Ceepackaging

Technology

Turnkey with Optima Group pharma

The line mainly consists of Inova components: a VWM 218 washing machine, a SHT 1L sterilizing tunnel with sterilizable cooling zone, a VFVM 7021 filling and closing machine prepared for isolator, fully automatic loading and unloading units for the vacuum dryer, a crimping machine, an isolator and a vacuum dryer by Klee.

A transfer port is installed in the top of the isolator to ensure contamination free transfer of the pharmaceutical powder from the product storage container to the isolator. Here, the double lid principle (the two lids protect each other when opened), ensures that the “transport” will be sterile and without particle contamination. The product is safely transferred to the auger filler through an internally routed telescopic tube. The auger filler fills one gram of powder into the previously sterilized vials and is currently equipped for one format. The dosing system operates with a filling accuracy s_rel of +/-3 %.

The filled containers can then either be closed directly or they can be dried prior to closing utilizing the Klee vacuum dryer. The loading and unloading of the vials are automated followed by another crimping station for the dried products. The line is also prepared for media fills. To accomplish this, an additional station has been designed that, if necessary, will fill a culture medium into the vials filled with powder. The peristaltic pump used for this purpose is installed on a trolley and can be added to the filling and closing machine when required. Here too, the filling takes place under isolator.

Powdery or Liquid – Vacuum or Freeze Dried –

Small or Big

The line’s format range can easily be expanded with additional format parts. Possible vial sizes are from 6R to 20H. Conversion to liquid filling is not complicated. Liquid pharmaceuticals in volumes of up to 20ml can be filled with a retrofittable time/pressure dosing module. Additionally, the Klee vacuum dryer can also be retrofitted for freeze drying with the refrigeration equipment easily integrated.

Apart from its versatility, the line offers a number of other interesting features: Thanks to the compact design - particularly of the filling machine, which including the bi-flow conveyor has a length of only 2,270mm – it is very easy to clean. The surfaces of the line can be vacuumed with a vacuum cleaner supplied by Inova. The next phase is a wipe-down disinfection followed by VHP decontamination with the isolator closed. Product contact parts are autoclavable and are mounted prior to VHP decontamination. For functional tests of the loading unit that are conducted in connection with the filling machine, sterilized vials can be used. Furthermore, the entire line can be connected to a SCADA system.