Poland - Blood Storage Containers

Description

The subject of the contract is the delivery of disposable sets of plastic containers for blood collection and preparation, divided into 3 tasksTask I Delivery of sets of triple containers for blood and its components, top - down, 40.000 units. Task II Delivery of empty lamellar containers a'1000ml, 1,000 piecesTask III Delivery of empty containers a'600ml for serum collection and preparation, 8,000 piecesTask III Delivery of empty containers a'600ml for serum collection and preparation, 1.
The kit must be sterile, apyrogenic, intended for single use, CE marked, made of plastic suitable for its function, latex free. There must be no fluid remaining after sterilization in the unit pack.2. The kit should include: a 450ml whole blood container with 63ml CPD, a 400-600ml container with 100ml of enrichment fluid, a 400ml-600ml empty plasma container and an additional container for blood sampling.3. The containers should be suitable for acute centrifugation. The CPD container must have holes in the top for attachment to the blood preparation presses. The containers must have a transverse hole in the weld seam at the bottom for hanging the container during transfusion. Preparation with Compomat G5 automatic blood presses in no more than 7 minutes. Containers for plasma and red blood cells should contain two ports secured with a shield, allowing the preparation to be transfused. Mother and enrichment fluid containers should have easily breakable "chambers". All containers must be transparent to allow visual assessment of fluids and blood components. In the event that automatic spigots can be broken in containers that are incompatible with current blood preparation presses, the bidder will cover the cost of software customization on the presses. All containers shall be transparent to allow visual evaluation of fluids and blood components. 4. Purpose: collection of whole blood and preparation of red cell concentrate without leukocyte-platelet cluster, leukocyte-platelet cluster and fresh frozen plasma (FFP).5 Fluids: CPD - 63ml, enrichment fluid SAGM or ADSOL - 100ml with the composition according to the current version of the European Pharmacopoeia monograph.6.Needle: thin-walled, with a shield guaranteeing the sterility of the set, 16G size, length from the base (place of holding) to the end of the needle not less than 45mm, preventing cutting the skin and clogging the needle, siliconed. The connection between the needle and the drain should be flattened to facilitate manipulation of the needle during insertion. There should be a sheath on the draw tube to slide over the needle, sliding loosely over the tube so that no blood is expelled at the end of the procedure. 7. Draw tube: 115-155cm long (from the container to the tip of the needle), secured with a clip or cannula, dry between the needle and the blood collection container. The thickness of the drain should allow for the use of devices such as: weigh mixer, drain sealer, roller. The drains connecting the set's containers are suitable for sterile connections using the TSCD and COMPODOCK techniques. 8. 8. pilot tube for pilot samples: 80-100cm next to the container for the CBC, absolutely transparent. 9. tube between CPD container and KKCW container with enrichment fluid: no shorter than 39 cm.10. tube at the KKCW container must be marked with numbers unique to the container in at least 6 locations.11. Integral parts: secondary sampling container capable of collecting a minimum of 30ml of blood sample at the start of donation, dry feeding tube secured with a clip or cannula. A holder with a pricker secured with a movable rubber membrane, for inserting standard vacuum tubes connected with the sample container for examination (it can be additionally secured with a cover).12. The labels on containers of a single set are to contain the following verbal information in Polish: description of the containers - purpose, type of material, composition of liquids in accordance with regulations of the European Pharmacopoeia (, manufacturer's data, LOT and REF numbers in alphanumeric form and bar codes in ISBT 128 standard (code length up to 20 characters), directions for use. The Ordering Party will accept containers, in which the composition of the fluids is in accordance with the European Pharmacopoeia 1. Platelet empty container (so-called "Breathing Container") with a capacity of 1000ml, is used for transferring and storing Platelet CBCs on a shaker for 5 days at a temperature of 20-240C. The PVC used for the manufacture of the empty container must comply with the requirements of the European Pharmacopoeia. The container is intended for single use only.2. The empty, platelet, breathable container must ensure the necessary gas exchange for platelet preparations during storage at 20-240C and throughout the product's shelf life, i.e. up to 5 days.3. Elements integrated with the container are two sterile ports for transfusion of blood components (platelets) and a minimum of one length of 43cm, made of PVC, numbered with the serial number (at least in 2 places). The thickness of the tube should allow the use of devices such as: tube sealer, roller. The tubing connecting the set's containers must be suitable for sterile connections using the TSCD and COMPODOCK techniques. The PVC must comply with the requirements of the European Pharmacopoeia. PVC must comply with the European Pharmacopoeia requirements. The plastic from which the container is made must be transparent allowing visual assessment of the blood component contained within. The ports must be protected with a membrane on the inside and with suitable protection on the outside to ensure sterility and allow easy access for connecting the transfusion set.4. The diameter of the tubing must be of such a size as to ensure that the tubing of different containers is compatible with each other and that they can be connected together in an open and closed system using a sterile tubing sealer.5. The container must be sterile and pyrogen-free, individually wrapped in foil packaging to prevent damage to the container. Individual containers must be packaged in damage-resistant bulk packaging. The master package may contain only one lot of containers. The primary packaging must be labelled with at least the following information: name of the producer, name of the containers (capacity), REF number, batch number, expiration date - information on storage.6 The method of sterilisation of the containers - in accordance with the requirements of Polish and European legislation on sterilisation of medical devices - packaging intended for blood components (medicines), including European Pharmacopoeia.7 The container must bear a firmly attached label which cannot be deformed or peeled off during the preparation.8. The container label should contain the following information (minimum requirements): name of medical device, container capacity, manufacturer's name - information in Polish; CE; REF number; batch number, expiration date, information about sterility and apyrogenicity, method of sterilization, intended for single use, about the use of phthalates - DEHP (if used) during production, what material the medical device is made of - information may be in the form of pictograms according to ISO 3826-2 norms and standards provided that instructions in Polish are attached, where the meaning of the pictograms is explained. Batch number and product code (both in alphanumeric and barcode form) should be in accordance with ISBT 128 system. 9. containers must be certified for use in the European Union and carry the CE mark.10. quality certificate must be attached to each batch of containers. Quality certificate should include batch designation, manufacturing and expiration dates, code number. 11. (11) Quality tests based on the European Pharmacopoeia, monograph 30303, version currently in force or equivalent, validated methods. Expiration date not less than 12 months from the date of delivery. The kit must be sterile, apyrogenic, intended for single use, CE marked, made of plastic suitable for its function, latex free. The kit should contain: a 600ml container for clotting 450ml of whole blood used to obtain serum, two empty 600ml containers and an additional container for blood sampling.Containers with dimensions (maximum parameters, counted from seal to seal, limiting the interior of the container): length - 18cm, width - 12.5cm.3.Needle: thin-walled, with a shield that guarantees the sterility of the set, 16G size, length from the base (place of holding) to the end of the needle - not less than 45mm, preventing cutting the skin and clogging the needle, siliconed. The connection between the needle and the drain should be flattened to facilitate manipulation of the needle during insertion. There should be a sheath on the draw tube to slide over the needle, sliding loosely over the tube so that no blood is expelled at the end of the procedure. The sheath is to prevent accidental puncture of the recipient.5. Draw tube: length 114-155cm (from the container to the tip of the needle), secured with a clip or cannula. Thickness of the drain should allow for the use of devices such as: weigh mixer, drain sealer, roller. The drains connecting the kit containers are suitable for sterile connections using TSCD and COMPODOCK techniques. 6. Master labels on single kit containers are to contain the following information in Polish: description of the containers - intended use, type of material, composition of liquids in accordance with the provisions of the European Pharmacopoeia (, manufacturer's data, LOT and REF numbers in alphanumeric and barcode form in ISBT 128 standard (code length up to 20 characters), directions for use. The Ordering Party shall accept containers in which the composition of liquids is compliant with the European Pharmacopoeia and given in English. The Ordering Party accepts the use of pictograms instead of some verbal information provided that instructions in Polish are enclosed where the meaning of pictograms is explained. Labels must be undeformed, resistant to spinning (no deformation), storage temperature, moisture, and impossible to peel off. 7. Storage temperature 00C-250C.8.The transport carton should: not easily crumple, contain no more than 30 sets packed individually or in pairs in transparent foil, the sets may be packed individually, contain a description with information in Polish: manufacturer's name, number of pieces in the package, LOT number, REF code, expiration date, storage conditions and other manufacturer's requirements.The collective packaging - inner, unless it is transparent, should have a description with information in Polish: type of container, fluids, LOT number, expiration date, storage conditions and kit shelf life after removal from the collective and individual packaging.10. Each delivery should be accompanied by a quality certificate for each batch.16. 1 to 2 batches are required in one delivery, with a shelf life of not less than 3 months from the date of manufacture, with a shelf life of not less than 12 months from the date of delivery.17.The offered containers must be placed on the Polish market in accordance with the Act of 20 May 2010 on medical devices (Journal of Laws of 2019, item 175, as amended).19. The offered containers must be CE marked in accordance with the relevant regulations.20. Quality tests based on the European Pharmacopoeia monograph 30303 version currently in force

Opportunity closing date

23 March 2022

Value of contract

to be confirmed