PLC automatic control sterile test isolation sterilization system

Aseptic Inspection Isolation System integrates the operating cabin, transfer window and vaporized hydrogen peroxide generator (VHP). After the integrated vaporized hydrogen peroxide sterilizer (VHP) kills the initial contaminated bacteria in the cabin, the experimental chamber (operating cabin) is pressurized to maintain the aseptic state of the cabin. After the first chamber of the experimental chamber is sterilized, the transfer chamber (killing cabin) The surface of the inspection product passed into the experimental cabin can be quickly and independently sterilized, and the inspection product enters the experimental cabin from the transfer door between the two cabins to realize continuous inspection of the inspection product. The sterilizing test isolators use a vaporized hydrogen peroxide sterilization process with a short sterilization time and a sterilization cycle of about 1 hour in the transfer chamber, which greatly improves the working efficiency; the sterilization is thorough, and the Bacillus stearothermophilus (ATCC12980 or ATCC7953) can be made. ) 6-log drop; good repeatability, patented drug delivery mode, and unique control mode, good sterilization repeatability, verifiable; environmentally friendly, hydrogen peroxide decomposes into water and oxygen, non-toxic and no residue Advantages; sterility testing using a sterile test isolator can effectively avoid the risk of false positives.Power supplyAC220V±22V / 50HzPower3000VADimensionsCustomNoise≤65dB (A) (sterile maintenance state)Working pressure -80 ~ 80Pa (adjustable)CleanlinessClass AAirflow modelOperating cabin turbulence (turbulent flow), transfer window laminar flowKill rateBacillus stearothermophilus drops 6-logHydrogen peroxide30% (analytical grade)Sterilization cycleTransfer cabin about 60min, experimental cabin + transfer cabin about 160minOperation port6 or 8 (double-sided operation)Pressure differential resolution0.1PaTemperature resolution0.1 ° CHumidity resolution0.1% RHHour leakage rateQ/V≤0.5%High efficiency filterH14 (Confair)
Regulatory requirements:
Sterility test is the last mandatory inspection before product release process.
Sterility test isolator will gradually replace the original must be implemented in A grade B background environment requirements.
Scope of application:
1. Applicable to the sterile room, microbial limit test room or positive room of the pharmaceutical company.
2. It is suitable for the sterile room, microbial limit test room or positive room of the drug test system.
3. Suitable for sterile rooms, microbial limit testing rooms or positive rooms of medical device companies.
4. Applicable to the hospital preparation room.
5. It is suitable for microbial detection of highly toxic and highly sensitizing drugs.
6. Suitable for microbial detection of biological products.
Suzhou meidi clean technology Co., Ltd was established in 2012, with great efforts we developed three excellent plants for water treatment equipment and clean room facilities. We're the pioneer supplier in China to provide integrated engineering solution for worldwide pharmaceutical,food,cosmetic,electronic and medical factory in compliance with EU GMP / US standard and WHO principle. Our company cooperates closely with well-known scientific research institutions and pharmaceuticals industry designing institutes to provide the most reasonable project design, the best quality equipment and the customized service to different factories from different markets. Meidi’s integrated engineering solutions include the clean room, auto-control and monitoring system, water treatment system, operation theatre other machinery, central laboratory and etc. Focused on customers' individual requirements, Meidi customizes engineering solutions meticulously for users on:*Pre-engineering consulting service*Production process selection*Equipment model selection and customization*Installation and commissioning*Validation of the equipment and process*Production technology transferring*Hard and soft documentation*Training for skilled workers and so on.based on the needs of users from worldwide, we continuously doing a lot of deep research and study on the development of air and water clean sector, pursue the endless improvement of our machinery and project quality. We will sincerely cooperate with related enterprises from worldwide and make unremitting efforts for human health.We can provide Pharmaceutical Turnkey project Service including all the pharmaceutical machineries and clean room projects from designing to construction
We can provide our project according to the international regulations like EU cGMP, USA , WHO GMP, UK MHRA, Australian TGA, etc
We can provide 30 year experience engineer team go give you free Consultation service
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We can provide free training service for your employee
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