Membrane Filtration Sterility Test

 
 

Complete Sterility Testing Solutions for
Complete Confidence

Request Information

Related Resources 

New Steritest™ NEO device, the Fourth Generation of Steritest™ Devices

The membrane filtration sterility test is the regulatory method of choice for filterable pharmaceutical products. The test is particularly suitable for samples containing preservative, bacteriostatic or fungistatic compounds, which inhibit microbial growth of potential contaminants. With membrane filtration, microorganisms are retained by a 0.45 µm pore size filter, and all inhibiting compounds are rinsed using a suitable rinse solution. Appropriate media, selected based upon their ability to support the growth of anaerobic and aerobic microorganisms, are then transferred to the membrane filters. A 14-day incubation period is required to obtain final test results. With our new device, we are raising the industry‘s standards, and driving innovation to provide you the most secure and reliable test ever.

Steritest™ NEO devices combined with our peristaltic pump, specific accessories and high quality culture media and rinsing fluids offer an optimized testing process compliant with USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>.

Select the right sterility testing membrane filtration solution according to your sample.


New features - Upgraded Steritest™ NEO membrane filtration devices

Continuous improvements without re-validation with the newly launched Steritest™ NEO membrane filtration devices. Discover also our new devices with a short needle for cartridge and small soft plastic containers for safer operation. Watch the videos to learn more.

I want to learn more about the new features

Discover our new Steritest™ NEO devices for cartridges and small soft plastic containers

Want to see the new Steritest™ NEO devices for cartridges, contact us


"Coloured clamps ensure ease of tracking tubing to canisters and make it easier to differentiate between media canisters, reducing the chance of wrong incubation. The new tear bags are easy to open."
-- Courtney Smith, Lead Technician - Microbiology Stockton Quality Control Laboratory - University Hospital of North Tees - United Kingdom

Meet the Industry Benchmark

  • Minimize false positives: closed Steritest™ NEO filtration devices reduce the risk of false positive results and avoid costly investigation and possible batch loss. There are no open containers or membrane manipulations, which could increase the risk of contamination.
  • Reduce false negatives: Steritest™ NEO filtration devices are the right answer to the danger that false negative results pose to patients. Through specific membranes, unique sealing technology and optimized device design, the unit allows efficient elimination of bacteriostatic, fungistatic or bactericidal agents.
  • Easy Identification with color coding and optimized traceability.
  • Quality check: each Steritest™ NEO device is subjected to rigorous in-process and release quality checks including 100% membrane and canister integrity tests as well as intense physical and microbiological testing. The detailed certificates of quality are available for download from our website.

Our sterility testing membrane filtration solutions:

 

Sterility testing solutions for products WITHOUT antimicrobial agents and medical devices

Blue canister base indicates mixed esters of cellulose membrane filters. This membrane provides an optimal filtration flow rate for standard products.

 

Product No. Illustration
(click to enlarge)
Description
TZHACA210 New Steritest™ NEO Devices for Liquids in Cartridges (Short Needle)
TZHALA210 Steritest™ NEO Devices for Liquids in Ampoules Steritest™ NEO Devices for Liquids in Ampoules
TZHALA205 Steritest™ NEO Devices for Liquids in Ampoules Steritest™ NEO Devices for Liquids in Ampoules (double packed)
TZHALA210 Steritest™ NEO Devices for Liquids in Collapsible Bags Steritest™ NEO Devices for Liquids in Collapsible Bags
TZHALA205 Steritest™ NEO Devices for Liquids in Collapsible Bags Steritest™ NEO Devices for Liquids in Collapsible Bags (double packed)
TZHALV210 Steritest™ NEO Devices for Liquids in Large Vials Steritest™ NEO Devices for Liquids in Large Vials
TZHALV205 Steritest™ NEO Devices for Liquids in Large Vials Steritest™ NEO Devices for Liquids in Large Vials (double packed)
TZHASV210 Steritest™ NEO Devices for Liquids in Small Vials Steritest™ NEO Devices for Liquids in Small Vials
TZHASV205 Steritest™ NEO Devices for Liquids in Small Vials Steritest™ NEO Devices for Liquids in Small Vials (double packed)
TZHADV210 Steritest™ NEO Devices for Soluble Powders in Vials Steritest™ NEO Devices for Soluble Powders in Vials
TZHADA210 Steritest™ NEO Devices for Soluble Powders in Ampoules Steritest™ NEO Devices for Soluble Powders in Ampoules
TZHAMD210 Steritest™ NEO Devices for Medical Devices and Collapsible Bags Steritest™ NEO Devices for Medical Devices and Collapsible Bags
TZHASY210 Steritest™ NEO Devices for Liquids in Syringes Steritest™ NEO Devices for Liquids in Syringes
TZHAPC210 Steritest™ NEO Devices for Liquids in Plastic Containers Steritest™ NEO Devices for Liquids in Plastic Containers

Back to our sterility testing membrane filtration solutions list.

I need help to identify the best unit to use with my sample or need more information

 

Sterility testing solutions for antibiotics, products WITH antimicrobial agents and medical devices

Red canister base indicates low absorption Durapore® PVDF membrane and specific drainage design.
This optimizes the rinsing of products that inhibit microbial growth.

 

Product No. Illustration
(Click to Enlarge)
Description
TZHVCA210 Steritest™ NEO Devices for Liquids in Cartridges New Steritest™ NEO Devices for Liquids in Cartridges
TZHVAB210 Steritest™ NEO Devices for Liquids in Ampoules Steritest™ NEO Devices for Liquids in Ampoules
TZHVAB205 Steritest™ NEO Devices for Liquids in Ampoules Steritest™ NEO Devices for Liquids in Ampoules (double packed)
TZHVAB205 Steritest™ NEO Devices for Liquids in Collapsible Bag Steritest™ NEO Devices for Liquids in Collapsible Bags (double packed)
TZHVLV210 Steritest™ NEO Devices for Liquids in Large Vials Steritest™ NEO Devices for Liquids in Large Vials
TZHVLV205 Steritest™ NEO Devices for Liquids in Large Vials Steritest™ NEO Devices for Liquids in Large Vials (double packed)
TZHVSV210 Steritest™ NEO Devices for Liquids in Small Vials Steritest™ NEO Devices for Liquids in Small Vials
TZHVSV205 Steritest™ NEO Devices for Liquids in Small Vials Steritest™ NEO Devices for Liquids in Small Vials (double packed)
TZHVDV210 Steritest™ NEO Devices for Soluble Powders in Vials Steritest™ NEO Devices for Soluble Powders in Vials
TZHVDV205 Steritest™ NEO Devices for Soluble Powders in Vials Steritest™ NEO Devices for Soluble Powders in Vials (double packed)
TZHVMD210 Steritest™ NEO Devices for Medical Devices and Collapsible Bags Steritest™ NEO Devices for Medical Devices and Collapsible Bags
TZHVAB210 Steritest™ NEO Devices for Powders and Superpotent Antibiotics Steritest™ NEO Devices for Powders and Superpotent Antibiotics

Back to our sterility testing membrane filtration solutions list.

I need help to identify the best unit to use with my sample or need more information

 

Sterility testing solution for products dissolved in solvents requiring increased chemical compatibility

Green canister base indicates low absorption Durapore® PVDF membrane, specific drainage design and polyamide canister polymer. This optimizes the chemical compatibility for products dissolved in solvents.

 

Product No. Illustration
(Click to Enlarge)
Description
TZHVSL210 Steritest™ NEO Devices for Solvents, Creams, Ointments, and Veterinary Injectables Steritest™ NEO Devices for Solvents, Creams, Ointments, and Veterinary Injectables
1.46628 Sterile Irradiated Isopropyl Myristate (IPM) Sterile Irradiated Isopropyl Myristate (IPM)

Back to our sterility testing membrane filtration solutions list.

I need help to identify the best unit to use with my sample or need more information

 

Sterility testing accessories for liquid transfer and dilution

Product No. Illustration
(Click to Enlarge)
Description
TZV000010 Steridilutor<sup>®</sup> NEO Devices without Expansion Chamber for Sample Preparation and Dilution Steridilutor® NEO Devices without Expansion Chamber for Sample Preparation and Dilution
TZVC00010 Steridilutor<sup>®</sup> NEO Devices with Expansion Chamber for Sample Preparation and Dilution Steridilutor® NEO Devices with Expansion Chamber for Sample Preparation and Dilution
TZA000010 Steridilutor<sup>®</sup> NEO Devices for Liquid Transfer Steridilutor® NEO Devices for Liquid Transfer
TEFG02525 Steritest™ Sterile Vent Needles Steritest™ Sterile Vent Needles

Back to our sterility testing membrane filtration solutions list.

I need help to identify the best unit to use with my sample or need more information