Enblok delivered the Aseptic Suite, along with the toxic and non-toxic cytotoxic isolators, as a turnkey project. The Aseptic Unit was self contained and serviced by dedicated, air-handling plants to ensure segregation expected by the MHRA. HEPA (High Efficiency Particulate Air) filters fitted on the air supply and external ducted air extract were to the appropriate ISO 14644-1 Classification of Air Cleanliness Standard.
Enbloc’s Validation Department carried out the commissioning and validation to achieve the MHRA licence including the DQ, IQ and OQ and continue to have an ongoing maintenance contract.
Vanguard Biovidenskab
Unit 1144 Regent Court, The Square, Gloucester Business Park, Gloucester, GL3 4AD
