Contract for the Supply, Installation, commissioning, and qualification of VHP Isolator systems

Description

It is proposed to establish a Aseptic Medicines Production Hub (AMPH) to be located at Northumbria Healthcare NHS Manufacturing and Innovation Hub, Seaton Delaval, Northumberland, to produce sterile medicines in a ready to administer presentation including: - Injectable chemotherapy medicines (Systemic Anti-Cancer Treatment – SACT) - Non-SACT Ready to Administer injectable medicines e.g. antibiotics (RtA) The planned aseptic manufacturing facility includes a number of isolator cleanrooms suites, with the minimum requirements to include: 2 x Ready to Administer medicines cleanroom suites – isolator room ‘as built’ to grade B / to house up to 7 Vapourised Hydrogen Peroxide (VHP) gassing isolators in each cleanroom suite. 1 x Injectable chemotherapy medicines cleanroom suite - isolator room ‘as built’ to as grade B / to house up to 7 VHP gassing isolators. 1 x Contingency suite consisting of a cleanroom area isolator room ‘as built’ to as grade B / to house up to 7 VHP gassing isolators. Microbiology cleanroom suite for sterility testing which will house one isolator. 1 x Administration area: offices, meeting rooms and staff welfare areas. All cleanroom suites will be controlled via separate AHU and a BMS. The manufacture of aseptic medicines will be performed within GMP grade A isolators within grade C production cleanrooms with associated grade D support rooms. The equipment will utilise Vaporised Hydrogen Peroxide (VHP) for the bio-decontamination of materials and the isolator surfaces. This process is for the Supply, Installation, commissioning, and qualification of VHP Isolator systems.

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