Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

What is HVAC? A system that deals with heating, ventilation and air conditioning is collectively termed as HVAC system. Sometimes it is called central heating or central air conditioning system and use air ducts by which it moves the air throughout the building. At one time considered a luxury, HVAC systems are now commonplace in new buildings, while it is an essential element in manufacturing industries because this system helps to control and maintain the temperature, humidity and air quality of the building. The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. In some countries, the GMP follows largely the country of the principal technology provider. All GMPs have one common theme which is cleanliness in all aspects. As per WHO and FDA the major emphasis in cGMP is on cleanliness and as for as the cleanliness of air is concern HVAC is the need of hour which confirms and assures the clean environment/atmosphere. What can HVAC do? HVAC system performs four basic functions: 1. Control airborne particles, dust and micro-organisms Thru air filtration using high efficiency particulate air (HEPA) filters. 2. Maintain room pressure (delta P). 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 (through doors or other openings) to reduce the chance of airborne contamination. This is achieved by the HVAC system providing more air into the cleaner space than is mechanically removed from that same space. 3. Maintain space moisture (Relative Humidity). Humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers. Humidity can affect the efficacy and stability of drugs and is sometimes important to effectively mould the tablets.

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

4. Maintain space temperature. Temperature can affect production directly or indirectly by fostering the growth of microbial contaminants on workers. Each of above parameter is controlled and evaluated in light of its potential to impact product quality. What HVAC cant do? 1. HVAC cannot clean up the surfaces of a contaminated surfaces, room or equipment 2. HVAC cannot compensate for workers who do not follow procedures

Parts of an HVAC system include the heating or air conditioning unit, the ductwork, and vents, both intake and outflow. The intake vents return air to the heating and cooling units through the ducts. The outflow vents distribute heated or cooled air throughout the building. A thermostat barometer and hygrometer are also considered parts of this system. Besides these meters, in order to maintain the particulate quality and microbiology of air certain types of filters are also used which are generally termed as pocket filters. A pocket filter is an air filter with pockets that is used with heating, ventilation and air conditioning (HVAC) filter appliances. It is used for reducing dust in the air. A pocket filter also can take in many other particle types. There are two types of material used for pocket filters: glass fiber and synthetic fibers and HEPA filters. Heating Central heating often used in cold climates to heat private houses and public buildings. Heating systems usually comprise of a boiler, furnace, heat pump or district hot water to heat water, steam or air. Piping distributes heated fluid and radiators transfer this heat to air and structures, e.g. floor heating system Ventilation It is the process of changing or replacing air in any space to control temperature or remove moisture, smoke, carbon dioxide, etc. Ventilation includes both the exchange of air to the outside as well as circulation of air within the building. It is one of the most

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

important factors for maintaining acceptable indoor air quality in buildings. Supplied air used for ventilation is filtered and cooled and/or heated inside air handling units. Air conditioning It refers to the cooling and de-humidification of indoor air for thermal comfort. Air conditioning systems are designed to stabilize the air temperature and humidity within an area. Excess heat from the circulating air is usually removed by a cooling coil that is supplied with cold water. To decrease relative humidity the circulating air needs to be cooled to a temperature below the dew point and then heated back to meet the requirement Air filtration The American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) recommend three types of filters with HVAC system.

1. Fiberglass filter: This throwaway air filter is the most common type. Layered fiberglass fibers are laid over each other to form the filter media and typically are reinforced with a metal grating that supports the fiberglass to prevent failure and collapse. 2. Polyester and pleated filters: These filters are similar to fiberglass filters but typically have a higher resistance to airflow and a superior duststopping ability. 3. High efficiency particulate arrestance (HEPA) filters: These units filter the air passing through them at a very fine scale. HEPA filters have the capability to filter 99.97 percent of all particles 0.3 microns or larger.

Composition of HVAC system A standard HVAC system consists of following parts: Starter panels Most motors (fans, pumps) are controlled through starter panels. Starter panels

usually include Run status indication Trip alarm indication (and reset)

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

H-0-A indication On/Off control (power) VFD control signal and feedback Relays These are the electrical switches used for controlling electrical circuits with other circuits of the system. Usually a hard current circuit is controlled with a weak current circuit. Relays are used for controlling devices that need to be powered off completely e.g. light groups, pumps, VFDs etc

Duct System It is the piping all over the organization which delivers the outcome of the HVAC system, Duct system should be carefully designed and special attention should be given to the air and heat leakage, the outer covering must be of good heat insulating material in order to minimize vapor condensation Air Handling Units (AHU) Air handling units are used for circulating air inside a building or a part of a building. AHU consists of two fans (exhaust and supply), filters, a heat recovery unit, and one or more coils for heating/cooling. To improve air quality circulating air is mixed with fresh air from fresh air handling units (FAHU).Usually equipped with a heat recovery unit for energy saving purposes. Supply air temperature kept constant so that temperature can be adjusted locally with thermostats. A standard air handling unit further divided into: Fresh air handling units (FAHU) Exhaust fans Supply fans Fan coil units (FCU) Variable air volume (VAV) systems

Besides these basic parts of air supply system, air handling units also equipped with some sensors too which include: Variable frequency drives

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

Variable frequency drive is a system for controlling the rotational speed of an alternating current (AC) electric motor by controlling the frequency of the electrical power supplied to the motor. Valves & valve drives Valves are used to control the flow of fluids in pipes. Valve drives are used to open and close valves with an electrical input command. Concentration sensors Typically carbon monoxide (CO) or carbon dioxide (CO2) concentrations are measured and if concentration exceeds 700 ppm more ventilation is needed Relative humidity sensors Usually includes temperature measurement as most relative humidity sensors use temperature compensation to reach more accurate results. Pressure sensors Pressure sensor measures the difference between two pressures introduced as inputs to the sensing unit, for example, measuring the pressure drop across a filter in an AHU When selecting an appropriate transducer it is important to know the measured range which should be at a difference of at least 5mmHg. Temperature sensors It include electric thermometers which detect the temperature difference between two certain areas and control the automatic switching and shifting of the units The principle scheme of the air flow in an HVAC system is given below

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

Airflow diagram
1. External fresh air inlet. 2. Heat Exchange Unit. Exhaust air to be released in the atmosphere is used to normalize the temperature of the incoming fresh air. 3. Fresh air intake conduit. Supplies fresh air to the distributor. 4. Distributor. Electronically controlled, it manages the air flowing into the cooling and heating units and the ratio of fresh to recycled air. 5. Air supply ducts. Supply air to the heating and cooling units. 6. Filters. Remove the smallest particles of dust, smoke, pollens and other contaminants. 7. Cooling (A/C) Unit. Electronically controlled, cools down the intake air to a temperature as a function of demand and other environment variables. 8. Cold air fan. Variable speed turbine type fan that maintains certain (positive) pressure in the cold air column. 9. Cold air column. Delivers cold air throughout the building. 10. Heating (Furnace) Unit. Electronically controlled, heats up the intake air to a temperature as a function of demand and other environment variables. 11. Warm air fan. Variable speed turbine type fan that maintains certain (positive) pressure in the warm air column.

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

12. Warm air column. Delivers warm air throughout the building. 13. Fresh air inlet. Electronically controlled, it allows a mixture of cold and warm air from the respective columns in the room. 14. Exhaust air outlets. Electronically controlled, remove exhaust air from the room. 15. Exhaust air column. Delivers the exhaust air from the building back to the power plant to complete the cycle. 16. Exhaust air fan. Variable speed turbine type fan that maintains certain (negative) pressure in the exhaust air column. 17. Recycled air distributor. Electronically controlled, it manages the volume of exhaust air released in the atmosphere and the portion of it used for recycling. 18. Exhaust air conduit. Air to be released is forced into the Heat Exchange Unit, where it is used to normalize the temperature of the incoming fresh air. 19. External exhaust air outlet.

Some suggested readings EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. HVAC: heating, ventilating, and air conditioning. Homewood, Illinois: American Technical Publishers. Swenson, S. Don (1995) Encyclopedic. Britannica Online. 2009. Indoor Air Quality and HVAC Systems. New York: Lewis Publishers. Bearg, David W. (1993). Ventilation and Infiltration chapter, Fundamentals volume of the ASHRAE Handbook, ASHRAE, Inc., Atlanta, Georgia, 2005 Air Change Rates for typical Rooms and Buildings. The Engineering ToolBox Room Air Change Rate. A Design Guide for Energy-Efficient Research Laboratories. Bell, Geoffrey. Geothermal HVAC: Heating and Cooling. United States of America: McGraw-Hill Companies. Egg, J (2011). Guidance for Filtration and Air-Cleaning Systems to Protect Building Environments. Howard, J (2003). Building environment standards. www.iso.org.

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Industrial Pharmacy/2013

Doc. No. Chp.IP.5/03/ 2013

Use of HVAC In Pharmaceutical Industry

Section Area Temperature Dry Products Manufacturing Section 1) Granulation (wet) NMT 30oC Granulation (dry) NMT 30oC 2) Compression NMT 30oC Lubrication NMT 30oC 3) Coating NMT 30oC Dry syrup filling NMT 30oC 1) Blistering NMT 30oC 2) packing NMT 30oC Steroid Section Lubrication NMT 30oC Compression NMT 30oC Packing NMT 30oC Penicillin section Lubrication NMT 30oC Encapsulation NMT 30oC Blistering and packing NMT 30oC Dry Powder filling NMT 30oC Oral Liquids Section 1) Manufacturing NMT 30oC section 2) Syrup storage NMT 30oC 3) Syrup filling and NMT 30oC Packing External Preparations Section 1) Manufacturing area NMT 30oC 2) Batch storage NMT 30oC 3) Filling and packing NMT 30oC Repackaging Section 1) Packing NMT 30oC Material Storage Section Raw material bulk store NMT 30oC Finished goods NMT 30oC Quality Control Lab Retained Section NMT 30oC Instrument Room NMT 32oC

Relative Humidity N. A NMT 45 % NMT 45 % NMT 45 % N.A NMT 45 % NMT 45 % NMT 45 % 45 5 % 45 5 % 45 5 % 45 5 % 45 5 % 45 5 % 45 5 % N.A N.A N.A

N.A N.A N.A N. A N. A N. A NMT 50% NMT 50%

NMT= Not More Than N.A= Not Applicable There must be a pressure difference of at least 5mmHg between corridor and section/room (Delta pressure), particularly negative pressure in corridor so that the contaminated air from the corridor may not enter into production area. As per WHO guidelines for cGMP recommends the clarity of air of production area should be 99.97%.

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