Pharmaceutical Cleanroom setup, Cleanroom setup, Cleanroom Validation

Cleanroom Validation

The pharmaceutical, aero space, medical, electronic, high-tech, semiconductor, and many other industries depend on cleanroom technology.  How to control the micro-organism is a key point to maintain the quality in medical or pharmaceuticals which can be performed by cleanroom. For pharmaceutical companies, clean, safe and contaminant-free products are imperative to manufacturing and distributing a viable product. Cleanroom play critical roles in maintaining contamination free production environments for critical processes.

The purpose of every cleanroom is to control an environment by limiting the presence of sub-micron particles and modifying inadequate environmental conditions. To ensure cleanroom is working as designed it is essential that a well planned and executed cleanroom validation testing,  certification and maintenance program is undertaken for operation and regulatory compliance.

To keep contaminants from entering the room in the first place, a pressurised environment is created by introducing air at ceiling level, after passing through a fan-powered HEPA filter. This creates an air pressure that is greater than that outside the cleanroom, which in turn pushes contaminants down towards the floor, and then out of the cleanroom through vents in the lower portions of the walls.

Parsan Engineers and consultants designed the process flow in a lean and efficient sequence, so that materials enter the cleanroom in one end and exit the other, with all necessary manufacture, assembly and packaging completed within the controlled environment, before it leaves.

Critical Role of Cleanroom is also maintained by wearing proper Cleanroom clothing. Clean room clothing is always worn by any member who will work inside, including a hair covering, booties and smock. A separate area is provided for gowning, whilst interior isolation is also enforced to prevent any chance of cross-contamination with the all-important end product.

When classifying a cleanroom, particle counts are performed at the work surface height. To ensure the cleanroom meets the required standard, pre-filters are used to remove the dirt and dust the human eye can actually see, whilst HEPA filters capture the minuscule particles that can’t be seen.

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