KUFill——The Advanced Aseptic Processing System Integrated with Isolator
Facing with fierce competition, pharmaceutical companies are feeling great pressures on new regulations compliance, lower cost not sacrificing quality. A system which is more flexible, reliable, safer and efficient automated equipment, with shorter delivery time, quick changeover, integration with isolator mostly containment design is expected by the trend of this market.
Tofflon KUFill can meet all the needs above. KUFill is a system designed for aseptic or aseptic & containment injectable manufacture processing, which is a combination of processing machine and isolator system with Vapor Phase Hydrogen Peroxide (VPHP) decontamination function.
Flexibility
KUFill can be designed for liquid filling, freezes drying, powder filling or multi-dosage requirement.
Safety
In KUFill, process machines are fully automated designed for as less intervention as possible during the production. the operator should be well trained to follow the SOP restrictedly when operate the isolator such as install parts, transfer stoppers, or do the microbe sampling without breaking the integrity of the Grade A or ISO 5 environment.
Safety sensors are equipped to protect the operator by preventing the miss operation during the production. Containment design is a must when the OEL of the product is lower than 10 μg/m3.
HEPA filters with containment design are used on the piping or channel of recirculation and exhaust. WIP and CIP are equipped inside the isolator chambers and ducts. Connections of neutralizer or WFI are reserved on the isolator.
Quicker Change Over
For relative smaller size of manufacture, Ready-to-Use (RTU) and Single-Use technology is applied in KUFill for the critical process. Time of sterilization, validation and risk of contamination can be reduced. Compare the high value of the product, the cost of these advanced technologies can be cost-effective.
Special catalytic devices are equipped to shorten the aeration phase of VPHP decontamination. A sequence of sterilization of freeze drier, filling SIP and VPHP cycle need to be consider when doing the cycle development and the media fill test.
Shorter Delivery Time
KUFill is supplied by one company - Tofflon. KUFill team has no barrier for internal technical communication among different machine teams by proper efficient project management and really help to shorten the delivery time.
KUFill Aseptic Processing Isolation System
KUFill is a system designed for aseptic or aseptic & containment injectable processing Integrated with Isolator which contribute a controlled environment which meet the regulation and products requirements:
- An absolute physical barrier between operators and the process
- Integrated with VPHP decontamination system to achieve a 6 log reduction of BI
- Grade A unidirectional airflow protect the critical area, ensure SAL 10-6
- Background cleanroom controlled Grade C (ISO 8)
- Temperature and humidity can be controlled by a dedicated HVAC system
Quality by Design
- Isolator can be designed for protect both personnel and product for aseptic and toxic process application.
- WIP and CIP can be equipped for isolator ducts and chamber cleaning. Connections of WFI or neutralizer.
- Operator should be use the isolator , such as interventions for installation, environment monitoring and transfer operations, strictly follow the SOP and without interrupt the Grade A (or ISO 5)condition, Safety sensors are used to detect the miss operation during the process.
- RTU and single-use technology are introduced to improve the time-saving change over and reduce the risk of cross contamination.
- The process of production in isolator is well designed before machine design. During Mock-up phase, all detailed operations or interventions will be simulated to optimize the design of ergonomics.
- Comply All GMP
- All processing data, alarm and warning, access information and so on will be reordered and plot into a unchangeable format. Upload to a MES is also possible.
- System with CE certification
- Meet the requirement of GAMP5
- One Control System (Siemens or Allen-Bradley) and one 15’ HMI