Blood Bag Testing Laboratory India | NABL Accredited

Auriga Research is a NABL-accredited blood bag testing laboratory providing comprehensive quality evaluation of PVC and non-PVC blood collection bags per IS 12065, ISO 3826, and Indian Pharmacopoeia standards. Our testing covers extractables, haemolysis, seal integrity, plasticiser migration, sterility, and biocompatibility required for CDSCO manufacturing licence approval.

Blood bags are critical medical devices where material quality directly impacts patient safety. Our testing programme verifies that bag materials do not leach harmful substances into stored blood, that seals withstand handling and centrifugation, and that anticoagulant solutions maintain potency throughout shelf life.

Blood Bag Testing Parameters

Extractables — reducing substances, heavy metals, UV absorbance per IP
DEHP/plasticiser migration into simulated blood and saline
Haemolysis rate and blood compatibility studies
Seal strength and peel strength per IS 12065
Water vapour transmission rate (WVTR)
Transparency and visual inspection
Anticoagulant solution potency (CPD/CPDA-1) by HPLC
Sterility testing per Indian Pharmacopoeia
Vinyl chloride monomer residue by headspace GC
Particulate contamination — sub-visible and visible particles

Who Needs Blood Bag Testing

Blood bag manufacturers applying for CDSCO manufacturing licence
Importers registering blood bags for the Indian market
Blood banks verifying supplier quality
Companies developing non-DEHP alternative plasticiser blood bags
Quality teams conducting periodic revalidation testing

Turnaround Time

Physical testing takes 5-7 business days. Chemical extractables and plasticiser migration take 10-12 business days. Haemolysis studies take 15-20 business days. Complete blood bag testing (all parameters including sterility) is delivered within 20-25 business days.

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Frequently Asked Questions

What tests are required for blood bag approval in India?

Blood bag testing in India follows IS 12065 and Indian Pharmacopoeia requirements. Key tests include extractables in saline and aqueous solutions (reducing substances, heavy metals, UV absorbance), haemolysis testing, seal strength and peel strength, transparency, flexibility, water vapour transmission rate, anticoagulant potency (CPD/CPDA-1), sterility, particulate contamination, and biocompatibility per ISO 10993. CDSCO requires this complete testing battery for manufacturing licence approval.

What material-specific tests apply to PVC blood bags?

PVC blood bags contain DEHP (di-2-ethylhexyl phthalate) as a plasticiser. Testing includes DEHP migration into stored blood (quantified by GC-MS), extractable content in aqueous and saline media, and vinyl chloride monomer residue. The Indian Pharmacopoeia specifies limits for these extractables. Non-DEHP blood bags (using TOTM, BTHC, or DINCH plasticisers) require equivalent extractable and compatibility testing.

What is the turnaround time for complete blood bag testing?

Physical tests (seal strength, transparency, dimensions) take 5-7 business days. Chemical extractables testing takes 10-12 business days. Haemolysis and blood compatibility studies take 15-20 business days. Sterility testing takes 14 business days per Pharmacopoeia requirements. A complete blood bag testing programme takes approximately 20-25 business days.