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Presented By

Farzana Sultana

BPH : 04806682

Department of Pharmacy

Stamford University Bangladesh

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“Application of filtration process in pharmaceutical

Industry”

Filtration

Solids and liquids are separated during filtration operations. Filters have different designs

and features with varying containment and control of liquids and vapours . When open

filters are used for hazardous materials, workers may be exposed to liquids, wet solids,

vapours and aerosols during loading and unloading operations. Closed process equipment

can be used to filter highly hazardous materials, reducing vapour emissions and preventing

worker exposures. Filtration should be performed in areas with spill control and good

dilution and LEV. Volatile solvent vapours can be exhausted through vents on sealed

process equipment and controlled by air emissions devices (e.g., condensers, scrubbers and

adsorbers).

Figure . A sparkler filter

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Air Filtration

1. Membrane

A compressed gas should be of appropriate purity (e.g., free from oil) and its

microbiological and particle quality after filtration should be equal to or better than that of

the air in the environment into which the gas is introduced. Compressed gases such as air,

nitrogen, and carbon dioxide are often used in cleanrooms and are frequently employed in

purging or overlaying.

Membrane filters can be used to filter a compressed gas to meet an appropriate high-

quality standard. These filters are often used to produce a sterile compressed gas to

conduct operations involving sterile materials, such as components and equipment. For

example, we recommend that sterile membrane filters be used for autoclave air lines,

lyophilizer vacuum breaks, and tanks containing sterilized materials. Sterilized holding

tanks and any contained liquids should be held under positive pressure or appropriately

sealed to prevent microbial contamination. Safeguards should be in place to prevent a

pressure change that can result in contamination due to back flow of nonsterile air or

liquid.

Gas filters (including vent filters) should be dry. Condensate on a gas filter can cause

blockage during use or allow for the growth of microorganisms. Use of hydrophobic filters,

as well as application of heat to these filters where appropriate, prevents problematic

moisture residues. We recommend that filters that serve as sterile boundaries or supply

sterile gases that can affect product be integrity tested upon installation and periodically

thereafter (e.g., end of use). Integrity tests are also recommended after activities that may

damage the filter. Integrity test failures should be investigated, and filters should be

replaced at appropriate, defined intervals.

2. High-Efficiency Particulate Air (HEPA)

HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing

should be performed at installation to detect integrity breaches around the sealing gaskets,

through the frames, or through various points on the filter media. Thereafter, leak tests

should be performed at suitable time intervals for HEPA filters in the aseptic processing

facility. For example, such testing should be performed twice a year for the aseptic

processing room. Additional testing may be appropriate when air quality is found to be

unacceptable, facility renovations might be the cause of disturbances to ceiling or wall

structures, or as part of an investigation into a media fill or drug product sterility failure.

Among the filters that should be leak tested are those installed in dry heat depyrogenation

tunnels and ovens commonly used to depyrogenate glass vials. Where justified, alternate

methods can be used to test HEPA filters in the hot zones of these tunnels and ovens.

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Adsorptive Depth Filtration

Activated carbon is used in the pharmaceutical industry to remove impurities from active

ingredient manufacturing. These impurities are typically derived from chemical reactions

that produce colored by-products. These colored by-products must be removed to maintain

drug purity and produce high-quality, on-spec intermediate compoundsActivated carbon

use in powdered form presents three primary areas of concern to the pharmaceutical

manufacturer, namely operator exposure to carbon dust, the quality of the process and the

operating costs associated with the use and handling of bulk activated carbon.

Figure . Adsorptive Depth Filtration

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Solvent & Bulk Chemical Filtration

Chemicals and solvents used in pharmaceutical manufacturing include alcohol, acetone,

methylene chloride and numerous other bulk chemicals for raw materials. Active

pharmaceutical ingredients are synthesized through chemical reactions that use solvents

together with other ingredients including catalysts. These bulk chemicals should be free of

particulate matter and contaminants prior to their use in manufacturing processes in order

to maintain process integrity and overall product quality.

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Sterilizing Grade Filtration (liquid & gas)

Sterilizing grade filtration requires robust filters designed for performance certification to

standards established by regulatory agencies, including absolute retention of certain

microorganisms and certification of filter integrity by the manufacturer. 3M Purification

supplies a variety of filter options for use in sterilizing grade filtration applications.

The applications for these products include:

• Nitrogen filtration and tank venting

• High Purity DI water and WFI systems

• Parenterals (SVP, LVP)

• Opthalmics

• Biologicals

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Water filtration

The water, steam and utilities used in pharmaceutical production is typically filtered to

remove particles, scale and impurities prior to its use. 3M Purification offers a variety of

filter options to meet the needs of these utility applications.

Water filtration is perhaps the most common application in the pharmaceutical industry.

Different standards for water quality exist in the pharmaceutical industry depending on

the application.

• USP Water for Injection (WFI)—for product formulation, equipment and container

cleaning and WFI steam production.

• USP Purified Water—for equipment and container cleaning, fermenter make-up water

(sterile filtered) and clean steam production.

• Utilities water—for heating/cooling process equipment.

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Pharmaceutical Production Overview

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References

1. Innovative Filtration Performance. Quality. Service.

2. Process Filtration Applications Pharmaceutical and Biotechnology Industries

- Donaldson

3. Guidance for Industry Sterile Drug Products Produced by Aseptic

Processing — Current Good Manufacturing Practice

4. FILTRATION SOLUTIONS

Pharmaceutical Manufacturing

-Amazon

5. Solutions for pharmaceutical filtration processes

6. Andrew L, Doug N and Derek J (2002) Mineral processing, plant

design, practice and control.

7. Subramanyam CVS, Setty TJ, Suresh S and Devi KV (2005)

Filtration In pharmaceutical engineering principles and practices,

Vallabh prakashan.