Supply of Radiopharmacy Isolators

This is a Prior Information Notice (PIN) to inform potential suppliers that NHS Wales Shared Services Partnership (NWSSP) on behalf of Velindre University NHS Trust, owing to circumstances beyond the Authority's control, is looking to place an immediate order for the supply of up to 3 Radiopharmacy Isolators of identical design that will be required for the Transforming Access to Medicines (TRAMS) Project, South-East Wales Hub.

This is a Prior Information Notice (PIN) to inform potential suppliers that NHS Wales Shared Services Partnership (NWSSP) on behalf of Velindre University NHS Trust, owing to circumstances beyond the Authority's control, is looking to place an immediate order for the supply of up to 3 Radiopharmacy Isolators of identical design that will be required for the Transforming Access to Medicines (TRAMS) Project, South-East Wales Hub.

Main Characteristics of the Requirement are as follows -

Dispensing Isolators for Technetium99m including:

Negative Pressure

3 Glove Process chamber, associated gloves and sleeves

2 Glove Elution Chamber, associated gloves and sleeves

Recessed, shielded, generator compartment for 2 Generators

Integrated dose calibrator

Viable air sampling equipment

Turbulent or Laminar air flow

Air Fan able to be integrated (by others) to ducted extract vents in in a cleanroom classified Grade C

Hydrogen Peroxide Gassing solution

Proven and in service for chamber decontamination

Development pathway that the Authority can pursue towards rapid transfer gassing of Tc99m kits

The whole offer to be compliant with MHRA Annexe 1 and Good Manufacturing Practice (GMP).

Full validation and commissioning support.

Manufacture in a UK facility with a proven track record of Radiopharmacy Isolator production for the NHS in the UK.

Quantity Required -

Up to 3 Isolators of identical design.

Design Maturity and timelines -

The Authority is seeking an “off the shelf” solution with no bespoke elements.

Detailed design work already completed and available for immediate Design Qualification (DQ).

Power and air flow requirements already clearly defined to facilitate cleanroom detailed design (by others) to RIBA Stage 4.

Gassing solution proven and in service for chamber decontamination.

Able to deliver the gassing component within 4 weeks of placing the order, to enable the authority to commence development work on the transfer decontamination process to proceed within existing Isolators, in parallel with build of the new Isolators.

Able to begin manufacture of up to 3 Isolators immediately, for the delivery of the first Isolator within 35 weeks, with the others to follow as soon as possible.

Delivery to Imperial Park Newport NP10 8BE.

The purchase order will be issued under standard NHS Terms and Conditions.

The Authority proposes the following payment profile linked to deliverable milestones:

1. Delivery of mature design documents ready for DQ – 20%

2. Factory Acceptance Test (FAT) Pass per unit – 70%

3. Site Acceptance Test Pass and delivery of all final documentation, manuals, and commissioning paperwork – 10%

Items 2 and 3 will be applied per individual Isolator, to facilitate the fastest delivery profile. The authority has secure undercover storage available so will require delivery of each Isolator immediately after passing FAT. Transfer of ownership will take place after delivery to the authority’s premises.

Potential suppliers who are interested are invited to express an interest to the email address below by NO LATER THAN 5pm on Monday 29th July 2024 -

[email protected]