Tender

1037 CLeaning Room Validation Consultancy Services

NOTTINGHAM TRENT UNIVERSITY

This public procurement record has 1 release in its history.

Tender

24 Jan 2020 at 13:31

Tender Notice
Summary of the contracting process

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.

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Notice Information

Notice Title

1037 CLeaning Room Validation Consultancy Services

Notice Description

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.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-ccaf45d4-bfd0-4742-9da0-64a363feaca7
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/55a9113f-b872-40eb-bf84-d2ea0ec1666e
Current Stage
Tender
All Stages
Tender

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

71 - Architectural, construction, engineering and inspection services

73 - Research and development services and related consultancy services

CPV Codes

71000000 - Architectural, construction, engineering and inspection services

73000000 - Research and development services and related consultancy services

Notice Value(s)

Tender Value
£50,000 Under £100K
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
24 Jan 20206 years ago
Submission Deadline
7 Feb 2020Expired
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
1 Mar 2020 - 30 Sep 2020 6-12 months
Recurrence
Not specified

Notice Status

Tender Status
Active
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
NOTTINGHAM TRENT UNIVERSITY
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
NOTTINGHAM
Postcode
NG1 4FG
Post Town
Nottingham
Country
England
Major Region (ITL 1)
TLF East Midlands (England)
Basic Region (ITL 2)
TLF1 Derbyshire and Nottinghamshire
Small Region (ITL 3)
TLF14 Nottingham
Delivery Location
TLF East Midlands (England)
Local Authority
Nottingham
Electoral Ward
St. Ann's
Westminster Constituency
Nottingham East

Further Information

Notice Documents

Notice URLs

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts. 

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