Overview
We provide end-to-end solutions for blood banks and plasma banks, covering setup, process design, equipment selection, manpower training, and international regulatory compliance.
Our expertise supports facilities engaged in blood component preparation, plasma sourcing, viral testing, and plasma fractionation for the production of plasma-derived

medicinal products (PDMPs) such as Albumin and Immunoglobulins.

Blood Bank – Purpose & Functions
A Blood Bank ensures a safe and adequate supply of blood and its components — Red Blood Cells (RBCs), Platelets, Plasma — for therapeutic use.
Core Functions

• Donor recruitment and medical screening

• Collection (whole blood & apheresis)

• Testing for HIV, HBV, HCV, Syphilis, and Malaria

• Component preparation by centrifugation

• Cold-chain storage and traceability

• Distribution and quality control

WHO Standards
Operations must comply with WHO Good Manufacturing Practices (GMP) for Blood Establishments and National Blood Policy standards.
All units are tested for transfusion-transmissible infections (TTIs) before release.

Blood Bank Setup & Management
Facility Design

• Donor screening, collection, testing, and component separation zones

• Unidirectional workflow with clean/dirty segregation

• Controlled temperature and humidity per GMP

Essential Equipment
Refrigerated centrifuges • Plasma extractors • Platelet incubators • Deep freezers (–30°C/–80°C) • NAT/ELISA analyzers • LIMS system
Manpower

• Medical Officer (Pathology / Transfusion Medicine)

• Blood Bank Technologist & Phlebotomist

• QA/QC Technicians & Support Staff

Training
All staff undergo continuous GMP and WHO quality system training for donor safety, aseptic handling, and traceability.

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Plasma Bank 
A Plasma Bank collects, tests, and stores human plasma for therapeutic transfusion and industrial use in plasma fractionation.
It supplies high-quality, virus-tested plasma for producing Albumin, Immunoglobulins (Gamma Globulin), and Coagulation Factors.
Core Operations

• Plasmapheresis collection from voluntary donors

• NAT and serological testing for viral markers

• Quarantine and qualified storage (≤ –30°C)

• Plasma pooling and documentation

• Release for fractionation or PDMP manufacture

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Plasma Processing & Fractionation
Plasma is processed using validated fractionation methods under GMP conditions:

Step & Description
Pooling - Qualified plasma units combined into controlled pools
Fractionation - Ethanol (Cohn) or Chromatography method to isolate proteins
Viral Inactivation - Solvent/Detergent Pasteurization, or Nanofiltration
Purification - Filtration, ultrafiltration, chromatography polishing
Formulation - Stabilization, aseptic filling, and packaging

Every step is validated for viral safety, product purity, and traceability in line with WHO TRS 941 & 987.

Facility & Equipment
A modern plasma bank must include:

• Plasmapheresis machines

• NAT/ELISA testing systems

• Pooling and mixing tanks

• Chromatography and ultrafiltration systems

• GMP-compliant cold storage (–30°C to –80°C)

• Environmental and temperature monitoring systems

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Quality & Compliance
We align every project with international regulatory requirements:

• WHO TRS 941 / 961 / 987

• EMA Plasma Master File (PMF)

• US FDA 21 CFR 640 Subpart G

• National regulatory authority standards

Key Compliance Elements

• 100% TTI & NAT testing

• Validated viral inactivation methods

• Full donor-to-batch traceability

• Internal & external audits (EQA, CAPA)

• Documentation under GMP & QMS principles

 

Training & Operations
Personnel receive certified training in:

• Donor screening & counseling

• Component preparation & storage

• Plasma pooling & processing

• Validation & equipment qualification (IQ/OQ/PQ/DQ)

• LIMS and traceability systems

• Emergency response & biosafety

 

Audit & Regulatory Readiness
Facilities are prepared for:

• WHO audits and National inspections

• GMP validation and viral clearance documentation

• QMS and CAPA system verification

• Regulatory dossier preparation and PMF submission

At a Glance
Process Area - Key Control - WHO Reference
Donor Management - Voluntary, Non-remunerated - TRS 961
Plasma Collection - NAT + Serology -TRS 941
Viral Safety - Inactivation/Removal Validation - TRS 987
Storage  ≤ –30°C (Plasma) -TRS 941
Distribution - Traceable Cold Chain TRS 961

 

Reference Links

• WHO TRS 941 — Human Plasma for Fractionation

• WHO TRS 961 — GMP for Blood Establishments

• WHO TRS 987 — Viral Inactivation and Removal

• Blood Services – Indian Red Cross Society Program

Plasma Fraction — Engineering Facilities for Safe, Compliant Plasma-Derived Products.