Validation document

FLP-1.5 FLUID-BED GRANULATOR COATER VALIDATION

PROJECT

FLP-1.5 FLUID-BED GRANULATOR COATER SOP

CIP SOP OF FLP-1.5 FLUID-BED GRANULATOR COATER

MAINTAIN SOP OF FLP-1.5 FLUID-BED GRANULATOR COATER

VALIDATION PROJECT OF FLP-1.5 FLUID-BED GRANULATOR
COATER
1.PREFACE

1.1Name: Validation project of FLP-1.5 FLUID-BID GRANULATOR COATER

1.2No:2015-060
1.3Form
department job signature date
Draft
Examine
Approval

1.4Members and duty

Name department job date

1.5 SUMMARY:
Put the powder material to be granulated into the fluid-bed granulator coater. The cold air is drawn
into the fluid bed through the pre filters and passes through the heating chamber behind the main
machine, heated to the desired temperature by the heater. The powder is fluidized in the fluid bed.
The adhesive for granulating is delivered to the nozzle by the liquid pump, which is sprayed to the
fluidized material after being sheared into droplets by air. The wetting powder grows by formation
of liquid bridges and then coalesce into larger agglomerate. The evaporating moisture is drawn out
by the fan.

The granulator is make up of inlet air filter，heater、main machine，fan、silencer、electric control

etc.

2.PURPOSE
With the test and the experiment in IQ, OQ and PQ, it is proved that the equipment have the
reliability and the importance in production and the granularity of particles produced by FLP-1.5
fluid-bed granulator coater conforms to the technological requirement.

2.1 Installation Qualification (IQ): Check and qualify that the installation of equipment is in
conformity with the design requirement and the information and document are in conformity with
the management of GMP.

2.2 Operation Qualification (OQ): Check and qualify that the operation of equipment is in
conformity with requirement about the design technical parameters.

2.3 Performance Qualification (PQ): Check and qualify that the production capability and rate of
acceptability conform to the requirements of the corresponding process.
3 data
Electrical heater 3KW
Power of fan 2.2KW
Voltage 380 V
Frequency 50 Hz
Phase 3p
4. IQ

4.1purpose
Check and qualify that the documents and attachments delivered with FLP-1.5 fluid-bed granulator
coater conforms to the requirements of application and management. Check and qualify that the
installation of FLP-1.5 fluid-bed granulator coater is in conformity with design requirement.
4.2 Qualification of Documents and Attachments
4.2.1 Qualification of Information and Attachments and Packaging Inspection
4.2.1.1 It is necessary to qualify the model and size of equipment, information, document, and
attachments delivered with equipment in accordance with packing lists of FLP-1.5 fluid-bed
granulator coater.
4.2.1.2 It is necessary to qualify that the operation range of equipment should be in conformity with
design requirement.
4.2.1.3 It is necessary to check, collect and keep the information and documents.
4.2.2 Confirm and check the results and record them in the following table and make the evaluation.
Conclusion
S/N Items Content and Request
pass√ failΧ
1 Model
FLP-1.5 fluid-bed granulator
2 Name
coater
3 No √
4 Application range √
5 Quantity √
6 Packing list √
7 Qualified certificate √
8 Operating instruction √
9 Material guarantee certificate √
10 Installment chart √
11 Electric principle and connection chart √
Instruction and quality certificate of
12 √
accessories
13 Spare parts list and quantity √
14 Attachments list and quantity √
Illustration of deviation and conclusion:

operator/time： rechecker/：time
4.3 IQ
4.3.1 It is necessary to check that installation location and space of equipment should meet to the
needs of production and be convenient for service and maintenance in accordance with the
installation drawings in the design of FLP-1.5 fluid-bed granulator coater
4.3.2 It is necessary to check that placement of equipment and material should conform to match and
satisfy the requirements in accordance with the installation drawings.
4.3.3 It is necessary to check the external power supply in accordance with the specifications of
FLP-1.5 fluid-bed granulator coater
4.3.4 It is necessary to check the material quality used for main parts in accordance with the
specifications of FLP-1.5 fluid-bed granulator coater
4.3.5 It is necessary to check the integrality and the others of equipment in accordance with the
appearance and drawings of FLP-1.5 fluid-bed granulator coater
4.3.6 Confirm and check the results and record them in the following table and make the evaluation.
Conclusion
S/N Items Content and Request Methods
pass√ failΧ
Production and
Proper space for production and According to design
1 Maintenance
service maintenance drawings
space
Overall Measuring with band
2
dimensions tape
Charging and discharging,
Direction of the
３ operation, material space should Visual check
machine
conform to process requirements.
material quality
Material SUS304（stainless Attached certificate of
４ outside Main
steel），contact surface Ra≤1.6µm Material Quality
machine
material quality
Material SUS304 （ stainless Attached certificate of
５ inside Main
steel）；inner surface: polished Material Quality
machine
Polishing, flatness, smoothness
Outside wall of
６ without dead area, cavity and gap, Visual check
equipment
and apparent damages.
Material: stainless steel, products Attached Certificate of
７ transfer trolley should conform to the relevant Quality and Certificate
state standards. of Qualification
Regular form, flatness, smoothness Visual check
８ Air tube and fastened connection Certificate of Material
without leakage. Quality
Contact material Polishing, flatness and smoothness
surface and without dead cleaning area. It is
９ Visual check
internal easy for the parts where it is
equipment required for washing to take apart.
Antistatic countermeasure. Shaking
１０ bag filter
rate no less than 80%
T of
１１ 180C~240C，RH：50%~65% With measuring
environment
１２ Air cleanness Cleanness grade: 104，differential With measuring
 pressure to normal production area:
≥4.9MPa
Auxiliary and Power supply, water supply,
１３ supporting compressed air supply and
facilities discharge devices
Safety protection Examining report of
１４ Accord with GB/T5226.1-96
area earthing the products
１５ Sealing material Silicon rubber with hygiene grade Certificate of Quality
In conformity with electric
１６ Control principle In accord with drawing
principle chart
No-load
Continuing idle operation for eight
１７ operation (idle
hours
operation)
Installation level
Longitudinal and latitudinal error Measuring with 0.5m
1８ for the whole
≤2mm/1000mm level gauge
machine
Clean in In conformity with requirements of
１９ Visual check
machine clean room
Illustration of deviation and conclusion:

operator/time： rechecker/：time

4.4 result

remarks Director /time

5. OQ
5.1 purpose
Check and test the technical parameters of equipment operation to qualify that FLP-1.5 fluid-bed
granulator coater be in conformity with requirement of the design technical parameters.
5.1.1 check before operation
Confirm and check the results and record them in the following table and make the evaluation.
Conclusion
S/N Inspection items before Operation
pass√ failΧ
Check that voltage of power supply is normal and check the
1
position of power switch before power on.
Check the external connection of earth wire and its contact. Earth
2
resistance ≤4Ω
3 Check that it is reliable in the operating state of meters and
 instruments
4 Idle operation is stable without fault and abnormal noise.
Conical spraying, homogeneous atomization without water
5
dropping.
6 Check that each of flanges is sealed.
7 Have complete auxiliary facilities including electricity, water, gas.
The installation of machine is in place and is aligned with
8 leveling. There is more than two-meter space around and above
the machine.
Illustration of deviation and conclusion:

operator/time： rechecker/：time
5.2 Qualification of Testing Meter and Instruments for Validation.
All testing meters and instruments used for validation should be qualified and the qualified results
should be recorded in the following table and their evaluations should be made.
Name of test The unit of
S/N Range of measure Term of validity Conclusion yes√ noΧ
equipment correction

Illustration of deviation and conclusion:

operator/time： rechecker/：time
5.3Items of Operation Qualification
·Qualification of operation for equipment
· Qualification of control program for equipment
· Qualification of safety6 performance for equipment
· Qualification of technical Index for equipment

5.3.1 Qualification of operation for equipment

Record the results of operation checked in the following table in accordance with the Operation
Instruction Manual and make the evaluation.
S/N Items Result : ok√no×
With the process condition of charging, discharging, particle
1 diameter, etc. the corresponding process shall be carried out under
the man’s control.
2 Stable operation without fault and abnormal noise.
No agglomeration and no blockage in nozzle. The air supply used
3
should be purified (1 x 104 grade purification)
Illustration of deviation and conclusion:

operator/time： rechecker/：time
5.3.2 Qualification of control program for equipment
Record the results of control program for equipment checked in the following table in accord with
the Operation Instruction Manual of FLP-1.5 fluid-bed granulator coater and make the evaluation.
S/N Items Result： ok√ no×
The manual action of control buttons in the motors and draught fans
1 should be correct. Each governing throttle plays the apparent action
for its performance without failure and out-of-control.
The indication on the operation panel is correct. The temperature
2 sensors set up in inlet and outlet air passage, and fluidization grain-
making room can be controlled and adjusted.
With power on, check the power-supply meter and voltmeter are in
3 good condition. Check that the display of air-inlet meter is correct
and set up the air0inlet temperature according to material process.
Illustration of deviation and conclusion:

operator/time： rechecker/：time

5.3.3 Qualification of safety performance for equipment

Record the results of safety performance for equipment checked in the following table in accord
with the Operation Instruction Manual of FLP-1.5 fluid-bed granulator coater and make the
evaluation.
S/N Qualification of Safety Performance Result： ok√ no×
1 When motor is overloaded, the machine shall stop operating
automatically and alarmed.
2 All electric apparatuses are safe and reliable and conform to the
requirements shown in GB/T5226.1-96 with flexible and correct
operation and equipped with earth devices and safety mark.
Illustration of deviation and conclusion:

operator/time： rechecker/：time
5.3.4 Qualification of Technical Index for Equipment
Record the results of Technical Index for equipment checked in the following table in accord with
the Operation Instruction Manual of Fluid-Bed Granulator Coater and make the evaluation.
Particle Yield
Purpose：Check and qualify that particle yield of Granulator、coater can satisfy the requirements of
production and design index.
Qualification of standard:10~65mesh/batch, particle 1.5 kg
Procedure：Select with screen for three times in accordance with the procedure qualified so as to
determine the stability of equipment.
Actual-measured
Times Qualified Standard Revolving Speed Revolving Speed of Average
Main Shaft
1
2
3
Illustration of deviation and conclusion:

operator/time： rechecker/：time
·Qualification of other technical index
S/N Items and requirements methods Result： pass√ fail×
1 Noise ( unload) ≤75db（A） Sound meter with GB/T3766
2 No noise and stable in no load Manual eyeballing
operation
3 No false signal in starting and Manual eyeballing
stopping
Illustration of deviation and conclusion:

operator/time： rechecker/：time

5.4 Qualification of operation conclusion

remarks Director/date

6.Qualification of Performance

6.1 Check and test the operation results of equipment, qualify that the production capability,
gathering rate, rate of acceptability of FLP-1.5 granulator coater shall be in conformity with the
corresponding technological requirements.
6.2 Items of Performance Qualification
•Safety of equipment in load operation
•Control correction of equipment in load operation
•Granulator、coater production capability of equipment in load operation
•Finished particle、coater yield of equipment in load operation
•Moisture content of finished particle of equipment in load operation
6.3 Qualification of Performance
6.3.1Safety of equipment in load operation
Under the load operation, check the safety performance of equipment in accordance with the items
qualified in 5.3.3 and Operation Instruction Manual of FLP-1.5 granulator coater and record the
results in the following table, and make the evaluation.

S/N Items Result: OK√ NO×

1 The fault shown in 5.3.3 is made artificially for successive
three times. All items are reached. The successful rate is
100%.
Illustration of deviation and conclusion:

operator/time： rechecker/：time
6.3.2Control correction of equipment in load operation
Under the load operation, record the results of control correction for equipment checked in the
following table in accord with the items qualified in 5.3.2 and Operation Instruction Manual of
fluid-bed Granulator coater, and make the evaluation.
S/N Items Result: OK√ NO×
The manual action of control buttons in the motors and draught fans
1 should be correct. Each regulating air flap plays the remarkable
action for its performance without failure and out-of-control.
The indication on the operation panel is correct. The temperature
2 sensors set up in inlet and outlet air way, and fluidization fluid
chamber can be controlled and adjusted.
With power on, check the power-supply meter and voltmeter are in
good condition. Check that the display of air-inlet meter is correct
3
and set up the inlet air temperature according to material process.
Check that each flange is sealed and connected parts are fastened.
Illustration of deviation and conclusion:

operator/time： rechecker/：time

6.3.3 Granulating production capability of equipment in load operation

Under the load operation, record the results of control correction for equipment checked in the
following table in accord with the items qualified in 5.3.2 and Operation Instruction Manual of
fluid-bed Granulator coater, and make the evaluation.

Qualification of purpose: Check and qualify that the capability of granulating shall satisfy the
requirements of production and design index.
Qualification of standard: ≤1.5 kg
Procedures of qualification:
1) Use particle material, name of material: starch;
2) Discharging granularity according to process: ____10_～65__mesh (In general, 40 mesh shall be
used for the range of 10~65 mesh);
3) The test shall be made in three batches with 0.5 h for each batch and the average value shall be
taken with the standard electronic weigh. The net weight of discharging material is respectively G1,
G2 and G3 in accordance with the standard operation regulations. .
4) Average production capability G = (G1+G2+G3)/1.5≥ qualified standard.
Net wt for Average value
Times granules(mesh) Test Time
each time blanking net weight
0.5h
Illustration of deviation and conclusion:

operator/time： rechecker/：time

6.3.4 Finished particle、coater yield of equipment in load operation

Under the load operation, record the results of finished particle yield for equipment checked in the
following table in accord with the requirement of the detailed process and Operation Instruction
Manual of fluid-bed Granulator coater, and make the evaluation..
Qualification of purpose: Check and qualify that finished particle yield shall satisfy the requirements of
production and design index.
Qualified standard: in conformity with the requirements of production, yield ≥80%;
Procedures of qualification:
1) Use particle material, name of material: ____
2) Discharging granularity according to process: ____mesh (In general, 100 mesh shall be used for
the range of 80~120 mesh);
3) Three batches of feeding material shall be taken with the standard electronic weigh, the net
weight of material G0;
4) The test shall be made for three batches in accordance with the standard operation regulations.
The material screened after crushing shall be taken with standard electronic weigh, the net weight of
material GK;
5) Yield of crushing materials = GK/ G0X100%≥80%
Material weight of
Net weight of Feeding Blank
Times each blanking Crashing yield = GK/ G0
material G0 granularity
GK
1
2
3
Illustration of deviation and conclusion:

operator/time： rechecker/：time

6.3.5 Finished particle moisture of equipment in load operation

Under the load operation, record the results of finished particle moisture for equipment checked in
the following table in accord with the requirement of the detailed process and Operation Instruction
Manual of fluid-bed Granulator coater, and make the evaluation..
Purpose: Check and qualify that the moisture content of finished particle shall satisfy the
requirements of production and design index.
Qualified standard: In conformity with the requirements of production, moisture content of finished
particle ≤2%
Procedures of qualification:
1)Use particle material, name of material: ____
2) Blanking granularity according to process: mesh of granularity max. ____10_ ～ 65__mesh and
mesh of granularity min. 65 mesh (The mesh of maximum and minimum can be chosen in the
range of 10~65 mesh);
3) The test shall be made in three batches. The moisture contentω in the material after drying shall
be measured with moisture content determinater.
4) qω≤2%
Times Times
1 1
2 2
3 3
Illustration of deviation and conclusion:

operator/time： rechecker/：time

6.3.6 Make the inspection in other aspects under the load operation of equipment.
Make the check in other field under the load operation of equipment and in accordance with the
requirements of the detailed process and Operation Instruction Manual of FLP-1.5 and record them in the
following table, and make the evaluation.
S/N Items and requirements methods Result: OK√ NO×
1 Effect of shaking cloth bag Manual
eyeballing
2 Cleaning, installing and taking apart: It Manual
is convenient to clean without dead area. eyeballing
It is easy to mount and dismount. And
also it is easy to dismount and clean
filtering bag .
3 Operation condition, control the power Manual
flying. eyeballing
Illustration of deviation and conclusion:

operator/time： rechecker/：time

6.4Qualification of performance conclusion

Remarks: Director/date
7. Evaluation of Results

7.1 After the above items are qualified and the tested conditions are identical with the accepted
standard, it means that this validation is finished successfully. It can bring into production after the

validation report is submitted to the quality control department with examination and approval.

7.2 Signature of Validation Group

Department Evaluation of Appraiser Date of Validation
Verified Results

7.3 Conclusion

Remarks: Director/date
8. Period of Validation

8.1 Validation shall be made when the main parts and components of equipment are replaced.
8.2 Verification shall be made at a time for every two years.
Standard Operation Regulations
Operation Procedure of FLP-1.5 Fluid-bed granulator coater

Edit: 2015 Effective Date: in 2015 No. :SOP

Issue Department:
Made by Examined by: QA Examination: Signature and Issue:
Date: Date: Date: Date:
Date of First Reexamination:
Examined Department: QA Examination: Sign and Issue:

1. Purpose: This regulation is set up for FLP-1.5 granulator coater.

2. Range: The procedure is suitable for operation of. FLP-1.5 granulator coater
3. Obligation:
1) The operators in post are responsible for the operation of the equipment.
2) Technologists and management persons of equipment are responsible for management and
supervision of operation of equipment.
4. Procedure
4.1 Purpose and performance
4.1.1 Purpose: This machine is suitable for powder material to granulator with spraying adhesive.
4.1.2 Performance
Electrical heater 3KW
Power of fan 2.2KW
Voltage 380V
Frequency 50Hz
Phase 3p
4.2 Structure and principle
4.2.1 Structure: This machine is made up of air filter, foundation, fluid-bed （exchange among the
three ） , spraying chamber, filter chamber, exhaust tube, draught fan, silencer, control cabinet,
adhesive, feeder, the magnetic-force stir etc.
4.2.1.1 Main machine: made up of bottom tower, fluid-bed, spraying chamber, filter chamber

The working room (fluidized bed, intermediate spraying chamber) is designed in upside-down-cone
form and becomes larger along the axial section area. It is beneficial to powder’s dropping and
avoids laminating. There is a little powder when granulating.
，it can keep even when coating.
4.2.1.2 Air filter: It is pre-filter.
4.2.1.3 It is composed of air exhaust pipe, draught fan and silencer. The draught fan is installed
separately from main machine with noise ≤75 db. The state of fluidization can be continuously
adjusted.
4.2.1.4 liquid-support system: it is made up the magnetic-force stir of and the pump. the adhesive
and coating-liquid are stirred so as to lower adhesive and improve the coating efficiency.
4.2.1.5 the "jimu" fluid bed: the FLP-1.5 model has the special features that the "jimu" fluid bed is
exchanged and all the parts are shared except the material-container. so the model is very suitable
for colleges and the development of new medicines.
4.2.1.6"top-spraying" fluid bed: the standardized material-container is used for drying and
granulating.
4.2.1.7"buttom-spraying" fluid bed: in the middle of the spring-style fluid bed there is leading-
direction pipe. the fluidization is regular. and it is suitable for coating with granules, powder.
4.2.1.8“Turbojet fluid-bed” The liquid-supporting pump transports the binder. And then sprayed into the
fluidization powder-material after being atomized through the nozzle. The powder gets together and grows up
after being dried. Finally the needed granules can be reached.

4.2.2 Principle：Put the powder material to be granulated into the fluid bed. The cold air is drawn
into the fluid bed through the pre, medium and final filters and passes through the heating chamber
behind the main machine, heated to the desired temperature by the heater. The powder is fluidized
in the fluid bed. The adhesive for granulating is delivered to the nozzle by the liquid pump, which is
sprayed to the fluidized material after being sheared into droplets by air. The wetting powder grows
by formation of liquid bridges and then coalesce into larger agglomerate or the film is made onto
material which is be coated. The evaporating moisture is drawn out by the fan.

4.3 Operation
4.3.1 Preparation before Operation
1) Power on and check that the power supply meter and voltmeter indicate well.
2) Check that the display of air-intake meter is correct and set up the inlet temperature according to
the material and process.
4.3.2 Starting Up
1）Feed the material in fluidized bed.
2) Start up the draught fan and adjust the air volume to the fluidized bed. Put the material container
in the bottom plate and make it contact the sensor.
3) Preheat the material. When it reaches the temperature of about 450C, start spraying liquid.
4) Regulate the spraying temperature and observe that cloth bag shakes normally.
4.3.3 Shutting Down
After operation, close down power supply and air supply.
4.3.4 Finishing Operation
1) Manually operate and shake the cloth bag.
2) Clean up the machine, discharge components such as fluidized screen plate and cloth bag and
clean them up. It should be required to clean the granulating chamber 、 tangential spraying
granulating coating bed and bottom spraying coating bed and dry the chamber with clear air or dry
naturally.
3)Clean up the outside of machine and the site of production and recover it in ready state.
4.3.5 Safety Operation
1) Make the thorough inspection for materials and the machine and check that all parts are fastened.
2) Check them before operation.
3) If there is the abnormal noise in machine, it should be shut down for check. The machine is not
started again until solved.
Cleaning Operation Regulations
Operation procedure of cleaning for FLP –1.5Fluid-bed granulator coater

Edit: 2015 Effective Date: in 2015 No. :SOP

Issue Department:
Made by Examined by: QA Examination: Sign and Issue:
Date: Date: Date: Date:
Date of First Reexamination:
Examined Department: QA Examination: Sign and Issue:
1、Purpose: This regulation is set up for cleaning operations of FLP-1.5 granulator、coater.
2、Range: The procedure is suitable for cleaning and antisepsis of FLP-1.5 granulator、coater
3、Obligation:
1)The operators in post are responsible for the operation of the equipment.
2)Technologists and management persons of equipment are responsible for management and
supervision of operation of equipment.
4、Procedures:
4.1 Condition and Frequency of Cleaning
4..1.1 It is necessary to make normal cleaning in changing batch number in same sort of products.
4.1.2 It is necessary to make thorough cleaning in changing the sort of products, i.e. after the
production of the original sort of products is finished.
4.1.3 The cleaning result shall be evaluated for normal cleaning and the sterilizing result shall be
evaluated for thorough cleaning. The thorough cleaning includes the normal cleaning.
4.2 Tools, Cleaning Agent and Sterilizing Agent
Special aspirator, water breaker, brush, non-woven fabric (without fur), cleaning agent, 75% alcohol
4.3 Cleaning Method
4.3.1 Remove hopper, discharge collect bag from barrel and ensure that there is not any residents in
container before cleaning and rinsing.
4.3.2 Rinse inside and outside of machine with warm water of high-pressure water gun and ensure to
rinse the barrel cover and discharging valve.
4.3.3 Push in the material hopper and seal the container.
4.3.4 Clean for 10 minutes after starting machine and draw out the water (if there is oil dirt, clean
with alkaline water)
4.3.5 Rinse the inner wall of granulating、、coater container with warm water again.
4.3.6 Remove material hopper trolley, dry with air and dry machine with gauze. Finally, clean the
above-mentioned places with ionic water until no residents of cleaning agent exist.
4.4 Sterilizing Method:
4.4.1 Clean all the parts discharged from machine with 75% alcohol.
4.4.2 Resemble all parts in machine. Clean the parts and working table surface contacted with
material with 75% alcohol after the trial-operation is qualified.
4.5 Drying Method:
4.5.1 Drying method with natural air.
4.6 Evaluation of Cleaning Result
4.6.1 No unclean scale exists after brushing with clean white silk.
4.6.2 Test the PH value in water after rinsing with pure water. The water shows neutrality.
4.7 Evaluation of Sterilizing effect.
4.7.1 Allow the residents conforming to the technological requirements with rinsing sampling
analysis method.
Standard Operation Regulations
Regulations of Maintenance and Repair for FLP-1.5 granulator coater

Edit: 2015 Effective Date: in 2015 No. :SOP

Issue Department:
Made by Examined by: QA Examination: Signature and Issue:
Date: Date: Date: Date:
Date of First Reexamination:
Examined Department: QA Examination: Signature and Issue:
1. Purpose: This regulation is set up for FLP-1.5 granulator coater.
2. Range: The procedure is suitable for maintenance and repair for FLP-1.5 granulator coater
3. Obligation:
1) The operators in post are responsible for the operation of the equipment.
2) Technologists and management persons of equipment are responsible for management and
supervisory of operation of equipment.
4. Procedures
4.1 Service Maintenance interval
4.1.1 Category of Service Maintenance
It includes minor overhaul, major overhaul and maintenance.
4.1.2 Intervals of Service Maintenance
Category Minor Overhaul Major Overhaul Maintenance
Intervals (h) 500 4750~5000 Daily
4.2 Contents of Service Maintenance
4.2.1 Minor Overhaul
4.2.1.1 Check cloth bag filter. Make routine shaking and keep the operation according to the ash
collection.
4.2.1.2 Check that there is not any broken opening in filtering bag. If a small hole exists, it should
be repaired or the filtering bag should be replaced.
4.2.1.3 Check the opening of spray nozzle and spray nozzle can open and close flexibly and
reliably.
4.2.1.4 Check that there are not blockages in spray nozzle and remove the blockages.
4.2.1.5 Make troubleshooting according to the actual errors.
4.2.2 Major Overhaul
4.2.2.1 It includes the contents shown in minor overhaul.
4.2.2.2 Air-intake Filter
The blockage of filter shall result in inadequate air flow and bring about abnormal drying operation.
The filter should be cleaned or replaced for every 2 ~ 3 months.
4.2.2.3 Check that the heater does not leak.
4.2.2.4 Check that fan and bearing are not worn out.
4.2.2.5 Check all the pneumatic parts.
4.2.2.6 Check and repair the electric control circuits.
4.2.2.7 Assembly, readjustment and trial-operation
4.3 Preparation before Overhaul
4.3.1 Technical Preparation
4.3.1.1 Information and document including the instruction of products, drawings, technical
standards.
4.3.1.2 Know the technical conditions including location, times of failure and the operation in FLP-
1.5 granulator coater.
4.3.1.3 Make the actual measurement and record the production capability, homogeneity，coater of
particle and rate of acceptability.
4.3.1.4 Drawing up Overhaul Plan
4.3.2 Preparation of Material
4.3.2.1 Spare parts for replacement and materials for overhauling
4.3.2.2 Tools and measuring instruments for dismounting and mounting.
4.3.3 Preparation of Safety and Technology.
4.3.3.1 Sterilize the parts for replacement, tools, meters and materials for service maintenance
before bringing in the site.
4.3.3.2 Remove all powder, dust, ash and impurities on equipment and in field.
4.3.3.3 Cut off the power supply and hang the warning sign with “No Permission to Start Up”
4.3.3.4 Repairmen should put on the cleaning clothes conforming to the cleaning requirements in
the production site.
4.4 Overhaul Method
4.4.1 Discharge
Granulating coater chamber
1) Remove the trolley
2)Take apart spray gun, sampling tube, screening net, etc.
4.4.1.2 Inlet-air system
1) Take apart the filters in primary, intermediate and high efficiency.
2) Take apart heating system, etc
4.4.1.3 Shaking bag filter
Take apart cloth bag frame, cloth bag, air cylinder, etc.
Regulations of Maintenance and Repair for FLP-1.5 granulator coater.
Edit: 2015 edition Effective Date: in 2015 No.: SOP
4.4.1.4 Take apart air-outlet door and pipes.
4.4.1.5 Take apart fan and silencer.
4.4.2 assembly
Assembly the above-mentioned parts and components according to the reverting orders.
4.5 Quality Standard of Overhaul
4.5.1 After trolley is reset, top and bottom flanges are aligned and sealed.
4.5.2 After spray gun, sampling tube and screening net are reset, there are not any leakages.
4.5.3 After assembling filters in primary, intermediate and high efficiency, there is not short circuit.
4.5.4 After assembling heater, there is not leakage.
4.5.5 After assembling the granulating coater chamber, it is ensured that there are leakages and
vibration in flap, pipes, fan. When the granulator operates. There are not abnormal noise and drags.
After assembling cloth bag, cloth bag frame and cylinder, they operate normally without leakages.
4.6 Trial-operation and Acceptance.
4.6.1 Preparation before Trial-Operation
4.6.1.1 Check that all driving parts are flexible and no metal impurities exist in
4.6.1.2 Lubricate in all lubrication points
4.6.1.3 The movement of each part is in cooperation and correction.
4.6.2 Trial-Operation
4.6.2.1 No-load Trial-Operation
1) Trial operation without load for no less than two hours
2) All parts operate normally without abnormal noise. .
3) Check that all parts and components which should conform to the requirements shown in 4.5.4 ~
4.5.5
4.6.2.2 Load Trial-Operation
1) Adjust the process and make trial operation with load for 48 hours.
2）The production capability of equipment should be in conformity with design requirements.
3）The noise of the whole equipment does not exceed 75db（A）
4）The yield of finished particle ≥85%
5）Final moisture content of product ≤2%
4.6.3 Acceptance
4.7 Maintenance and Troubleshooting
4.7.1 Maintenance
4.7.1.1 Make the daily inspection for equipment and made the record of operation.
4.7.1.2 Keep the equipment clean, parts be complete, fasteners be fastened. In general, after 100h
operation, all fasteners should be checked again. If they are loosen, it is necessary to fasten them
timely.
Standard Operation Regulations
Regulations of Maintenance and Repair for FLP-1.5 granulator coater
Edit: 2015 edition Effective Date: in 2015 No.: SOP
4.7.1.3 During period of operation, it is prohibited to make any readjustment, cleaning and
inspection.
4.7.1.4 The machine and electric equipment should be well earthed.
4.7.1.5 When the granulating chamber is cleaned, it should be careful to prevent clear water from
affecting the motor and control cabinet.
4.7.1.6 Make routine inspection.
4.7.1.7 Make routine inspection.
4.7.1.8 Lubricate the lubrication points according to the regulations before starting and operation.
4.7.1.9 When it operates for a certain time, powder and ash should be removed with “Manual” on
and the cloth bag should be cleaned or replaced for a certain time. .
4.7.2Trentment of common trouble
Common trouble Possible reason Methods to solve
（ 1 ） ． Filter no shaking for a long
（ 1 ） ． Check filter bag, shaking
time. much powder is adhered in the
it.
1、The state of fluid-bed is cloth bag
no good. （ 2 ） ． Fluidization height is too
（2）turn down the flap. Shake the
excessive, the negative pressure is high
filter bag.
in bed
（1）．Check that there is not any
broken opening in filter bag, if a
（1）．Filter bag cracking small bole exists, it should be
2 ． There is much fine
repaired or the filter bag should be
powder in exhaust air
replaced.
（ 2 ）． Negative pressure is too high
（2）．Regulate the flap
to exhaust fine powder.
（ 1 ） ． Lower the degree of
humidity of particles. （2）do
（ 1 ） ． The moisture of particles is not put enough wet particles
too high. first, put them after drying
slightly
（1）．The wet particles does not
be putted in too long ．
3 ． There is much gap and
（ 2 ） ． before starting,
dead area in fluid-bed. （ 2 ） ． Wet particle is out of time in the manual action of flap
container. to open and close should
be done for several times,
note the rhythm of
cylinder strong movement
in fluid-bed , shake the
particles, avoid the gap.
（ 1 ） ． Some wet particles are （1）．Methods as（3）．（2）
4．There is the phenomena disabled in container. （2）
of blocked in fluid-bed.
（ 2 ） ． Operation of filter bag is too （ 2 ） ． Regulate period of filter
long. bag
（1 ）．Check the opening of nozzle, （ 1 ） ． Check whether nozzle is
there is the phenomena of trickle. sensitive and reliable
（ 2 ）． Pressure of compressed air is （ 1 ） ． Regulate atomization
lower. pressure（2）．Reduce the voltage
5 、 particles are not even of pump, turn down the liquid flow.
during the granulating. （1）．Check nozzle, remove the
（3）．There are masses in nozzle.
blockages in nozzle
（4）outlet of nozzle is no proper for （ 1 ） regulate the atomization
atomization angle. angle of nozzle
（ 1 ） 、 air flow is not enough, （1）enlarge the flap
fluidization is slow.
6、it is easy to agglomerate （2）、liquid feeding is too fast during （ 2 ） lower revolving speed of
and adhere when coating. the granulating. pump
（ 3 ） inadequate air flow in central （ 3 ） lower the height of central
barrel. barrel