Aseptic testing is an extremely important step before releasing sterile products. False positive and false negative experimental results, as well as equipment malfunctions and human errors, can cause significant time and financial losses to customers and directly affect the final release of products.

MilliporeThe company was the first in the world to propose“Closed aseptic testing”The concept is similar to that of the United StatesFDAWe have jointly established and developed methods and standards for closed aseptic testing, which have been widely recognized by pharmacopoeias and drug safety agencies around the world.MilliporeThe company is constantly improving its equipment for closed aseptic testing in accordance with the requirements of various pharmacopoeiasCanisterTo provide the most advanced and safe technology for the constantly improving drug safety requirements.

3-Canister EquinoxAseptic testing system

3-Canister EquinoxThe sterile testing system is a three head sterile testing equipment designed specifically for the Chinese market, suitable for the special requirements of the Chinese Pharmacopoeia Part III for biological products. It strictly follows the requirements of the Chinese Pharmacopoeia and is appliedCMCCThe strain undergoes sleeve based growth promotion experiments and rigorously verifies the automated production process,100%Testing and inspection system to ensure the high quality of the sleeve.

3-Canister EquinoxMain features of aseptic testing system:

¨ Pump head automatically closes, easy and safe operation

¨ Set up through computerSOPProgram, pre-set experimental parameters for each step of the aseptic testing process, convenient for operators to use

¨ Water droplet shaped design effectively avoids interference with laminar flow state

¨ There are different designs for different inspection environments (laminar flow table or isolator) to meet your various needs

¨ The host design has no dead corners or difficult to clean parts such as screws. Parts with pollution risks can be disassembled and steam sterilized

¨ Can provide standardIQ/OQVerification services enable you to handle audits with ease

Technical Specifications

material

Frame, pump head, bracket:316Lstainless steel

Operation panel, including display screen: polyester

Drainage base: polyacetal

Drainage pipeline: silicone

For laminar flow table

Size of pump body(Height x Width x Depth)：250mm×350mm×300mm

Pump body weight:14KG

Isolator used

Size of pump body (height x width x depth):152mm×350mm×322mm

Weight of pump body:18.5KG

Power Supply:24Vdirect,150W

Disinfection: outer surface Alcohol wiping

Pump head, knob, bracket, discharge base steam sterilization

SteriSecureAseptic testing sleeve

MilliporecompanySteriSecureThe sterile testing device is designed to meet the requirements of the current pharmacopoeia of the People's Republic of ChinaSteriSecureAseptic testing equipment can facilitate customers' smooth entry into the vast Chinese market.SteriSecureThe sterile testing device includes a high flow rate mixed fiber filter membrane, which can detect the vast majority of sterile drugs at high filtration speeds. It is an ideal tool box and reliable guarantee for sterile inspection membrane filtration method.

SteriSecureMain characteristics of sterile testing sleeves：

¨ The closed design avoids the risk of accidental contamination and ensures the complete sealing of the sterile testing device through packaging control of the filter membrane, integrity control of the sleeve, and linkage control of the pipeline.

¨ Ergonomic reagents can be suitable for various types of drugs to be tested

¨ SteriSecureThe device undergoes strict quality testing to ensure consistent and reliable sterile monitoring results.SteriSecureEach packaging box of the sterile testing device contains a certificate that records the quality standards and test results, ensuringSteriSecureThe device is non-toxic, has no residual antibacterial ingredients, and is sterile to avoid false positive and false negative results in sterile testing.

SteriSecureTechnical parameters of sterile testing sleeve

Sleeve base filter membrane:0.45umMixed cellulose

Filter cartridge material: styrene acrylonitrile

The Conduit:PVC

Needle adapters: stainless steel and polyamide6-6

Pipeline length:850mm

Maximum work pressure: at25At ℃3.15bar(In)770Fdown45psi）

Validity period:2year

Aseptic inspection of culture medium and rinsing solution

MilliporeThe quality control department conducted multiple tests on the culture medium and rinse solution used for aseptic testing, particularly in terms of sterility testing. AtISO 9001：2000Production takes place within the facility,MilliporeThe formula and testing of sterile testing medium and rinsing solution comply with the pharmacopoeias of the United States, Japan, and EuropeMilliporeThe strict internal quality control standards required by the company. The product has been validated and packaged with a screw cap (sealed with a diaphragm).

¨ Trypsin soy broth medium（TSB）Can detect yeast, mold, and aerobic bacteria

¨ Liquid thioglycolic acid culture medium（FTM）Can detect yeast, mold, aerobic bacteria, facultative anaerobic bacteria, and anaerobic bacteria. Provide two types, standard pharmacopoeia formula and improved clarification formula（CFTM）The latter can further increase visual clarity and also meet the requirements of pharmacopoeias in various countries

¨ Aseptic flushing solutionATheDandKcan be paired withMilliporeThe sterile testing system is used in combination. liquidA(Including)0.1%Peptone is a conventional diluent or cleaning solution used to test antibiotics and substances containing preservatives. When testing antibiotics, objects containing phospholipids or oils, and labeling as“Aseptic enzymatic reaction”When installing the device, the liquidDAs a cleaning agent, it is very useful. When testing substances containing petrolatum, it is usually recommended to use liquidsKAs a cleaning agent.

Product Information