Fine microbial-contaminant control

Mycoplasma Filtration

Fine membrane filtration for contamination-risk control in cell-culture processes.

A 0.1 µm pore rating alone does not establish a validated mycoplasma-removal claim

Mycoplasma filtration product family
Scalable fine-membrane filtration portfolio Disc · Capsule · Cartridge
2 media PES and PVDF
0.1 µm Final membrane layer
3 structures Single and graded options
10 cm²–3.2 m² Available filtration area

Scale media filterability studies into controlled manufacturing.

The portfolio supports filtration steps where control of very small microbial contaminants is required. Disc, capsule and cartridge formats cover laboratory evaluation, process development, media preparation and manufacturing-scale operation, with single-use fluid paths or reusable-housing options.

Format 01 · Disc

Small-area media and membrane evaluation

Disc-format filters support small-volume testing, media filterability studies and comparison of single-layer and graded configurations.

  • Filtration area from 10 to 20 cm²
  • 1/4–1/2 in. stepped hose-barb connection
  • Filterability and challenge-development studies

Filtration area 10–20 cm²

Format 02 · Capsule

Closed disposable filtration for media preparation

Ready-to-connect capsules support media preparation and other contamination-controlled process steps from development through manufacturing.

  • Areas from 180 cm² to 3.2 m²
  • Sanitary-flange and hose-barb options
  • Selected T-style sanitary connections

Available scale Development to production

Format 03 · Cartridge

Housing-compatible filtration for larger volumes

Cartridges support production volumes in compatible reusable housings and allow selection of end adapters and O-ring materials.

  • Double-open-end, 222 and 226 configurations
  • Customizable O-ring options
  • Areas from 180 cm² to 3.2 m²

Housing interfaces DOE · 222 · 226

Membrane and graded-structure selection

Balance fine retention with capacity for the actual media.

PES and PVDF hydrophilic membranes are available with a 0.1 µm final layer. Single-layer and graded structures allow retention requirements to be balanced with the capacity needed for clean or more complex cell-culture fluids.

2 media Hydrophilic membrane choices
Single / graded Membrane-layer structures
01 0.1 µm Single fine-retention layer for relatively clean media and process fluids Single layer
02 0.2 / 0.1 µm Integrated 0.2 µm upstream layer protecting the 0.1 µm final membrane Graded protection
03 0.45 / 0.1 µm Graded structure for media or biological fluids with higher particulate or colloidal loading Higher loading

Contamination-risk control for media and sensitive culture steps.

Capacity and recovery can be strongly affected by media composition, supplements, colloids and protein content. Representative-fluid testing is essential before scale-up.

01

Chemically defined media

Fine filtration of compatible chemically defined culture media.

02

Supplement-containing media

Filtration of serum-containing or supplement-containing media after capacity and recovery assessment.

03

Media components and raw materials

Filtration of media components and selected compatible biological raw materials.

04

Culture-process protection

Contamination-risk control before sensitive fermentation and cell-culture operations.

05

Biological solutions

Filtration of compatible serum, protein and biological solutions.

06

Validated fine-microbial retention

Selected intermediate or final steps where product-specific challenge validation supports the required claim.

Define the challenge model, media load and operating limits.

Use representative media in small-area studies and challenge the selected configuration at defined operating limits. Scale-up should preserve membrane type, construction and process conditions whenever possible.

01

Required claim

Define the required mycoplasma-retention claim and challenge-validation approach.

02

Media composition and load

Provide supplement level, colloidal load, particle content and other fouling contributors.

03

Product interaction

Assess protein or growth-factor adsorption risk and the required product recovery.

04

Batch and operating limits

Confirm batch volume, processing-time target, differential pressure and temperature.

05

Integrity and sterilization

Define the integrity-test method, acceptance criteria and sterilization method.

06

Fluid-path strategy

Confirm single-use or reusable configuration and whether an upstream prefilter or graded membrane is required.

Configuration matrix

Review membrane media, filtration areas and interfaces.

Availability depends on the selected medium, pore structure, filtration area and filter format. Not every option is available in every combination. Media selection should consider growth-factor and protein adsorption, chemical compatibility, sterilization conditions and the intended integrity-test method.

Media selection Format configuration

Media options

Media General characteristics Suggested applications
PES Hydrophilic membrane offering high liquid flow, easy wetting and low nonspecific adsorption Cell-culture media, media supplements, buffers and protein-containing biological solutions
PVDF Hydrophilic membrane with low protein adsorption and good mechanical and chemical resistance Product-recovery-sensitive media, biological solutions and valuable process intermediates

Product configurations

Format Filtration area Connection or end options
Disc-format filter 10–20 cm² 1/4–1/2 in. stepped hose barb
Capsule filter 180–660 cm²; 0.25–3.2 m²; selected 0.8–2.4 m² configurations 9/16, 3/4, 1-1/4 and 1-1/2 in. sanitary flanges; 3/8, 1/2, 9/16, 5/8, 3/4 and 1 in. stepped hose barbs; 1/4–1/2 and 1/4–3/8 in. multi-stepped hose barbs; selected 1-1/2 in. sanitary T-style connection
Cartridge filter 180–660 cm²; 0.25–3.2 m² Double open end, 222 and 226 end configurations; customizable O-ring options

Prepare the right fine-filtration configuration.

Confirm the required claim, representative media, membrane, pore structure, filtration area, filter format, integrity-test method, sterilization strategy, connections and challenge-validation package before submitting the final RFQ for technical review.