Membrane Filtration Sterility Test

Steritest™ NEO: our fourth generation of sterility testing membrane filtration devices

The membrane filtration sterility test is the regulatory method of choice for filterable pharmaceutical products, as cited in the USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>.

Membrane filtration sterility testing using the Steritest™ NEO deviceThe 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. Large volumes and oily products dissolved in emulsifying agents can also be tested by membrane filtration method, increasing sensitivity and reducing volume of culture media. Appropriate culture 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 by checking turbidity.

Our sterility test consumables ensure that pharmaceutical products are never exposed to the environment during the testing process. Filtering, rinsing, media transferring, and incubating are all conducted within the Steritest™ NEO closed system.

There is no need to open the containers or manipulate the membrane at any time-greatly reducing the risk of adventitious contamination resulting in false positive.

When used with the Steritest™ Symbio pump and accessories, and Steritest™ culture media and rinsing fluids, the Steritest™ NEO devices offer the highest levels of quality and reliability and a fully regulatory compliant testing process.

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

Continuous improvements without re-validation of sterility testing membrane filtration devices

The 4th generation of Steritest™ devices is enriching with additional elements raising the industry standards, and driving innovation to provide you the most secure and reliable test ever.

Watch the video to discover all the new improvements.

 

New Steritest™ NEO devices for cartridges and small soft plastic containers.

 

 

New Steritest™ NEO short needle device A brand new short needle for small sample containers
Experience dexterity with the new 20 mm length needle when piercing cartridges or small soft plastic containers, without compromising the flow rate.
New Steritest™ NEO protective caps Protective caps for long needles are now in 2 parts
The protective cap in 2 parts gives access to either a short (35 mm) or a long (60 mm) needle designed to fit your sample packaging configuration. Color-coded protectors help you to differentiate the needle type once covered.
New Steritest™ NEO needle guard and needle protector New designed needle guard and needle protector
Grips on the guard and ridges on the protector improve the confidence in needle manipulation.
New Steritest™ NEO device color clamp canister Colored clamps
Prevent filling errors and improve your workflow clarity, thanks to the pre-installed colored clamps and the existing blackline, for accurate media filling.
New Steritest™ NEO device 25 mL volume graduation 25 mL volume graduation
Be precise and improve your workflow accuracy through the addition of a 25 mL graduation line and volume engraved in the Steritest™ NEO canisters.
New Steritest™ NEO device placement mark Placement mark
Be sure to place the Steritest™ tube in the pump head precisely using the placement mark.
New Steritest™ NEO device easy opening Easy opening
Opening of the accessory bag is now simple and improves your workflow convenience thanks to the pre-cut line. No need for scissors.
New Steritest™ NEO device color coding Color coding
Clear packaging identification: selection of the appropriate box of Steritest™ NEO device is made much clearer thanks to the color-coded label based on canister base color and using a needle/application drawing.
New Steritest™ NEO device peel-off label Peel-off label
Peel-and-stick label to place in a lab notebook for improved traceability.

 

 

"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 sterility testing 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.

Blue Base – Steritest™ DevicesSterility 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

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Red Base – Steritest™ DevicesSterility 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)
TZHVAB210 Steritest™ NEO Devices for Liquids in Collapsible Bag Steritest™ NEO Devices for Liquids in Collapsible Bags (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

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Green Base – Steritest™ DevicesSterility 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)

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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

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