CLEANROOM
Certified ISO 14644 Class 7 Cleanroom
Liquidyne offers a wide range of disposable and single-use systems produced in the only state-of-the-art, certified clean room in the State of Colorado. Pharmaceutical and biotechnology companies currently use disposable technologies in their manufacturing process because of the benefits the systems provide, including: - Faster time-to-market with quicker build and validation of facilities - Lower costs with reduced capital investments - Less risk of cross-contamination - Optimized process efficiency - Elimination of cleaning and cleaning validation requirements - Higher throughputs with faster turnaround times - Reduced plant complexity. Our cleanroom is a modular unit comprising an ISO 8 transfer area into an ISO 7 production area. It’s also environmentally monitored in compliance with the ISO standards and our other internal quality standards. These controls ensure our ability to control the particulate and microorganisms present on the product. This is critical in supporting customer needs as well as the progress toward sterilization validation. The validation of the sterilization process helps support customer needs for sterile single use custom assemblies. We can provide you with modular, pre-assembled and gamma-irradiated single-use systems that are closed, sterile, and ready-to-use. With our direct access to the industry’s best-in-class manufacturers.
Class 7 Certified Cleanroom
The foundation of cleanroom standards is the micrometer or micron. The micron is the size of the particles to be filtered from the cleanroom. A cleanroom's classification is determined by how clean the air is associated with the number of particles per volume of air. Liquidyne's cleanroom is ISO 14644 Class 7 certified. This class certification means that particles smaller than 0.5 microns are not considered. Class 7 certified cleanrooms have a concentration of particles of ≥0.5 microns and above should be below 352,000. For particles 1 micron and above, concentration per volume of air is 83,200 or lower, and for particles of 5 microns and above 2,930 or lower.
Certified ISO 14644 Class 7 Cleanroom
The foundation of cleanroom standards is the micrometer or micron. The micron is the size of the particles to be filtered from the cleanroom. A cleanroom's classification is determined by how clean the air is associated with the number of particles per volume of air. Liquidyne's cleanroom is ISO 14644 Class 7 certified. This class certification means that particles smaller than 0.5 microns are not considered. Class 7 certified cleanrooms have a concentration of particles of ≥0.5 microns and above should be below 352,000. For particles 1 micron and above, concentration per volume of air is 83,200 or lower, and for particles of 5 microns and above 2,930 or lower.
At Liquidyne, we prioritize our commitment to quality and consistency. In 2017 we achieved ISO 9001:2015 Quality Management System certification to ensure we can repeatedly deliver consistently high-quality products and solutions. Being ISO 9001:2015 QMS Certified by Orion Registrar, Inc, together with our USP Class VI Testing, ASME Bioprocessing Equipment (BPE), and EHEDG certification guarantee, we have the methodologies to assure quality. We will quickly and accurately rectify any issues if any of our products are ever in non-conformance.
Get In Touch
About your project