Cleanroom Validation Services

A Cleanroom 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 Cleanrooms play a very crucial role in these industries. Whether it is dust, microbes, moisture, chemical vapors or aerosol particles, any type of contamination is unacceptable. More precisely said, the inside area of a Cleanroom has a controlled level of contamination which is specified by the number of particles per cubic meter at a specific particle size.
The dust particles, microbial matter, dirt, etc. can throw a negative impact on the activities being carried out in the laboratory The Cleanrooms are of absolute importance in the fields which are very sensitive like Biotechnology, Life sciences, Nanotechnology, Semiconductors, etc. The air penetrating into the Cleanrooms from outside is filtered to eliminate dust and other impurities. To get rid of internally generated contaminants, the air inside the clean room keeps on circulating constantly through an Ultra Low Penetration Air (ULPA) or/and High Efficiency Particulate Air (HEPA). The entry and exit is made through airlocks which may include an air shower stage.
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.

Some of our Services for Cleanrooms Include:

• Airborne Particle Count Monitoring
• Bacterial count determination in air under specific operating conditions
• HEPA Filter Integrity Test.
• Compressed Air Testing Services as per ISO 8573
• Air Flow Visualization Study.
• Determining Microbiological Exposure on clothes and body of the personne
• Determination of Total Organic Carbon (TOC)
• OT Room Validation in Hospitals as per NABH Guidelines.
• AMC Services of OT Rooms.
• Fume Exhaust System-Testing and Validation Services
• HEPA Filter Leak Test
• Medical Compressed Air Testing as per USP and GA Guidelines
• Microbial sampling and enumerating the surfaces.
• Autoclave Validation Services/li>
• AMC Services for Cleanrooms
• Qualification of production facilities after installation, reconstruction and standstill, etc
• Velocity Measurements
• Light Intensity Test, Sound Level Test, Contaminant Test and Recovery Test in Cleanrooms

We offer a broad range of Environmental Monitoring Services for Cleanrooms and can also provide you with customized hygiene-monitoring programs to fulfill your needs.