Emflon® II Membrane Autoclave Vent Filters product photo Primary L

Emflon® II Membrane Autoclave Vent Filters

Product sterilization using the vacuum autoclave method is a critical process demanding the highest performance standards for equipment and precise quality control procedures. Vacuum-break filters used at the end of the sterilizing cycle must therefore satisfy these standards and prove reliable and effective even under extremes of operating conditions.

Pall has developed a special autoclave vent filter (AVF) incorporating Emflon II membrane: a modified-PVDF porous membrane with outstanding performance characteristics. When the filter medium is pleated into a high-surface-area autoclave vent filter, a filter unit of high flow capacity and considerable mechanical strength is obtained.

Features and Benefits

Total Bacterial and Bacteriophage Retention

Filters with Emflon II membrane have been validated by a range of techniques. In bacterial challenge tests using Pseudomonas diminuta in both aerosol and liquid form, total bacterial retention is achieved. In addition, aerosol challenge tests using T1bacteriophage (0.05 micron x 0.1 micron)  and smaller particles permit extrapolation to a gas removal rating of 0.01 micron. Thus removal of bacteria and bacteriophage is ensured, giving complete security during the vacuum break period, regardless of in-rush flow rate.

Effective in Wet or Dry Air

The hydrophobic nature of the Emflon II membrane, together with its fully validated microbial ratings ensure effective sterile filtration in wet or dry conditions. There is no need to prevent condensation, or to dry the filter cartridge. Furthermore, AVF filters do not permit 'grow-through' of bacteria under any conditions.

Efficiency Independent of Flow Rate

AVF filters are not influenced by air velocity. Limiting orifices, as fitted to non-absolute (so called 'depth type') filters are therefore not required. High flow rates can be used to provide maximum benefits.

High Mechanical Strength

The design and composition of AVF filters provide exceptional mechanical strength in both flow directions. Only pure polypropylene and Emflon II membrane melt-sealed together are used to produce a compact, light-weight filter cartridge with no metal parts to rust or corrode.

Steam-Sterilizable

AVF filters can be steam-sterilized repeatedly at up to 140ºC in an autoclave.

Guaranteed Performance and Reliability

All filters are 100% tested for integrity before despatch using the high sensitivity forward flow test developed by Pall. This ensures that the filter will meet the exacting performance standards specified. In addition, a double layer of Emflon II membrane in each cartridge provides total reliability and security throughout the service life.


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Description
Product sterilization using the vacuum autoclave method is a critical process demanding the highest performance standards for equipment and precise quality control procedures. Vacuum-break filters used at the end of the sterilizing cycle must therefore satisfy these standards and prove reliable and effective even under extremes of operating conditions.

Pall has developed a special autoclave vent filter (AVF) incorporating Emflon II membrane: a modified-PVDF porous membrane with outstanding performance characteristics. When the filter medium is pleated into a high-surface-area autoclave vent filter, a filter unit of high flow capacity and considerable mechanical strength is obtained.

Features and Benefits

Total Bacterial and Bacteriophage Retention

Filters with Emflon II membrane have been validated by a range of techniques. In bacterial challenge tests using Pseudomonas diminuta in both aerosol and liquid form, total bacterial retention is achieved. In addition, aerosol challenge tests using T1bacteriophage (0.05 micron x 0.1 micron)  and smaller particles permit extrapolation to a gas removal rating of 0.01 micron. Thus removal of bacteria and bacteriophage is ensured, giving complete security during the vacuum break period, regardless of in-rush flow rate.

Effective in Wet or Dry Air

The hydrophobic nature of the Emflon II membrane, together with its fully validated microbial ratings ensure effective sterile filtration in wet or dry conditions. There is no need to prevent condensation, or to dry the filter cartridge. Furthermore, AVF filters do not permit 'grow-through' of bacteria under any conditions.

Efficiency Independent of Flow Rate

AVF filters are not influenced by air velocity. Limiting orifices, as fitted to non-absolute (so called 'depth type') filters are therefore not required. High flow rates can be used to provide maximum benefits.

High Mechanical Strength

The design and composition of AVF filters provide exceptional mechanical strength in both flow directions. Only pure polypropylene and Emflon II membrane melt-sealed together are used to produce a compact, light-weight filter cartridge with no metal parts to rust or corrode.

Steam-Sterilizable

AVF filters can be steam-sterilized repeatedly at up to 140ºC in an autoclave.

Guaranteed Performance and Reliability

All filters are 100% tested for integrity before despatch using the high sensitivity forward flow test developed by Pall. This ensures that the filter will meet the exacting performance standards specified. In addition, a double layer of Emflon II membrane in each cartridge provides total reliability and security throughout the service life.
Specifications

Manufacturing Standards

Autoclave vent filters are non-fiber releasing and conform to CGMPs for parenteral drugs. All components arc FDA-listed for food contact use and assembled under cleanroom conditions. Where vacuum-break filters are required to conform to British Standard BS3970, AVF filters meet or exceed the requirements. For example, when tested for sodium chloride penetration in accordance with British Standard BS3928, AVF fillers give a penetration of less than 0.003% - the sensitivity limit of the lest. Aerosol challenge with Pseudomonas diminuta, T1bacteriophage (0.05 micron x 0.1 micron) and smaller particles permit extrapolation to a gas removal rating of 0.01 micron. For other manufacturing standards. Pall will be pleased to advise on the performance of AVF filters.

Selection of Filters

The high flow capacity of AVF filters in conjunction with correct filter sizing can provide substantial cost savings. The smaller size filter with the part number AVF021 is suitable for most laboratory or production vacuum autoclaves. Larger autoclaves may require the double-area filter with the part number AVF022, which can often replace two existing non-absolute filters of lower flow capacity, thus giving cost benefits and added reliability.

Filter sizing will depend on the vacuum used, the size of the autoclave, maximum vacuum-break time required, and the restrictions to flow caused by valves and pipework. As a guide to selection, vacuum break curves for both sizes of filter are shown below. For example, to achieve a two-minute maximum vacuum-break from 737 mm Hg (29" Hg) of vacuum (i.e. approx. 25 mm Hg [1.0" Hg] absolute pressure) the following sizing limits are obtained from the graph:
 
Part Number Maximum Autoclave Volume
AVF021V002PVJ 2.2 m3 (75 ft3)
AVF022V002PVJ 2.8 m3 (100 ft3)
 

Some allowance for blockage of the filter must be included. This will depend on the level of airborne contamination and the service life required, but as an approximate guide, fillers may be sized at 50% of the maximum vacuum-break time specified by the user at the end of the service life.

 
Specification AVF021V002PVJ AVF022V002PVJ
Surface Area 0.11 m2 0.22 m2
Length 87 mm 150 mm
Diameter 56 mm 56 mm
End Adaptor 12 inch BSPP, male thread 12 inch BSPP male thread
Gasket EPR EPR
Steam Sterilization Temperature (Autoclave) Up to 140 °C Up to 140 °C
Differential Pressure limit at 80 °C 4.1 bar 4.1 bar
 

Ordering Information
 
Part Number Maximum Autoclave Volume
AVF021V002PVJ 2.2 m3 (75 ft3)
AVF022V002PVJ 2.8 m3 (100 ft3)
 
Application
Filters - Gas
Segment
Filtration