Bio Assay Division
The Bio Assay Division currently carries out three mandatory parameters prescribed by the Pharmacopoeia for the Biological prior to its release for human use. The parameters are :
In- vitro parameter:
(a) Sterility Test :
Direct Inoculation Method
Membrane Method
Closed system (Steritest)
In-Vivo Parameters
(b) Abnormal Toxicity Test
(c) Rabbit Pyrogen Test
The Sterility Testing Laboratory of the Bio Assay Division was made operational in April 2009 in its designated location, and has since tested and reported 30 samples of Biologicals referred to it by various methods.
The Abnormal Toxicity and the Rabbit Pyrogen tests have been standardized and necessary approvals by the Institutional Animal Ethics committee(IAEC) have been obtained in the meeting of the IAEC held on the 20.07.2009. These tests shall be performed in the Animal Facility of the Institute which is registered with the CPCSEA since 2004.
Biologicals referred for testing and methods used
S.No. |
Biological Sample Referred |
No. of samples |
Test Conducted |
1. |
Insluin |
16 |
Membrane method & Closed system |
2 |
ST pase |
01 |
Direct Inoculation |
3 |
HEP 5 (Heparin) |
01 |
Closed system |
4 |
Human Albumin |
12 |
Membrane method & Closed system |
5 |
Others |
02 |
Direct Inoculation |
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