Requirements and Maintenance of HVAC System in Manufacturing Facilities : Pharmaguideline
  •   Pharmaguideline Courses Enroll Now
  • Aug 27, 2024

    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 conditions in the manufacturing area. Therefore, environmental conditions of the manufacturing area are critical factors in manufacturing a high-quality product.

    Importance of HVAC system at Manufacturing Facility

    Production of high-quality products is often determined by 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 the 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 are 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 a 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 the 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 commercial HVAC system cause production loss because HVAC breakdown means production breakdown in pharmaceuticals where you can't work without the HVAC system. It takes time to repair the HVAC system that costs more than the repairing cost. It is better to schedule preventive maintenance for the commercial 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 the long term, it would save money and time and finally it would save manufacturing cost.

    Controls of HVAC System 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 the 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.

    2 comments: Post Yours! Read Comment Policy ▼

    Please don't spam. Comments having links would not be published.


    Popular Categories

    QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
    Online Courses


    Follow Pharmaguideline



    DOCUMENTS

    PHARMACEUTICAL DOCUMENTS




    Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

    View


    adsbypg


    GET APP FOR NEWS UPDATES


    Android App