Section one: Contracting authority
one.1) Name and addresses
Northumbria Healthcare Facilities Management Limited
Northumbria House, Unit 7/8 Silverfox Way
Newcastle Upon Tyne
NE27 0QJ
Contact
Mr Kevin Marshall
kevin.marshall@northumbria-healthcare.nhs.uk
Telephone
+44 150129
Country
United Kingdom
Region code
UKC - North East (England)
Internet address(es)
Main address
https://www.northumbria.nhs.uk
Buyer's address
https://www.northumbria.nhs.uk
one.3) Communication
Access to the procurement documents is restricted. Further information can be obtained at
https://procontract.due-north.com
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://procontract.due-north.com
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Contract for the Supply, Installation, commissioning, and qualification of VHP Isolator systems
Reference number
DN698053
two.1.2) Main CPV code
- 33000000 - Medical equipments, pharmaceuticals and personal care products
two.1.3) Type of contract
Supplies
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKC - North East (England)
two.2.4) Description of the procurement
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.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
End date
30 April 2025
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
three.2) Conditions related to the contract
three.2.3) Information about staff responsible for the performance of the contract
Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
7 December 2023
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.7) Conditions for opening of tenders
Date
7 December 2023
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.3) Additional information
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.
six.4) Procedures for review
six.4.1) Review body
Northumbria Healthcare Facilities Management Limited
7 Silver Fox Way, Cobalt Business Park
North Shields
NE27 0QJ
Country
United Kingdom