Ampoule sealer - small to medium scale batches Background: The Agency requires an efficient Ampoule sealing solution for its site located at; National Institute for Biological Standards and Control Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG A Centre of the Medicines and Healthcare Products Regulatory Agency The purpose of this early engagement is to check the market and based on that decide the sourcing strategy.

Our budget is between £60,000 - £80,000 +VAT.

We will run an open tender and if approved will aim to publish between September - October 2022.

The Agency will use the Atamis e-tendering portal (https://health-family.force.com/s/Welcome ) to publish this opportunity.

If under threshold evaluation criteria will be on; 60% Technical and 40% Price If over threshold; 50% Technical, 40% Price and 10% Social Value Specification: 1.

An automated flame sealing station that could deliver batches( 50-2000 containers) of sealed ampoules (currently 2.5ml or 5ml ampoules) with a low level of fail (<=1%) and at a processing rate quicker than 500 per hour.

2.

To produce consistent smooth domed hermetic glass seals without any glass fragments or fragility that may then result in post storage cracking/breakage.

3.

To be able to lift the closure from the nitrogen-back-filled ampoule just before sealing so as to permit the flame sealing to occur without "popping" due to over pressure and maintaining the oxygen level within the sealed ampoules to below 1% oxygen (as determined by in house non-invasive oxygen measurement).

4.

To operate with minimal user intervention other than loading and unloading.

5.

To be operable in an ordinary classification laboratory and to have a footprint ideally not exceeding 1.5m x 1.5 m.

6.

To require minimal servicing and between batch interventions.

7.

To meet all current UK and European standards for health and safety of operation and to operate ideally from single phase power.

8.

Due to the nature of the scientific work, we would need UK based support for the unit either by the manufacturer or through an agent.

High marks weighting will be awarded for quicker support.

9.

Easily changeable parts if this is a requirement between different container sizes.

Deadlines: Unit to be deliverable and installed by February 2023 Leadtime will form part of the contract and any deviations might result in contract termination at suppliers cost.