--- title: "1037 CLeaning Room Validation Consultancy Services" ocid: "ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7.json" source: "Contracts Finder" current_stage: "Tender" buyer: "NOTTINGHAM TRENT UNIVERSITY" published: "2020-01-24" --- # 1037 CLeaning Room Validation Consultancy Services Buyer: NOTTINGHAM TRENT UNIVERSITY Current stage: Tender OCID: ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7.json) ## Summary The Nottingham Trent University is seeking bids for the "1037 Cleaning Room Validation Consultancy Services" tender, which falls under the category of architectural, construction, engineering and inspection services. This procurement is currently in the tender stage, with submissions due by 7 February 2020. The project is located in the East Midlands, UK, and has an estimated value of £50,000, following an open procurement method. The contract is expected to commence on 1 March 2020 and conclude by 30 September 2020. This tender presents a significant opportunity for businesses specialising in consultancy services related to validation and regulatory compliance within the medical technology sector. Companies with expertise in clean room standards and validation processes, particularly those familiar with FDA and MHRA regulations, will find this contract particularly suitable. The collaboration is aimed at establishing state-of-the-art clean rooms critical for supporting innovative medical technologies, creating pathways for business growth in a rapidly advancing field. ## Notice The Medical Technologies Innovation Facility (MTIF) is being established to support organisations in developing innovative medical technologies. The philosophy is to work with strategic partners to take innovations from bench to bedside. MTIF is in the process of building two facilities one on the Clifton campus of Nottingham Trent University and the second on the Boots Enterprise Zone (BEZ). Both facilities will contain clean rooms. On the Clifton campus we have specified an ISO Class 6 clean room where the emphasis is on protecting the product rather than the patient as no materials produced at Clifton will be used in man. The philosophy at BEZ is different with the emphasis on patient safety as products produced at BEZ will be used in clinical trials and BEZ may become an initial launch site for low volume, high value medical devices. In order to meet the regulatory requirements of our customers the three clean rooms at BEZ will operate to FDA class 10,000and MHRA Grade C specifications. Our clean rooms are being validated for the following reasons: * To ensure that the design of the facility is fit for its intended purpose; * To ensure that the facility, equipment and environment meets User Requirement Specifications (URS); * To ensure that the facility, equipment and environment meet defined regulatory requirements of FDA class 10,000 and MHRA Grade C; * To ensure that the facility, equipment and its environment function together as a system to meet defined standards. MTIF requires a specialist contractor to deliver a full validation programme from development of the URS through the design control phase to establishing the routine procedures for monitoring and control, ending with the establishment of procedures to identify and manage changes that constitute the need for cleanroom re-validation. The specialist contractor will be responsible for generating all protocols and reports, undertaking or supervising all validation activities including the production of Standard Operating Procedures ensuring compliance with the appropriate FDA, MHRA and ISO standards. Our expectation is that the validation will be undertaken wherever possible and will be integrated with the commissioning activities of the clean room fabricator. The Contractor will be available for the first regulatory authority inspection to present the clean room validation programme Additional information: In order to express an interest in this or any NTU tender - Register/Login to Intend and select the relevant tender from the current tenders tab. Click on Express an Interest and then select ITT in order to view the tender documentation. ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/55a9113f-b872-40eb-bf84-d2ea0ec1666e | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Open | | Procurement method details | Open procedure (below threshold) | | Tender suitability | SME | | Awardee scale | Not specified | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 24 Jan 2020 | | Submission deadline | 7 Feb 2020 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 1 Mar 2020 - 30 Sep 2020 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £50,000 | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | NOTTINGHAM TRENT UNIVERSITY | | Locality | NOTTINGHAM | | Post town | Nottingham | | Postcode | NG1 4FG | | Country | England | | ITL 1 | TLF East Midlands (England) | | ITL 2 | TLF1 Derbyshire and Nottinghamshire | | ITL 3 | TLF14 Nottingham | | Local authority | Nottingham | | Electoral ward | St. Ann's | | Westminster constituency | Nottingham East | | Delivery location | TLF East Midlands (England) | ## CPV Codes ### Divisions - 71 - Architectural, construction, engineering and inspection services - 73 - Research and development services and related consultancy services ### Codes - 71000000 - Architectural, construction, engineering and inspection services - 73000000 - Research and development services and related consultancy services ## Release History - 24 Jan 2020 at 13:31 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/55a9113f-b872-40eb-bf84-d2ea0ec1666e ## Documents - https://www.contractsfinder.service.gov.uk/Notice/55a9113f-b872-40eb-bf84-d2ea0ec1666e 24th January 2020 - Opportunity notice on Contracts Finder - https://in-tendhost.co.uk/ntu Link to Intend - The University's Tendering Portal ## Notice URLs - http://www.ntu.ac.uk ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7.json.