Seitz® P-Series Depth Filter Sheets product photo Primary L

Seitz® P-Series Depth Filter Sheets

Optimized for Low Extractables, Endotoxins and Beta Glucans

Seitz depth filter media meet the highest pharmaceutical standards for:

  • Quality
  • Lot-to-lot consistency
  • Manufacturing control
  • Low extractable content
  • Low endotoxin content
  • Low beta glucans content

Benefits

  • P-grade sheets are steam sterilizable to 125 °C for 30 minutes
  • All P-grade depth filter sheets meet the specifications for the biological tests listed in the current version of the USP Class VI at 121 °C
  • P-grade sheets are fully lot traceable
  • Supporting Validation Guide available upon request. Please reference USTR2366

Seitz P-series depth filter sheets were specifically developed for the strict requirements in the biotech and pharmaceutical industries. Manufactured with stringent in-process control methods assures consistent filtration quality, a high purity of filter medium, and alignment with the requirements of the pharmaceutical industry.

The P-series depth filter sheets are available in 11 different grades. Due to specific manufacturing methods, the distinguishing feature of the P-series sheets is their high purity resulting in a very low release of extractables as well as an extremely low endotoxin content (<0.06 EU/mL prior to rinsing with 50 L/m2 WFI). As part of Pall’s standard flushing recommendations, further reduction of extractable and endotoxin levels can be achieved (as documented in Pall Validation Guide reference USTR 2366).

Scalability and Convenience

The P-series depth filter media is also available in a wide range of capsule and module formats and sizes, enabling the choice of the most convenient and efficient filter for the specific process requirements. 

The range in filter sizes provides effective scalability, for processing volumes from <1 L to over 20,000 L, while the single-use capsule formats offer increased processing efficiencies and reduced operator exposure to potentially hazardous fluids. For scalability table, showing effective filtration areas, please refer to specifications section.

Available Product Range and Typical Applications

  • EKX-P up to SUPRA 80 P grades are ultra fine particle
    and microorganism-reducing filter sheets for depth
    filtration in the biotechnology and pharmaceutical
    industries. Typical applications include clarification of
    fermenter broth, TFF permeate, cell cultures, protection
    of chromatography columns and TFF membrane processes,
    protection of sterile filter membranes, filtration of
    therapeutical proteins, vaccines, diagnostics and blood
    products, filtration of nutrients and DNA and virus removal. 
  • K 100 P up to K 250 P are depth filter sheets for fine filtration in the pharmaceutical and biotechnology industries. Typical applications include filtration of fermenter broth, TFF permeate, therapeutical proteins, vaccines, diagnostics and blood products, filtration of nutrients, separation of adsorbents, and filter aids.
  • K 700 P, K 900 P and T 1500 P are depth filter sheets for coarse filtration in the biotechnological industries. Typical applications include filtration of fermenter broth, cell culture, therapeutical proteins, vaccines, diagnostics and blood products.
  • V100P is a depth filter sheet for fine filtration of feedstreams where virus or virus-like-particles are the product of interest, like vaccines or gene therapy

Materials of Construction

The filter matrix specifically developed for the P-series depth filter media provides particle retention rates down to 0.05 μm and enables optimal pre-filtration of biological products as well as protection of downstream process steps.

Comprised of cellulose fibers, filter aids (diatomaceous earth and perlite) and resins, the P-series depth filter media takes advantage of two dynamic mechanisms for the removal of contaminants, electrokinetic charge and size exclusion.

Cellulose is used to construct the initial filter matrix to which filter aids and other additives are impregnated into and improve contaminant removal and loading capabilities of the filter sheets.

Filter aids such as diatomaceous earth and perlite are immobilized within the cellulose matrix in various concentrations to provide specific contaminant removal, screening and permeabilities to each grade in the P-series family of depth filter sheets.

Resins are utilized as binders for the filter matrix to improve the filter sheets’ overall wet tensile strength. Due to their electokinetic adsorption properties, resins are also used to increase the retention of small particles, those smaller then the actual porsity of the filter medium, host cell proteins, endotoxins, DNA, and viruses.

The filter sheets meet the specifications set forth in the US Code of Federal Regulations Title 21, parts 177.2260 e, f, g, h, i, j, k, l, the materials for all plastic components are listed in US Code of Federal Regulations Title 21, part 177.1520. The Quality Management System of Pall has been certified according to DIN EN ISO 9001 by TÜV Cert (Certification Office TÜV Rheinland, Sicherheit und Umweltschutz GmbH).

Technical Service

For best possible results and maximum reliability it is recommended a test run under actual process conditions is performed. Depth filtration requires detailed knowledge of the product and the filtration sequence. In this area, Pall specialists can provide valuable assistance; they are able to perform filtration tests at the production or R & D site or in our Scientific and Laboratory Services (SLS) laboratories. Pall offers hands-on assistance and places its extensive technical resources at the disposal of its customers in the form of worldwide technical advice, including cost reduction programs, process review and problem solving.



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Description

Optimized for Low Extractables, Endotoxins and Beta Glucans

Seitz depth filter media meet the highest pharmaceutical standards for:

  • Quality
  • Lot-to-lot consistency
  • Manufacturing control
  • Low extractable content
  • Low endotoxin content
  • Low beta glucans content

Benefits

  • P-grade sheets are steam sterilizable to 125 °C for 30 minutes
  • All P-grade depth filter sheets meet the specifications for the biological tests listed in the current version of the USP Class VI at 121 °C
  • P-grade sheets are fully lot traceable
  • Supporting Validation Guide available upon request. Please reference USTR2366

Seitz P-series depth filter sheets were specifically developed for the strict requirements in the biotech and pharmaceutical industries. Manufactured with stringent in-process control methods assures consistent filtration quality, a high purity of filter medium, and alignment with the requirements of the pharmaceutical industry.

The P-series depth filter sheets are available in 11 different grades. Due to specific manufacturing methods, the distinguishing feature of the P-series sheets is their high purity resulting in a very low release of extractables as well as an extremely low endotoxin content (<0.06 EU/mL prior to rinsing with 50 L/m2 WFI). As part of Pall’s standard flushing recommendations, further reduction of extractable and endotoxin levels can be achieved (as documented in Pall Validation Guide reference USTR 2366).

Scalability and Convenience

The P-series depth filter media is also available in a wide range of capsule and module formats and sizes, enabling the choice of the most convenient and efficient filter for the specific process requirements. 

The range in filter sizes provides effective scalability, for processing volumes from <1 L to over 20,000 L, while the single-use capsule formats offer increased processing efficiencies and reduced operator exposure to potentially hazardous fluids. For scalability table, showing effective filtration areas, please refer to specifications section.

Available Product Range and Typical Applications

  • EKX-P up to SUPRA 80 P grades are ultra fine particle
    and microorganism-reducing filter sheets for depth
    filtration in the biotechnology and pharmaceutical
    industries. Typical applications include clarification of
    fermenter broth, TFF permeate, cell cultures, protection
    of chromatography columns and TFF membrane processes,
    protection of sterile filter membranes, filtration of
    therapeutical proteins, vaccines, diagnostics and blood
    products, filtration of nutrients and DNA and virus removal. 
  • K 100 P up to K 250 P are depth filter sheets for fine filtration in the pharmaceutical and biotechnology industries. Typical applications include filtration of fermenter broth, TFF permeate, therapeutical proteins, vaccines, diagnostics and blood products, filtration of nutrients, separation of adsorbents, and filter aids.
  • K 700 P, K 900 P and T 1500 P are depth filter sheets for coarse filtration in the biotechnological industries. Typical applications include filtration of fermenter broth, cell culture, therapeutical proteins, vaccines, diagnostics and blood products.
  • V100P is a depth filter sheet for fine filtration of feedstreams where virus or virus-like-particles are the product of interest, like vaccines or gene therapy

Materials of Construction

The filter matrix specifically developed for the P-series depth filter media provides particle retention rates down to 0.05 μm and enables optimal pre-filtration of biological products as well as protection of downstream process steps.

Comprised of cellulose fibers, filter aids (diatomaceous earth and perlite) and resins, the P-series depth filter media takes advantage of two dynamic mechanisms for the removal of contaminants, electrokinetic charge and size exclusion.

Cellulose is used to construct the initial filter matrix to which filter aids and other additives are impregnated into and improve contaminant removal and loading capabilities of the filter sheets.

Filter aids such as diatomaceous earth and perlite are immobilized within the cellulose matrix in various concentrations to provide specific contaminant removal, screening and permeabilities to each grade in the P-series family of depth filter sheets.

Resins are utilized as binders for the filter matrix to improve the filter sheets’ overall wet tensile strength. Due to their electokinetic adsorption properties, resins are also used to increase the retention of small particles, those smaller then the actual porsity of the filter medium, host cell proteins, endotoxins, DNA, and viruses.

The filter sheets meet the specifications set forth in the US Code of Federal Regulations Title 21, parts 177.2260 e, f, g, h, i, j, k, l, the materials for all plastic components are listed in US Code of Federal Regulations Title 21, part 177.1520. The Quality Management System of Pall has been certified according to DIN EN ISO 9001 by TÜV Cert (Certification Office TÜV Rheinland, Sicherheit und Umweltschutz GmbH).

Technical Service

For best possible results and maximum reliability it is recommended a test run under actual process conditions is performed. Depth filtration requires detailed knowledge of the product and the filtration sequence. In this area, Pall specialists can provide valuable assistance; they are able to perform filtration tests at the production or R & D site or in our Scientific and Laboratory Services (SLS) laboratories. Pall offers hands-on assistance and places its extensive technical resources at the disposal of its customers in the form of worldwide technical advice, including cost reduction programs, process review and problem solving.

Specifications

The filter sheets meet the specifications set forth in the US Code of Federal Regulations Title 21, parts 177.2260 e, f, g, h, i, j, k, l, the materials for all plastic components are listed in US Code of Federal Regulations Title 21, part 177.1520. The Quality Management System of Pall has been certified according to DIN EN ISO 9001 by TÜV Cert (Certification Office TÜV Rheinland, Sicherheit und Umweltschutz GmbH).

  • P-grade sheets are steam sterilizable at 125 °C for 30 minutes. 
  • All P-grade depth filter sheets meet the specifications for the biological tests listed in the current version of the USP Class VI at 121 °C.
  • P-grade sheets are fully lot traceable.
  • Supporting Validation Guide available upon request.

Typical Permeability


Typical permeability (L/m2/min) @ 1 bar

Retention Rating


Retention rating in µm

 

Filter Media Specifications

 
Code Depth Filter Type Retention Rating
in µm
Typical Ash Content
in %
Endotoxin Level in EU/mL
(before rinsing)
PEKX EKX-P 0.05 - 0.2 62 < 0.06 EU/mL
PEKS  EKS-P 0.1 - 0.3  58 < 0.06 EU/mL
PEKM EKM-P

0.2 - 0.5

51 < 0.06 EU/mL
PEK1  SUPRA EK 1 P 0.2 - 0.5 47 < 0.06 EU/mL
P050  KS 50 P 0.4 - 0.8 46 < 0.06 EU/mL
P080  SUPRA 80 P 1.0 - 3.0 49 < 0.06 EU/mL
P100 K 100 P 1.0 - 3.0 46 < 0.06 EU/mL
V100 V 100 P 2.0 - 4.0 52 < 0.06 EU/mL
P200  K 200 P 3.0 - 6.0 46 < 0.06 EU/mL
P250  K 250 P 4.0 - 9.0 46 < 0.06 EU/mL
P700 K 700 P 6.0 - 15.0 46 < 0.06 EU/mL
P900 K 900 P 8.0 - 20.0 46 < 0.06 EU/mL
P1500 T 1500 P 11 - 30.0 33 < 0.06 EU/mL
 

For regulatory and validation information please contact Pall for the relevant product validation guide.

Furthermore the following documents are available:

  • Technical Data Sheet
  • Certificate of Analysis available on request
  • EU Safety Data Sheet

Important Note:- Use of this product in a manner other than in accordance with Pall’s current recommendations may lead to injury or loss. Pall cannot accept liability for such
injury or loss. Because of developments in technology, these data and/or procedures are subject to continual review and update. Please contact Pall for additional information.

Scalability - Effective Filter Area

 

 
Filter Design and Size Effective Filter Area
Supracap™ 50 Capsules (< 1 to 3 L)  
Capsule  22 cm2 (3.41 in.2)
Supracap 100 Capsules (3 to 100+ L)   
 5 in. capsule  0.05 m2 (0.54 ft2)
 10 in. capsule  0.1 m2  (1.08 ft2)
 20 in. capsule  0.2 m2  (2.15 ft2)
 30 in. capsule  0.3 m2  (3.23 ft2)
Supracap 200 Capsules (50 to 2,000+ L)  
Capsule with 9 cells   1.0 m2 (10.8 ft2)
Capsule with 16 cells  1.8 m2 (19.4 ft2)
Supradisc™ I Modules (50 to 20,000+ L)   
Size code 203   0.3m2 (3.3 ft2)
Size code 205   0.5 m2 (5.5 ft2)
Size code 209   1.0 m2 (10.8 ft2)
Size code 216   1.8 m2 (19.4 ft2)
Size code 409   2.1 m2 (22.6 ft2)
Size code 416   3.7 m2 (40.0 ft2)
Size code 421   5.0 m2 (54.0 ft2)
Supradisc II Modules (50 to 20,000+ L)  
Size code 232  1.8 m2  (19.4 ft2
Size code 440   5.0 m2 (54.0 ft2)
Stax™ Capsules (50 to 20,000+ L)   
Small 0.5 m2 (5.5 ft2
Medium 1.0 m2 (10.8 ft2)  
Large  2.0 m2 (21.5 ft2)
 

 

 

 

 

Ordering Information

Please contact your local Pall representative for ordering information for this product.

Application
Filters - Depth
Segment
Depth Filtration