Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on April 27, 2023 by The Health Master
Blood Centre (Bank) – requirements at a glance
Requirements of areas / rooms for blood Centre (Bank)
Rooms or areas and equipment requirements for each room along with room temperature conditions for Blood Centre (Bank).
| Sr. No. | Room | Minimum requirement of equipment | Air Conditioner (A/C) or Room Temperature |
| 1 | Registration area | Weighing scale Height scale Table / Chairs | Room Temperature |
| 2 | Medical Examination Room | BP Apparatus Stethoscope Thermometer Hb meter Alcohol swabs Test tubes Syringes Examination table Table / Chairs | Room Temperature |
| 3 | Counselor Room | Register / Notebook IEC Material Table / Chairs | Room Temperature |
| 4 | Blood Collection room | Hygrometer (Temp./Humidity) Donor Couches BP Apparatus Sealer for blood bag Oxygen cylinder EDTA & Plain Vacutainers I/V Stand Blood Collection Monitor (weighing + Mixing) Emergency Drugs | A/C |
| 5 | Serology Room | Timer Automated machine for Immunohaematology Hygrometer (Temp/Humidity) Bench-top Sealer Rh-View Box Incubator Microscope Micro Pipette (100 µl-1000µl) Dry Bath Incubator Table Top Centrifuge Machine | A/C |
| 6 | TTI Lab | Rotary VDRL Shaker Fully Automated Infection Marker Machine / Elisa Reader Hygrometer (Temp./Humidity) Refrigerator for storage of reagents / kits Micro Pipette (10µl-1000µl) Dry Bath Incubator Table Top Centrifuge Machine | A/C |
| 7 | Blood Storage Area | Refrigerators ( independent for tested and untested blood / blood components) with alarm, recording devices | Room Temperature |
| 8 | Sterilization & Washing Area | Autoclave (vertical) Hot Air Oven Washing facilities Cabinets for keeping washed glass wares | Room Temperature |
| 9 | Rest cum refreshment Room | Table / Chairs / Sofas Domestic Refrigerator Recovery Bed | A/C |
| 10 | Apheresis room | Cell Separator /Aphesis Handy Sealer BP Apparatus Stethoscope Alcohol Swabs Oxygen Cylinder Donor Couches Blankets Hygrometer (Temp. / Humidity) Emergency Drugs I/V Stand | A/C |
| 11 | Component preparation Room | Deep Freezer (-30˚C) Deep Freezer (-80˚C) (Quarantine) Platelet Agitator & Incubator Automatic Component Extractor Refrigerated Centrifuge – 6000i | A/C |
Application Form and Fee
Application Forms and required fee for grant and renewal, additional items and duplicate license of Blood Centre (Bank)
| Application Form for grant or renewal | 27-C |
| License to be granted on Form | 28-C |
| Fee for grant or renewal | ₹ 7500/- |
| Renewal to be issued on Form | 26-G |
| Late Fee per month for 6 months | ₹ 1000/- |
| Additional item fee per item | ₹ 300/- |
| Duplicate License fee | ₹ 1000/- |
Storage conditions for Whole Human Blood IP / Blood Components:
Storage conditions for Whole Human Blood IP / Blood Components
| Sr. No. | Name of blood/Components | Storage Temperature in degree Celsius | Expiry Date |
| 1 | Whole Human Blood I.P. | 2-6 | 35 days in CPDA-1 |
| 2 | Concentrated Human Red Blood Corpuscles I.P. | 2-6 | 42 days in CPD-SAGM |
| 3 | Platelet Concentrate IP. | 20-24 | 5 days |
| 4 | Fresh Frozen Plasma BP. | <-30 | 365 days |
| 5 | Cryoprecipitate Antihaemophilic Factor IP. | <-30 | 365 days |
| 6 | Single Donor Platelets (SDP) prepared using Plateletpheresis / cell Separator | 20-24 | 5 days |
| 7 | Cryo-poor Plasma. | <-30 | 365 days |
| 8 | Granulocyte Concentrate. | 20-24 | 1 days |
| 9 | Leucocyte-Reduced Red Cell. | 2-6 | 42 days in CPD-SAGM |
| 10 | Leucocyte-Reduced Platelet Concentrate. | 20-24 | 5 days |
| 11 | Leucappheresis using cell separator (leading to single donor platelet / leucocyte.). | SDP 20-24 | 5 days |
| -do- | Leucocyte 2-6 | 1 days | |
| 12 | Random Donor Platelet. | 20-24 | 5 days |
| 13 | Platelet Rich Plasma | 20-24 | 5 days |
Area requirements:
Area requirements for the Blood Centre (Bank) and to manufacture components
| Sr. No. | Various Processes | Minimum Area in Sq. Mt. |
| 1. | Manufacture of Whole human blood IP | 100 |
| 2. | Carrying out of Aphaeresis process | 10 |
| 3 | Preparation of Blood Components | 50 |
Map for Blood Centre (Bank):
Ideal Map for Blood Centre (Bank)
List of SOPs used in Blood Centres
List of SOPs used in Blood Centres, click the link below to download:
List of SOPs used in Blood Centres
FAQs – on Blood Bank / Centre (Part-1)
FAQs – on Blood Bank / Centre (Part-2)
FAQs – on Blood Bank / Centre (Part-3)
FAQs on Legal Metrology & Blood Bags
Pharmacopoeial status of Blood and its components
Your Guide to Preventing and Treating Blood Clots
Adequate and safe blood transfusion for all: Article
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