Cleanrooms and all local containment equipments like Biosafety and Laminar Flow Cabinets are significant capital investments to perform research and manufacturing processes in a sterile and aseptic environment. Therefore, regular testing and validation of the cleanroom and its equipment is critical not just for regulatory compliance but also to avoid any unplanned downtime during critical operations. The core objective of regular testing and validation is to examine if the cleanroom is performing as per designed Cleanroom ISO 14644 Class conditions and reporting the observations.
Regular validation, in fact, reduces the risk of product flaws and expensive downtime. Besides, the quality of air in cleanrooms and clean air appliances is crucial for research and manufacturing processes that require sterile and predictable environmental conditions. It is critical in the research, manufacturing, laboratories, and sterile packaging facilities associated with industries, including aerospace, pharmaceuticals, research facilities, semiconductor, optics, and laser industries.
What is cleanroom and cleanroom equipment?
In order to assemble an aseptic manufacturing site, contaminants, including dust, airborne microorganisms, and aerosol particles, are filtered out in a cleanroom. Most cleanrooms are employed to produce sensitive products like electronics, pharmaceuticals, and medical appliances.
A cleanroom can be grouped into different contamination categories depending on the number of particles permitted per cubic meter. Additionally, cleanrooms can further control parameters, including moisture, humidity, airflow, and temperature.
A few items on the list of cleanroom equipment that need regular validation include Pass Boxes, Laminar Flow Work Stations, Air Showers, Fume Hoods, HEPA Filters, Replacement HEPA Filters, Ventilated Storage Cabinets, and other Enclosures.
Importance of validating cleanroom and equipment regularly:
Since cleanrooms and equipment are required for many different applications and in sterile manufacturing facilities, regularly validating both is vital for a number of inevitable reasons. Validating the equipment in the cleanroom contributes to ensuring that the facility’s design is fit for the intended purpose.
Additionally, it assures that the surroundings, machinery, and facility all meet the specific User Requirement Specifications (URS), adhere to established regulatory criteria, and work as a system to comply with specified standards.
Ending
Performing cleanroom validation at regular intervals (at least once a year) is necessary if you manage a cleanroom in research, medicinal, or sterile manufacturing facilities. Regular validation is important, as are monitoring, inspection, and certification. If not, there is a greater chance you won’t fulfill your statutory obligations. If there is any level of contamination arising in the cleanroom, the safety of your sterile manufacturing processes, products and personnel will be subjected to a greater risk.
Alpha Linear offers a broad array of services associated with cleanroom testing and validation through the help of our team of highly qualified validation engineers. We offer turnkey Cleanroom design to construction and assembly, through protocol document development and cleanroom validation. We work consultatively with our customers to give individually tailored acceptance criteria validating cleanrooms as per ISO 14644 or EU GMP standards.
Sources:
https://www.autocal.net/clean-room-area-validation.php
https://www.modular-cleanroom.net/cleanrooms/testing-validation/