Validation of Sterile zone's
Sterile zones is an modular environment in which the following factors are kept under control; temperature, relative humidity, air particles, microbes, differential pressure, and air flow. Validation is performed to meet required standard. A Sterile zone is an artificially created environment where air filtration and distribution, utilities, construction materials, instruments and equipments are maintained in a controlled manner. They are often employed in Healthcare industries and other precision based industries. The production and research area needs to be contamination-free thus Sterile zone play a very crucial role in these industries.
The dust particles, microbial matter, dirt, etc. can throw a negative impact on the activities being carried out in the laboratory. The Sterile zone are of absolute importance in the fields which are very sensitive like Biotechnology, Life sciences, Nanotechnology, Semiconductors, etc. The air penetrating into the sterile zones from outside is filtered to eliminate dust and other impurities.
To maintain the performance of Cleanrooms, they must be checked and validated after a specific period of time. Some of the Regulatory bodies like WHO and USFDA have enforced CGMP (Current Good Manufacturing Practice) specifying certain Rules and Regulations on different aspects for checking and ensuring the absence of any type of contamination in the Cleanrooms.
Spectro provide services based on latest information, innovative techniques and stringent decontaminating techniques for Cleanroom construction, validation, maintenance and inspection services as per the specified National and International Standards.. ISO 14644-1 is the current International Standard for defining contamination levels in a Cleanroom. Our trained personnel understand your delicate environment and assure you with the best of services and results.