杭州金波医药科技有限公司

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Room 1501,Building 9,N0.125 Wen'er Road,Xihu District,Hang,hou,Zhejiang,China
www.kingbopharmatech.com

1.1 Application scenarios

♦ Solid/Semi-solid Formulations

♦ Multi-functional Fluidized Bed

♦ Wet mixing granulator

♦ Tablet press

♦ Auto-capsule filling machine

♦ Paste filling and sealing machine

♦ Liquid formulation

♦ Medicinal water solutions

♦ Purified water preparation system

♦ Injection water preparation system

♦ liquid mixing system

♦ Fully automatic liquid distribution system

♦ CIP/SIP system

♦ Freeze-drying machine solutions

♦ Industrial freeze dryer

♦ Freee dryer Auto loader

♦ Aseptic filling linkage line

1.2 Multi-functional Fluidized Bed

The design and processing technology of the fluidized bed are strictly implemented in accordance with our independent innovation standards, and our advanced manufacturing level has been praised by foreign counterparts as "German quality, made in China", which is close to or even exceeds the international brand equipment in terms of reproducibility and uniformity.

1.3 Wet mixing granulator

The wet mixing granulator uses the strong mixing effect of the mixing paddle to make the material (powder) form a three-dimensional motion state of axial, radial and tangential in the container, so that the material is mixed evenly and then made into true spherical particles by the vertical cutter.
This series of products adopts the traditional horizontal cylinder and cone structure, which has high material turnover efficiency and good uniformity. The equipment has the advantages of simple operation, high production efficiency, stable performance, good product process reproducibility, and good uniformity, less fine powder and good fluidity.

1.4 Tablet press

High precision pressing system: Advanced servo control technology ensures high consistency of tablet weight and hardness.
Flexible modular design: Support a variety of die specifications and yield requirements, adapt to a variety of tablet forms of production.
High efficiency operation: Stable operation of equipment, rapid mold change, minimize downtime, improve production efficiency.
Intelligent monitoring system: Built-in real-time data acquisition and analysis functions can monitor key parameters such as tablet force and tablet thickness to support quality management.

1.5 Auto-capsule filling machine

It is a capsule filling machine equipped with a closed system for handling highly effective drugs to achieve complete isolation from active substances during operation, maintenance and equipment cleaning.
The equipment achieves this by employing a range of automated processes and providing a true isolation solution.
The simple interaction between the components of the device in the isolated area is a closed preparation line for filling highly active drug capsules.

1.6 Paste filling and sealing machine

Paste filling and sealing machines are the perfect solution for low speed, fully automatic filling and sealing ready-to-use nested containers (pre-filled needles, syringes, ink cartridges). Paste filling machine adopts modular design, from the synchronous station turntable, pipe, standard, standard lift, filling, filling door, filling lift, sealing, finished product ejection, each system adopts servo motor control and modular design. The machine design concept is advanced, the whole machine adopts a total of 12 sets of servo motors and 12 sets of drive control system. The design of the machine completely abandons the traditional filling machine through the main motor to drive the main shaft of each CAM and various connecting rod mechanism concept.

1.7 Purified water preparation system

The preparation of purified water should take drinking water as raw water and adopt appropriate unit operation or combination method. Common methods for preparing purified water include membrane filtration、ion exchange and electrodeionization (EDl). Among them,membrane filtration can be subdivided into microfiltration ultrafiltration, nanofiltration and reverse osmosis (RO).

1.8 Injection water preparation system

The qualified raw water enters the condenser after being pressurized by the multi-stage pump and then enters each effect preheater in turn (the raw water is heated by the secondary steam and distilled water in the condenser, heated by the industrial steam condensate in the primary effect preheater, and heated by the condensate of the secondary steam after entering the primary effect preheater), and then enters the effect evaporator and is sprayed on the inner wall of the heating pipe through the feed water distributor, so that the feed water flows in a film on the pipewall, and is heated and vaporized by the industrial steam. The generated secondary steam with water droplets enters the steam water separation device from the lower end of the evaporation chamber. The separated pure steam enters the next effect as heating steam, and the raw water not evaporated enters the next effect. Repeat the above process. The pure steam produced by the end effect enters the condenser and is cooled together with the condensed water from all effects except the first effect. After the non condensable gas is discharged (according to the different models, the continuous discharge device of such non condensable gas may also be seton the evaporator), it becomes water for injection. The outlet is subject to on-line conductivity detection. The qualified distilled water is output as water for injection, and the unqualified distilled water will be discharged

1.9 Fully automatic liquid distribution system

The design shall be carried out according to the actual needs of customers onsite and the disinfection requirements. With GMP SPE engineering guidelines and FDA specifications as the design concept, the space shall be reasonably used, the use and operation shall be convenient, and the high-quality clean pipe fittings shall be selected to ensure that the design and installation are free of dead corners, pollution, reasonable reflux control, and fully meet the requirements of users and verification requirements.

1.10 CIP/SIP system

It is suitable for cleaning large, medium and small equipment with compact structure, small floor area and convenient installation and maintenance. The cleaning fluid can be recycled with high utilization rate. Less vulnerable and long service life. lt can conveniently and effectively clean storage tanks, pipe-lines and other production equipment on site. The whole cleaning process is operated in sealed production equipment, storage tanks and pipelines, thus greatly reducing the risk of secondary pollution. The cleaning work can be programmed and automated. Extracorporeal circulation system can effectively reduce energy consumption. There are single tank, double tank and multi tank for users to choose.

1.11 Industrial freeze dryer

The industrial model freeze dryer with drying capacity up to 1,000 Liters, cover most demand for vial or other material commercial production, compliance with cGMP and FDA. More optional systems available, main features are:

♦ Automatic shelf stoppering under vacuum

♦ Automactic control for freeze drying, SIP and ClP

♦ Scada control system compliance with GAMP regulationand save up to thousand recipes

♦ Shelf flatness lass than 1.0mm, temperature uniformity lessthan 1℃

♦ Energy saving control system by control compressor andvacuum pump

♦ Environment friendly refrigerant

♦ Flexible arrangement design, suit user's plant layout,thusspace saved

Model	LYOPRO-10.0	LYOPRO-13.0	LYOPRO-16.0	LYOPRO-20.0	LYOPRO-25.0	LYOPRO-30.0	LYOPRO-40.0	LYOPRO-50.0
Ice capacity(Kg)	200	260	320	400	500	600	800	1000
Shelf area(m²)	9.72	12.96	15.84	19.80	24.75	30.00	42.00	49.50
Shelf size(L*W)(mm)	1200*900	1200*1200	1200*1200	1500*1200	1500*1500	2000*1500	2000*1500	2200*1500
Useable Shelf No	9	9	11	11	11	10	14	15
Vial loading quantity φ16 φ22	40000 20000	56000 28000	68000 34000	80000 40000	100000 50000	120000 60000	175000 85000	200000 100000
Inter.Shelf distance(mm)	100	100	100	100	100	100	90	90
Shelf ultimate cooling temperature(℃)	-55	-55	-55	-55	-55	-55	-55	-55
Condenser ultimate cooling temperature(℃)	-75	-75	-75	-75	-75	-75	-75	-75
Ultimate vacuum(Pa)	≤1.0	≤1.0	≤1.0	≤1.0	≤1.0	≤1.0	≤1.0	≤1.0
Installation dimension(LWH)(mm)	60001750 3800	68002000 3800	68002000 4200	75002000 4200	72003000 4200	76003000 4200	76003200 4500	96002300 4700
Weight(Kg)	10000	12500	15000	17500	20000	25000	30000	35000
Power(KW)	63.0	77.5	91.5	120.0	135.0	147.0	179.0	215.0

1.12 Free dryer Auto loader

We offer reliable and high speed auto loading and unloading system(ALAUS) for commercial freeze drying process, Compliance with GMP and FDA for sterile products of vial and bulk materials freeze drying, fully automatic and high precision control with all moving system driven by servo motor. We offer solutions as below:

Fixed row by row system for vials:

♦ Designed for automatic vial convey from filer to freeze dryer pizza door, and convey to capper after unloading, vials pushing and pull with row by row

♦ Optional equip with sterile isolator, Rabs system

♦ Fully automatic running without manual operation

Fixed tray by tray loading system.

♦ Designed for automatic load trays into freeze dryer through pizza door from filler or dosing system (for bulk material/liquid), and convey to packing unit(for bulk material/liquid) or capper after unloaded. Trays moving row by row

♦ No change parts required, suitable for different vial size application

♦ Best solution for sterile APl or other bulk material

♦ Optional equip with sterile isolator, Rabs system

♦ Fully or semi-automatic running

1.13 Aseptic filling linkage line