Supply of Demineralised Bone Matrix Syringe

Supply of Demineralised Bone Matrix Syringe<br/><br/>NHS Blood & Transplant (NHSBT) intends to undertake a procurement tender exercise for syringe to package Demineralised Bone Matrix Paste and Putty<br/><br/>NHSBT now wishes to commence a formal procurement process and is seeking to engage with suppliers available in the marketplace. This will aid identification of opportunities and gauge market interest in this field.<br/><br/><br/><br/>Requirements<br/><br/>NHSBT TES process cortical bone into DBM Paste and Putty grafts. The cortical bone is donated from deceased donors. The syringe must be suitable for containing DBM paste and putty grafts and allow dispense of <br/>this product during surgery. <br/><br/>Technical Requirements<br/><br/>• If provided sterile, syringe must be packaged and sterilised (not by gamma-irradiation) with a visible confirmation of sterilisation and expiry date for packaging on each pack.<br/>• If provided sterile, plunger must not be inside barrel of syringe prior to initial sterilisation if ETO sterilisation is used. This is to ensure all surfaces of syringe are sterile.<br/>• Must be suitable for sterilisation by gamma-irradiation (25-40kGy) with the graft inside.<br/>• Syringe must be of a suitable size to hold the DBM Paste and Putty in 1cc, 5cc, and 10cc sizes and have the plunger placed inside. The syringe must be easily handheld for use within theatre. <br/>• Must be an open bore syringe supplied with a dead-end cap.<br/>• Must be able to be stored at –80°C in a freezer and on dry ice.<br/>• Syringe must be made of polycarbonate material and must not be opaque.<br/>• Expiry date of each batch must be a minimum of 1 year from date of delivery.<br/>• The package will be CE marked for the purpose of tissue storage.<br/><br/>Environmental/Sustainability Requirements<br/><br/>• NHSBT requires suppliers to take responsibility for their impact on the Environment and where relevant society. Suppliers are required to demonstrate an Environmental Management System e.g.ISO14001 or an equivalent EMS. NHSBT may require the auditing of this system. Where an EMS does not exist suppliers will be required to demonstrate adequate management of their impact and where suitable may be required to develop an EMS system.<br/>• Suppliers must comply with all legislation governing Environmental obligations. Failure to do so will result in exclusion from tendering.<br/><br/><br/>Stock Holding and Business Continuity – Quality/EP Critical Only<br/><br/>• The Contractor must hold a minimum un-reserved buffer stock of one month's usage (based on NHSBT’s normal volume usage), unless otherwise agreed by NHSBT.<br/>• Two different batches should be available for delivery to any of the Authority’s warehouses or centres within 24 hours, the Contractor should ensure their stock is rotated as usual as no obsolete stock will be NHSBT’s. responsibility.<br/>• In addition to these minimum requirements extra stock may need to be held in the supply chain. In such a case, the Contractor and NHSBT will from time to time agree appropriate stock holding requirements, and these will be confirmed in writing by NHSBT.<br/>• Suppliers may be required to confirm stock levels, batch numbers and expiry dates upon request from NHSBT.<br/>• As a supplier of critical consumables and/or services to NHSBT, the supplier is required to have a documented Business Continuity plan covering, at least, all aspects and locations of their business which impact the supply of the goods or services which are supplied to NHSBT. Wherever possible any such plan should have been constructed to comply with the relevant British Standard for Business Continuity (BS 25999 Parts 1&2). In the future NHSBT may seek evidence of independent certification to this standard.<br/>• Any supplier Business Continuity plan as above should be regularly reviewed, updated, and tested or exercised at least every two years.<br/><br/><br/>It is NHSBT's intention to hold pre-procurement supplier engagement meetings the week of 12th February 2024 to 23rd February 2024.the meetings will be held remotely; the dates are to be confirmed. To enable NHSBT to finalise arrangements (e.g. send meeting details and agree time slots) for the meeting’s, interested organisations are required to send an expression of interest via email to Sahithi Bandi - sahithi.bandi@nhsbt.nhs.uk no later than 17:00 hrs (GMT) on 09/02/2024. This should include a list of your potential attendees and a brief overview (or a website link) of the Goods / Services which might be offered. <br/><br/>No business whatsoever is guaranteed under any resulting framework agreement or contract, and there is no guarantee that any framework agreement or contract will be put in place in relation to this notice. No compensation etc. will be paid if a tender or resulting framework agreement is withdrawn for any reason. Bidders should take part in this process only on the basis that they fully understand and accept this position.<br/><br/>It should be noted that this procurement exercise may allow other Health authorities to use any agreements awarded.