Sterilevial Powder Preparation Production Line

1 Overview of production line

the production line is mainly suitable for production of sterile powders of high output.

The production line is composed of XHL-QCLW series ultrasonic bottle washing machine, XHL-QHX series hot air circulation tunnel oven, XHL-KFG series aseptic powder metering and filling machine and XHL-ZG series capping machine. The unit has the functions of washing, drying and sterilizing, filing and stoppling, capping and sealing. It is mainly suitable for production of sterile powders in pharmaceutical enterprises. By adding the RABS system, it can meet Class A(ISO5 level)requirements for aseptic preparation environment, and the unit meets the new version GMP requirements.

 

2 Function flow chart

 

3 Performance features

The bottle washing machine adopts mechanical hands to clamp the bottles, suitable for vials of various specifications.

The water-gas spray needles adopt the reciprocating tracking insertion mode for bottle washing, featured by good washing effect and energy saving. It is also provided with a device that prevents the needle holder from shaking to enhance the accuracy of the spray needle s insertion into the bottle and reduce the occurrence of needle breakage.

The water and gas pipes are totally separable from the spray needles, so that cross contamination is avoided and GMP requirements are met.

The buffer block is installed before the bottle discharging screw of the bottle washing machine to protect the screw and reduce bottle breakage.

Bottle discharging is realized by the integral imported synchronous belt that is connected to the bottle pushing block and conveys ampoules with stable and reliable running.

The oven adopts hot air circulation heating with even temperature and energy saving.

The oven is provided with the function of protecting against sudden power-off to ensure safe running.

The oven can be equipped with the circulation water cooling device that does not consume wind volume in the room, reduces the risk of unbalanced differential pressure in the room and achieves good cooling effect.

The oven can be equipped with the differential pressure automatic balancing and regulating system to reduce the problems of deviation at the high temperature section caused by unbalanced differential pressure in the room and oven, temperature rise in the filling room, washing and drying room, etc.

The oven is provided with DOP inspection ports(including inspection ports for wind pressure, wind speed and dust particles).

The cooling section in the oven is provided with the sterilization function(specially chosen by FDA).

The oven mesh belt can be equipped with the ultrasonic and CIP cleaning systems.

The filling machine adopts the world s most advanced design concept, featured by high speed, accurate filling and convenient replacement of parts.

The filing machine adopts the AC servo motor to drive the filing screw to turn with accurate filling volume.

The adjustment of filling volume of the filling machine can be realized through the touch screen.

The filling machine can be equipped with the 100-grade circulation laminar flow hood.

The filling machine is provided with the functions of n filling in case of no bottle and n stoppling in case of no bottle.

 

4 Main technical parameters

Scope of use	1-30ml
Production capacity	250(2 head)	400(4 head)
Bottle washing pass rate	99.9%
Bottle washing breakage rate	≤0.1%
Sterilization temperature	300-350°C
Filling error	≤3.0
Stoppling pass rate	≥99.9%
Air laminar flow cleanliness	100%
Vacuum pumping speed	25m³/h	50m³/h
Capacitance	96	235.5
Power supply	380V50Hz
Total weight	8200kg