Overview Of The Cleanroom Industry In Modern Times

Prospects of the Indian cleanroom equipment industry

The main driving factor for innovation in the cleanroom equipment industry is the evolving industrial sector. Increasing industrial activity among sectors has led to tightening of safety regulations & high standards of workplace protection, this has been a major macroeconomic boom factor in the cleanroom equipment industry. The focus of innovation has been on the areas of maximum operational safety, ease of functioning, easy disposal of, cost-efficiency, and low maintenance of Cleanroom equipment. Growth prospects are abounding across East, South Asian, and Middle East African regions.

Impact of Covid on Cleanroom Equipment Industry

The global health crisis triggered by COVID – 19 has made it imperative for Cleanroom Equipment Industry to move at a rapid pace along with researchers, regulators, and contract research companies to develop diagnoses, treatments, and vaccines. Healthcare professionals require tremendous challenges in providing specific and effective care in a controlled environment, thus cleanroom equipment that comes in contact with diagnostics has to maintain the highest standards to prevent the risk of infection. High operational costs of cleanroom equipment have also been a major driver across pharmaceutical and medical device manufacturers in deciding the economics of the sector.

Which segments of the cleanroom equipment have the maximum growth opportunities?

The global cleanroom equipment market is segmented based on type, end-use industry, and region. Major growth is expected in the HVAC system cleanroom equipment system based on its temperature maintenance characteristics. Demand for replacing the conventional cleanroom technology with restricted access barrier systems (RABS) and isolators has increased given the COVID-19 pandemic and the stringent codes it bought.

Strength, weakness, opportunities, and threats faced by the Cleanroom Industry

Growth prospects are high across the East Asian, South Asian & Middle East & African healthcare sectors, while technological advancements in the production of cleanroom equipment are anticipated to create significant opportunities for cleanroom equipment. Furthermore, maximum operational safety, ease in functioning, ease of disposing, cost-efficiency, and low maintenance are highly anticipated to propel the demand for cleanroom equipment across various end-use industries. Key restraining factors such as low replacement rate of maximum cleanroom equipment, the complex installation process of cleanroom equipment, and reluctance in setting up a cleanroom facility in developing and undeveloped economies, may hinder growth over the forecast period.

Steps needed to be taken for the improvement of the industry

The use and maintenance of cleanroom equipment is a complex process. Proper SOPs and standards need to be developed & regulated to stay abreast of the large technological growth in cleanroom equipment. Regulations need to provide requirements with respect to the environmental, product, or facility parameters which are expected from the equipment. Training and protocols of installation need to be provided by the manufacturer to ensure no damage occurs to end users’ facility, personnel, or product. Cost-effective replacement of parts should be developed to reduce the replacement rate of the equipment.

What are govt regulations for the industry?

India follows EU cGMP standards along with ISO 14644-1 standard for cleanroom equipment. Standards like FDA are applicable only when dealing with end-users located in US or countries following US standards. Strict regulations need to be enforced on manufacturers who are trying to beat the pricing by passing inferior quality equipment to end-users. Particular cleanroom equipment requires specific testing instruments, regulated SOPs, and personnel, for eg: HEPA filters, Dispersed oil particle testing/Integrity testing should be ensured to make sure that they meet the efficiency specification and are properly seated in their frames.

What kind of support do you expect from the government?

Any incentives given to the pharmaceutical industry will indirectly boost the cleanroom equipment industry. It is essential that the development of pharmaceutical HUBS & SEZ is increased. There should be a focus on establishing material testing labs & facilities in industrial clusters. This provides the equipment manufacturers as well as end-users the ability to get their materials tested before or on delivery to differentiate between products.