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

Concepts

• newcastle upon tyne
• medical equipment and pharmaceuticals
• isolator cleanrooms suites
• isolator room
• isolators
• cleanroom suite - isolator room
• a cleanroom area isolator room
• vhp isolator systems
• vhp isolator
• vhp

Location

North East England:

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.

CPV Codes

• 33000000 - Medical equipments, pharmaceuticals and personal care products

Indicators

• This is a one-off contract (no recurrence)
• Renewals are not available.
• Staff qualifications are relevant.

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. ** Tender documents are available free of charge by registering on the Proactis e-tendering portal https://procontract.due-north.com/ Supplies that are not already registered will need to register to obtain the documents. It should be noted that publication of this notice does not provide any commercial guarantee that a contract will be concluded. It does not bind the Trust to accept any offer and reserves the right to accept an offer in either whole or part. The Contracting authority is not responsible for any costs incurred by bidders in relation to participation in this process.