Membrane filtration method1,2:
General procedure for all formulation--
How to prepare sample for different dosage forms (membrane filtration):
Solutions: Solution can directly take as a sample most commonly. Suspensions: Add sufficient quantity of fluid A for rapid filtration. Oils and oily solutions: if less viscous then directly filter without dilution and if more viscous then dilute with proper diluents. Ointments and creams: prepare 1%w/v with suitable diluents with the help of heat if required but NMT 40@C. Sterile Devices: take the sample and shake it for 10 min with 50 ml of suitable broth then instantly pass the mixture through membrane filter which is previously moisten with liquid. Membrane is wash with broth 50 ml for 3-4 times and incubates the test media.
There are some special procedure for surgical cotton, and suture/ligature etc.
Direct inoculation method1,2:
General Procedure--
Observation and interpretation of results1:
Incubation temperature
EP specified 30-32@C for bacteria and 20-25@C for fungi.
USP specified 30-35@C for bacteria and 20-25@C for fungi.
Incubation time
EP specified at least 7 days unless and until specified in any official monograph.
USP specified at least 7 days for steam sterilized product and sterilized by membrane filtration method, but at least 14 days for product sterilized by other methods.
Frequency of observation
Every day; stir the test tube and then observe.
Interpretation of results
-
If no growth or contamination batch passes test.
-
If growth observed and authority will permit to repeat the test then repeat test with greater care.
-
If again growth observed in repeat test, authority will allow repeating unless same microorganism is observe in the two tubes.
-
Generally, one repeat test is allowed for bulk sample and two repeat tests are allowed for final container sample according to WHO.
-
If 2 or more/3 or more and any growth observed in 1st , 2nd, 3rd test respectively then batch will considered an unsuitable (fails sterility test).
References:
-
Cooper and Gunn's Dispensing Pharmacy. CBS publisher, New Delhi, 12 th Ed: 541-572.
-
Indian Pharmacopoeia. Govt. of India, ministry of health and family welfare. India, 2007: 53-59.
This page does not contain any plagiarized material
Comments
Siva Mavuduru
Sun, 09/05/2010 - 07:42
Permalink
Hi Abhigna What are the
Regards Siva Ganesh
sivaganesh_honey@yahoo.com
keep smiling
About Me
http://www.pharmainfo.net/sivaganesh
My Blogs
http://www.pharmainfo.net/sivaganesh/blog
P.V.ABHIGNA
Thu, 09/09/2010 - 08:00
Permalink
Dear Siva, Here some membrane
ABHIGNA.P.V.
Mrudula Boyapati
Sun, 09/05/2010 - 12:50
Permalink
Hiii ABHIGNA
P.V.ABHIGNA
Fri, 10/01/2010 - 18:38
Permalink
why alternate
ABHIGNA.P.V.
TK Indira
Wed, 09/08/2010 - 15:21
Permalink
Dear abhigna
T.K. Indira. http://www.pharmainfo.net/tkindira
-- "Our greatest glory is not in never falling, but in rising every time we fall..." Team 'Char'minar.
P.V.ABHIGNA
Fri, 10/01/2010 - 18:32
Permalink
there are
ABHIGNA.P.V.
Santosh kumar. JH
Wed, 09/08/2010 - 17:09
Permalink
Abhigna, 1. The text of the
Regards,
Santosh Kumar
http://www.pharmainfo.net/santosh-kumar-jh
P.V.ABHIGNA
Thu, 09/09/2010 - 08:12
Permalink
thanks for suggestions
ABHIGNA.P.V.