RequiredExperience with Government Bid to RA enabled No Blood Bags ( 20000 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description Blood Bags * Clinical Purpose Collection
Requiredprocessing and storage of whole blood and blood components * Disposable Yes * PRODUCT INFORMATION Conformity to standard for Blood Bag ISO 3826/IS 15102: Latest Revision * Type of blood bag Triple Triple Capacity of blood 350 ml 350 ml 1/7 Bag Material of Bag (Medical grade) DEHP Plasticized PVC * Blood Collection Bags should be collapsible non vented sterile containers complete with collecting tube for completely closed system to avoid the chances of contamination Yes * Flexible pre-sterilized and pyrogen free Yes * Non toxic
Requirednon haemolytic
Requiredbiocompatible material Yes * There should be no risk of contamination and air embolism (closed system) with all leak proof seals (Disposable bags) Yes * Slit on both sides of the bags should be enough to accommodate 5 -10 ml volume test tubes Yes * The capacity of the bag should be enough to prevent any bollooning/ripture of the abg from the seam when it is filled up with the requisite volume of blood Yes * TUBING OF BAG Flexible kink resistant tubing Yes * Non sticking Yes * Transparent Yes * Leak Proof Yes * Length of tubing from primary bag to needle ≥ 80 Cm * The tubing should have same ID/segment number as that on the bag Yes * The tubes should have multiple printed ID/segment numbers Yes * 2/7 Clamp provided for closed system Yes * NEEDLE Needle Size 16 G * Ultra thin walled and straight to reduce penetration force and enable painless vein puncture Yes * Sharp
Requiredregular and smooth margins and bevelled tip Yes * Rust proof Yes * Tightly fixed with hub covered with sterile guard Yes * Hermetically sealed Yes * The needle should not separate from the tube at any point of time
Requiredespecially while removing it from the vein for donor safety Yes * The needle must confirm to ISO 1135-3 standard Yes * EXTERNAL PORT Tamper proof and should not be re- capped Yes * Easily accessible Yes * ANTICAOGULANT AND PRESERVATIVE SOLUTION Type of anticoagulant present CPD CPD Quantity of anticoagulant solution 14 ml per 100 ml of blood * Solution should be clear and colorless Yes * There should be no discoloration of solution on storage at room temperature Yes * Additive soultion present Yes Yes Type of additive solution SAGM SAGM Quantity of Additive solution(ml) 100 100 Anticoagulant and/or additive solution should Yes * 3/7 be sterile and pyrogen free Availability of anticoagulant/additive quality check certificate from manufacture (proof of same to be submitted to buyer) Yes * LABEL Non-peel off Yes * Heat sealed/Pressure embossed label Yes * The label should remain attached between room temperature to - 80°C with a tranparent adhesive Yes * Date of manufacturing
Requireddate of expiry and batch number must be mentioned on each bag Yes * RESISTANCE TO DISTORTION Bag (Fiiled to normal capacity) shall withstand a acceleration of 5000 g for 30 min at temperature 4°C to 24°C without becoming permanently distorted Yes * Bag (Fiiled to normal capacity) should be able to withstand temperature upto - 80°C without breakage Yes * PACKAGING Individual bag packed in plastic pack and multiple bags packed in moisture proof aluminum foil (Protective dual packaging) eliminating microbial contamination on surface maintaining the contents of the bag Yes * The supplier should ensure proper transportation of the consignment of blood bags in temperature controlled conditions (Storage temperature Yes * 4/7 should not exceed 30°C) CERTIFICATIONS & REPORTS Availability of valid drug license issued from competent authority defined under Drugs and Cosmetics Act
Required1940 (Proof of the same to be submitted to buyer on demand) For Manufacture
RequiredFor Sale * Drug License Number - * Drug License Date - * Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) ISO 13485
RequiredGMP
RequiredWHO GMP ISO 13485
RequiredGMP
RequiredWHO GMP Certification Number - * Certification Date - * Product Certifications (Proof of the same to be submitted to buyer on demand) ISO
RequiredBIS
RequiredEU-CE
RequiredUS-FDA ISO
RequiredBIS
RequiredEU-CE
RequiredUS- FDA Four digit number of notified body If product is EU-CE certified 6442 * Product Certification Number - * Product Certification Date - * Certificate issuing Authority - * Each batch supplied should be accompanied with quality assurance test report from NABL approved lab/any lab approved fron govt of India as well as in house lab Yes * Biocompatibility of the material of the plastic blood bags must be certified by the manufacturer and must be supported by the test reports of cell culture cytotoxicity
Requiredhemolysis
Requiredsystemic Yes * 5/7 infections (acute toxicity)
Requiredsensitization
RequiredInra-cutaneous injection (irritation)
Requiredpyrogen test and Sterility (test report for the same to be submitted for each batch) Submission of manufacturer's documented evidence of biochemical parameters (plasma pH
RequiredATP % of initial volume
Required2-3 DPG % of initial volume
Requiredplasma K+
Required% of viable red cells
RequiredDEHP leaching mg/100 ml
RequiredDEHP should not be more than 0 point 01% w/v in the PVC) of blood stored in CPDA/CPDA-1 CPD-SAGM containing DEHP plasticized PVC blood bags manufactured by the company on 28th/35th/42nd day of storage Yes * SHELF LIFE Shelf Life from the date of manufacture (in months) 30 30 Stability report from a recogniozed laboratory must be submitted to the buyer at the time of supply Yes * The product should have atleast 3/4 of the total shelf life at the time of dispatch to the consignee Yes * * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
