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Published 18 Dec 2018

Service contract for production filling isolator

Medicines and Healthcare products Regulatory Agency · United Kingdom

Key facts

Engagement closes
08 Jan 2019
Buyer type
Central government

Description

Agency need a contract to provide annual service, calibration, repairs, modifications and supply of parts original manufacturer (Metall & Plastic) parts for its production filling isolator. We are under the impression that there is only one supplier which can provide the required service. Before we proceed further, I want to check, can you do this? For further details, please read the following text. Description: The Production isolator is part of a filling line for liquid or Freeze-dried products in screw-capped vials. The isolator houses a B&S filling machine and interfaces with a Serail Freeze dryer. The inside of the isolator is designed to be sanitised with Formaldehyde after every run. There are two transfer isolators which are used to transfer equipment and filled vials from one end of the line to the other for the capping process. The isolator runs under negative pressure with HEPA filtration and CG-air distribution system, and has a refrigeration unit with heating and cooling from 4°C to 30°C.

Annual servicing to include but not limited to: Visual inspection of CG-membranes - Replace, repair as necessary Visual inspection of isolator lighting - Replace, repair as necessary HEPA / ULPA integrity testing - Replace, repair as necessary Check and adjustment of pressure switches Leak testing of gloves and half-suit - Replace, repair as necessary Leak testing of transfer isolators - Replace, repair as necessary Leak testing of pneumatic gaskets - Replace, repair as necessary Leak testing of filling isolator without transfer isolators - Repair as necessary Replace compressed air filter Replace PLC battery Refrigeration unit Change filter & oil check system for leaks and operation.

Annual Calibration: Pressure transmitters Flow sensors Temperature sensor Relative humidity sensor Pressure gauges

Potential suppliers if they feel they can meet the requirement should email [email protected] to register an interest.

If no submissions of potential interest are received by close of play 08 January 2019, it is then intended to perform a direct award without competition to the sole supplier we believe can deliver the required service.

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