Task # 1:

Supply of kits for the reduction of biological pathogens in clinical use plasma (FFP) obtained from whole blood or apheresis.

Task # 2:

Supply of kits for the reduction of biological pathogens in low-fat platelet cell concentrates (UKKP) from apheresis suspended in a mixture of plasma and enrichment solution

1. Biological disease reduction kits in plasma for clinical use (FFP) obtained from whole blood or apheresis must be sterile, apiroggenous.

2. The kits must ensure the reduction of biological pathogens in a plasma unit of a volume between 170 ml and 360 ml.

3. Kits must ensure the effectiveness of reducing biological pathogens to a safe level.

4. The kits must be capable of reducing biological pathogens in plasma before shock freezing and after thawing of the plasma immediately before release.

5. The plasma storage container shall be capable of shock freezing at a minimum of -60°C, safe storage of plasma below -25°C (up to -90°C) and thawing at +37°C, preserving the flexibility and sterility of the container.

6. The kits must ensure that the FFP maintains the appropriate values of the quality control parameters – total protein concentration – above 50 g/l, factor VIII activity – above 50 IU/100 ml, on average (after freezing and thawing) ≥ 70% of the value for the plasma unit, fibrinogen – on average ≥ 60% of the value for the plasma unit

7. The diameter of the drains of the sets is equal to the diameter of the drains of the containers for the collection and preparation of blood and blood components, which allows the drains to be joined aseptically.

8. All drains must be flexible, allow easy rolling, as well as effective welding.

For a detailed description, see SWZ

1. Biological pathogen reduction kits in low-cost-aphetic apheresis platelet cell concentrates (UKKP-Af) suspended in a mixture of plasma and enrichment solution intended for clinical use must be sterile, apirogenic

2. Kits shall ensure the reduction of biological pathogens in UKKP-Af. with a volume of 250 ml to 450 ml

3. Kits must ensure the effectiveness of reducing biological pathogens to a safe level

4. The kits must guarantee maintenance by UKKP-Af. appropriate values of quality control parameters: platelet count >3 x 1011 /unit.

5. The diameter of the drains of the sets is equal to the diameter of the drains of the containers for the collection and preparation of blood and blood components, which allows the drains to be joined aseptically

6. All drains must be flexible, allow easy rolling, as well as effective welding

7. The material used for containers must be clear, leak-proof and allow visual assessment of the component contained in the container

8. A label must be permanently affixed to the plasma storage container, which must not be damaged or detached during preparation and storage. The working label should have the appropriate dimensions to affix the ISBT-compliant main label to it.

See SWZ for a detailed description.