The Critical Role of Cleanroom
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 […]
The Process for Undertaking Air Particle Counts
The particulate tests are done using Climet – CI-752X calibrated air particle counter. The Process for Undertaking Air Particle Counts is done as per OEM best practice guidelines. Airborne particulate testing requires to confirm the level of air quality against the Cleanroom ISO 14644-1 standard for Clean rooms. The Process for Undertaking Air Particle Counts […]
Clean room Industry in India – on the path to progress
The cleanroom industry is one of the major industries growing at lightning speed in today’s world. Increasing Global health crisishas made it imperative that the pharmaceutical industry moves at a rapid pace alongside researchers, regulators, and contract research companies to develop a diagnosis, treatment, and vaccines. Cleanroom technologies and services play an important role in […]
Why regular HVAC/clean room Validation is important statutory requirement in Pharma or medical device Industry?
HVAC/Cleanroom Validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines. Process parameters and controls are determined during the validation of any process or system. Only installing HVAC (Heating Ventilation and Air conditioning) system isn’t always completely effective until a […]
Potential Cleanroom Validation Hazards
For maintaining the health and safety and adhering to the high standards of a controlled cleanroom environment requires thorough training and routine testing and inspections because there are many potential hazards in clean rooms. Several common cleanroom validation hazards are listed below: Pass Through Areas –if onehas to bring a lot of equipment and parts […]