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.
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.
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.
Brand new short needle for small sample containers
An upgraded, easy-to-open accessory bag with a pre-cut line
New placement mark to place the tube in the pump head precisely
Pre-installed colored clamps prevent any media transfer errors
Redesigned needle guard with grips
Newly designed needle protector with ridges
Clear packaging identification with newly designed color-coded label based on the canister
Peel-off label for improved traceability
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
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.
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
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.
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.
Discover our full sterility testing portfolio based on over 45 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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