ITT_29678 Quarterly & Yearly Verification of Aseptic suite and Air Handling Unit
Bath and Northeast Somerset, Swindon and Wiltshire STP · United Kingdom
Key facts
- Estimated value
- £25,000
- Closing date
- 21 Sep 2018
- Contract starts
- 01 Nov 2018
- Contract ends
- 31 Oct 2020
- Procedure
- Restricted procedure (above threshold)
- Buyer type
- Other public body
Description
Quarterly and yearly verification of aseptic suite and air handling unit.
The aseptic services unit at the Royal United Hospitals Bath NHS Foundation Trust is currently an unlicensed section 10 aseptic unit preparing cytotoxic, monoclonal antibody and radiopharmaceutical products. In the near future the unit is looking to obtain a manufacturing special licence.
1.1 Isolators The unit has 5 Cirrus laminar flow isolators: 2 x Cytotoxic Cirrus Alto isolators - each containing 6 HEPA filters 1 x Monoclonal Cirrus Alto isolator - with 6 HEPA filters 1 x Radiopharmacy Cirrus Incus isolator - with 8 HEPA filters 1 x Radiopharmacy Cirrus Stratus isolator - 4 HEPA filters
1.2 Cleanrooms 16 graded rooms with 27 associated HEPA filters. 2 types of HEPA filter diffuser face - Swirl and 4-way
1.3 Air Handling Unit (AHU) The AHU uses 100% fresh air with no recirculation and has two separate air intakes units each with their own fan and motor sets and one combined extract unit with its own fan and motor unit.
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