The pharmaceutical industry building adopts the centralised air-conditioning system with the characteristics of complicated structure, numerous equipment, relatively concentrated, high level of energy consumption, flexibility larger. Energy consumption and energy efficiency have been an argument. It was a very good solution for pharmaceutical companies. So, the heating, ventilation and air system encompass heating, ventilation and air-conditioning (HVAC) which is an integral component of pharmaceutical facility functionality. The system is needed for the maintenance of a suitable temperature, for continuous flow of air, which ultimately prevents cross-contamination and accumulation of air and to ensure the cooling of air in the premises. The three core facets of HVAC system validation comprise of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Validation of HVAC system is an essential subject to provide documented evidence about the accuracy of results produced by it. The validation of HVAC system involves systemised and assembled documents of functional specifications and design. The various parameters to be evaluated for the validation of HVAC system include airflow pattern, airflow velocity, air changes per hour, filter leak test, particle count, viable monitoring, filter integrity test, pressure difference, recovery test for temperature and humidity, temperature and humidity uniformity, and fresh air determination.
Introduction
Validation is a very vast topic in the field of pharmaceutical sciences. It ensures the accuracy of results being produced by any system. Maintenance of quality of products is of great importance, especially in the field of pharmacy as this field deals with drugs which directly affect the human body. The HVAC system is an extremely vital concern, which aids to enhance and maintain the quality of drug products. It assists in achieving an adequate temperature, ventilation, and airconditioning in the premises. The HVAC system design has an immense impact on the prevention and control of cross-contamination and for the achievement of a hygienic condition at the workplace. Temperature and ventilation are very important parameters to be perpetuated during the processing as well as storage of the various drug substances and drug products, which ultimately influence their standard. Airconditioning not only means cooling of air but also embrace temperature, moisture in the air (humidity), the supply of outside air for ventilation, filtration of airborne particles, and air movement in the occupied space. HVAC systems are of great importance to architectural design efforts for four main reasons. Firstly, these systems often require substantial floor space and/or building volume for equipment and distribution elements that must be accommodated during the design process. Secondly, HVAC systems constitute a major budget item for numerous common building types. Thirdly, the success or failure of thermal comfort efforts is usually directly related to the success or failure of a building’s HVAC systems (when passive systems are not used), even though the HVAC systems should be viewed as part of the larger architectural system. Last, but not least, maintaining appropriate thermal conditions through HVAC system operation is a major driver of building energy consumption. Through field investigation, the pharmaceutical factory adopts a shift working system, 8 hours per shift, working time of 250 days, the production cycle of each batch of a drug for 7 days, after each production cycle need for equipment maintenance and disinfection. Fans run for 24 hours at the rate of 40 ~ 45Hz on production and the rate of 30 ~ 35Hz on duty. Through the data statistics of 2012, a conclusion was reached to energy.
Power consumption of clean area was such as shown in Fig. 2. Fig. 2 shows that the power consumption load of the pharmaceutical production workshop was very high. In A class zone, fan power consumption was up to 0.92kW/m2; Cooling and lighting power consumption were respectively 0.25 kW/m2 and 0.04 kW/m2. In B class zone, fan power consumption was 0.15 kW/m2;Cooling and lighting power consumption were 0.19 kW/m2 and 0.04 kW/m2. In C class zone, fan power consumption was 0.10 kW/m2; Cooling and lighting power consumption were 0.15 kW/m2 and 0.03kW/m2. In D class zone, fan power consumption was 0.05kW/m2; Cooling and lighting power consumption were 0.13 kW/m2 and 0.03 kW/m2. Among all kinds of power consumption, fan power consumption was larger. Fan power consumption in A class-zone was 18.4 times that in D class zone, and the level of lighting power consumption was no less essential. Therefore, to meet the purification production condition, lower the level or the area of cleanroom was air for ventilation, filtration of airborne particles, and air movement in the occupied space. HVAC systems are of great importance to architectural design efforts for four main reasons. Firstly, these systems often require substantial floor space and/or building volume for equipment and distribution elements that must be accommodated during the design process. Secondly, HVAC systems constitute a major budget item for numerous common building types. Thirdly, the success or failure of thermal comfort efforts is usually directly related to the success or failure of a building’s HVAC systems (when passive systems are not used), even though the HVAC systems should be viewed as part of the larger architectural system. Last, but not least, maintaining appropriate thermal conditions through HVAC system operation is a major driver of building energy consumption. Through field investigation, the pharmaceutical factory adopts a shift working system, 8 hours per shift, working time of 250 days, the production cycle of each batch of a drug for 7 days, after each production cycle need for equipment maintenance and disinfection. Fans run for 24 hours at the rate of 40 ~ 45Hz on production and the rate of 30 ~ 35Hz on duty. Through the data statistics of 2012, a conclusion was reached to energy.
In A class zone, fan power consumption was up to 0.92kW/m2; Cooling and lighting power consumption were respectively 0.25 kW/m2 and 0.04 kW/m2. In B class zone, fan power consumption was 0.15 kW/m2;Cooling and lighting power consumption were 0.19 kW/m2 and 0.04 kW/m2. In C class zone, fan power consumption was 0.10 kW/m2; Cooling and lighting power consumption were 0.15 kW/m2 and 0.03kW/m2. In D class zone, fan power consumption was 0.05kW/m2; Cooling and lighting power consumption were 0.13 kW/m2 and 0.03 kW/m2. Among all kinds of power consumption, fan power consumption was larger. Fan power consumption in A-class zone was 18.4 times that in D class zone, and the level of lighting power consumption was no less essential. Therefore, to meet the purification production condition, lower the level or the area of cleanroom was an effective energy-saving measure to reduce the energy consumption of the fan.
Storage in pharmaceutical parts
Many products can be safely stored at uncontrolled room temperature. However, the temperature in the upper part of a store can exceed (+) 40-degree C even in temperate climates. In cold climates, the temperature will drop below freezing in unheated stores. Such temperature extremes may damage some items.
The potency of vaccines, sera, test kits, and many other items depends on cold storage. Vaccines, in particular, are temperature-sensitive and must be kept at a precisely controlled temperature from the point of manufacture to the point of administration. Cold chain defects are a frequent cause of problems in immunisation programs. Narcotics and other controlled substances should be kept in a secure room or in a safe. Ideally, a red warning light or warning bell that will activate when the door is unlocked should be fixed close to the store. The keys to the secure storage should be kept in safe. For the evaluation of this parameter, a titanium tetrachloride stick is taken and burnt and the burning stick is placed in front of the air handling unit (AHU). The distribution of smoke is observed. It should be uniform. To achieve appropriate cleanliness in the premises, high-efficiency particulate air (HEPA) filters are used. The HEPA filters are employed to ensure the aseptic condition. The integrity of the filters should be checked at regular intervals by performing a leak test. HEPA filters are a part of the AHU. The area of HVAC is divided into four hypothetical grids and the air velocity is measured at each grid and then the average air velocity (V) is calculated. The area of the HEPA filter inlet (A) is calculated in feet and the total air volume (T) is then calculated by multiplying the average velocity of the air and the area of the inlet (T = A × V). After this, the volume of the room is calculated and the air changes per hour are obtained by dividing the total air change by the volume of the room. In the AHU, the outside fresh air, combined with the return air from the cubicles, is treated by AHU and supplied to the laboratory area. A part of the air exiting from the laboratory rooms is directly exhausted into the atmosphere by an exhaust fan, while the remaining air is recirculated to the AHU as return air by a return fan. The air entering into the AHU is filtered by pre-filters and medium filters and then air-conditioned for humidity and temperature control and is supplied to the laboratory area by a supply fan at the desired pressure. The supply air is terminally filtered by HEPA filers at the entrance to the clean rooms. The fresh air intake is observed at the inlet on the fresh air damper. The total air change is calculated. The intake fresh air is divided by the total air change in the room and multiplied by 100 to obtain the per cent fresh air intake on each cycle by the HVAC system in all the individual rooms. The uniformity of temperature and humidity are monitored by employing a calibrated thermometer and manometer, respectively. The two parameters are monitored on a daily basis, documented in the format and stabilisation is ensured within the specified limit. It is calculated by making use of the manometer attached at the walls of the adjacent area. The pressure difference is generally kept between 5 and 20 mmHg pressure. The recovery of temperature and humidity is checked. For this, the humidity and temperature are checked at the off position of the HVAC system. Then the humidity is increased to 75 per cent and temperature to 400-degree C and again the temperature and humidity are measured after switching on the HVAC system, and the time required to stabilise the temperature and humidity is noted.
The designer to determine the type of heat recovery used to transfer heat between the exhaust air stream and the fresh outdoor airstream, such as:
• Enthalpy wheel—rotation transfers both heat and moisture between two side-by-side airstreams.
• Heat pipe—a sealed pipe with refrigerant that transfers heat between side-by-side airstreams.
• Air-to-air heat exchanger—typically a plate-and-frame heat exchanger that transfers heat between two side-by-side airstreams
• Run-around loop—a system that pumps heat-transfer fluid between two heat exchangers, one in the outdoor airstream and the other in the exhaust. Outdoor air (OA) rates for pharmaceutical manufacturing clean and utility spaces typically range between 5 per cent and 15 per cent.
Cleanroom air change rates are high and drive small temperature differentials between supply air and room set points. Mixing return air with OA at 5 per cent–15 per cent at design winter conditions is more likely to lead to a cooling load rather than a heating load, making heat recovery on these systems ineffective. Air-handling systems with low air-change rates—such as those for mechanical utility spaces—do not benefit from exhaust-air heat recovery either. These areas have equipment that emits enough heat to eliminate the need for heating throughout the year. Some of the general requirements may be stated in the form of certain parameters like:
- Size of the equipment
- Speed of the equipment
- Effectiveness of the equipment
- Availability of spares, change parts, and prompt services at a reasonable cost
- Ease of operation, cleaning, and maintenance
- Low dust and sound generation
- Lesser breakdowns
- Materials of construction
- Auto-control system
- Easy changeover
- Overall good construction and workmanship
The fresh air intake is observed at the inlet on the fresh air damper. The total air change is calculated. The intake fresh air is divided by the total air change in the room and multiplied by 100 to obtain the per cent fresh air intake on each cycle by the HVAC system in all the individual rooms.
Distribution channel in India
There are many activities in the area of cold chain management in pharmaceuticals due to increased government initiative and funding in this area. India has an old but quite good public distribution system for pharmaceuticals across the country. The major pharmaceuticals are in localised pockets near to Delhi and are distributed all over the country from there.
Warehousing in pharmaceuticals cold supply chains is a very big problem in this case. This sector is rather unorganised and inefficient and the public distribution system in pharmaceuticals is not very effective either. There is a lot of wastage during storage, lead times are high and security issues are not considered. The aim would be to develop good warehouses and cold chains. So finally, the pharmaceuticals cold chain needs to be improved significantly. Therefore, the government is currently making substantial investments in this area, mainly in the pharmaceutical cold chains though. Even though the logistics sector is growing, whether it is roads, aviation, railways, containers or the use of various modes of transport, the amount of the technical knowledge in the sector is quite low. But in the manufacturing part of the curriculum, workers have an understanding of different technologies so that they can find a natural way to enter those sectors. In the areas of logistics, there is a great need for education, but there are not enough institutions that offer training in logistics. However, the skill development efforts in the transportation, warehousing and packaging sector are an important trend. Not only skills but also attitude and behaviour are important in managing pharmaceuticals cold chains need to be dramatically improved. India is a very rapidly developing country, especially when it comes to its infrastructure. For co-operations, the needs of other countries should be identified in order to find concrete and efficient solutions to reach a win-win situation for both sides.
Conclusions
The pharmaceutical plants are a venue where facilities are provided for medicine research also. The installation of the HVAC system to that place has an important role in controlling the comfort, IAQ, aseptic conditions and suitable indoor thermal conditions for creating an ideal working environment to researchers and staff and drug manufacturing plant. The IAQ and thermal comfort in the plant side is important as it may affect the work and health of the workers and the quality of drugs.
A very clean indoor environment for pharmaceutical goods and thermal comfort for productivity and satisfaction of indoor building occupants are the characteristics of a pharmaceutical plant. To ensure a clean environment the IAQ must be maintained within the acceptable limit suggested by ASHRAE. A pharmaceutical plant always has a chemical and a washing room where TVOC (total volatile organic compound) concentration is obviously too high. There should be an increased ventilation rate for better dilution in order to keep the TVOC concentration below the standard limits. In order to minimise the energy use, the temperature setpoint for room air should be in between 22.5 and 26-degree C.
