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Granulation line for pharmaceutical solid dosage forms

Views: 9     Author: Site Editor     Publish Time: 2024-06-18      Origin: Site


1.Oral Solid Dosage Granulation Line Description

If you are in the pharmaceutical manufacturing industry, then you should consider buying this premium solid dosage granulation machine. This pharmaceutical granulation equipment will ensure there is no cross-contamination.

Solid oral dosage granulator combines mixing, granulation, and drying processes to ensure continuous and stable production, The granulation drying production line can highly increase the yield of finished products.

The vacuum conveying device and lifting turnover discharging system can greatly decrease labor intensity and avoid dust pollution. it means that the Granulator drying production line saves on the cost of labor.

Hywell machinery oral solid dosage equipment (wet granulation line system) adopts automatic PLC control with the graphical interface. This means that the operation and process parameters can be set automatically for history review and print.

The CIP system in the solid dosage form granulation line can fulfill well cleaning effect for the granulator and dryer. The ex-proof system, reliable interlock, and earthing ensure the safety of the people, equipment, and environment.

If you would like to buy a custom solid-dose pharmaceutical manufacturing line, Hywell will work hard to meet the process and specifications. We can customize the designs and sizes of granulation lines.

Would you like to buy this solid-dose manufacturing process line? then Send your inquiry on Hywell machinery right now. Hywell company is a reliable and reputable solid dosing granulation line manufacturer in China. Hywell Machinery Co., Ltd will support with Project Initial design — Project Initial confirm — Project detailed design — Project confirm — Select Equipment specification. To provide the advanced service for customers, and to insure all the machines are suitable for each production line of customers.

2111

Solid Dosage Granulation

3111

Solid Dosage Granulation



2. Name and Type of the Equipment


The Granulation line for pharmaceutical solid dosage forms Consists of the Following Sections:


A: Granulation line for pharmaceutical solid dosage forms(High shear granulator)

B: Granulation line for pharmaceutical solid dosage forms(wet granulator)

C:  Closed linkage line(Fluid-Bed dryer)

D: Granulation line for pharmaceutical solid dosage forms(pneumatic vacuum loader)

E: Granulation line for pharmaceutical solid dosage forms(dry granulator)

F: Granulation line for pharmaceutical solid dosage forms(hopper mixer)




3 . Function of the Equipment


Equipment introduction: The Granulation line for pharmaceutical solid dosage formssystem is composed of a high shear granulator, wet granulator, fluid bed dryer (granulator), pneumatic vacuum feeder, dry granulator, hopper mixer and other feeding and discharging systems and connecting components. During the granulation process, powder materials are put into the wet granulator. All processes are operated in a closed environment, each device is compatible and smooth, and the final product is mixed and then tableted.

1. GHL-15 mixing and granulator: first step to mix the different kinds dry powder, when the different powder mixed into uniform, and then to add the binder into GHL machine to made into the required damp material , final the  cutting knife makes the wet material into graunles.

2.  The wet granule will discharge into wet granulator (Conical Mill) from GHL-15 to get required size.  

3.  After wet mill, the wet granule will be discharge and sucked into FL-20 fluid bed dryer for drying by negative pressure of FL-20 exhaust fan.

4.  After drying, HS-1 will suck the dried granules from FL-20 into the dry granulator (Conical Mill).

5.  After dry mill, the dried granule will be discharge into HF-30 for blending

6. After blending and then materials will be send to tableting machine.



4. Technical Specifications



A. Granulation line for pharmaceutical solid dosage forms(High shear granulator)



(1). Technical Parameters Performance Table


SN

Item

Unit

Model

1.    

Model


GHL-15

2.    

Tank   volume

L

10

3.    

Load   materials

kg/batch

5-8

4.    

Stir   power

KW

2.2kw

5.    

Stir   speed

r.p.m

30~960 inverter control

6.    

Chopper   power

KW

0.75

7.    

Chopper   speed

r.p.m

50~2990 inverter control

8.    

Compressor   air pressure

Mpa

0.4-0.6

9.    

Compressor   consumption

M⊃3;/min

0.1

10.  

Materials   temperature

Normal   temperature

11.  

Noise

db

<45db


(2). Equipment features


1. Hywell company produces a series of small high-speed mixers that can complete mixing in one go, with a good mixing effect and no cross-contamination. It meets the GMP requirements of the pharmaceutical industry and is suitable for trial production of new products and medium and small batch production in laboratories and scientific research and teaching units.

2. This type of equipment has a safety interlocking device, which is safe and reliable when used; the equipment adopts a horizontal machine structure with good overall rigidity, simple structure, and easy maintenance; the main components are installed inside the machine body, covered with a 304 stainless steel casing, and the parts that are in direct contact with the material are all made of 304 stainless steel; the granulation process is closed, equipped with an elbow stirring paddle, with a 15-degree angle with the bottom of the pot, and the material quickly generates a burst flow during mixing, and 2-5 cutting knife sets.

3. This type of equipment uses a dual frequency converter to adjust the speed of the stirring paddle and cutting knife, and automatically controls the operation of the machine with timing; electrical control, and touch screen operation. PLC touchscreen control and button control are two modes for users to choose.

GHL1

High Shear Granulator

GHL3

High Shear Granulator

GHL-3

High Shear Granulation


(3) Equipment system composition and description


Name

Description

Mark

Main machine system

Base

Frame structure/stainless steel   plate/motor/pneumatic control components


Raw   material container

The material tank is designed with   a positive cone. The material rolls up and down from bottom to top during   mixing, and the material is mixed evenly. The inner wall is smooth and easy   to clean/integrated interchangeable


                                                                                 

Organic   glass cover/liquid port

Customized   closing cover to prevent dust leakage during work


 

The gap between the large knife   and the bottom of the material container is less than 1mm/large knife, and   the small knife shaft has a mechanical air seal device, which prevents   lubricating oil from leaking out and materials from leaking in. It is easy to   disassemble and clean.


Liquid   filling system (quick atomization and liquid filling is required)

Pressure   atomizing spray gun pressure tank filling

Optional,   standard is manual feeding liquid

Discharging device

Pneumatic   opening/quick opening disassembly for easy cleaning


Transmission system

Brand   motor direct connection synchronous start.


Seal

Metal mechanical seal plus gas   seal is used to ensure that no dirt leaks out of the shaft and no material   enters the shaft seal and gets stuck.


Control system


Cabinet

304 operation box


Control and operation mode

PLC program control/touch screen   operation


Electrical components

PLC human-machine interface/module/inverter


Pneumatic components

Yadek



(4). Main outsourcing brands


SN

Name

Model

Brand

Mark

Electrical components


1

Master control PLC programmable   controller


Siemens


2

Inverter

2.2kw

China


3

Inverter

0.75kw

China


4

Master control shared touch screen   and supporting expansion modules

10inch

Siemens


5

Electrical components

1unit

Siemens


6

Pneumatic components

1unit

Yadek


Other


7.

Mixing motor

2.2kw

Wannan


8.

Cutting motor

0.75kw

Wannan




(5). Machine Materials


SN

Product Components

Materials

Mark

1.

Main unit cover

SS304

δ=2.5

2.

Main unit frame

A3

δ=10

3.

Main unit side cover

SS304

δ=2

4.

Raw material container

SS304

δ=6

5.

Stirring paddle/cutting knife

SS304

δ=8 δ=3

6.

Operation cabinet

SS304

δ=2

7.

Gasket

silicone rubber

Food grade

8.

Motor



Note: Inner surface mirror polishing ≤ 0.4μm,   outer surface brushed polishing ≤ 0.8μm.



B: Granulation line for pharmaceutical solid dosage forms(wet granulator)



(1). Main technical parameters


Item

unit

Model   and specification

Production capacity

Kg/H

5-50

Motor power

kw

0.75

Speed

rpm

180-1440

Control speed mode

--

Frequency control speed regulation

Screen aperture

mm

Φ1-8


(2). Application Overview


2.1. Dry and wet granulation homogenization and granulation.

2.2. Crushing and granulation of agglomerated materials.

2.3. Wet material granulation.

2.4. Crushing of heat-sensitive materials.


(3). Equipment features


3.1. Low heat and dust during operation.

3.2. The stator screen is made of stainless steel plate and is not easy to damage.

3.3. It can handle sticky, gummy, hot and wet materials.


(4). Configuration


Name

Materials

Model

country of origin

Main body

SUS304

δ=1.5mm

Hywell   Machinery

Hopper

SUS304

δ=2mm

Hywell Machinery

Pelletizing knife

SUS304

δ=8

Hywell Machinery

Screen

SUS304

Φ1-8 Specify any specification

Hywell Machinery

Motor


0.75kw

Wannan

Inverter


0.75kw

China

Electrical components



Siemens



C:  Granulation line for pharmaceutical solid dosage forms(Fluid-Bed dryer)


(1). Technical Parameters


SN

Item

Unit

Model

1

Functional module


--

Top spray

--

Granulating pot (top spray)

2

Raw material container volume

L

20

Production capacity

G/Batch

3-5

3

Number of spray guns

Head

1

4

Electric heating power

kw

6

5

Compressed   air

pressure

Mpa

0.4-0.6

Consumption

M3/h

0.3

6

Fan power

Kw

4

7

Fan air volume

Hz

0~50   controllable

8

Inlet air temperature

°C

Room temperature -100℃ controllable

9

Material temperature

°C

Automatic display

10

Spray flow rate

r/min

0~100   adjustable

11

Clean-up time

s

Settable

12

Yield rate

%

≥99%

13

Product moisture


5‰~5%   related to humidity

14

Noise

dB

Fan isolation treatment less than   65 decibels


FL

fluid bed dryer

FL2

fluid bed dryer

FL43

fluid bed dryer



(2). Equipment use and process introduction



a. Equipment application


The material is suspended in a fluidized state under the action of clean hot air flow (negative pressure). Its surface is in full contact with the hot air, and is evenly heated, achieving the best heat exchange state, thus having extremely high efficiency. With a suitable spray system and further structural improvements, the fluidized bed becomes a multi-purpose process equipment that combines drying, granulation, and granulation.

This machine is equipped with a "top spray" system and is mainly used for mixing, drying, and granulation operations in the pharmaceutical, food, chemical and other industries.


b. Process introduction:


Put the powder material for granulation into the fluidized bed, and the cold air enters from the heating chamber at the rear of the main machine. After being heated to the required temperature of the inlet air by the primary, medium and heater, it enters the fluidized bed. The powder is fluidized in the bed, and the granulation binder is sent into the double-fluid atomizer by the infusion pump. After being atomized, it is sprayed onto the fluidized material. The powders bridge each other, aggregate into granules and grow. After the water evaporates, it is carried out of the machine by the exhaust air.


c. Features:


(1) Granulation is performed through powder, which improves fluidity and reduces dust flying.

(2) The heavy-weight granulation method is adopted, and both heavy-weight and light-weight granulation can be performed.

(3) The spraying, mixing, granulation and drying processes are carried out simultaneously, which greatly reduces the process.

(4) Special anti-static filter bags are used to prevent the occurrence of static electricity.

(5) Granulation is carried out in a sealed system without leakage and dust flying.

(6) The equipment can be operated manually or automatically.

(7) The granulation process parameters are stable and the repeatability is extremely high.

(8) The equipment has no dead corners, fast unloading, and is easy to rinse, which complies with GMP standards.



(3). Equipment system composition


Name  

Description

Intake air treatment system

Primary and secondary efficiency   filter

-   Primary effect (100 mesh stainless steel screen) (G4).

- Medium   effect (non-woven cotton protective net/primary effect (F7).

-   Pressure difference detection, meter display.

Electric heating tube

- 304 stainless steel electric   heating tube.

- Stainless steel cabinet, using   Siemens temperature module analog control adjustment to ensure temperature   control accuracy of ±3℃.

Cabinet

- Junior   and high efficiency filter: single layer, heater: special profile, double   layer insulation.

Air inlet pipe

- 90°   air supply duct from the air inlet processor to the cylinder base.

- The   number of ducts is limited to the standard equipment layout provided in the   layout diagram (Note: the above components and part of the air supply duct   are installed in non-clean rooms).

- The   temperature sensor quick interface of the air supply duct near the cylinder   base.

Installation sequence

- Primary and medium efficiency   filter-heater-high efficiency filter-material container

Main machine system

Foundation

-   Connected to the side supports, suspended design, easy to clean the equipment   and the floor.

-   Equipped with a drain outlet with quick-open connection at the lowest point.

-   Air-tight airbag on the base.

- Airbag   seal between the base and the top ring

Materials tank

- Top spray raw material   container.

- The pull rod for moving the   container is equipped with two height-adjustable fixed gaskets to ensure the   balanced insertion of the container.

- Eccentric shafts are set on both   sides of the container, which cooperate with the support and limit seat plate   on the trolley to ensure the horizontality of the container.

- A plexiglass window is set at   the front and back of the container, sealed with a silicone pad.

- The container is equipped with a   product sampler.

- The bottom of the container is   equipped with a swirl airflow distribution plate and a stainless steel mesh.

Automatic discharging device

- The cylinder controls the   discharge valve.

- It is used for closed automatic   discharge, and the discharge port is lower than the screen to ensure clean   discharge.

- After the closed discharge   device is completed, it can be completely disassembled and cleaned, without   sanitary dead corners.

Spray   granulation drying chamber

-   Suspended on the side support, can be rotated out horizontally.

-   Multiple vertically arranged spray gun mounting holes and hole covers, the   hole covers adopt a chuck quick-release structure, easy to install and   remove. After installation, the hole cover is flush with the inner wall of   the cylinder.

-   Tempered glass window, sealed with silicone pad.

- Set   the negative pressure feed port and quick-release pneumatic valve with   appropriate inclination angle to use the equipment's own negative pressure to   feed and avoid material accumulation.

Filter   Chamber

-   Bag-type anti-static cloth filter vibration dust removal, continuous   fluidization state, continuous spray granulation, and drying.

-   Special structure of filter suspension frame with automatic guide and locking   function.

-   Cylinder lifting system, convenient for lifting and installation of filter   bag, dust removal system with guide rod device.

-   Automatic pneumatically operated open/closed damper. Downward end face seal,   a good sealing effect, improves the powder cleaning efficiency of the filter.   It can prevent non-clean air backflow from polluting the cylinder and clean   area.

-   Organic glass window, sealed with silicone pad, used to observe the working   condition of the product filter bag.

- Temperature   sensor quick interface on the exhaust short pipe.

Observation light

- An observation window is set on   the back of the spray granulation drying chamber (including adding a window),   equipped with a lighting spotlight.

Cylinder base and top ring airbag   seal

- A silicone airbag is set between   the cylinder base and the top ring, and the airbag is inflated and sealed.   (Including adding a quick interface for compressed air on the base).

Spray liquid system

Spray   gun

- Single-head single-nozzle   pressure-type sprinkler, three-stage atomization design, improved   "gas-liquid-gas" mixing ratio, high-precision CNC machining, good   atomization quality, no drop-like or linear liquid flow phenomenon.

- All media enter the sprinkler   from their respective pipelines in the coaxial gun body, and the gun body is   equipped with a positioning pin and a locking nut.

- A control device for manually   adjusting the atomization air pressure through a pressure reducing valve.

liquid supply pump

- High quality peristaltic pump   head, dedicated stepless speed regulation drive, no external extension board   required.

Exhaust   air system

Fan

- Centrifugal high-pressure fan   with shock absorber, installed in the box.

- The fan inlet and outlet are   connected to the exhaust pipe and silencer through flexible joints to isolate   the fan vibration.

Exhaust duct

- The exhaust pipe from the fan to   the filter chamber exhaust is installed in the non-purified room. The number   of pipes is provided according to the equipment installation diagram.

Fan automatically changes   frequency to adjust air volume

Automatic   air volume adjustment

Control   System

Strong   and weak current cabinet

- The operating box is made of   SUS304 and is placed in the operating room, meeting GMP requirements.

- The operating box has display   instruments and a touch screen operation interface.

- The electrical box contains all   necessary control electrical appliances and wiring, including PLC program   controller, air switch, relay, contactor, inverter, etc.

Control and operation mode

- PLC program control, Chinese and   English interface, setting data, etc.

- PLC settings for power on/off   lock.

- Temperature, atomizing air   pressure, liquid supply pump speed, powder cleaning cycle and frequency   (touch screen display and setting), fan frequency conversion.

- Touch screen, instead of control   buttons. Intuitive screen and multiple parameter display, flexible setting   and adjustment.

Process program storage

It can store 20 sets of mixing   process programs with different recipes.

System security access

The factory sets 3 levels of   access passwords with different permissions to ensure system data security   and data integrity.

Record

Record the names, process   procedures and operators  of the 20   groups of drugs produced recently for traceability query; data can be   exported to a USB flash drive.

Fault alarm

Alarm for loss of normal   production conditions, overload alarm.

Pneumatic components

- Execution control element.



D:  Granulation line for pharmaceutical solid dosage forms(pneumatic vacuum loader)



(1). Equipment Features


The pneumatic vacuum feeder uses compressed air to generate high vacuum through a vacuum generator to transport materials. It does not require a mechanical vacuum pump and has the advantages of simple structure, small size, maintenance-free, low noise, easy control, elimination of material static electricity, and compliance with GMP requirements. The high vacuum generated by the vacuum generator eliminates the stratification of the transported materials and ensures the uniformity of the components of the mixed materials. It is the preferred equipment for automatic feeding of machines such as tablet presses, capsule filling machines, dry granulators, packaging machines, grinders, and vibrating screens.

When compressed air is supplied to the vacuum generator, the vacuum generator generates negative pressure to form a vacuum airflow, and the material is sucked into the suction nozzle to form a material airflow, which passes through the suction pipe to reach the hopper of the feeder. The filter completely separates the material from the air. When the material fills the hopper, the controller automatically cuts off the air source, the vacuum generator stops working, and the hopper door automatically opens, and the material falls into the hopper of the equipment. At the same time, the compressed air automatically cleans the filter through the pulse backflush valve. When the time is up or the material level sensor sends a feeding signal, the feeder is automatically started.


(2). Parameter of technical


SN

Item

Parameter

1

Conveying capacity

50-300kg/h

2

Binding volume

1.1L

3

Working pressure

0.4-0.6Mpa

4

Compressed air consumption

180NL/min


(3). Configuration list


Name

Qty

Mark

Vacuum generator

1 piece

China

304 stainless steel filter

4 pieces

China

Vacuum hopper (SUS304)

1 set

Hywell machinery

Compressed   air backflush system

1 set

1unit

China

Pneumatic parts

China

Control System

Circuit board

1 set

Hywell   machinery

Switching power supply

1 piece

China

Solenoid valve

1 piece

China

Suction   hose (Φ25)

Imported PU hose (food grade)

3 meters

China

Stainless steel suction nozzle   (Φ25)

1 piece

Hywell machinery




E: Granulation line for pharmaceutical solid dosage forms(dry granulator)



(1)  Main technical parameters


Item

Unit

Model

Production capacity

Kg/H

5-50

Motor power

kw

0.75

Speed

rpm

180-1440

Control speed mode

--

Frequency   conversion control speed

Screen aperture

mm

Φ1-8


(2). Application Overview


2.1. Dry and wet granulation homogenization and granulation.

2.2. Crushing and granulation of agglomerated materials.

2.3. Wet material granulation.

2.4. Crushing of heat-sensitive materials.



(3). Equipment features


3.1. Low heat and dust during operation.

3.2. The stator screen is made of stainless steel plate and is not easy to damage.

3.3. It can handle sticky, gummy, hot and wet materials.


(4). Configuration


Name

Materoals

Model

Mark

Main body

SUS304

δ=1.5mm

Hywell   Machinery

Hopper

SUS304

δ=2mm

Hywell   Machinery

Pelletizing knife

SUS304

δ=8

Hywell   Machinery

Screen

SUS304

Φ1-8   Specify any specification

Hywell   Machinery

Motor


0.75kw

Wanan

Inverter


0.75kw

China

Electrical components



Siemens


F. Granulation line for pharmaceutical solid dosage forms(hopper mixer)



(1). Technical Parameters


SN

Item

Unit

Model

1

Model

--

HF-30

2

Hopper capacity

L

30

3

Maximum working load

Kg

2-15

4

Filling factor


0.5-0.8

5

Working speed

r/min

3-25/   Adjustable

6

Motor power

Kw

0.55


(2). Overview


HS series laboratory hopper mixer is a type of hopper mixer. It is one of the equipment to complete the small-scale mixing process of solid dosage medicine production. It is mainly used for mixing solid particles and powders, particles and particles, powders and powders in the pharmaceutical industry. It is also suitable for the production process of powder materials in the food, fine chemical industry and other industries. It has the advantages of good mixing effect and no cross contamination and dust pollution.


(3). Product Features


1. The hopper can be removed and sent to the cleaning room for cleaning or sterilization in the sterilization room.

2. The mixing hopper and exposed surface of this machine are made of high-quality austenitic stainless steel 304, with a smooth and flat surface and no concave structure, which complies with the GMP regulations for pharmaceutical production.

3. The inverter speed regulation ensures stable and reliable operation.

4. The transmission system consists of a reducer with a brake motor, with a simple transmission chain and reliable braking.




(4). Functional description (button control system)


Function items

Description

Basic/Optional

Feeding

Manual   feed

The operator opens the mixing   hopper cover and manually adds materials

Basic

Mixing

Mixed speed control

Adjustable within (3~25) rpm range

Basic

Time setting

Can be set arbitrarily within (0~60) min

Basic

Rotation direction

Single direction rotation

Basic

Stage setting

Set speed mixing → rotation positioning

Basic

Discharging

Gravity   discharge

Place the material receiving container   under the discharging butterfly valve and open the butterfly valve for   gravity discharging.

Basic

Process   Automation





(5). Configuration list


Name

Model

Material

Original

Main unit

δ=1.5mm

Inner channel steel/outer SS304

Hywell

Hopper

30L

SS304

Hywell

Feed port


SS304

Hywell

Discharge port


Stainless   steel butterfly valve

Hywell

Electrical components

Touch   button


Chint

Matching motor

0.55kw


Wanan

Bottom of silo with wheels

∅50

Bracket   304/wheel polyurethane

China



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