1-30ml Sterile Vial Liquid Lyophilized Preparation Production Line
1 Overview
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-KBG liquid filling machine and XHL-KGL series capping machine. The unit has the functions of washing, drying and sterilizing, filling and stoppling( half stoppling and full stoppling), capping and sealing. It is main suitable for production of lyophilized(water injection)aseptic injection 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. Main technical parameters
Product model Washing
|
whashing
|
XHL-QCLW40
|
XHL-QCLW60
|
XHL-QCLW60
|
XHL-QCLW80
|
XHL-QCLW100
|
XHL-QCLW120
|
XHL-QCLW120
|
drying
|
XHL-QHX620/3500
|
XHL-QHX620/4500
|
XHL-QHX620/4500
|
XHL-QHX620/5820
|
XHL-QHX620/5820
|
XHL-QHX6207140
|
XHL-QHX6207140
|
filling
|
XHL-SFYG/4
|
XHL-SFYG/6
|
XHL-SFYG/8
|
XHL-SFYG/10
|
XHL-SFYG/12
|
XHL-SFYG/20
|
XHL-SFYG/24
|
pressing
|
XHL-ZG/2
|
XHL-ZG/12
|
XHL-ZG/12
|
XHL-ZG/16
|
XHL-ZG/16
|
XHL-ZG/24
|
XHL-ZG/24
|
applicable specifications
|
2-30ml
|
number of filling heads
|
4
|
6
|
8
|
10
|
12
|
20
|
24
|
production capacity(2ml)
|
120
|
180
|
200
|
300
|
400
|
500
|
650
|
bottle washing pass rate
|
≥99.9%
|
bottle washing breakage rate
|
≤0.1%
|
sterilization temperature
|
300-350
|
exhaust air volume
|
3000
|
4100
|
7500
|
8000-10000
|
filling accuracy
|
≤0.5%
|
stoppling pass rate
|
≥99.9%
|
capping pass rate
|
≥99.9%
|
air laminar flow cleanliness
|
100%
|
vacuum pumping speed
|
10
|
30
|
50
|
60
|
60
|
100
|
120
|
capacitance
|
66.6
|
75.6
|
10.6
|
212.6
|
232.6
|
power supply
|
380V 50Hz
|
total weight(kg)
|
6300
|
6300
|
7900
|
9400
|
10900
|
14600
|
Introduction to XHL-QCLW series
1 Introduction to XHL-QCLW series ultrasonic bottle washing machine
The ultrasonic washing machine is mainly used for washing small and medium-volume oral liquid bottles in the pharmaceutical industry. It can automatically complete the whole production process including bottle feeding, ultrasonic washing, external washing, internal washing and bottle discharging. The machine runs stably and reliably with low breakage rate. The output can be steplessly regulated and the operation is convenient. It can be used singly, and can also work with tunnel sterilization dryer and filling and capping unit for linked production.
The vial after cleaning by the machine has high cleanliness and meets GMP requirements.
2 Introduction to XHL-QHX series airflow sterilization oven
Adopting an integral tunnel structure, the machine automatically completes the whole production process including bottle feeding, preheating, drying, cooling and bottle discharging. The laminar flow principle and the hot air high-speed disinfection process are used to dry the vessels in the Class A tunnel. It is an internationally popular and effective drying device with uniform heat distribution
The machine can be used singly, and can also work with the previous washing machine and the next filing unit for linked production.
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 provide 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 oven cavity can be subject to all-round, multi-angle high pressure water washing.
The filing machine adopts the worlds most advanced design concept, featured by high speed, accurate filling and convenient replacement of parts.
The filling machine adopts the AC servo motor to drive the filling screw to tum with accurate filling volume.
The adjustment of filling volume of the filing 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 provide with the functions of no filling in case of no bottle and no stoppling in case of no bottle.
Introduction to XHL-KBG Series Low And Medium-speed Sterile Val Liquid Preparation Production Unit
1,Overview
The XHL-KBG-120 antibiotic glass bottle liquid (sterile injection)full stoppling(semi-stoppling filing machine is a new generation product developed by our company to adapt to the development of domestic biological products and blood products engineering, especially for new freeze-drying technology. With advanced control system, accurate filling, stable performance and beautiful appearance, the machine is an ideal product for the production of freeze-dried agents, liquid preparations and blood products, and is suitable for working with production lines. It is also suitable for the production of vials in other industries such as veterinary drugs and nutrient solutions.
2,Performance features
- The metering steps are set by microcomputer, and the peristaltic pump is used for filling with high precision and wide dosage adjustment range. The ceramic pump can also be used. It is suitable for liquids of various viscosities.
- Easy cleaning and disinfection, no pollution.
- Filling is stopped if there is no bottle. Function of automatic display of counts.Variable frequency speed control.
- Bottle feeding, metering, filling and automatic stoppling can be completed automatically.
- The 100-grade laminar flow protection device can be installed according to customer requirements.
- The whole machine is designed according to GMP requirements.
3,Main technical parameters
product model
|
XHL-KBG60/XHL-KBG/60A
|
XHL-KBG120/XHL-KBG120A
|
scope of applocation
|
1-30ml
|
stable production capacity(bottles/min)
|
50-60
|
100-120
|
filling volume error
|
≤0.5%
|
actimatic stoppling rate
|
≥99.9%
|
power supply
|
220380V50/60Hz
|
power
|
≤5kw
|
vacuum degree
|
6.6×10·MPa
|
vacuum consumption
|
14m'/h
|
single machine noise
|
≤70dB
|
weight
|
1000kq
|
Introduction to XHL-ZG Series Rotary Vial Capping Machine
1,Overview
Mainly used for the sealing of antibiotic bottles in pharmaceutical factories
2,Performance features
The machine adopts the side-mounted single-knife flexible rolling type capping structure to automatically complete such procedures as bottle feeding, cap unscrambling and capping. It has such advantages as high speed, low breakage rate and beautiful appearance at the capping part of the aluminum cap.
3,Main technical parameters
product model
|
XHL-ZG/12
|
XHL-ZG/16
|
XHL-ZG/24
|
applicable specifications
|
1-30ml antibiotic bottle
|
production capacity(bottles/min)
|
300-400
|
400-500
|
500-600
|
number of cap pressiong heads
|
12
|
16
|
24
|
capacitance
|
≤1.5kw
|
net mass(kg)
|
110
|
1300
|
1500
|
pass rate
|
≥99.95%
|
power supply
|
220/380V 50Hz
|