| products appearance | Light yellow, flat surface, no cracks, no visible impurities and bubbles |
| physicochemical property | |
| Sterility and water retention | 30-35ºC,Culture for 5 days, no bacterial growth,Culture for 5 days, no bacterial growth, no obvious water loss phenomenon |
| Packing | Class A laminar flow production line automatic canning, to avoid the risk of personnel pollution |
| Growth experiment | Inoculate the corresponding strains 50-100CFU according to the pharmacopoeia, and the ratio of the mean number of colonies on the test solid medium to the mean number of colonies on the control medium should be within the range of 0.5-2, and the size of the colonies should be consistent with the colonies on the control medium |
PH acceptable, gel strength 500-750g/cm2
| Item | Model | description | culture | usage |
| CP020028 | D55A | PETRI DISH | TSA | Surface microbial sampling without disinfectant and antibiotic residues |
| CP020029 | D55B | PETRI DISH | TSA with Lecithin and Tween 80 | Surface microbial sampling of residual disinfectant |
| CP020030 | D55C | PETRI DISH | TSA with Lecithin and Tween 80,Penicillin G | Sampling of surface microorganisms from residual penicillin antibiotics |
| CP020032 | D55E | PETRI DISH | SDA | For fungal detection on surfaces |
| CP020033 | D90A | PETRI DISH | TSA | Microbial detection of airborne settling bacteria and floating bacteria without disinfectant and antibiotic residues |
| CP020034 | D90B | PETRI DISH | TSA with Lecithin and Tween 80 | Microbial detection of airborne settling bacteria and floating bacteria in residual disinfectants |
| CP020035 | D90C | PETRI DISH | TSA with Lecithin and Tween 80,Penicillin G | Microbial detection of airborne settling bacteria and floating bacteria with residual penicillin antibiotics |
| CP020037 | D90E | PETRI DISH | SDA | For airborne fungal detection |
| CP020075 | D90F | PETRI DISH | TSA with Cephalosporinase | Microbial detection of airborne sedimentation bacteria and floating bacteria with residual cephalosporin antibiotics |
| CP020109 | D90G | PETRI DISH | EMB | Isolation and identification of Escherichia coli and Aerogenes |
| CP020110 | D90H | PETRI DISH | NA | Generally used for bacterial culture, transfer, rejuvenation, bacterial enhancement |
| CP020116 | D90R | PETRI DISH | R2A | For the determination of the total number of colonies in purified water |
The collection collection incubator is carefully manufactured by forty processes, each in strict accordance with the ISO9001 quality system and ISO14001 environmental system requirements. 100% of the products passed the integrity test, achieving continuous improvement in quality traceability and quality. According to the testing requirements of different dosage forms and packaging forms, various cups, filter materials and matching needles were selected, and various collection incubators were designed and developed to meet various sterilization tests. need.
Combination product: Product rinse sterility test is only applicable to products with hollow tubes, such as infusion and infusion sets, which are not suitable for soaking and the fluid channel is marked as sterile, this method is easy to operate and requires modification of FTM media with liquid D rinse products, The eluate was membrane filtered and placed in FTM and SCDM. This method is usually not used.
Bulk drugs / biopharmaceuticals
Bulk drugs (API) have been sterilised according to USP 71 prior to release to the manufacturing process.
Bulk biologics are tested for sterility according to 21 CFR 610.12, which requires a medium (FTM) with sample test sizes listed in the document and a capacity of not less than 10 ml.10
Interpretation of sterility test results
Technicians must be trained in growth testing methods during the cultivation process. Growth is determined by observing a medium that is generally transparent and transparent with respect to the light source, and the turbid (turbid) area of the medium indicates the growth of microorganisms. Once growth is detected, the suspect container is tested to confirm that the turbidity present is due to microbes, not due to decomposition of the sample; sometimes, the sample becomes cloudy due to particle shedding or chemical reaction with the medium. After testing, return to the incubator for the remainder of the incubation period. Samples turbid in the medium were transferred and displayed for four days on the 14th day of the test
Hangzhou Winteam scientific Instruments Co. Ltd. established 2010,is an innovative and national high-tech enterprise, Hangzhou Eagle plan enterprise, Hangzhou science and technology enterprises which engages the scientific research development, manufacturing, marketing and services .
The company has a young team proficient in technologies, meticulous in division of labor and harmonious in cooperation. Therefore, the top-level talent, first-class production conditions, excellent product quality, forward- looking marketing sense and rich service experience together is the largest advantage of the company. With the honest operation and good service as the lead, high quality as the guarantee, and the highly professional dedication and social mission as the drive, the company has been increasingly booming at an amazingly high speed.
The company located in Qingshan Lake Sci-Tech city in Lin'an District ,Hangzhou City, covers an area of 35000m² with over 40000 m²building area.
The company has got the ISO9001 quality management system certification, and ISO14001 environment management system certification. ISO13485 Medical device management system certification, Intellectual property management system certification, integrity management system certification, after-sales service certification, and has more than 50 patents.
The company principally manufactures the sterility test pump, sterility test canister, microbial limit test system, sterility isolator system, Atomized hydrogen peroxide sterilization instrument. The product of the company has not only been used by local food and medicine drug control institutes of all types, Disease Control and Prevention Centers, large medicine manufacturers ,medicine research institutes. hospitals, Universities and other enterprises or public departments, but also sold to Europe, Africa, Australia and South-east Asia.
Quality to win and win future".Winteam ,sticking to the emprise purpose of "Focus on people, Excellence in quality all the time and serving all the customers, has taken the quality as the source of benefit, honest operation as the foundation of competitiveness and outstanding service as the approach to take the market, hoping to keep pace with the time and develop with the society together.
