Micronclean operate two distinctly different manufacturing cleanrooms in Skegness.
The ISO Class 5 Manufacturing Cleanroom in Skegness was our first manufacturing cleanroom. It was specifically designed and built to allow for the safe cleanroom dosing of alcohols and other disinfectants into trigger sprays, pre-saturated mops and wipes in dedicated LAF cabinets alongside the manufacture of other cleanroom consumable products.
In 2017, Micronclean designed, built and qualified a brand new purpose-built GMP Grace C (ISO Class 6) cleanroom for the assembly and packing of MicronDevices Sterile Packs. The design encompassed state of the art air handling and filtration systems, materials transfer capability, continuous pressure monitoring and a two-stage changing suite. Within this facility we have the capability to rapidly develop custom packs to meet customer specific requirements. In addition to custom packs, our in-house software BRC (Batch Record and Control) provides full traceability which is extremely beneficial to both Micronclean and its customers.
The ISO Class 6 cleanroom is fully qualified to ISO 14644-1 Class 6 (at rest) and EU GMP Grade C. In addition to annual re-qualification by specialist cleanroom validation engineers, the cleanroom is surveyed quarterly for particulate levels and every two weeks for microbiological counts. Micronclean have a laboratory in Skegness which has been carrying out environmental testing of the company’s various cleanrooms since 1989.
To always ensure continuity of supply to our customers, Micronclean does not operate a ‘just in time policy’ for any of its cleanroom products. Instead, we hold substantial stocks of both components and finished products meaning our customers never have to go without.