SaintyCo HZD 1500 IBC Bin Blenders FAT Documents

SAINTYCO INTERNATIONAL GROUP
HZD1500 BIN BLENDER
Factory Acceptance Test (FAT) Protocol
Serial No: 170205
Year of Mfg: 2017.02

JN/JS/FAT-HZD1500
version：V01
Factory Acceptance Test Protocol for HZD1500 Bin Blender
Writer’s Signature
Your signature indicates that the preparation of this file (Edit/Revision) complies with the technical
standards of the equipment system, GMP requirements and industrial production techniques for bin
blender. It also fully reflects the necessary tasks that shall be completed during the qualification
procedure, and it can implement the FAT of the equipment.
Name Title Signature Date Company
Xinglan Pan Technician 20170107 SAINTYCO
Checker’s signature
Your signature indicates you have carefully read this document and have confirmed its exactness
and this document fully reflects the FAT tasks, and it can implement the FAT of the HZD1500 Bin
Blender.
Wenju Pei Technician 20170107 SAINTYCO
Approver’s signature
Your signature indicates that this preparation and the relative scope of this document comply with
the technical production standards and all the including files and information are sufficient and can
be applied directly.
Lei Zhang Technical Manager 20170110 SAINTYCO

JN/JS/FAT-HZD1500
version：V01
Content
Content...................................................................................................................................................................2
1. Purpose........................................................................................................................................................ 3
2. Responsibility...............................................................................................................................................3
2.1 Responsibility of SAINTYCO.................................................................................................................... 3
2.2 Responsibility of Wyeth............................................................................................................................. 3
3. Equipment description................................................................................................................................3
3.1 Nameplate....................................................................................................................................................3
3.2 Main function and technical application..................................................................................................4
3.3 Structural features...................................................................................................................................... 4
3.4 Main Technical parameters.......................................................................................................................6
4. Testing items and acceptable standard................................................................................................... 6
4.1 Precondition.................................................................................................................................................6
4.2 Qualification of equipment documents....................................................................................................8
4.3 Qualification of equipment appearance.................................................................................................. 7
4.4 Qualification of material and surface roughness...................................................................................8
4.5 Qualification of components list............................................................................................................... 9
4.6 Qualification of electric cabinet and wiring diagram...........................................................................10
4.7 Qualification of electric power transmission and signal transmission..............................................11
4.8 Lifting and clamping systems operation qualification.........................................................................12
4.9 Operation qualification of blending drive and braking system..........................................................13
4.10 Qualification of equipment safety protection system.......................................................................... 15
4.11 Qualification of touch screen and PLC functions.................................................................................16
4.12 Qualification of the software....................................................................................................................18
5 Qualification of the Personnel..................................................................................................................19
6 Deviation report..........................................................................................................................................20
7 Deviation list................................................................................................................................................27
8 Remark........................................................................................................................................................ 27
9 Attachment list............................................................................................................................................ 28
10 Check and approve................................................................................................................................... 29
11 Change control........................................................................................................................................... 24
Attachment: FAT summary report....................................................................................................................25

JN/JS/FAT-HZD1500
version：V01
1. Purpose
Factory Acceptance Test (FAT) protocol is to qualify whether the HZD1500 bin blender is in
accordance with design requirements and customer’s requirements. FAT will be executed by the
technical personnel before equipments leaving factory and the test result will be checked by the
customer.
2. Responsibility
2.1 Responsibility of SAINTYCO
 Compile and check the FAT protocol.
 Execute FAT test, record test result, check raw data.
 Dispose and resolve the deviation problem
 Provide the adjusted certificates for needed instruments.
 Compile and check the FAT report
2.2 Responsibility of Wyeth
 Approve the FAT protocol.
 Provide suggestions for the compile and execute of the FAT protocol.
 Dispatch personnel in the spot, check the test result and data
 Approve the FAT report
3. Equipment description
3.1 Nameplate
 NAME：Bin Blender
 MODEL：HZD1500
 POWER SUPPLY： 440V/60Hz
 SPEED： 3~15r/min
 RATED CAPACITY：1500L
 POWER： 10.5 kW
 WEIGHT：
 DATE ：
NO.：

JN/JS/FAT-HZD1500
version：V01
3.2 Main function and technical application
HZD1500 Bin Blender, it is mainly used in pharmaceutical industry for blending the solid dosage
process; it can automatically finish the lifting, clamping and falling. Moreover, it is rotating
according to the assigned craft parameter to finish mixing.
3.3 Structural features
Main parts
 Supporting column, Outsides Cover
 Rotary system: Gear-box, Electric and signal transmission device, Rotary Frame.
 Lifting system: Gear box for lifting, Right/left gear box, Lead screw nut, Lead pole, Cover
 Electric control system, Electric control box, Operation terminal, Sensor
 Safety measures, photoelectric isolation in mixing area, Alarm mark
3.4 Main Technical parameters see table B5-01
Table B5-01 Main Technical Parameters
Model HZD1500
Adaptive bin type LDZ1500 LDZ1000-1500 LDZ500-1500
Capacity L 1500 1000 500
Working load kg 750
Working speed r/min 3～15
Mixing time min 1～60
Mixing motor power kW 7.5
Lifting motor power kW 3
Testing items and acceptable standard
4.1 Precondition
Qualify carefully that this FAT protocol has been approved and the HZD1500 Bin Blender has been
checked by the Quality Control Department. Ensure that all the preconditions for the FAT have been
fulfilled. And then record the qualification results in the Tests Report TR01 and the deviations
occurred during the FAT process in the Deviations Report DR.

JN/JS/FAT-HZD1500
version：V01
TR01
Item
Preconditions
Preconditions Confirmed result
Qualify the FAT protocol has been approved □Y □N
Qualify HZD1500 bin blender, to have been inspected by
Inspection Dept
□Y □N
Needed documents(design drawings and design requirements)
available
□Y □N
Equipment parameters sheet
Series No. □Y □N
Overall dimension According to confirmed details □Y □N
Manufacturer Zhejiang SAINTYCO Technology
Limited
□Y □N
Remark:
Record the difference
Item Standard Confirmed result
Y N
Equipment No. HZD1500 □Y □N
Bin volume 1500L □Y □N
Charging coefficient 0.5~0.8 □Y □N
Working speed （3~15）r/min □Y □N
Mixing time 1~60min □Y □N
Mixing Motor power 7.5kW □Y □N
Hydraulic station motor power 3kW □Y □N
Power voltage AC440V±10% □Y □N
Power frequency 60Hz±0.5Hz □Y □N
Product contact material 316L □Y □N

JN/JS/FAT-HZD1500
version：V01
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.2 Qualification of equipment documents
Verify that the necessary reference documents for installation and commissioning, operation and
maintenance of the equipment are available. And then record the qualification results in the Tests
Report TR02 and the deviations occurred during the FAT process in the Deviations Report DR.
TR02
Document Name
Document content
Result
Y N N/A
Product Manual Structure features and working principle □Y □N □N/A
Installation and Debugging □Y □N □N/A
Equipment Operation □Y □N □N/A
Trouble shooting and analysis □Y □N □N/A
Maintenance □Y □N □N/A
Electrical diagram Main power □Y □N □N/A
AD/AC Power supply □Y □N □N/A
Cabinet DC power-supply distribution □Y □N □N/A
Operating panel connection □Y □N □N/A
PLC □Y □N □N/A
Motor control □Y □N □N/A
CPU 224XP input/output □Y □N □N/A
EM222 output □Y □N □N/A
Main control cabinet □Y □N □N/A
Operating panel □Y □N □N/A
Device tag list □Y □N □N/A
Terminal-connection diagram □Y □N □N/A
Diagrams Outline drawing □Y □N □N/A
Installation foundation diagram □Y □N □N/A
Yes/Y No/N
All the above documents are available and have been approved
Remark：

JN/JS/FAT-HZD1500
version：V01
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.3 Qualification of equipment appearance
Qualify the equipment appearance is all right and tidy without any crack. And then record the
qualification results in the Tests Report TR03 and the deviations occurred during the FAT process in
the Deviations Report DR.
TR03
Item
Standard
Confirmed result
Y N N/A
Cleanness The cover of whole machine is clean, without dirt and rust. □Y □N □N
/A
Support chassis No rust, no peeling off antirust paint □Y □N □N
/A
Sheet metal No sharp angle，flat, no concave-convex face and eyeable
damage
□Y □N □N
/A
Rotary frame Smooth connection ,no dead angle, no concave-convex ,no
scratch and crack and surface polish treatment
□Y □N □N
/A
料斗
Bin
Without crack, nick or damage, internal/external surfaces
polish treated, Rain≤0.2μm，Raout≤0.4μm
□Y □N □N
/A
Charging valve Open/close flexible, seal reliable. □Y □N □N
/A
Bin lid Open/close flexible, seal reliable. □Y □N □N
/A
Electric apparatus Install steadily and reliable □Y □N □N
/A
Wire and cable Connection reliable with no loosen □Y □N □N
/A
Operation panel The relative info. is clear. □Y □N □N
/A
Touch panel Interface of touch panel is clean without nick or spot □Y □N □N
/A
/Y /N
Completed, no crack, tidy.

JN/JS/FAT-HZD1500
version：V01
Remark：
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.4 Qualification of material and surface roughness
Check the relative certificates or material reports; qualify all the surfaces which contacts with the
products comply with GMP requirements. And then record the qualification results in the Tests
TR04
Item
Material Surface
Expectation Actual Expectation Actual
Contact parts Bin 316L Ra≤0.4μm
Butterfly valve 316L
Bin lid 316L
Other parts Post shell 304
Control box 304
/Y /N
All the materials accord with design requirements
Ra≤0.2μm Bin internal roughness Ra≤0.4μm
Ra≤0.4μm External roughness Ra≤0.4μm
Attached material certificates and roughness test report

JN/JS/FAT-HZD1500
version：V01
Remark：
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.5 Qualification of components list
Qualify the components list of the equipment in which the names, manufacturers, models and other
infos are included. And then record the qualification results in the Tests Report TR05 and the
deviations occurred during the FAT process in the Deviations Report DR.
TR05
Item
Manufacturer Item
Technical
parameter
Transformer Rebb BK-650VA 入 in440V/出 out220V
Printer Brother HL-2250N DC5V
Inverter Danfoss VLT2875PT4B20SBRODBEOO 7.5kW
Key switch Mean well NES-100-24
Safety fuse Mingrong RT18-32
Proximity switch ORMON E2E-X10MF1 DC24V
Middle relay OMRON MY2NJ DC24V/AC220V
AC contactor SCHNEIDER LC1D09M7C/ LC1D18M7C AC220V
Thermal relay SCHNEIDER LRD-10C/ LRD-05C 4-6A/0.63-1A
Breaker SCHNEIDER OSMC32N2C2/OSMC32N3D32
Travel switch SCHNEIDER XCJ-103
Emergency stop button SCHNEIDER EC9E-BV311NR
Key switch SCHNEIDER EC9E-S3K20N
Button base SCHNEIDER ZB2BZ102C/ ZB2 BZ101C
Touch screen SIEMENS 6AV2124-0MC01-0AX0 12” 寸
PLC SIEMENS 6ES7 214-2BD23-0XB8
Motor SIEMENS BEIDE YBEJ100L2-4P-3KW-B3 3kW
Reduction box SEW DFAFS67-17.4-B5Ⅱ
Reduction box SEW DK107-YBEJ7.5KW-4P-96.15-
B3B
7.5kW

JN/JS/FAT-HZD1500
version：V01
/Y /N
All equipment parts meet the design requirement.
Remark:
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.6 Qualification of electric cabinet and wiring diagram
Qualify the layout of control/electric cabinet, control/electric equipment and wiring diagram are
consistent with the installed equipment. And then record the qualification results in the Tests Report
TR06 and the deviations occurred during the FAT process in the Deviations Report DR.
TR06
Reference
Headline/No. Edition/date
Main power Main power Ver1
Control circuit Control circuit Ver1
PLC PLC Ver1
Terminal-connection diagram Terminal-connection diagram Ver1
/Y /N
Principle diagram should accord with setup ultimate state of electric cabinet
Layout and installation of the components should accord with layout
diagram.
Input, output connection and middle line should accord with wiring diagram.
The ultimate state of terminal should accord with terminal diagram.
Remark：

JN/JS/FAT-HZD1500
version：V01
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.7 Qualification of electric power transmission and signal transmission
Check whether the conditions of electric power transmission and signal transmission comply with
requirements. And then record the qualification results in the Tests Report TR07 and the deviations
occurred during the FAT process in the Deviations Report DR
TR07
Item
Contents
Confirmed result
/Y /N N/A
Lifting motor Input wire □Y □N □N/A
Number of wire accord with design diagram
Rotary motor Input wire □Y □N □N/A
Number of wire accord with design diagram
Operation control
component
Number of wire accord with design diagram □Y □N □N/A
PLC AC 220V power supply, input &output point, data transfer
cable matches power supply cable and controller, every
wiring connection points are consistent with wiring
diagram.
□Y □N □N/A
Touch panel Power supply of DC24V, displays data image.
Communication cables match touch panel and PLC.
Wirings connections comply with wirings diagram
□Y □N □N/A
/Y /N
Power transmission accord with power requirement
Signal transmission accord with design requirement
Remark：

JN/JS/FAT-HZD1500
version：V01
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.8 Lifting and clamping systems operation Qualification
Check operating conditions of the blender; qualify whether operations of lifting and clamping
systems comply with design requirements. And then record the qualification results in the Tests
TR08
Item
Standard
Results
Y N N/A
Lifting reducing
motor
Operating current is continuously stable; during the
clamping and loosening, the current value is not higher than
110% of the motor rated current ( ) A .
A A □N/A
Operating process without oil leakage or abnormal noise □Y □N □N/A
During 5 times continuously operating process, the rising
temperature of the middle of the motor cover is not more
than 35°C.
℃ ℃ □N/A
Direction: Clockwise □Y □N □N/A
Left/right gearbox No leakage and unusual noise □Y □N □N/A
Lead screw nut No leaking lubricant, no block during running process, no
unusual grating.
□Y □N □N/A
Lead pole No leaking lubricant, no block during running process, no
damage on the pole surface.
□Y □N □N/A
Bin lock When lifting , the bin fixed and no move. □Y □N □N/A
/Y /N
All item according with design
Remark：

JN/JS/FAT-HZD1500
version：V01
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.9 Operation qualification of blending drive and braking system
Qualify the blending drive and brake systems comply with design requirements. And then record
the qualification results in the Tests Report TR09 and the deviations occurred during the FAT
process in the Deviations Report DR.
TR09
Item
Standard
Test result
Y N N/A
Mixing motor Current is continuously steady, no current curve in mixing
process, current value should be lower than rated current
value of the motor （）110％A
A A □N/A
No leakage and unusual noise □Y □N □N/A
Operate continuously in 20 mins, rising temperature of the
middle of the gearbox cover is not more than 35℃
℃ ℃ □N/A
Mixing time Time deviation is lower than 5s □Y □N □N/A
Mixing speed
deviation is lower
than rated 2%
When rated speed is 3r/min, the actual speed □Y □N □N/A
When rated speed is 10 r/min, the actual speed □Y □N □N/A
When rated speed is 15r/min, the actual speed □Y □N □N/A
Braking test During the normally working ， braking is steady after
program auto. Finished.
□Y □N □N/A

JN/JS/FAT-HZD1500
version：V01
Rotary action immediately stops in the right position after
press emergency switch.
□Y □N □N/A
Stop position Rotary frame auto. Stop at the horizontal position. □Y □N □N/A
Bin lock When rotation, the bin is fixed and no move. □Y □N □N/A
/Y /N
All the above test items accord with design requirement.
Remark：
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd

JN/JS/FAT-HZD1500
version：V01
4.10 Qualification of equipment safety protection system
Check whether the safety alarm labels, emergency stop device, infrared ray isolation and sensors,
and microswitch comply with requirements. And then record the qualification results in the Tests
TR10
Item
Standard
Confirmed result
Y N N/A
Process safety 一、System earthing resistance ≤4Ω □Y □N □N/A
二、On working
1. Infrared safety isolating appliance works reliable.
2. Emergency stop button works reliable
3. Siren and alarm lamp respond on switching on the
system and function alteration.
□Y □N □N/A
三. Manual running lifting, falling reliable □Y □N □N/A
Bin orientation
sensor
Sensor is reliable. Line signal accords with design. □Y □N □N/A
Clamp in place
signal
Sensor is reliable. Line signal accords with design. □Y □N □N/A
Fall in place signal Sensor is reliable. Line signal accords with design. □Y □N □N/A
Earthing resistance System earthing resistance≤4Ω □Y □N □N/A
/Y /N
All the above test item accord with design requirement
Remark：

JN/JS/FAT-HZD1500
version：V01
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd
4.11 Qualification of touch screen and PLC functions
Qualify the correct menu of the touch screen, corrects operation reactions of touch buttons, correct
orders signals transmissions comply with program requirements; printing contents are consistent
with pre-confirmed contents (requirements for production process management). And then record
the qualification results in the Tests Report TR11 and the deviations occurred during the FAT
process in the Deviations Report DR.
TR11
Item
Standard
Confirmed result
Y N N/A
Touch
screen
Background
light
Turn on system, background light on. Turnoff
system, background light off.
□Y □N □N/A
Function test Touch selecting button，then the relative menu will
appear
□Y □N □N/A
PLC Functions
setting
Multilevel parameter control □Y □N □N/A
Manual and auto operation control mode □Y □N □N/A
Self diagnose and failure analysis □Y □N □N/A
History data check and print □Y □N □N/A
Operation
modes
Manual operation mode □Y □N □N/A
Auto operation mode
Printer content Clearly print printing time, medicine code,
medicine No., mixing time, mixing speed and
operation code.
□Y □N □N/A
Printing time After mixing finishes, auto. Print working data. □Y □N □N/A
/Y /N

JN/JS/FAT-HZD1500
version：V01
All the above test item accord with design
Attached with the original record of printing.
Remark：
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd

JN/JS/FAT-HZD1500
version：V01
4.12 Qualification of the software
Qualify the installation software for installation and backup has been provided. And then record the
qualification results in the Tests Report TR12 and the deviations occurred during the FAT process in
the Deviations Report DR.
TR12
Control software
Type of control
software
Edition/Date
Confirmed result
Y N
/Y /N
The installed applications have been marked correctly
Installed applications are consistent with backups
Remark：
Deviation recorded in deviation record
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd

JN/JS/FAT-HZD1500
version：V01
5 Qualification of the Personnel
Qualify all the personnel participating in the execution of this protocol. List personnel name,
signature, abbreviation, department/company and date in the Test Report TR13.
TR13
Department/company
Name Signature Abbreviation Date
/Y /N
All people participating in FAT has registered.
Remark：
Executed by: Date:
SAINTYCO yyyy/mm/dd
Reviewed by: Date:
Wyeth yyyy/mm/dd

JN/JS/FAT-HZD1500
version：V01
6 Deviation report
Record all the deviations occurred during the execution of the whole protocol in the Test Report
TR14.
Procedure □ FAT Deviation No.
Deviation description：
Effect for qualification result: □bigger □normal □ little □ less
Validated by: checked by:
Date:
Cause Analysis
Signature/date:
Corrective Action
Signature/date:
Corrective Action result
If deviation not solved or not accord with, check if it effect the final result
YES NO
Re-inspected by (Signature)： Check (Signature)：
Date：

JN/JS/FAT-HZD1500
version：V01
7 Deviations list
Record all the deviations occurred during the executed FAT and the solution date in TR15.
TR15
Deviation report
TR No.
Test report
Description
8 Remark
When the remark part of the test report hasn’t enough space for writing or new pages may needed,
Test Report TR16 can be used, if so, record the number and headline of the TR.
Test report TR NO. Title

JN/JS/FAT-HZD1500
version：V01
9 Attachment list
Record all the attachment, mark the page and related test report17
TR17
Attachment No.
Description Test report No.

JN/JS/FAT-HZD1500
version：V01
10 Check and approve
The FAT protocol becomes FAT report when the FAT protocol has been filled out with test records
and original datum. The FAT report is submitted to the customer (WYETH) for confirmation and
results must be filled in the TR18.
TR18 Checking and approval for the executing
Check the test result and original data. Come to the final conclusion about this FAT.
PASS FAIL
If there are unsolved deviation, please fill in the following item.
Qualify if these unsolved deviations may influence the ultimate conclusion of the FAT or not.
YES NO
NOTE:
Executed by : Date :
SAINTYCO yyyy/mm/dd
Reviewed by : Date :
Wyeth yyyy/mm/dd
Approved by : Date :
Wyeth yyyy/mm/dd

JN/JS/FAT-HZD1500
version：V01
11 Change control
Any modification to the equipment must be recorded in the TR19 and shall be checked and
approved by both parts, and then modified files should be archived
TR19
Modification No.
Modified contents Position in the dossier

JN/JS/FAT-HZD1500
version：V01
SAINTYCO International Group www.saintyco.com
Attachment：FAT summary report
(Factory Acceptance Test Summary Report )
1 purpose
Create FAT conclusion report of HZD1500 Bin blender, as the basis for SAINTYCO Technology to
supply HZD1500 Bin blender to Wyeth.
2 Range
The test report of HZD series Bin Blender, (leaving factory No._______ ） is produced by
SAINTYCO .
3 Summary
The FAT activities of the HZD Series Bin Blender have been executed according to the
pre-confirmed FAT protocol. Testing personnel has qualified all items according to the regulated
process of this protocol and provided records of the tested items. After checking and auditing of
testing processes, records and deviations report, qualify contents of this protocol have not been
modified during the implementation process, records are full and true and comply with protocol
requirements.
Serial No. HZD Series Bin Blender passed FAT after discussing by the validation
group.
4 Process and result summary
Content Description Page
TR01 Precondition
TR02 Equipment document Qualification
TR03 Equipment appearance Qualification
TR04 Material and surface check
TR05 Component list Qualification
TR06 Electric cabinet and wiring diagram Qualification
TR07 Connection for power transmission and signal transmission
TR08 Lifting and locking system operation qualification
TR09 Mixing driving and braking system Qualification
TR10 Safety protection system Qualification
TR11 Functions of the touch screen and PLC Qualification

JN/JS/FAT-HZD1500
version：V01
SAINTYCO International Group www.saintyco.com
TR12 Software installation qualification
TR13 Personnel Qualification
TR14 Deviation report
TR15 Deviation list
TR16 Remark
TR17 Attachments list
TR18 Checking and approval for the executing
TR19 Change control
Summary Pass the FAT of No._______________ bin blender.
Summarizing
person
Date
5 Validation conclusion and analysis
This FAT process meets the protocol requirement through reviewing and checking the FAT process
and content record. Record is actual and integrated without adding or deleting relative range.
By checking / auditing of the test process and test reports, after discussing, all the members of the
validation group, declare unanimously that FAT activities comply with protocol requirements; the
HZD Series Bin Blender, Serial No complies with design requirements and costumer’s
requirements.
Validation team major：
Validation team vice：
Date：
6 Signature list (omit)
7 Attachment
Test report (TR) total _______ pages.
Deviation report (DR) total ______ Share(s), ______ pages.

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