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Needle destroyer (wherever necessary). III. PROCESSING OF BLOOD COMPONENTS FROM WHOLE BLOOD BY A BLOOD BANK The Blood components shall be prepared by blood banks as a part of the Blood Bank services. The conditions for grant or renewal of licence to prepare blood components shall be as follows: - A. ACCOMMODATION: (1) Rooms with adequate area and other specification, for preparing blood components depending on quantum of workload shall be as specified in item B under the heading ―1. BLOOD BANKS/BLOOD COMPONENTS‘ of this Part. (2) Preparation of Blood components shall be carried out only under closed system using single double, triple or quadruple plastic bags except for preparation of Red Blood Cells Concentrates, where single bags may be used with transfer bags. B. EQUIPMENT : Drugs and Cosmetics Rules 1945 317 (i) Air Conditioner; (ii) Laminar air flow bench; (iii) Suitable refrigerated centrifuge; (iv) Plasma expresser; (v) Clipper and clips and/or dielectric sealer; (vi) Weighing device; (vii) Dry rubber balancing material; (viii) Artery forceps, scissors; (ix) Refrigerator maintaining a temperature between 2 degree centigrade to 6 degree centigrade, a digital dial thermometer with recording thermograph and alarm device, with provision for continuous power supply; (x) Platelet agitator with incubator (wherever necessary); (xi) Deep freezers maintaining a temperature between minus 30 degree centigrade to minus 40 degree centigrade and minus 75 degree centigrade to minus 80 degree centigrade; (xii) Refrigerated Water bath for Plasma Thawing; (xiii) Insulated blood bag containers with provisions for storing at appropriate temperature for transport purposes; C. PERSONNEL: The whole time competent technical staff meant for processing of Blood Components (that is Medical Officer, Technical Supervisor, Blood Bank Technicians and Registered Nurse) shall be as specified in item C, under the heading ― 1. BLOOD BANKS/BLOOD COMPONENTS‖ of this Part. D. TESTING FACILITIES: General: Facilities for A, B, AB and O groups and Rh(D) grouping. 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)], VDRL, HIV I and HIV II antibodies and malarial parasites shall be mandatory for every blood unit before it is used for the preparation of blood components. The results of such testing shall be indicated on the label. E. CATEGORIES OF BLOOD COMPONENTS: (1) CONCENTRATED HUMAN RED BLOOD CORPUSCLES: The product shall be known as ―Packed Red Blood Cells‖ that is Packed Red Blood Cells remaining after separating plasma from human blood. General Requirements: (a) Storage: Immediately after processing, the Packed Red Blood Cells shall be kept at a temperature maintained between 2 degree centigrade to 6 degree centigrade. (b) Inspection: The component shall be inspected immediately after separation of the plasma, during storage and again at the time of issue. The product shall not be issued if there is any abnormality in color or physical appearance or any indication of microbial contamination. (c) Suitability of Donor: The source of blood for Packed Red Blood Cells shall be obtained from a donor who meets the criteria for Blood Donation as specified in item H under the heading ―I. BLOOD BANKS/BLOOD COMPONENTS‖ of this Part.