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：V01Factory Acceptance Test Protocol for HZD1500 Bin Blender


Writer’s SignatureYour signature indicates that the preparation of this file (Edit/Revision) complies with the technicalstandards of the equipment system, GMP requirements and industrial production techniques for binblender. It also fully reflects the necessary tasks that shall be completed during the qualificationprocedure, and it can implement the FAT of the equipment.

Name Title Signature Date Company

Xinglan Pan Technician 20170107 SAINTYCO

Checker’s signatureYour signature indicates you have carefully read this document and have confirmed its exactnessand this document fully reflects the FAT tasks, and it can implement the FAT of the HZD1500 BinBlender.


Wenju Pei Technician 20170107 SAINTYCO

Approver’s signatureYour signature indicates that this preparation and the relative scope of this document comply withthe technical production standards and all the including files and information are sufficient and canbe applied directly.


Lei Zhang Technical Manager 20170110 SAINTYCO

JN/JS/FAT-HZD1500



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



1. PurposeFactory Acceptance Test (FAT) protocol is to qualify whether the HZD1500 bin blender is inaccordance with design requirements and customer’s requirements. FAT will be executed by thetechnical personnel before equipments leaving factory and the test result will be checked by thecustomer.

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



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 beenchecked by the Quality Control Department. Ensure that all the preconditions for the FAT have beenfulfilled. And then record the qualification results in the Tests Report TR01 and the deviationsoccurred during the FAT process in the Deviations Report DR.

JN/JS/FAT-HZD1500



TR01Item Preconditions

Preconditions Confirmed result

Qualify the FAT protocol has been approved □Y □N

Qualify HZD1500 bin blender, to have been inspected byInspection Dept

□Y □N

Needed documents(design drawings and design requirements)available

□Y □N

Equipment parameters sheet

Series No. □Y □NOverall dimension According to confirmed details □Y □NManufacturer Zhejiang SAINTYCO Technology

Limited□Y □N

Remark:

Record the difference

Item Standard Confirmed resultY 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



Executed by: Date:SAINTYCO yyyy/mm/dd

Reviewed by: Date:Wyeth yyyy/mm/dd

4.2 Qualification of equipment documentsVerify that the necessary reference documents for installation and commissioning, operation andmaintenance of the equipment are available. And then record the qualification results in the TestsReport TR02 and the deviations occurred during the FAT process in the Deviations Report DR.

TR02Document Name Document content Result

Y N N/A

Product Manual Structure features and working principle □Y □N □N/AInstallation and Debugging □Y □N □N/A

Equipment Operation □Y □N □N/ATrouble shooting and analysis □Y □N □N/A

Maintenance □Y □N □N/AElectrical diagram Main power □Y □N □N/A

AD/AC Power supply □Y □N □N/ACabinet DC power-supply distribution □Y □N □N/A

Operating panel connection □Y □N □N/APLC □Y □N □N/A

Motor control □Y □N □N/ACPU 224XP input/output □Y □N □N/A

EM222 output □Y □N □N/AMain control cabinet □Y □N □N/AOperating panel □Y □N □N/ADevice tag list □Y □N □N/A

Terminal-connection diagram □Y □N □N/ADiagrams 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






4.3 Qualification of equipment appearance

Qualify the equipment appearance is all right and tidy without any crack. And then record thequalification results in the Tests Report TR03 and the deviations occurred during the FAT process inthe Deviations Report DR.

TR03Item Standard

Confirmed resultY 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 eyeabledamage

□Y □N □N/A

Rotary frame Smooth connection ,no dead angle, no concave-convex ,noscratch and crack and surface polish treatment

□Y □N □N/A

料斗

BinWithout crack, nick or damage, internal/external surfacespolish 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



Remark：




4.4 Qualification of material and surface roughnessCheck the relative certificates or material reports; qualify all the surfaces which contacts with theproducts comply with GMP requirements. And then record the qualification results in the TestsReport TR04 and the deviations occurred during the FAT process in the Deviations Report DR.

TR04

Item

Material SurfaceExpectation 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



Remark：




4.5 Qualification of components list

Qualify the components list of the equipment in which the names, manufacturers, models and otherinfos are included. And then record the qualification results in the Tests Report TR05 and thedeviations occurred during the FAT process in the Deviations Report DR.

TR05Item Manufacturer Item Technical

parameterTransformer Rebb BK-650VA 入 in440V/出 out220V

Printer Brother HL-2250N DC5VInverter Danfoss VLT2875PT4B20SBRODBEOO 7.5kW

Key switch Mean well NES-100-24Safety fuse Mingrong RT18-32

Proximity switch ORMON E2E-X10MF1 DC24VMiddle relay OMRON MY2NJ DC24V/AC220VAC contactor SCHNEIDER LC1D09M7C/ LC1D18M7C AC220VThermal relay SCHNEIDER LRD-10C/ LRD-05C 4-6A/0.63-1A

Breaker SCHNEIDER OSMC32N2C2/OSMC32N3D32Travel switch SCHNEIDER XCJ-103

Emergency stop button SCHNEIDER EC9E-BV311NRKey switch SCHNEIDER EC9E-S3K20NButton base SCHNEIDER ZB2BZ102C/ ZB2 BZ101CTouch screen SIEMENS 6AV2124-0MC01-0AX0 12” 寸

PLC SIEMENS 6ES7 214-2BD23-0XB8Motor SIEMENS BEIDE YBEJ100L2-4P-3KW-B3 3kW

Reduction box SEW DFAFS67-17.4-B5ⅡReduction box SEW DK107-YBEJ7.5KW-4P-96.15-

B3B7.5kW

JN/JS/FAT-HZD1500



/Y /N

All equipment parts meet the design requirement.

Remark:




4.6 Qualification of electric cabinet and wiring diagramQualify the layout of control/electric cabinet, control/electric equipment and wiring diagram areconsistent with the installed equipment. And then record the qualification results in the Tests ReportTR06 and the deviations occurred during the FAT process in the Deviations Report DR.

TR06Reference 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 /NPrinciple diagram should accord with setup ultimate state of electric cabinet

Layout and installation of the components should accord with layoutdiagram.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





4.7 Qualification of electric power transmission and signal transmission

Check whether the conditions of electric power transmission and signal transmission comply withrequirements. And then record the qualification results in the Tests Report TR07 and the deviationsoccurred during the FAT process in the Deviations Report DR

TR07Item

ContentsConfirmed 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 controlcomponent

Number of wire accord with design diagram □Y □N □N/A

PLC AC 220V power supply, input &output point, data transfercable matches power supply cable and controller, everywiring connection points are consistent with wiringdiagram.

□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 requirementSignal transmission accord with design requirement

Remark：


JN/JS/FAT-HZD1500





4.8 Lifting and clamping systems operation Qualification

Check operating conditions of the blender; qualify whether operations of lifting and clampingsystems comply with design requirements. And then record the qualification results in the TestsReport TR08 and the deviations occurred during the FAT process in the Deviations Report DR.

TR08

ItemStandard

Results

Y N N/A

Lifting reducingmotor

Operating current is continuously stable; during theclamping and loosening, the current value is not higher than110% 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 risingtemperature of the middle of the motor cover is not morethan 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, nounusual grating.

□Y □N □N/A

Lead pole No leaking lubricant, no block during running process, nodamage 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






4.9 Operation qualification of blending drive and braking system

Qualify the blending drive and brake systems comply with design requirements. And then recordthe qualification results in the Tests Report TR09 and the deviations occurred during the FATprocess in the Deviations Report DR.

TR09

ItemStandard

Test result

Y N N/A

Mixing motor Current is continuously steady, no current curve in mixingprocess, current value should be lower than rated currentvalue of the motor （）110％A

A A □N/A

No leakage and unusual noise □Y □N □N/AOperate 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 speeddeviation is lowerthan 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 afterprogram auto. Finished.

□Y □N □N/A

JN/JS/FAT-HZD1500



Rotary action immediately stops in the right position afterpress emergency switch.

□Y □N □N/A

Stop position Rotary frame auto. Stop at the horizontal position. □Y □N □N/ABin 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：




JN/JS/FAT-HZD1500



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 TestsReport TR10 and the deviations occurred during the FAT process in the Deviations Report DR.

TR10

ItemStandard

Confirmed result

Y N N/A

Process safety 一、System earthing resistance ≤4Ω □Y □N □N/A

二、On working1. Infrared safety isolating appliance works reliable.2. Emergency stop button works reliable3. Siren and alarm lamp respond on switching on thesystem and function alteration.

□Y □N □N/A

三. Manual running lifting, falling reliable □Y □N □N/A

Bin orientationsensor

Sensor is reliable. Line signal accords with design. □Y □N □N/A

Clamp in placesignal

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






4.11 Qualification of touch screen and PLC functionsQualify the correct menu of the touch screen, corrects operation reactions of touch buttons, correctorders signals transmissions comply with program requirements; printing contents are consistentwith pre-confirmed contents (requirements for production process management). And then recordthe qualification results in the Tests Report TR11 and the deviations occurred during the FATprocess in the Deviations Report DR.

TR11Item Standard

Confirmed result

Y N N/A

Touchscreen

Backgroundlight

Turn on system, background light on. Turnoffsystem, background light off.

□Y □N □N/A

Function test Touch selecting button，then the relative menu willappear

□Y □N □N/A

PLC Functionssetting

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

Operationmodes

Manual operation mode □Y □N □N/A

Auto operation mode

Printer content Clearly print printing time, medicine code,medicine No., mixing time, mixing speed andoperation code.

□Y □N □N/A

Printing time After mixing finishes, auto. Print working data. □Y □N □N/A

/Y /N

JN/JS/FAT-HZD1500



All the above test item accord with design

Attached with the original record of printing.

Remark：




JN/JS/FAT-HZD1500



4.12 Qualification of the software

Qualify the installation software for installation and backup has been provided. And then record thequalification results in the Tests Report TR12 and the deviations occurred during the FAT process inthe Deviations Report DR.

TR12Control software

Type of controlsoftware 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



JN/JS/FAT-HZD1500



5 Qualification of the PersonnelQualify all the personnel participating in the execution of this protocol. List personnel name,signature, abbreviation, department/company and date in the Test Report TR13.

TR13Department/company Name Signature Abbreviation Date

/Y /N

All people participating in FAT has registered.

Remark：




JN/JS/FAT-HZD1500



6 Deviation reportRecord all the deviations occurred during the execution of the whole protocol in the Test ReportTR14.

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



7 Deviations listRecord all the deviations occurred during the executed FAT and the solution date in TR15.

TR15Deviation report

TR No.Test report Description

8 RemarkWhen 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



9 Attachment listRecord all the attachment, mark the page and related test report17

TR17Attachment No. Description Test report No.

JN/JS/FAT-HZD1500



10 Check and approveThe FAT protocol becomes FAT report when the FAT protocol has been filled out with test recordsand original datum. The FAT report is submitted to the customer (WYETH) for confirmation andresults 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 NONOTE:

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



11 Change controlAny modification to the equipment must be recorded in the TR19 and shall be checked andapproved by both parts, and then modified files should be archived

TR19Modification No.

Modified contents Position in the dossier

JN/JS/FAT-HZD1500

version：V01

Factory Acceptance Test Protocol for HZD1500 Bin Blender

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 tosupply HZD1500 Bin blender to Wyeth.

2 Range

The test report of HZD series Bin Blender, (leaving factory No._______ ） is produced bySAINTYCO .

3 Summary

The FAT activities of the HZD Series Bin Blender have been executed according to thepre-confirmed FAT protocol. Testing personnel has qualified all items according to the regulatedprocess of this protocol and provided records of the tested items. After checking and auditing oftesting processes, records and deviations report, qualify contents of this protocol have not beenmodified during the implementation process, records are full and true and comply with protocolrequirements.

Serial No. HZD Series Bin Blender passed FAT after discussing by the validationgroup.

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

Factory Acceptance Test Protocol for HZD1500 Bin Blender

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.

Summarizingperson Date

5 Validation conclusion and analysis

This FAT process meets the protocol requirement through reviewing and checking the FAT processand 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 thevalidation group, declare unanimously that FAT activities comply with protocol requirements; theHZD Series Bin Blender, Serial No complies with design requirements and costumer’srequirements.

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.

saintyco hzd 1500 ibc bin blenders fat documents

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