The EU public tender concerns the purchase and supply of various gases for cylinders, batteries and cryotanks (including rental of cryotanks). Gas types are purchased packaged as stand-alone cylinder (40L, 50L mm.), battery (12x50L bottle) and liquid nitrogen. Liquid nitrogen is supplied with continuous filling of cryotanks of 4000kg and 8000kg, each with their own quality, documentation with associated CoA or batch as well as documentation for the delivery.
Production, packaging and analytical control, as well as deliveries of the gases, must be carried out and documented in accordance with current standards for pure gases and pharmaceutical gases with associated documentation and full traceability:
- ISO9001:2015
- EudraLex Vol 4 Part I: Basic Requirements for Medicinal Products, annex 6 for GMP use.
The associated certificate of analysis (CoA) shall maintain requirements specifications for the clean gas species
iht.:
- European Pharmacopoeia (Ph. Eur.)
The gas supplier must be able to supply special gas mixtures, with a certificate of analysis.
The EU public tender concerns the purchase and supply of gases for cylinders, batteries and cryotanks (as well as the rental of 2 cryo tanks).
Gas supplies handled by Campus Service on behalf of users at Statens Serum Institut (SSI) comprise a wide range of gases (special gases, mixed gases, industrial gases, etc.) both with and without associated analysis certificate (CoA).
A variety of gas types and quality are purchased packaged as stand-alone cylinder (40L, 50L, etc.), battery (12x 50L bottle) and in addition liquid nitrogen is purchased.
Liquid nitrogen is delivered with continuous filling of the two on-site pressure vessels (cryotanks) of 4000kg and 8000kg, each with their own quality, documentation with associated CoA or batch as well as documentation for the delivery - filled volume/quantity, tanker no. etc.
Production, packaging and analytical control, as well as deliveries of the gases, must be carried out and documented in accordance with current standards for pure gases and pharmaceutical gases with associated documentation and full traceability:
- ISO9001:2015
- EudraLex Vol 4 Part I: Basic Requirements for Medicinal Products, annex 6 for GMP use.
The associated certificate of analysis (CoA) must maintain requirements specifications for the clean gas species in accordance with:
- European Pharmacopoeia (Ph. Eur.)
- Additional requirements set by SSI for specialty and specified gas mixtures.
The gas supplier must be able to supply special gas mixtures, with associated analysis certificate, according to pre-agreed requirements and specification and within the agreed timeframe.
More information about the tender can be found in the tender documents.