Disposable Blood Bag System

Introduction

Blood bag system is a disposable bio-medical device used for collection, storage, transportation and transfusion of human blood and blood components. The system consists of a single or multiple bag connected with tubes, needle, needle cover, clamp etc. The Blood Bags are made of plastic material which are compatible with blood.

Blood Bags can successfully replace the use of glass bottles for collection, storage, transportation and transfusion of blood and blood components since bottles require exhaustive cleaning, rinsing and autoclaving procedures and there are chances of breakage at any stage. Further, use of disposable bags eliminates the possibility of any contamination.

The technology has been licensed to four Indian companies having capacity of 3 million bags per annum each enabling total production capacity of the country to 12 million bags per annum, The total demand of the country is at present estimated to be 10 million bags per annum. However, the product has been accepted internationally and there exists a substantial global demand of the product offering a very good export potential.

Process

The following major steps are involved in the manufacture of blood bags system

• Compounding -The PVC material is compounded with a number of additives like plasticisers, stabilisers, lubricants etc. The formulation is used for making bags and tubes.
• Extrusion -The compounded PVC is extruded through a die for converting the plasticised material into sheet form. The extruded sheet, after slitting, is cut into desired size and sent to welding section. The donor and transfer tubing's are made by extrusion of PVC compounds.
• The tubes are then printed, and appropriate length are cut in line and sent to welding section.
• Injection Moulding - The components like transfusion port, needle cover, clamp etc. are produced by injection moulding. The components are ultrasonically cleaned and dried in drying oven. The needle is fixed in the needle holder.
• Welding - The blood bags are fabricated by high frequency welding technique. Sized PVC sheets are placed between electrodes and high frequency at high voltage is applied. PVC gets heated very rapidly and sealing takes place between electrodes. Transfusion ports, donor and transfer tubing's are then kept in appropriate position with the bag and welded to form integral part of the blood bag system. Welded bags are trimmed. Clamps and needle coverings are fixed on the tubing's. After inspection the acceptable bags are sent to labelling section.
• Preparation of Anticoagulant Solution -The anticoagulant constituents are premixed and solution is prepared in a pyrogen free distilled water. All the operations are done in conformity to GMP. The anti-coagulant solution is filled in the blood bags.
• Sterilisation-Steam autoclave is used to sterilise the blood bags.
• Done at this Inspection - 100% inspection is stage to eliminate particulate matter, leak and other visible defects. The inspected bags are subsequently packed in the foil pack and are cartooned.

Advantages of Indian technologies

• Low capital investment
• High employment potential
• Maximum use of local raw materials and manpower resources
• Adaptable levels of sophistication

Plant Parameters

Capacity, Million/ Yr.	3
No.of Shifts / day	2
Working days / Yr	300
Land Area, m2	20,000
Covered Area, m2	2200

Manpower

Managerial	4
Skilled	136
Unskilled	21

Raw Material

PVC Resin	97.5
Additives	52.5
Poly Carbonate	1.5
Poly Propyline	16.5
Utilities(per day)
Power, KwH	3840
Water, KL	100
Plant & Machinery
Sheet extrusion Line	Injection moulding m/c
H F Welding m/c	High speed mixer
Tube marking m/c	Vol. filling equipment.
Ultrasonic cleaner	Autoclave
Licence Period	10 Years
Operating Experience	Proven

For further information please contact

National Research Development Corporation
( A Government of India Enterprise )
20-22, Zamroodhpur Community Center
Kailash Colony Extension
New Delhi 110 048. India
Ph: +91-11-26419904, 26417821, 26480767, 26432627
Fax: 011-26231877, 26460506, 26478010
Website: www.nrdcindia.com
E-mail: write2@nrdcindia.com