During 2013 SciQuip Ltd completed the installation of one of our large MMM Venticell 1L Depyrogenation Chambers to an FDA approved British Contract Drug Manufacturer in Newcastle.
The new plant for production required a large hot-air sterilization chamber with depyrogenation for fast, volume depyrogenation and hot air sterilisation of glass ampoules before filling on the production line. The MMM Venticell 1L, 1500 litre class 5 fulfilled all of our clients requirements with multiple parameter control including sufficient speed of cycle, temperature stability, complex solution for the loading system, additional measuring of various pressure differentials and control via a state of the art SIEMENS PLC system from both sides of the device. The Venticell 1L Depyrogenation oven complies with the GAMP 5 standard.
The sterilization chamber with depyrogenation had to respect the ISO 5 class clean room premises, i.e. to continuously clean the inner atmosphere through the depyrogenation chamber via internal HEPA filters. Despite the tight delivery deadline, we performed 45 client specific changes to the sterilization chamber, including adjustment of the control software so to meet the British regulation for depyrogenation HTM 2010
Certified to ISO9001 & ISO14001