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>.
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. 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.
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.
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.
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 designed needle guard and needle protector
Grips on the guard and ridges on the protector improve the confidence in needle manipulation.
Prevent filling errors and improve your workflow clarity, thanks to the pre-installed colored clamps and the existing blackline, for accurate media filling.
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.
Be sure to place the Steritest® tube in the pump head precisely using the placement mark.
Opening of the accessory bag is now simple and improves your workflow convenience thanks to the pre-cut line. No need for scissors.
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.
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
Blue canister base indicates mixed esters of cellulose membrane filters. This membrane provides an optimal filtration flow rate for standard products.
Red canister base indicates low absorption Durapore® PVDF membrane and specific drainage design. This optimizes the rinsing of products that inhibit microbial growth.
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.