Requirements and Maintenance of HVAC System in Manufacturing Facilities : Pharmaceutical Guidelines

Requirements and Maintenance of HVAC System in Manufacturing Facilities

Maintenance of Temperature and Humidity is essential in pharmaceutical manufacturing to produce a quality product. Maintenance of HVAC system within time is also important to save cost.
Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper environmental condition in the manufacturing area. Therefore, environmental conditions of manufacturing area is a critical factor to manufacture a high-quality product.

Importance of HVAC system at Manufacturing Facility

Production of high-quality products is often determined the environment under which the products are being processed. Pharmaceutical products require high quality because sometimes these are used in critical conditions. HVAC systems are meant to control humidity, temperature, air, and all forms of possible contamination during manufacturing processes.
HVAC System Maintenance

Need to Maintain Temperature & Humidity in Facility

Importance of maintaining a suitable level of temperature and humidity at your pharmaceutical facility is necessary for the following reasons:1. Drugs manufacturing processes require different levels of temperature for effective blending of main ingredients.
2. The manufacturing process of certain drugs leads to the generation of excess heat which if not controlled may lead to equipment damage or even explosions.
3. Certain drugs require cold storage after they are manufactured to ensure that their quality does not degenerate. For instance, if vaccines are exposed to higher temperatures, their levels of potency is lowered. If on the other hand they are stored under very low temperatures, they have produced an adverse and unexpected reaction (reactogenicity).
4. Many tablet drugs need to be coated with adhesive components that must be properly cooled to remain effective. Therefore the desired temperature levels must be provided.

5. Pathogens thrive in warm and humid conditions. If not controlled, products get exposed to contamination subjecting users to health risks.
6. High levels of humidity can directly affect the nature of certain drugs. For instance, some tablets may absorb excess moisture leading to their ineffectiveness or their quick deterioration.
7. There is need to comply with World Health Organization guidelines with regard to storage of pharmaceutical products. There is need to provide for storage conditions as required by different types of drugs. To achieve this, environmental conditions have to be monitored accordingly. Pharmaceutical products, according to the guidelines need to be kept in well ventilated and dry conditions with temperatures in the range of 15 to 25 °C.
8. It required to comply with conditions of regulatory body and regulations. Various government agencies are responsible for monitoring and ensuring that pharmaceutical firms comply with required environmental standards. Failure to do this would lead to the closing of facilities.

Breakdown Costs More

Frequent breakdowns in HVAC system cause production loss because HVAC breakdown means production breakdown in pharmaceuticals where you can't work without HVAC system. It takes time to repair the HVAC system that costs more than the repairing cost. It is better to schedule a preventive maintenance for HVAC system. It would prevent the breakdown during the manufacturing process and finally save production cost.

It is also important to have qualified and experienced engineering staff. It can cost more initially but in long term, it would save money and time and finally it would save manufacturing cost.

Controls of HVAC Temperature and Humidity

Temperature: HVAC systems are equipped with thermostats which allow you to control temperatures through system's remote controls. Depending on the specific environment, the system will automatically maintain configured temperatures.
Humidity: A special system unit called humidifier enables you to control humidity within your facility. While it can be installed as part of HVAC system, you may purchase it as an independent unit and have it installed by an expert in the area.

Conclusion

Investing in a comprehensive HVAC system is an essential requirement for your pharmaceutical firm for guaranteed quality and standard. Requirements can vary, and you may need customized solutions to fit your operations.

Other than having a working HVAC system in place, it is also essential to ensure the system is well maintained for smooth and efficient operation at all times. Having trained technicians ready to respond to service requirements is therefore of great significance.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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