IPDB › China Industry › Manufacturing & Processing Machinery
China, Chinese Sterility Testing Isolator Meeting GMP Standards for Pharmaceutical, Medical and Laboratory Use1 Industrial Products Supplier Manufacturer Details, price list catalog:
China Industrial Products Supplier Manufacturer List Catalog
Pharmaceutical Equipment MachineryMedicine Detecting InstrumentMedical and Laboratory UseSterility Testing IsolatorMeeting GMP Standards
Tksage(Shenzhen)Technology Group Co., Ltd.
Preview:
Product DescriptionSterility testing isolatorThe most widespread application of isolators is in the pharmaceutical industry, as drug research and production processes require an additional physical barrier to isolate operators from the sterile production environment and protect products from contamination.Common processes such as dispensing, weighing, batching, crushing, sampling, etc. can be performed in a positive pressure sterile isolator.Isolators are generally used in conjunction with the operation chamber and pass box, or can be used separately. The airflow design and flow direction of isolator are similar to those of biosafety cabinet, except that the isolator cabinet is fully enclosed under positive pressure, while the Class II biosafety cabinet is semi-enclosed by negative pressure, and the Class III biosafety cabinet is fully enclosed by negative pressure. These cabinets are designed according to their functions. The isolators can be large or small, and most of the functions and sizes are customized to the user's needs. In the use process, the operating samples and equipment are transferred to the operation chamber through the pass box, then the pass box door is closed, and the experimenters operate through gloves.Sterility testing isolatorThe sterile isolator is mainly used for sterile production and testing. VHP sterilization system can be configured and customized according to customer's requirements. The airtight isolator is mainly used to completely separate personnel from the production process during operation to avoid contamination or cross-contamination of products. Sterile inspection and microbiological inspection are carried out to ensure the authenticity of test results and protect the safety of operators. The main structure of the chamber is made of stainless steel and tempered glass, with hard chamber structure and laminar or turbulent flow, in line with Class A standard when in static state.AdvantagesGlove Leak DetectorThe inner chamber adopts laminar flow (turbulent flow) air supply, and the airflow shape is professionally designed to ensure the purification level;Monitor the pressure, temperature, and air speed of the internal chamber in real time, and automatically control and adjust them;Integrate LOG sterilization program, with the microbial killing rate reaching Log 6 or higher;The isolator airtightness is tested in strict accordance with ISO14644-2 standard.Waste can be immediately and quickly discharged from the work area through the RTP, aβ valve, to ensure a clean environment inside the isolator (optional);Support PLC control with touch screen operation and key operation interlocking control, to effectively prevent misoperation;Monitor key parameters in real time, and store data and charts for easy export and printing;The online detection system of dust particles, the online sampling system of airborne microbe and the online detection system of hydrogen peroxide concentration can be integrated as required;Online glove leak detector can be equipped;The product can be customized according to customer needs.It is a special equipment used for testing the leakage rate of gloves/cuffs for isolation systems (barrier isolation systems);The data cannot be modified and can be integrated into the production reports in real time;Complies with computer verification, with audit trail function;Provides ergonomic operating handle, enjoying unique and compact appearance;Adopts unique airtight design;All materials meet medical grade and food grade requirements;Supports three-level user management.ProductmodelTKSAGE-ISO2050(S2)TKSAGE-ISO2450(S3)TKSAGE-ISO3150(S4)TKSAGE-ISO3150(W8)Overall dimensions:2050*850*24802450*850*24803150*850*24803150*1100*2480Glove station:2gloves3gloves4gloves8glovesAir distributionLaminar flowChamber airtightnessComply with ISO10648-2 standard requirements, and EU and FDA regulatory requirements.Door systemInterlocking systemFilterG4 primary-efficiency filter + H14 high-efficiency filterControl systemPLC intelligent control system (industrial PC, Siemens S7-1200 PLC, three-level permission control, electronic signature, audit trail)Intelligent monitoringDifferential pressure of isolator chamber /HEPA differential pressureAir speed at the air outlet/Leakage rate per hourGas concentration/Temperature and humidityPressure testing±80PaSystem integrationOnline monitoring of temperature and humidity/air speed/hydrogen peroxide concentration/particles/airborne microbe, etc.Leakage rate per hour<0.5% Vol/hrPower supply220V/5KWNote: The specifications listed in the table are for customers' reference only, and the clean pass box can be designed and made according to customers' requirements.Company ProfileTKSAGE (Shenzhen) Technology Group Co., Ltd.TKSAGE (Shenzhen) Technology Group Co., Ltd. ("TKSAGE") is a professional service provider and manufacturer that integrates research and development, design, manufacturing, sales, and installation of clean environment equipment and sterilization technology. The company is headquartered in Shenzhen and boasts two production facilities and one R&D Center. One of the factories covers an area of 35,000 square meters, while the R&D center operates from a comprehensive Grade A office building spanning 2,000 square meters.TKSAGE has a highly skilled professional clean equipment manufacturing team, with technical staff making up 36% of the total workforce. It has several production workshops, including filtration, sheet metal, welding, assembly, and warehousing. Advanced CNC equipment, laser cutting, fully automatic welding and other large-scale mechanical equipment are used in production. The key products include gel seal HEPA box, laminar flow pass box, negative pressure weighing booth, Class A laminar flow hood, VHP pass box, VHP generator, VHP HVAC sterilization system, sterile isolator, cell therapy isolator, negative pressure isolator, medical pass box, Class 100 clean bench, biosafety cabinet, BIBO, bio-closed valve, high efficiency exhaust box, clean trolley, fan filter unit (FFU), air shower, cargo air shower, spray shower, clean booth, air shower pass box, clean wardrobe, hand dryer, high/medium/primary-efficiency filter/high temperature-resistant filter, etc.2000m230000+m2The company has become a member of the Chinese Contamination Control Society, a council member of the Guangdong Association of Cleanroom Technology, a member of the China Association for Vaccines, and a member of China Association for Pharmaceutical Equipment. Moreover, the company is recognized as a distinguished contributor to China's biotechnology, and a designated R&D partner of Sun Yat-sen University. Furthermore, the company has obtained several certifications, including the National High-Tech Enterprise Certificate, the Specialized, Refined, Differential and Innovative Enterprise Certificate, and a number of national invention and utility model patent certificates, and has passed the IS09001-2015 quality management system certification, 3C certification, CE certification, UL certification, etc.The company's registered trademark, "TKSAGE," has earned a strong reputation within the industry. It has also been awarded the titles "China's Famous Brand Enterprise" and "Famous Brand Enterprise of Shenzhen". TKSAGE has established the subsidiaries of Shenzhen AIX Air Purification Co., Ltd. and Shenzhen EX Technology Co., Ltd. with the continuous development and strategic layout of the company's scale, clean equipment technology and sterilization technology. Together, these enterprises provide comprehensive clean/sterilization equipment solutions for laboratories, biopharmaceuticals, life sciences, healthcare, food safety, aerospace, microelectronics, chips, semiconductors, and new energy industries.Adhering to the values of "Customer, Integrity, Innovation, Quality, Win-win, Team, Excellence," TKSAGE aims to create a clean environment, improve life quality through technological innovation. The company is committed to continually delivering maximum value to customers and moving toward a brighter future.Enterprise CultureVision:Become a global leading system integration supplier and service provider of clean environment and sterilization technology.Mission:Improve life quality with technology and innovation, pursue a clean environment, and continuously maximize customers valueValues:Customer Integrity Innovation Quality Win-win Team ExcellenceContinue to create the maximum value for our customersCustomers who choose us - TKSAGE--Partial serving customersBio-safety labCellular genesOperating roomlife sciencesCenter for Disease ControlHealth drugs and food processingScientific ResearchInstitute of StateBio-pharma SolutionCNC punching machineCNC bending machineLaser cutting machineAutomatic filter pleating machineAutomatic filter pleating machineAutomatic filter test benchEnterprise honorMultiple national invention patents and utility model patent certificatesISO9001-2015 quality management system certificationISO9001/3C/CE/UL/ANABMember unit of Chinese Contamination Control SocietyCouncil member of Guangdong Laboratory AssociationMember unit of China Pharmaceutical Association of Plant EngineeringCouncil member of Chinese Contamination Control SocietyStrategic partner of Dandelion Pharmaceutical Service PlatformNational Specialized, Refined, Differential and Innovative EnterpriseMember unit of Shenzhen Cleaning AssociationMember unit of China Association for VaccinesNational High-tech Enterprise CertificateLife Science Sterilization EquipmentBiopharmaceutical Cleanroom EquipmentVHP Pass Box/Clean Pass Box/Xenon light pass boxBiosafety Airtight Pass Box/Laminar Flow Pass BoxNegative pressure isolator/Sterility testing isolatorLaminar Flow Pass Box/Class A Laminar Flow Hood/Negative Pressure Weighing Room/Biological Clean BenchBiosafety Cabinet/Class A Laminar Flow Transfer CartElectronics & Energy Contamination Control EquipmentAir Filtration SystemsAir shower pass box/Biosafety Inflatable Sealed Door/Intensive Shower Room/Cargo Shower Room/Clean Storage WardrobeAir Shower Room/Automatic Hand Washing and Drying MachinePrimary Efficiency Panel Filter/Primary Efficiency Bag FilterMedium Efficiency Synthetic Bag Filter/Medium Efficiency V-Bank FilterHigh Efficiency Filter With Separator /High Efficiency Filter Without SeparatorRoom 1819, Building 5A, Fenglong Shengang, No. 333 Longfei Avenue,Longcheng Street, Longgang District, Shenzhen, GuangdongPost code: 518172TKSAGE (Shenzhen) Technology Group Co., Ltd.
Purchasing Request
Note: Send your purchase request, and we will screen suppliers or manufacturers for you free of charge...