validation of membrane filter
TRANSCRIPT
1
Validation of Membrane Filter
Mr. Sagar Kishor Savale[Department of Pharmaceutics]
Department of Pharmacy (Pharmaceutics) | Sagar savale
2
Introduction1
Why Validate?
What needs to be Validate?
Who is responsible for Validation
Elements of validation study Conclusion
3
Why Validate Good Manufacturing Practice
For LVP,SVP, ophthalmic, veterinary medicine, bulk chemicals & in-vitro diagnostic
For Good business Practice A control process gives reproducibility
& product consistency with in known limits
Provides license to do business.
4
What Needs to be Validate?Before any work is initiated to
validate a filter prerequisite must be satisfied
The filter itself must be consistent & reproducible from lot to lot
5
Who is responsible for Validation2
Drug Manufacturer is responsible
Drug Manufacturer should select a filter manufacturer who Provide sufficient information and services to facilitate the Validation
Q.A. Manager & Q.A. Team
6
Components of Validation Study3,4,5, l ll
Destructive testing –
Non destructive testing – - Bubble point test – - Diffusion test - - Pressure Holding testing –
Water intrusion test -
7
Continue..Filter Inertness –
Operating Conditions –
Fibers –
Endotoxins –
Toxicity -
8
Destructive Testing 3,5,4
Select 0.22 µm filter discs Solution of culture media
-Brevundimonas diminuta- Pseudomonas diminuta
The effluent is then passed through a second 0.45 µm assay filter disc
placed on an agar plate and incubated
9
Non-Destructive Testing 5,4 l
Bubble Point Testing -
Connection of filter holder to a pressure regulated system
Arrangement of filter and filter holder
10
Continue.
Appearance of bubbles
11
Observation of Defects 5
Compressed Air
Defective pore
00000 Memb. Pore
Liquid-----------------------
Air Pressure at 50 psi
Membrane Filter(0.22µm
Pore Size)
12
In Process bubble point testing 5
5 psi
When the applied pressure reachesthe bubble point pressure of the>50 psifilter, liquid is displaced from the(3.5 bar)filter pores.
>50 psi
13
Diffusion Test 5
water is collected in a graduated cylinder and by using a stop-watch, the rate of diffusion is measured in milliliters of water per minute. Thisrate is then compared to a standard established for the particular filter system
Gas Pressure
Water-filledFilter
14
.
Pressure Holding testing5
Water intrusion test ll
also name as Water Flow Integrity test
Filter Inertness 6,l
Operating Conditions 4
-Temperature-Time -Pressure
15
Fibers lll
Any filter which after any appropriate pretreatment such as washing or flushing will not release fiber into the component of drug product
Fiber exceeding 2.5 µm must be eliminated
16
Endotoxins 6,7
Filter does not add Endotoxin to a drug product
Endotoxin content of new filter will depend on quality control process of filter manufacturing, filter manufacturer and the water used in filter manufacturing
17
Toxicity 6
filter does not cause any toxicological effect.
All filter material of construction should be addressed
It is then responsibility of drug manufacturer to ensure that contract of the filter and drug product does not result in any toxic by product
18
Conclusion
Filter validation performed by Q.A. Team & drug manufacturer is not just a regulatory requirement it also makes good business.
It start with a filter requirements specification
From this specification it is simply a matter of choosing the method that allow verification of the requirements
19
References1. Potdar AM. Pharmaceutical Quality Assurance,1st
ed. Published by Nirali Prakashan; 2006.P. 8.13
2. Syed Imtiaz Haider. Pharmaceutical Master Validation Plan , The Ultimate Guide to FDA,GMP and GLP Compliance, informa healthcare;2010. P. 329-331
3.VALIDATION OF BACTERIAL RETENTION BY MEMBRANE FILTRATION: A PROPOSED APPROACH FOR DETERMINING STERILITY ASSURANCE (January 1, 1983)
20
continue4. Reinhard Baumfalk, systems development of
the Biotechnology Division, Sartorius AG, Weender Landstrasse, D-37075 Göttingen, Germany, 94-108
5. Millipore ,Manual of filter integrity test methods, India pvt Ltd Bangalore ,Page 99-121
6. American Society for Testing and Materials. "Standard test method for determining bacterial retention of membrane filters utilized for liquid filtration."Philadelphia, PA 1993, Page F-838-83.
21
continue
7. Jornitz MW ,Advances in Biochemical Engineering/Biotechnology. Sterile Filtration. Vol. 98, Chap. 6. Springer Verlag. Berlin. 2006.
22
Web References -1.www.bioprocessresources.com/
servicelist/information/filterintegritytesting
ll. www.springerlink.com
lll. www.gmp.compliance.org
23
THANK YOU…