right HVAC system is critical.
Facilities assessment
The size and layout of your plant will impact the design of the HVAC system. A large, multi-zone facility will require a more complicated system compared to a smaller operation. HVAC engineers will visit the plant to assess the requirements like airflow patterns, equipment placement, and zone classification requirements.
Specific requirements
Different areas within the pharmaceutical facilities have varying environmental requirements. Cleanrooms will have more stringent temperatures, humidity, and filtration requirements. Warehouses, on the other hand, may prioritise temperature for product stability.
Budgetary constraints
HVAC systems come with various control systems, from simple on/off systems to sophisticated PLC systems. While selecting a pharmaceutical HVAC system for your plant, it is crucial to balance functionality, regulatory compliance, and your budget. Consider the operational costs, energy requirements, and maintenance costs.
Scalability and Future Needs
Consider the potential future growth and expansion while selecting an HVAC system. A modular system allows for easier integration of additional components as your plant evolves. Careful planning at this stage will prevent expensive system overhauls in the future.
Stay abreast of the latest HVAC trends
Top HVAC manufacturers on Venwiz
Aquachill Systems India Private Limited
Aquachill Systems India Private Limited specialises in providing engineering, procurement, construction, and turnkey solutions for HVAC, Process Cooling, CHPC Architecture, and Gas Turbine Inlet Air Cooling. With over 14 years of experience, Aquachill offers design, supply, installation, and commissioning services for industries like power & energy, metals & mining, chemicals, and pharma.
Knnd Associates Pvt Limited
Knnd Associates Pvt Ltd., based in Bengaluru Urban, specialises in the supply and installation of HVAC systems. They offer high-quality HVAC solutions to industries such as Oil & Gas, Power & Energy, Metals & Mining, and Industrial Machinery & Tools. With 26 years of experience and a workforce of 300 skilled professionals, Knnd Associates Pvt Ltd. is committed to providing reliable and efficient HVAC solution
Metec design and construction
Metec Design And Construction Engineers India Private Limited, based in Tiruvallur, specialises in providing comprehensive MEP (Mechanical, Electrical, and Plumbing) solutions. With over 20 years of experience, they are ISO 9001:2015, ISO 14001:2015, and OSHAS 18001:2007 certified. Metec offers supply, installation, erection, and commissioning services for substations, panels, HVAC systems, access control systems, steel structures, storage tanks, and vessels. They serve industries such as Telecom & IT, Food Processing & Beverage, Automotive, Chemicals, and Pharma.
Conclusion
Pharmaceutical companies rely on HVAC systems. They regulate various parameters to ensure a perfect environment for producing drug and vaccinees. Selecting the right system for your facility requires careful consideration of its size, layout, and specific needs.
Venwiz can be a valuable resource in this process. Our extensive database connects you with pre-vetted HVAC vendors, ensuring you find the perfect partner for your facility environment.
For further insights into the latest developments in the manufacturing sector, visit our LinkedIn page.
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