This seminar discusses membrane filtration processes used for drug product sterilization. It introduces various types of membrane filtration including microfiltration, ultrafiltration, reverse osmosis, and gas separation. Validation of membrane filters is also covered, outlining testing for reproducibility, sterilization integrity, microbial challenges, and endotoxins. The presentation emphasizes that validation is necessary to ensure membrane filters consistently produce safe, effective products meeting quality standards.

1. “SEMINAR ON MEMBRANE FILTRATION”
Department of Pharmaceutics
Presented by
MR. ANKIT L SHARMA
Roll No.-05
Credit -2
P.D.E.A’s S.G.R.S college of Pharmacy Saswad.

2. Content
Introduction
Types of membrane filtration Process
Validation of membrane filtration

3. Introduction
 Membrane filtration is used for sterilization of drug product
and used in sterilization process
 There are two types of filter used in filtration process
(1) Depth filters: Consist of fibrous or granular materials so
packed as to form twisted channels of minute dimensions and
they are made of diatomaceous earth, unglazed porcelain
filter, sintered glass or asbestos.
(2) Membrane filters: These are porous membrane about 0.1
mm thick, made of cellulose acetate, cellulose nitrate,
polycarbonate, and polyvinylidene fluoride, or some other
synthetic material.
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4. Types of Membrane filtration Processes
1.Microfiltration
2.Ultrafiltration
3.Reverse osmosis
4.Gas separation/permeation

5. Paul Ashall, 2007
Microfiltration (MF)
.Porous membrane; particle diameter 0.1 – 10 μm.
.Microfiltration lies between UF and conventional
filtration.
.Membrane filtration can be used for final filtration or
prefiltration.

6. Paul Ashall, 2007
Ultrafiltration(UF)
Ultratrafiltration is the process of separating extremely
small particles and dissolved molecules from fluid .
Membrane pore diameter 0.001 – 0.1 μm.
Membrane performance affected by:
• Concentration polarisation
• Membrane fouling
• Membrane cleaning
• Operating pressure

7. Paul Ashall, 2007
Reverse osmosis
Osmotic pressure is pressure required to equalise
solvent activities.
If P > osmotic pressure is applied to more
concentrated solution, solvent will diffuse from
concentrated solution to dilute solution through
membrane (reverse osmosis).

8. Gas separation
• can be used for separating gas mixtures
where they act as a permeable barrier
through which different compounds move
across at different rates or not move at all.
The membranes can be nonporous, polymer,
etc. and the gas molecules penetrate
according to their size, diffusivity, or solubility.

9. What is Validation?
 Validation may be defined as Establishing documented
evidence which provides a high degree of assurance that a
specific process will consistently produce a product meeting
its pre-determined specifications and quality attributes.
 It has been made mandatory by the regulatory bodies to
prove the safety, efficacy, Purity & effectiveness of the drug
product, medical devices & biologics in the marketplace &
health system.
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10. Why Validation is needed?
Validation is vital for
 Safety
 Lower costs
 Elimination of premature replacement
 Identification of high maintenance cost
 Reduction of variation in results
 Greater confidence in the reliability of results
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11. Validation Testing
 Physical
 Reproducibility of filter
 Sterilization
 Integrity test
 Microbial challenge test
Chemical
Inertness
Activity/stability
Test for antimicrobial activities
 Biological
 Endotoxin
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12. (1) Reproducibility of filter
 Membrane filters should be routinely discarded
after processing of single lot because there are
chances of contamination or cross contamination of
product.
 Factor that can affect in filtration process include
viscosity, surface tension of material to be filtered,
ph, flow rates, time, temperature etc.
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13. (2) Sterilization
 Validation of sterilization method of filter is
necessary because filter it self cause contamination
of the product.
 To validate use of sterilizing grade filter it is not only
prove that the filter is adequately sterilized but also
method does not damage the filter.
 Most preferred method is moist heat sterilizing.
 Variable like heat up, cool down, pressure,
temperature, time, if it is uncontrolled it lead to
filter failure.
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14. (3) microbial challenge test
 To ensure filter is not undergoing degradation
,deformation or some change under condition of
use.
 Drug product not causing organism to shrink
resulting non sterilizing condition.
 Care should be taken that drug product should not
be toxic to organism.
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15. (4) Endotoxin
 Validation must address filter does not add
endotoxin to drug product.
 It depend on quality control process of the filter
manufacturer, water used in manufacturing, choice
of filter vendor, verification are not done properly.
 Millipak filter unit contain less than 0.5 units of
endotoxin per ml as per USP bacterial endotoxin
test.
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16. Thank You