Pharmabiz
 

Strict compliance norms make cleanrooms mandatory

Nandita Vijay, BengaluruThursday, April 24, 2014, 08:00 Hrs  [IST]

Due to clean air requirements, a stringent compliance parameter in almost all pharma manufacturing and storage facilities make cleanroom awareness and requirements to become a basic necessity. Modifications in products, increasing production capacities and adding new products requires the cleanroom facilities also to be modified or expanded.

A cleanroom constructed with pre-fabricated panel construction have the provisions to be modified as the room dimensions can be increased or decreased to suit the new requirements. With a finalized plan, the modifications can be taken up with ease and within a fairly less time compared to similar activities with civil construction.

Cleanrooms are built to minimize dust and microbial particles in the air that is being circulated. The room air pressure is also maintained and controlled based on the process requirements. Cleanrooms are also categorized on the type of air pressure maintained within the cleanroom. For air-borne particles which are contagious, the cleanrooms are maintained with negative air pressures so that the contagious air does not move out of the room. This air is filtered and thrown into the atmosphere. In cases where the process cannot tolerate dust particles beyond a certain particle size inside the clean room, the dust particles in the room are always maintained within the prescribed range and also these rooms are always monitored at a positive pressure higher than the surrounding so that the unwanted dust particles do not enter this clean room from outside. Most of the pharmaceutical units do have cleanroom requirement for their daily manufacturing requirements, P Sukumaran, Executive Director, Rinac India Ltd told Pharmabiz in an interaction.

There are several players in the country in the cleanroom space providing equipment, infrastructure and the solutions. Iclean, Fabtech, GMP are leading names in India for HVAC and related clean room facilities

Rinac India Ltd manufactures double skin insulated sandwiched panels which are used in the pharma / food / automobile industry for the clean zone applications – walls and ceiling. “Our product range covers the industrial double skin panels with accessories, doors, view windows etc. The panels are manufactured in their two manufacturing facilities- one in Maharashtra, Murbad near Kalyan and at the other unit in Karnataka, Tavarekere, Magadi Main Road, Bengaluru Rural”, he added.

The panels from the manufacturing unit in Murbad are manufactured from the automatic continuous line. These panels have a maximum width of 1,000mm and lengths even more than 12,000 mm. While using these panels for ceiling application, one to two cut-outs per panel can be made depending on the panel thickness and panel span. The cut outs can be made either at factory or at site depending upon the site requirements. The insulation material will be either RPUF ( Rigid Polyurethane Foam ) or PIR ( Poly Isocynurate Rigid Foam) sandwiched between Pre Painted Galvanised Sheets on either sides, explained R Anish Simha, Sr. General Manager, Rinac India.

The panels from the manufacturing unit based in Bengaluru are manufactured from the semi automatic production line facility. The maximum panel width is 1,200mm and length about 8,000mm. At this unit, we can cater to pre- painted galvanised iron sheet on one either sides, PPGI on one side of the panel and SS on the other, SS on either sides etc based on the specific requirement. The insulating material can be either RPUF or rock wool. Standard accessories are PVC covings, view windows, doors etc. Embedded return air risers and embedded conducts are additional features that can be provided, informed Simha. Apart from the wide range of manufacturing capabilities, Rinac is equipped with experienced design and execution team to meet customer’s project schedules.

The company has chipped in its expertise in cleanroom for pharma majors including Biological Evans, DRL, Aurobindo Pharma, Orchid Chemicals, Biocon, Syngene, Origin Discovery, Aventis etc to name a few. “Our panels used in clean zones have been installed abroad by a few agencies. There are more that four to five players catering to this sector of the industry. However considering the wide range of products and its flexibility, all under one roof, Rinac has an added advantage, added Simha.

The cleanroom market is growing and customer’s expectations for delivery, on time completion, quality to meet requirements of various certifying agencies, economical solutions etc are need of the hour. Rinac has been able to keep up these requirements and is geared up to put in all required efforts to keep meeting the ever- increasing customer’s needs. Rinac cleanroom panels have been supplied and installed in many cleanrooms for various clients and could successfully meet the end user requirements, said Sukumaran.

 
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