Recently, small batches and patient specific or high-tech medicines for new therapies, such as precision medicine, used for R&D or clinical trials are getting ever high attentions.
The aseptic production process might need to be adjusted frequently, and a short changeover time between batches or multiple products production is preferred. Meanwhile the facilities are limited in spaces and with a lower cleanliness level (Grade D). To achieve a quick, flexible, cost-effective and compact production line, Tofflon works for a valuable and competitive solution - Mini KUFill.
Mini KUFill is an integrated system, which includes compact designed isolator and filling machine. The user will benefit from easy of operation on one HMI and get the key process data on one report. Mini KUFill is expandable design to the possibility of integration with other process machines such as washing machine, depyrogenation tunnel, freeze dryer and so on. Custom design is also available, which is suitable for different layout arrangements.
Single or multi-functional of filling and closing process can be integrated according to your products and at a dosing speed around 25~50 vials/min. A pilot scale freeze dryer is equipped and manual loading is designed. A half-suit is used when freeze dryer is loaded and unloaded manually. Auto loading/unloading is also possible to be integrated, which helps reducing interventions during the process.
The isolator can be designed for both aseptic and containment, and a VPHP is integrated to decontaminate surfaces inside the isolator chamber.
A high efficiency catalysts unit is used to break the high concentration H2O2 vapor rapidly. Generally, a 6-log spore reduction against highly resistant BI is required for the surface decontamination. After the decontamination cycle, the hydrogen peroxide inside the isolator chamber will be eliminated to lower than 1 ppm or even lower (30 ppb) at the end of aeration phase. Stable parameters control, such as evaporate temperature and dosing rate, ensures a reproducible validated cycle of VPHP decontamination.
An AHU (Air Handling Unit) also can be equipped to control the temperature and humidity inside the isolator as the process requires.
For both aseptic and containment application, WIP/CIP function is equipped. Bottom plate of chamber will be slope design for better drainage. Bag-in-bag-out HEPA Filters or other safety-changed HEPA Units are used in air return of isolator.
Ready-to-Use and Single-Used Technology are really good solutions for Mini KUFill, by using washing machine and depyrogenation tunnel for containers and stoppers are not necessary anymore and promote a quick shifting between processes. Contamination risk can even lower because less transfer operation takes place during the process when you conduct environment monitoring.
Mini KUFill meets all GMP and FDA Guidelines for pharmaceutical production, meanwhile it's a cost-effective, flexible solution for the future pharmaceutical industry.