As the name suggests, cleanrooms are workplaces with highly controlled contamination. It provides a conducive environment for extremely sensitive and intricate processes by ensuring low levels of airborne pollutants like dust, microbes, aerosol particles, bacteria, chemical vapours etc. Cleanrooms are required across a wide range of industries from the electronic industry to aerospace, information technology, automotive but it finds major application in the pharmaceutical industry to abide by the stringent manufacturing conditions. The requirement of cleanrooms is increasing with the growing emphasis on zero tolerance of defects, quality checks, and control to meet the Food and Drug Administration (FDA) and Current Good Manufacturing Practice (cGMP) certification.
Considering that pharmaceutical sector is vulnerable to contamination as it forms an intricate part of the healthcare industry, it is crucial to ensure the highest quality end products. Hence, the cleanrooms are designed and constructed in a manner that suffices a controlled environment with intensively regulated and monitored temperature, humidity, air motion, air pressure flow patterns, viable organisms, airborne particles etc. to render sterile and pure drugs along with germ free atmosphere for medical and biological applica tions. Therefore, quality air is essential for cleanrooms. But considering that the cleanrooms are large spaces, it becomes difficult to retain the sterility of the area. Moisture is a constant source of trouble intervening with the various pharmaceutical processes. Uncontrolled humidity is the major cause of microbial growth and corrosion. It is responsible for condensation on work surfaces leading to schedule delays and inferior quality products.
In addition to this, humidity often causes product spoilage resulting from contamination. Delving deep into the issue, the various pharmaceutical products are highly hygroscopic in nature and moisture-sensitive. Therefore, in the presence of high humidity in manufacturing facilities, fine powders tend to absorb moisture and disrupt the powder feed to the tableting press as a result of clogging. The powder inconsistency arising from moisture absorption is the major factor responsible for the crumbling and clogging of tablets. Compounding the already existing problems, there are instances of heat damage and moisture intrusion resulting from difficulty in adjustments in bed temperature and spraying rates due to variations in humidity. Additionally, humidity in air duct work offers just the right moist environment fostering the growth of bacterial colonies, further expediting the process of contamination. Therefore, effective humidity controlling mechanism should be in place to curb the moisture menace. Desiccant dehumidification technology is the most suitable solution for maintaining the dew points consistently at very low levels, achieving -60°C. It keeps the cleanroom relative humidity between a narrow range of 35- 40 per cent RH for all roundthe-year operations. Humidity is very critical in cleanrooms.
As stated above, on the one hand where too high humidity promotes bacterial growth, metal and equipment corrosion, condensation, and water absorption, on the other hand, low humidity resu lts in static build-up and discharge issues. Furthermore, poorly controlled humidity leaves uncomfortable working conditions for the employees. The desiccant-based dehumidification rightly provides the RH level that is constantly maintained within the close bandwidth of ±2 % RH at a temperature below 20′ C (70′ F). The technology is highly efficient at reducing air moisture beyond the level achieved by a standard HVAC-grade refrigeration system. The desiccant dehumidification works on the principle of passing the air through the desiccant medium which adsorbs moisture.
It comes with greater dehumidifying power, hence making use of a desiccant system along with a ir conditioning substantially reduces the load on the HVAC system. It is a great source of saving energy by adding to the efficiency of the HVAC system and also reduces its chances of wear and tear. Along with humidity, air contamination is another reason for concern in the cleanroom environment. Unclean air can take a toll on the employee’s health due to its hazardous nature full of harmful contaminants like hydrogen sulphide, sulphur dioxide, etc. that cause respira tory problems, headache, fatigue, and low productivity. The Gas Phase Filtration System is the most economical and effective process for the removal of corrosive gases. Cumulatively, the desiccant dehumidification and gas-phase filtration together protect the integrity of the processes and products within the clean room environment in the pharmaceutica l industry.
•Author is CEO of Bry-Air!
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