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Steritest® NEO Membrane Filtration Sterility Test

Latest Steritest® NEO Features

Sterility testing is one of the most crucial steps in pharmaceutical product release. The membrane filtration sterility test is the regulatory method of choice for filterable pharmaceutical products, as cited in the USP 71, Ph. Eur 2.6.1, and JP 4.06.

Steritest® Neo Devices

The test is particularly suitable for samples containing preservative, bacteriostatic, or fungistatic compounds, which inhibit the 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 the membrane filtration method, increasing sensitivity and reducing the 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.

The 4th generation of Steritest® devices is enriching with some additional elements contributing to significantly improving workflow safety, reliability, and convenience. 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, thereby greatly reducing the risk of adventitious contamination resulting in false positives.

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.


Latest Steritest® NEO Features

The 4th generation of Steritest® devices with additional elements simplifies every aspect of testing, from handling to traceability to the reliability, all within a closed concept system. The ease and convenience enable you to increase productivity while maintaining the highest levels of quality.

Watch the video to discover all the new improvements.


New features of Steritest® NEO device is created to improve your workflow safety, reliability, and convenience.

Evolution of convenience

Color-coded protective cap in 2 parts help you to differentiate the needle type once covered.


Protective caps for long needles are now in 2 parts.
Watch the video to learn more

New 20 mm length needle is used to pierce cartridges or small soft plastic containers


Brand new short needle for small sample containers 

The pre-cut line in the accessory bag improves workflow convenience


An upgraded, easy-to-open accessory bag with a pre-cut line

Helps to precisely place the Steritest® tube in the pump head


New placement mark to place the tube in the pump head precisely

Cutting sterility testing tubes with a clamp


The new Velax® cutting clamp allows a safe and clean cut of the tubes

Pre-installed colored clamps help in accurate media filling


Pre-installed colored clamps prevent any media transfer errors 

Redesigned needle guard with grips


Redesigned needle guard with grips

The needle guard and protector improves confidence in needle manipulation


Newly designed needle protector with ridges

A needle being used with the Steritest® needle guide to access the sterility test sample in a Steritest® NEO canister.


The new needle guide allows safe and easy access to the sample anytime

Accessing a sterility test sample in a Steritest® NEO canister using the needle-free valve


The new needle-free valve is a safe solution for planned sampling or injection

Color-coded labels aid in packaging identification and selection of the appropriate box of Steritest® NEO device


Clear packaging identification with newly designed color-coded label based on the canister

Peel-and-stick label improves traceability


Peel-off label for improved traceability 

Smart 2D data matrix barcodes on labels for sterility testing


Smart Label with 2D data matrix barcode to retrieve product data for easy processing

Engraved 25 mL graduation line and volume for improved workflow accuracy


25 mL volume graduation marks on the canisters 


"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 the 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 releases 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

Get some insights in our high quality production of Steritest® NEO devices in our Center of Excellence, France.


Sterility testing solutions for products WITHOUT antimicrobial agents and medical devices

Steritest® NEO blue canisters for products without antimicrobial agents and medical devices

The “Blue Base” Steritest® NEO devices offer the ultimate flexibility. Perfect for use with most pharmaceutical drugs that do not have antimicrobial activity, our mixed esters of cellulose HA membrane allow fast flow rates for optimum throughput performance and reduction in testing time. A range of ergonomic needles is available to meet specific drug packaging requirements as well as simplify handling for gloved operators.

Liquids in ampoules and collapsible bags
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Liquids in large vials
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Liquids in small vials
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Medical devices and collapsible bags
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Liquids in syringes
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Soluble powders in ampoules
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Liquids in plastic containers
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Soluble powders in vials
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Sterility testing solutions for antibiotics, products WITH antimicrobial agents and medical devices

Steritest® NEO red canisters for antibiotics, products with antimicrobial agents, and medical devices

The “Red Base” Steritest® NEO devices, ideally suited for antibiotic sample testing, incorporate our Durapore® (PVDF) HV membrane, offering broad chemical compatibility and low binding properties. The chemical composition of the extremely thin 0.45 μm Durapore® membrane provides low antibiotic binding, which improves rinsing efficiency and reduces the risk of false negative results. The canister design ensures efficient rinsing of residual antimicrobial agents, and the needle and connections minimize the risk of antibiotic residuals

Antibiotics
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Powders and super potent antibiotics
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Liquids in large vial
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Liquids in small vial
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Soluble powders in vials
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Medical devices and collapsible bags
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Recommended accessories
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Sterility testing solution for products dissolved in solvents requiring increased chemical compatibility

Steritest® NEO green canisters for products dissolved in solvents requiring increased chemical compatibility

The ‟Green Base” Steritest® NEO devices are suited for viscous products, such as creams and ointments, which are normally diluted in a sterile solvent, such as isopropyl myristate (IPM) to improve filterability. The solvent-resistant nylon canister and the Durapore® (PVDF) HV membrane ensure perfect chemical compatibility with IPM and other solvents. The reinforced base structure and canister connection guarantee an unmatched pressure resistance of the testing device during the whole filtration process. The ‟Green Base” Steritest® NEO devices are the perfect choice for testing solvents, creams, ointments, and veterinary injectables.

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STERILITY TESTING ACCESSORIES FOR LIQUID TRANSFER AND DILUTION

Streamline your workflow with our range of sterility testing accessories available for sample preparation and dilution. Steridilutor® NEO devices offers tubing and needle assembly to dissolve powders, or for the transfer of liquids. Steritest® vent needles is used for venting glass vials with rubber septa and rigid plastic vials, or media bottles.

Streamline your workflow with our range of sterility testing accessories available for sample preparation and dilution. Steridilutor® NEO devices offers tubing and needle assembly to dissolve powders, or for the transfer of liquids. Steritest® vent needles is used for venting glass vials with rubber septa and rigid plastic vials, or media bottles. The needles can also be used for sterility and growth promotion qualification of media batches.

Sample Preparation and Dilution
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Liquid Transfer
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Sterile Vent Needles
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Sterility Test Sampling Solutions

Needle guide and needle-free valve sterility test sampling solutions mounted on Steritest® NEO canisters.

Throughout the incubation process of Steritest® NEO Devices for compendial sterility testing, it may be necessary to access the container to subculture, reincubate, or identify microorganisms within a turbid medium. It is pivotal to ensure that sterility remains intact and uncompromised throughout these procedures. Mounting a needle guide or a needle-free valve to your canister will help improve safety while performing this task. 

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Complete Sterility Testing Solutions for Complete Confidence

Discover our full sterility testing portfolio based on over 50 years of experience and expertise. Our large variety of devices and pumps, along with sterile culture media and rinsing fluids can help you to stay compliant, whether you use membrane filtration or direct inoculation methods. Reduce the sterility testing workload and focus on your critical lab activities thanks to our extended Steritest® services portfolio. The experienced application and validation engineers will assist in method development and validation implementation within the QC microbiology laboratory. They will also provide basic and advanced technical training on sterility testing, in person or remotely.

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