The subject of the order is the delivery of disposable sets of plastic containers for collection and blood preparation broken down into 3 tasks

Task I Delivery of sets of triple containers for blood and its up-down components in the amount of 40,000 pcs and delivery of sets of quadruple containers for blood and its components for the collection and preparation of KKCz, up-down with in-line fitter in the amount of 70,000 pcs.

Task II Delivery of hollow plate containers a'1000ml in the amount of 1.000 pcs.

Task III Delivery of kits of hollow containers with a capacity of a'600ml designed to obtain serum in the amount of 8.000 pcs.

1. The kit must be sterile, apirogenic, for disposable use, CE marked, made of plastic adapted to function, not containing latex. There must be no liquid left after sterilization in the unit package.

2. The kit should include: 450ml whole blood container with 63ml CPD, 400-600ml container with 100ml enriching fluid, 400ml-600ml empty plasma container and additional blood sampling container.

3. Containers should be suitable for spinning using the technique of sharp spin. The container with CPD must have at the top of the holes to be hooked on the presses for blood preparation. The containers must have in the lower part in the weld a transverse opening to suspend the container during transfusion. Preparation using automatic blood presses Compomat G5 in no more than 7 minutes. Containers for plasma and KKCz should contain two ports each protected with a shield allowing transfusion of the preparation. Native and enriching fluid containers are supposed to hold easily breakable “fireplaces”. All containers must be transparent to allow visual evaluation of fluids and blood components. In case of automatic breakage in containers incompatible with presently held blood preparation presses, the tenderer will cover the costs of adjusting the software in the press. All containers must be transparent to allow visual evaluation of fluids and blood components.

4. Purpose: whole blood collection and preparation of red blood cell concentrate without leukocytic sheepskin, leukocytic platelet sheepskin and freshly frozen plasma (FFP).

5. Liquids: CPD — 63ml, enriching fluid SAGM or ADSOL — 100ml with a composition consistent with the current version of the European Pharmacopoeia monograph.

6. Needle: thin-walled, with a cover guaranteeing the aridity of the kit, size 16G, length from the root (holding place) to the end of the needle not less than 45mm, preventing skin cutting and clogging of the needle, silicated. The connection of the needle with the drain should be flattened to facilitate the manipulation of the needle during puncture. On the drain, there is supposed to be a shield to the needle, loosely sliding over the drain, so that no blood stuffing occurs after the procedure is completed. The cover is supposed to protect against accidental jamming of the downloader.

7. Drawing drain: length 115-155cm (from the container to the root of the needle), secured by a clip or cannula, dry in the section between the needle and the blood container for pre-donation tests. The thickness of the drain is intended to allow the use of devices of the type: weight mixer, drain welding machine, roller. Drains connecting kit containers adapted to sterile connections using TSCD and COMPODOCK techniques.

8. Drain for pilot samples: 80-100cm with container for KKCz, absolutely transparent.

9. Drain between CPD container and KKCz container with enriching fluid: not less than 39 cm.

10. The drain at the KKCz container must be marked with numbers unique to the container in at least 6 places.

11. Integral parts: additional sampling container enabling a minimum of 30ml blood sample to be taken at the beginning of donation, dry supply drain protected by a clip or cannula. Handle with a puncture protected by a moving rubber membrane, for the introduction of standard vacuum tubes connected to test sample container (can be additionally protected by a cover).

12. The parent labels on the containers of a single set are intended to contain the following word information in English: description of containers — purpose, type of plastic, liquid composition in accordance with the regulations of the European Pharmacopoeia (, manufacturer's data, LOT and REF number in alphanumeric form and codes barcode in ISBT 128 standard (code length up to 20 characters), tips for use. The Ordering Party will accept containers in which the composition of liquids is compatible with the European Pharmacopoeia

1. Hollow plate container (so-called breathable container”) with capacity of 1000ml, is used for transfer and storage of Plate Blood Cell Concentrate on the shaker for 5 days at 20-240C. PVC used in the manufacture of the empty container must comply with the requirements of the European Pharmacopoeia. Container for single use only.

2. The empty, lamellar, breathable container must provide the necessary gas exchange for platelet preparations at a temperature of 20-240C, during the entire period of validity of the preparation i.e. up to 5 days.

3. Components integrated into the container are two sterile ports for transfusion of blood components (platelets) and a minimum one drain with a minimum length of 43cm, made of PVC, numbered series number (minimum in 2 places). The thickness of the drain is intended to allow the use of devices of the type: drain welding machine, roller. Drains connecting kit containers adapted to sterile connections using TSCD and COMPODOCK techniques.

PVC must comply with the requirements of the European Pharmacopoeia. The material from which the container is made must be transparent allowing a visual evaluation of the contained inside the container, the blood component. Ports must be protected by a membrane from the inside and adequate protection from the outside for aridity, allowing easy access to the roller kit connection.

4. The diameter of the drains should have dimensions to ensure the mutual compatibility of the drains of different containers and allow them to be connected in an open and closed system using a welding machine for sterile drain connection.

5. The container must be sterile and without pyrogen, packed individually in a foil pack preventing damage to the container. Single packaging must be packed in damage-resistant bulk packaging. The bulk pack may contain containers of only one series. The bulk packaging must be marked with a label containing the minimum of the following data: manufacturer name, name of containers (capacity), REF number, series number, expiration date — storage information — storage.

6. The method of sterilization of containers - compliant with the requirements of Polish and European law concerning the sterilization of medical devices — packaging, intended for the production of blood components (medicines), including the European Pharmacopoeia.

7. There must be a permanently fixed company label on the container, which cannot be deformed or peeled off during the preparation.

8. On the label of the container should be the following information (minimum requirements): name of medical device, container capacity, manufacturer name — information in Polish; CE; REF number; series number, expiration date, sterility and apirogenic information, sterilization method, destination for single use, on use at the time of production of phthalates — DEHP (if used), from what material the medical device is made — information may be in the form of pictograms in accordance with ISO 3826-2 standard and standards provided that instructions are included in Polish, where explained is the meaning of pictograms. The series number and product code (in alphanumeric form and barcode) should be compatible with ISBT 128. There should also be an empty space on the label to enter the necessary data, e.g. date of download, donation number.

9. Containers must be certified for use within the European Union and the CE mark.

10. A quality certificate must be attached to each series of containers. The quality certificate should include the series designation, the date of manufacture and expiration date, code number.

11. Qualitative tests based on European Pharmacopoeia monograph 30303 version currently in force or equivalent, validated methods.

12. Expiration date not less than 12 months from the date of delivery.

1. The kit must be sterile, apirogenic, for disposable use, CE marked, made of plastic adapted to function, not containing latex. There must be no liquid left after sterilization in the unit package.

2. The kit should include: a 600ml container for clot collection 450ml whole blood used for serum acquisition, two 600ml empty containers and an additional container for blood sampling.

Containers with dimensions (maximum limit parameters, counted from welding to welding, limiting the inside of the container): length — 18cm, width — 12.5cm.

3. Purpose: taking whole blood used for serum acquisition.

4.Needle: thin-walled, with a cover guaranteeing the aridity of the kit, size 16G, length from the root (holding place) to the end of the needle not less than 45mm, preventing skin cutting and clogging the needle, silicone. The connection of the needle with the drain should be flattened to facilitate the manipulation of the needle during puncture. On the drain, there is supposed to be a shield to the needle, loosely sliding over the drain, so that no blood stuffing occurs after the procedure is completed. The cover is supposed to protect against accidental jamming of the downloader.

5. Drawing drain: 114-155cm length (from the container to the root of the needle), secured by a clip or cannula. The thickness of the drain is intended to allow the use of devices of the type: weight mixer, drain welding machine, roller. Drains connecting kit containers adapted to sterile connections using TSCD and COMPODOCK techniques.

6. The parent labels on the containers of a single set are to contain the following word information in Polish: description of containers — purpose, type of plastic, liquid composition in accordance with the regulations of the European Pharmacopoeia (, manufacturer's data, LOT and REF number in alphanumeric form and codes barcode in ISBT 128 standard (code length up to 20 characters), tips for use. The Ordering Party will accept containers in which the composition of liquids is compatible with the European Pharmacopoeia and is given in English. The Ordering Party shall allow the use of pictograms instead of certain verbal information provided that instructions are included in Polish, where the meaning of pictograms is explained. Labels must be undeformed, resistant to spin (can not be deformed), storage temperature, moisture, impossible to peel off.

7. Storage temperature 00C-250C.

8. Transport carton should:

not to be easily crushed,

contain not more than 30 sets packaged individually or two in transparent film,

kits can be in addition to the individual packaging packed bulk,

contain a description with information in Polish: manufacturer name, number of pieces per package, LOT number, REF code, expiration date, storage conditions and other requirements of the manufacturer.

in each carton there should be a readable instruction on the procedure in Polish, containing the description of the containers, the composition of the kit, the rules of application.

9. Bulk packaging — inner, unless transparent, should have a description with information in Polish: container type, liquids, LOT number, expiration date, storage conditions and storage time after removal from the bulk and individual packaging.

10. Each delivery is to be accompanied by a quality certificate for each series.

1 to 2 series is required in one delivery, not less than 3 months from the date of manufacture, with an expiry date of not less than 12 months from the date of delivery.

17. The offered containers must be placed on the market on the Polish market in accordance with the law of 20 May 2010 on medical devices (Journal of Laws of 2019 item 175 as amended).

19. The containers offered must be marked with the CE mark in accordance with the applicable regulations.

20. Qualitative research based on European Pharmacopoeia monograph 30303 version currently in force