Strathclyde Pharma Solutions Equipment Service & Maintenance

Description

Strathclyde Pharma Solutions, a research group within University of Strathclyde's Strathclyde Institute for Pharmacy and Biomedical Sciences is a MHRA licensed manufacturing facility, supplying investigative medicinal products to clinical trials. We require a Supplier to undertake annual servicing and calibration of equipment as well as service cover for emergency call out. As part of our clean room facility, we generate our own Water For Injection which feeds associated equipment. The WFI System comprises of a 500L 316L stainless steel tank, circulation pump, control panel and a circulation loop of pipe work with 4 off-take sample areas. This system is connected to the Telstar Steam Generator, the Telstar Freeze Drier Clean in Place system and the Lancer Washer. The whole system is operated under automatic control. The Contracting Authority is seeking a supplier who will perform annual maintenance, and where appropriate, calibration. Additional equipment that also require to be serviced and all equipment is listed below. - Telstar GVP 86E Pure Steam Generator with Condensing Unit - Storage vessels - Distribution loops incl. POU valves on WFI loop, and PSG loop - Telstar Oven HED 500 - Telstar Autoclave AVV 350 DV - Lancer Glassware Washer 1600 PCM DPSS Lot 1: The Contracting Authority requires a supplier that can fulfil the below non-exhaustive list of requirements: -The Supplier shall deploy suitably qualified engineers on a periodic basis to carry out equipment adjustment and planned preventative maintenance activities. -Planned servicing and maintenance visits shall be agreed in advance between the Supplier and the Contracting Authority. - Where the Supplier is unable to attend a scheduled visit, they shall notify the Contracting Authority at the earliest opportunity, and such notification must be acknowledged. - During scheduled visits, the Supplier shall undertake routine repairs, adjustments, and replacement of consumable parts arising from normal use. - All works shall be undertaken during standard operating hours: Monday to Friday, 08:00 – 17:00 (SIPBS operating hours). - The Supplier shall provide telephone support with a targeted response time of four (4) hours to address equipment issues and maintain operational continuity. - Where issues cannot be resolved remotely, the Supplier shall provide on-site support within a targeted forty-eight (48) hours to minimise downtime. - Where issues persist beyond these response targets, the Supplier shall provide additional labour resources as required to restore equipment functionality. - The Contracting Authority is considering a fully inclusive contract model in which all associated costs, including labour, travel, expenses, spare parts, replacement engineer time, and software updates, are included within the Contract. - The Contract shall include coverage of non-consumable parts at no additional cost. - The Contract is expected to cover all listed equipment, associated components, and spare parts for a proposed duration of twenty-four (24) months. - The Supplier shall provide calibration services where applicable and issue calibration certificates upon completion. - The Supplier shall provide a written service report following each visit within an agreed timeframe. - The Supplier may be required to work alongside the University’s Insurance Inspector where applicable. - The Supplier shall be able to provide evidence of training for all staff performing activities upon request. - The Supplier shall generate a pre-approved protocol for the work prior to commencement of calibration/maintenance activities. - The Supplier shall hold ISO14001 Environmental standard - The Supplier must hold ISO45001 for Health & Safety or OHSAS18001. - The Supplier will hold ISO9001 for Quality. - The Supplier must maintain a Health & Safety policy.. Economic operators may be excluded from this competition if they are in any of the situations referred to in regulation 58 of the Public Contracts (Scotland) Regulations 2015.