HZD 1500 IBC Bin Blender IQ Documents -SaintyCo

Qualification _Documentation for

HZD1500 PART1:General Part

Installation Qualification (GP- IQ )

Equipment:HZD1500 Bin Blender

Machine Serial No.: 140205

HZD1500 Bin BlenderInstallation Qualification

Prospective Validation

Installation Qualification Protocol for HZD1500 Bin Blender

JN/JS/IQ-HZD1500

version：V01

SAINTYCO INTERNATIONAL GROUP

Writer’s signatureYour signature indicates that the preparation of this file (Edit/Revision) complies with the validationproject of the equipment, installation requirements of GMP and GEP for bin blender. It also fullyreflects the necessary tasks that shall be completed during the validation procedure, and it canimplement the Installation Validation of the HZD1500 Bin Blender.

Name Title Name Date Unit

Checker’s signature

Your signature indicates you have carefully read this document and have confirmed its exactness andthis document fully reflects the validation tasks, and it can implement the Installation Validation of theHZD1500 Bin Blender.


Approver’s signature

Your signature indicates that this document complies with the general plan of enterprise validation, thetechnical production standards and all the including files and information are sufficient and can bedirectly applied. After the approval, any modification or correction to the aim of this document or to thevalidation standard must be done in improving this document, and before the execution of themodified/corrected document, it must be approved.


0


JN/JS/IQ-HZD1500

version：V01


Table of contents

TABLE OF CONTENTS.................................................................................................................................................2

1 PURPOSE.............................................................................................................................................................4

2 VALIDATION SCOPE.............................................................................................................................................4

3 PROTOCOL CHECKING.........................................................................................................................................4

4 ORGANIZATION AND RESPONSIBILITIES............................................................................................................. 4

SYSTEM DESCRIPTION

6 VALIDATION PROCEDURES AND RECORDS.........................................................................................................7

6.1 DOCUMENTS QUALIFICATION................................................................................................................................7

6.2 QUALIFICATION OF THE KEY MATERIAL................................................................................................................8

6.3 （N/A）QUALIFICATION OF CALIBRATION OF INSTRUMENTS AND METERS (N/A)............................................8

6.4 QUALIFICATION OF SYSTEM LUBRICATION...........................................................................................................9

6.5 QUALIFICATION OF EQUIPMENT INSTALLATION POSITION AND ROOM.............................................................. 9

6.6 QUALIFICATION OF THE INSTALLATION OF UTILITY SERVICES......................................................................... 10

6.7 QUALIFICATION OF THE CORRECT CONNECTION FOR POWER TRANSMISSION AND SIGNAL TRANSMISSION10

6.8 QUALIFICATION OF TESTS OF THE PLC I/O......................................................................................................11

6.9 INSTALLATION QUALIFICATION OF THE SOFTWARE...........................................................................................11

6.10 QUALIFICATION OF THE MAIN COMPONENTS OF THE BLENDER....................................................................11

6.11 SAFETY MEASURES........................................................................................................................................... 12

6.12 QUALIFICATION OF THE EQUIPMENT APPEARANCE....................................................................................... 12

6.13 ATTACHED PAGE OF THE RECORD...................................................................................................................13

7 DEVIATIONS....................................................................................................................................................... 13

7.1 DEVIATIONS LIST............................................................................................................................................13

7.2 DEVIATIONS REPORT..................................................................................................................................... 13

8 ATTACHMENTS LIST............................................................................................................................................13

9 REPORT....................................................................................................................................................................13

10 CHECKING AND APPROVAL.............................................................................................................................14

11 ALTERATION CONTROL.................................................................................................................................... 14


JN/JS/IQ-HZD1500

version：V01


RECOURD:

DOCUMENTS QUALIFICATION........................................................................................................................................15

QUALIFICATION OF KEY MATERIAL............................................................................................................................... 17

QUALIFICATION OF CALIBRATION OF INSTRUMENTS AND METERS............................................................................18

QUALIFICATION OF SYSTEM LUBRICATION...................................................................................................................19

QUALIFICATION OF THE INSTALLATION POSITION AND ROOM OF THE EQUIPMENT.................................................20

QUALIFICATION OF THE INSTALLATION OF UTILITY ENGINEERING.............................................................................21

QUALIFICATION OF CORRECT CONNECTIONS OF POWER AND SIGNAL TRANSMISSION......................................... 22

QUALIFICATION OF THE TESTS OF THE PLC INPUT/OUTPUT (I/O)..........................................................................23

INSTALLATION QUALIFICATION OF THE SOFTWARE....................................................................................................24

QUALIFICATION OF THE MAIN COMPONENTS OF THE BLENDER................................................................................25

QUALIFICATION OF THE SAFETY MEASURES...............................................................................................................26

QUALIFICATION OF EQUIPMENT APPEARANCE............................................................................................................27

ATTACHED PAGE OF THE RECORD..............................................................................................................................28

DEVIATIONS LIST............................................................................................................................................................29

DEVIATIONS REPORT.................................................................................................................................................... 30

ATTACHMENTS LIST........................................................................................................................................................31

CHECKING AND APPROVAL OF THE EXECUTION.................................................................................................... 32

APPENDIX:

APPENDIX I：INSTALLATION QUALIFICATION REPORT..........................................................................................33

APPENDIX Ⅱ：ABBREVIATIONS............................................................................................................................36


JN/JS/IQ-HZD1500

version：V01


1 Purpose

The purpose of this protocol is to provide guiding and technical standards to the installation of theHZD1500 Bin Blender.

This is to establish the validation protocol in order to obtain a document certifying that the HZD1500Bin Blender has been installed according to GMP and GEP requirements.

The acquisition of this document proves that the installation of the HZD1500 Bin Blender has beenimplemented according to the approved protocol.

This protocol is the second part of the validation protocol of the HZD1500 Bin Blender: InstallationQualification (IQ).

2 Validation Scope

Validation scope covers ① the hardware, ② utility system installation (electric power), ③ trainingand ④ others of the Bin Blender manufactured by SAINTY that is installed in Room ______________,ID No.______________

Validation does not include separated validation of history data.

3 Protocol Checking

At the following times, please check and ensure the suitability of this protocol:

When the principal part of the validation has been modified

When the validation scope has been modified

When the design has been modified

Prior to the execution of the IQ

During the review after the IQ has been completed.

4 Organization and Responsibilities

Define roles and responsibilities properly, according to their concrete division of labor.

All the personal participating to the execution of this protocol must provide their sample of signature.

Name Title Department Function


JN/JS/IQ-HZD1500

version：V01


5 System description

5.1 Nameplate

NAME： Blender

MODEL： HZD1500

POWER SUPPLY： 440V/60Hz

SPEED： 3~15r/min

RATED CAPACITY：1500L

POWER： 10.5 kW

WEIGHT：

DATE ：

NO.：

5.2 Main functions and technical use

When the bin has been loaded in the blending frame, the blender can complete lifting of the bin, andprocesses the rotation of the frame according to the expected technical parameters, thus it achievesthe blending of the materials inside the bin. It is mainly used in pharmaceutical industries for blendingmaterials in the solid dosage production procedure.

5.3 Characteristic of the configuration

The blender mainly consists of the following parts:

Supporting frame, Body of the frame, Cover board

Lifting structure, Lifting reducer, Lifting screw-nut pairs, Casing (Cover)

Rotary system, Rotary reducer, Power and signal transmission devices of the rotary part,

Rotary frame

Electrical control system, Electrical control box, Operation terminal, Sensors

Safety measures, Photoelectrical isolation of the Blending area, Warning labels


JN/JS/IQ-HZD1500

version：V01


5.4 Main technical parameters , see Table B3-01

Table B3-01 Main Technical Parameters

Model HZD1500

Adaptive bin type LDZ

150

0

LDZ1000-1500 LDZ500-1500

Capacity L 150

0

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

5.5 Manufacturer

SaintyCo International Group : 402#, Tower-1, Pearl Mansion, Block-3, Rui’an city, Zhejiang Province, China

Website：www.saintyco.com

Email：[email protected]：（86）0577-66612826

5.6 Tests procedure

5.6.1 Every validation results shall be truly and integrally filled in the Installation Qualification ReportIQR, this manual has provided a template of IQR.

5.6.2 Inspector and checker will decide whether the validation results are up to scratch, IQR shallclearly indicate whether the validation has been passed. Inspector and checker shall sign and recordthe date on the related chapters and sections; putting a tick as signature is forbidden. On places thatare not suitable to the system, please use N/A for indicating and write the reason the suitable place.

5.6.3 The inspection file shall be kept as part of the inspection records, all the main accidents shouldbe recorded on the inspection file, such as system damages or failures causing the stop of theinspection.

5.6.4 A group (or a day) of validation accomplished, validation group shall summarize briefly theformed results or datum and shall conclude it (including inspection datum which are not up tostandard).

5.6.5 All deviations appeared during validation shall be recorded in the Deviation Report (DR).

5.6.6 After analyzing inconsistent items and deviations, they shall be validated again; this validation


JN/JS/IQ-HZD1500

version：V01


can used actual protocol or change for another mode of qualification.

5.6.7 Every validation finished, results or records shall be analyzed again to form the InstallationQualification Report. The Report should explicitly mention whether this validation has been passed ornot.

5.6.8 All the records, IQR, DR and the lastly formed Installation Qualification Report shall be arranged,filled in a document for archiving and should be kept and saved as part of the equipment dossier.

6 Validation procedures and records

6.1 Documents Qualification

Purpose

Qualify the documents pursuant to installations of the blender system and its utility services are

fully valid.

Procedure

Check carefully the following documents and qualify their integrality and validity:

Packing list

Certificate of conformity/Production inspection report and others.

Material certificates of Key components (Components in direct contact with medicine)

Product manual and manual of key outsourcing components

List of attachments (Spare parts of the machine)

List of engineering drawings, including: installation foundation drawing, outline dimension drawing

and electrical principal drawing, etc…

Qualification standard

The above suitable documents have all been provided and approved.

Record

Record the validation result in IQR01;

Record deviation appeared during the qualification process in the deviation report.


JN/JS/IQ-HZD1500

version：V01


6.2 Qualification of SOP feasibility

Purpose

Qualify the SOP of the blender system have been checked and approved.Procedure

Check SOP version and approval status.Qualification standard

Qualify the SOP of the blender system have been checked and approved.Record

Record the validation result in IQR02;Record deviation appeared during the qualification process in the deviation report.

6.3 Qualification of the key material

Purpose

Qualify the materials of the blender system which can influence quality of product and safety of utilitysystem accord with design requirements.

Procedure

Check the manufacturing materials certificates of the following parts of the system; they shall complywith GMP requirements:

Bin body

Bin lid

Lid seal

Butterfly valve seal

Control box

Machine housing

Qualification standard

Material of the bin complies with designed URS requirements.

Record



6.4 Qualification of calibration of instruments and meters (N/A)

Purpose

Qualify the instruments and meters used by the blender system have been calibrated.


JN/JS/IQ-HZD1500

version：V01


Procedure

According to the instruments and meters list of the blender system, check the calibrationcertificates or certificates of conformity;

Qualify the key meters have been calibrated, and their calibration is in their period of validity;

Process the calibration of the instruments and meters under user’s responsibilities.

Acceptable standard

The instruments and meters used by the blender system have been calibrated.

Record



6.5 Qualification of system lubrication

Purpose

Qualify the lubrication positions and points of the system and the used lubrication complies with GMPrequirements.

Procedure

Check drawings of lubrication positions of the system, list of lubrication points(IQR04),qualify the lubrication of the system complies with the design requirements;

Check the lubrication certificates of the key lubrication points, qualify they comply with GMPrequirements.

Acceptable standard

The lubrication positions and points of the system and the used lubrication complies with GMPrequirements.

Record



6.6 Qualification of equipment installation position and room

Purpose

Qualify the installation position and room of the equipment comply with requirements of the layoutdrawing; qualify whether they can satisfy the requirements for production and system service.

Procedure

According to layout drawing or installation position drawing and completion drawing; on site, observethe installation position and room shall comply with the drawing.

Acceptable standard

The installation position and room of the equipment comply with requirements of the layout drawing.


JN/JS/IQ-HZD1500

version：V01


Record



6.7 Qualification of the installation of utility services

Purpose

Qualify power of the blender system and installation of the utility services comply with equipmentrequirements and management requirements of the utility engineering.

Procedure

Check carefully and qualify voltage of the power loop, power, line No., cable model as well as modeland No. of the switch cabinet fulfill the requirements of engineering design of the system, operationconditions of the equipment and system management for electric power.

Acceptable standard

Power of the blender system and installation of the utility services comply with equipmentrequirements and management requirements of the utility engineering.

Record



6.8 Qualification of the correct connection for power transmission and signal transmission

Purpose

Qualify power of the blender system and installation of the utility services comply with equipmentrequirements and management requirements of the utility engineering.

Procedure

According to product manual, qualify the status of power transmission and signal transmission complywith design requirement.

Rotary motor

Lifting motor

PLC

Touch screen

Printer

Sensor

Electric components of control part.

Acceptable standard

Equipment power transmission and signal transmission comply with design requirement.

Record



JN/JS/IQ-HZD1500

version：V01



6.9 PLC Qualification of tests of the PLC I/O

Purpose

Check the I/O of the system, inspect whether the connection of PLC card is correctly connected.

Procedure

According to the electrical principal drawing, test the I/O points.

Acceptable standard

Qualify there isn’t any error connections of the I/O.

Record



6.10 Installation Qualification of the software

Purpose

Qualify the installed software editions of the blender are exact and have no error.

Procedure

Qualify all the needed software editions comply with the software criterion of the manufacturer,including the following applications software:

Qualify the edition No. of the operation system

Qualify the edition No. of the HMI

Qualify the edition No. of the software

Qualify the disk No. of the backup

Acceptable standard

All needed software editions for the system have been installed.

Record



6.11 Qualification of the main components of the blender

Purpose

Qualify the installation of the main components of the blender system complies with URS/FATrequirements.

Procedure

According to URS /FAT, qualify the following items:


JN/JS/IQ-HZD1500

version：V01


Frame body

Rotary reducer

Lifting reducer

Collector ring device

Electric control system

Operation terminal

Sensors

Acceptable standard

The installation of the main components of the blender system complies with URS/FAT requirements.

Record



6.12 Safety measures

Purpose

Qualify the installation of the hardware system of the blender complies with requirements for safetyproduction.

Procedure

Qualify the following items:

Electrical safety

Operation safety

Acceptable standard

The installation of the hardware system of the blender complies with requirements for safetyproduction.

Record



6.13 Qualification of the equipment appearance

Purpose

Qualify the appearance of the blender system has not been damaged or injured during the installationprocess.


JN/JS/IQ-HZD1500

version：V01


Procedure

Check the following items:

Nameplate

Cover

Rotary frame

Bin

Electrical control box

Acceptable standard

The appearance of the blender system has not been damaged or injured.

Record



6.14 Attached page of the record

If the main record pages are not enough, the record like IQR14 can be used, then give a clearindication of the title of the number and Qualification record reference.

7 Deviations

7.1 Deviations list

Collect all the deviations appeared during the IQ activities to form the deviations list and indicate dateof solution.

7.2 Deviations report

Record all the deviations and their management occurred during the protocol execution process and

analyze their effects on Validation conclusion.

Record the records contents, cause analysis, improved situations and effects on Validation conclusion

in the deviations report.

8 Attachments list

Collect all related documents, records, videos. CDs, use them as attachments for the validation report.

Compile the attachment list, specify the pages and use conditions.

9 ReportCollect all records and reports of chapters 6, 7 and 8. Validation group uses procedures below to form

the final validation report:


JN/JS/IQ-HZD1500

version：V01


Check the review of the IQ process

Check and analyze the records

Check and analyze the deviations report DR

Draft out report

Discuss and approve the report

Form the formal Installation Qualification Report

10 Checking and Approval

Report is checked and approved by authorized person.

Validation Report and its attachments shall be arranged, filled in a document for archiving and should

be kept and saved as part of the equipment dossier.

Appendix I has provided an example of Installation Validation Report.

11 Modification control

Any change of the equipment must be checked and approved by both parts, and then changedfiles should be archived.

JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version：V01


IQR of HZD1500 Bin BlenderRecord No. IQR：01 Manufacturer Saintyco

Record/Date Check/Date

name： Documents Qualification

Document Name （PASS）（FAIL）（N/A）

Packing list

Certificate of conformity

FAT protocol

Materials certificate

Product manual

Inverter manual

Installation foundation Dwg

Outline dimension Dwg

Electrical principal Dwg

Other：

Any deviation? □（YES） □（NO）

Deviation recorded in DR, DR No. is：DR

Recorder Checker Checker CheckerSignatureDate





name：SOP Qualification of SOP feasibility

Item Description Result

SOPOperation SOP

Has been checked and approved by authorizedpersonnel

□Yes □NoAll revisions have been checked and approved

It is the current effective version

SOPWashing SOP




SOPMaintenance SOP




Other：



Recorder Checked Checked CheckedSignatureDate





name：Qualification of key material

Part name Required Material Real material Material report No.

Bin body 316L

Bin lid 316L

Lid seal Silicone

Butterfly valve seal Silicone

Control box 304Machine housing 304

Other：








name：Qualification of calibration of instruments and meters（N/A）

Instruments and meters Calibration

No. Name Manufacturer Model Range/Precision

Critical?Y/ N

Calibrationdate Expiry Date

Other：








name：Qualification of system lubrication

NO. Lubrication point Distance to product (materials) Lubricationperiod Lubrication medium

1 Left/right gearboxFar from product (medicine), it doesn’t

influence product safety directly3 months High-quality lubricant

2 Lifting screw-nut pairFar from product (medicine), it doesn’t

influence product safety directly2 months High-quality lubricant

3Bottom guide rod ofthe lifting mechanism

Far from product (medicine), it doesn’tinfluence product safety directly

2 months High-quality lubricant

4Left/right bearings ofthe rotating body

Far from product (medicine), it doesn’tinfluence product safety directly

1 year High-quality lubricant

5 Lifting reducerFar from product (medicine), it doesn’t

influence product safety directlyRefer to motor

manualRefer to motor manual

6 Rotary reducerFar from product (medicine), it doesn’t

influence product safety directlyRefer to motor

manualRefer to motor manual

Other：








name：Qualification of the installation position and room of the equipment

ItemResult

Yes No

Room accords with technical layout □Yes □No

Room accords with completion drawing or elevation drawing □Yes □No

Site temperature18℃～45℃ □Yes □No

site humidity level 25％～85％ □Yes □No

Other：








name：Qualification of the installation of utility engineering

Item Description

Electric power

Power supply：440 V/60Hz/3P

Power：Rotary power：7.5 kWLifting power：3 kW

Wire section：4.0 mm²; 2.5 mm²; 1.0 mm²; 0.5 mm²

Cable type： VVRP RVV

System earthing Protection earthing：Resistance≤4Ω

Other：








name：Qualification of correct connections of power and signal transmission

Item DescriptionResult

Yes No

Mixing motor 3x4mm²+1x2.5 mm² □Yes □No

Lifting motor 3x2.5mm²+1x1.5 mm² □Yes □No

PLC24V

Power supply 24V, actions of I/O are agile and reliable□Yes □No

Touch panelDC24V

Power supply 24V, displays data and picture□Yes □No

Printer 220V Power supply 220V □Yes □No

Various sensorsSensitive actions of proximity switches/photoelectric

switches/limit switches□Yes □No

Strong electricityelectric elements of the

control partReliable actions of inverters, contactors and relays □Yes □No

Other：








name：PLC Qualification of the tests of the PLC Input/Output (I/O)

Item DescriptionResult

Yes No

Input

Sensors for binin position

Mandatory input position, bin in position, signallight 0.3 of the PLC illuminates

□Yes □No

upper limitMandatory input position, bin clamped in position,

signal light 0.4 of the PLC illuminates□Yes □No

Lower limitMandatory input position, bin fallen to groundposition, signal light 0.5 of the PLC illuminates

□Yes □No

Safety barrierMandatory input position, bin fallen to groundposition, signal light 0.6 of the PLC illuminates

□Yes □No

Emergencystop

Mandatory input position, bin fallen to groundposition, signal light 0.7 of the PLC illuminates

□Yes □No

Output

Lifting sensorsMandatory output position, bin is lifting, signal light

0.1 of the PLC illuminates□Yes □No

Falling sensorsMandatory output position, bin is falling, signal light

0.1 of the PLC illuminates□Yes □No

Contractingbrake

Mandatory output position, system is braking,signal light 0.1 of the PLC illuminates

□Yes □No

Other：








name：Installation Qualification of the SoftwareItem Description Conformance

Yes No

Operation interface Qualify the edition No. of PLC program □Yes □No

HMI Qualify edition No. of HMI program □Yes □No

System Siemens S7 200Qualify the OS of the system is Siemens S7 200

□Yes □No

Backup Set with backup, backup disk No. is □Yes □No

Other：








name：Qualification of the main components of the blender

Item Description ConformanceYes No

Frame body

Installation foundation complies with requirements of user’smanual

The anchor bolts are reliably locked and loosing preventionmeasures are implemented.

The frame body has not been hit during its installation andthe anti-rust layer is kept intact.

□Yes □No

Rotary reducerModel：DK107-YBEJ7.5KW-4P-96.15-B3B

Power：7.5 kW□Yes □No

Lifting reducerModel：YBEJ100L2-4P-3KW-B3+DFAFS67-17.4-B5Ⅱ

Power：3 kW□Yes □No

Top lid of pharmabin

No seal leakage of top lid of pharma bin, locked reliable,nomaterial leakage.

□Yes □No

Electric controlsystem

Components shall comply with electric parts listDevices arrangement shall be consistent with lines No. and

electric diagramNo wires loosening

□Yes □No

Operationterminal

Touch panel has a clear display, it has no distinctnessscratch or spot

□Yes □No

Other:








name： Qualification of the safety measures

Item DescriptionConformanceYes No

Electricsafety

Labels Driving Power connection has “Electricity Danger” labelProtective Earthing label □Yes □No

Earthing resistance Correct earthing, resistance ≤4Ω □Yes □NoShell (control box

body) Only use key or tool to open it □Yes □No

Motor overloadingprotection

Designed with motor overloading protection,when overloaded, system emits overload alarm

signal□Yes □No

Insulation failureprotection

Designed with system insulation failureprotection (Air switch) □Yes □No

Operation

safety

Designed with obvious alarm labels warning any misoperation □Yes □Yes

The blending rotary area has been reliably isolated □Yes □Yes

The emergency stop switch is set to operator’s most convenientposition(control panel/machine column)

□Yes □Yes

System is designed with optic and acoustic alarm devices alarmingany system failures or malfunctions

□Yes □Yes

Other：








name：Qualification of equipment appearance

Item Description ConformanceYes No

Labels Without any nick; with clear characters and pattern □Yes □No

Externalhousing

Flat and smooth surface without obvious concave convexsurface, spot or nick

□Yes □No

Rotate frameFlat and smooth surface without obvious concave convex

surface, spot or nick□Yes □No

Pharma BinFlat and smooth surface without obvious concave convex

surface, spot or nick□Yes □No

Electric controlcabinet

Flat and smooth surface without obvious concave convexsurface, spot or nick

Sheet metal parts have not obvious distortionDoor lock is well kept

Operation panel has no nick; with clear characters and pattern.Devices on the panel are well kept and are not distorted

□Yes □No

Other：








name：Attached page of the Record

Record No. IQR Record name PagesTotal pages:Page No.:





name：Deviations list

Deviation No.Qualificationrecord No.

Description Date of solution





name：Deviations Report

Deviation No. Record No.

Deviation Description：

Signature Date

Reason analysis：

Signature Date

Improvement measure： Improvement result：

Signature/Date Signature/Date

Improvement results have positive effects on

installation validation

Yes No





name： Attachments listAttachment

No.Attachment name Page

Application validation recordNo./Name





name： Checking and Approval of the execution

Check the IQ results and original data, then form the ultimate conclusion of the IQ:

PASS FAIL

If there’s still unsolved deviations, please fill down the following content:

Qualify if these unsolved deviations may influence the ultimate conclusion of the IQ.

YES NO

Note：

Executed by

Signature Date

Checked by

Signature Date

Checked by

Signature Date



Appendix I: Installation Qualification Report

（Installation Qualification Report）

1 Purpose

This is to set the validation report of the HZD1500 Bin Blender, and to conclude if the activities of IQmeet equipment requirements, and if the Equipment qualification can be concluded.

2 Scope

Installation Qualification of the HZD1500 Bin Blender manufactured by SAINTY that is installedin Room , ID No.

The making of the IQ tests is to ensure that the complete functions of the installation fullycomply with the design specifications.

The contents of this validation document refer to the equipment, testing steps, specifications,documentation. This information will be used to ensure that the blender has been installed,operated and run according to the user’s design specifications and company’s requirements.

This document is compiled by SAINTY INTERNATIONAL GROUP, and then the relatedapproval signature, supporting documents and other documentation will be included. Anysupporting datum and documentation shall be attached to the inspection report.

3 Responsibilities

Validation team is responsible for this report.

4 Summary

The validation of this equipment activities have been done according to the procedure requirementsof the Company (Management regulations of equipment validation), the validation group proceedsaccording to the validation protocol of the HZD1500 Bin Blender. The protocol should have the entireIQ validated and results of the checking listed. By the validation process, the checking and auditingof the reports and deviations reports, qualify that the protocol, during the implementation process,has no modification, is real and complete and accords with requirements of the protocol.

The validation group, after has discussed, approves the Installation Qualification (IQ) of the BinBlender.

5 Confirmed Record Summary



No. Item Evaluation and analysis

1 IQR1： PASS□ FAIL□ N/A□

















Conclusion

Activities of the Installation Qualification accord with the requirements of the protocol,

installation of the Bin Blender accords with standards of the equipment and design,

industrial manufacturing and GMP requirements. And can go to the next step activities

and equipment validation or equipment trial operation.

6 Validation conclusion

The group, after has checked the content report of the equipment validation and has discussed,approves that the Installation Qualification (IQ) of the equipment accords with the requirements ofthe protocol, thus Operational Qualification (OQ) and Performance Qualification (PQ) of theequipment can be performed.

By the validation process, the checking and auditing of the reports and deviations reports, qualifythat contents related to the IQ of the protocol, during the implementation process, have not beenmodified, records are real and complete. The members of the validation group, after have discussed,declares unanimously that activities of the Installation Qualification accord with the requirements ofthe protocol, installation of the Bin Blender accords with standards of the equipment and design,blender system accords with industrial manufacturing and GMP requirements. And can go to thenext step activities and equipment validation or equipment trial operation.

7 List of signatures of validation group members (Brief)



8 Signature

Executed by

SignatureDate

(dd/mm/yyyy)Checked by

SignatureDate

(dd/mm/yyyy)Checked by

SignatureDate

(dd/mm/yyyy)



Appendix Ⅱ： Abbreviations

AC Alternating current

A Ampere

V Volt

Hz Hertz

PLC Programmable Logic Controller

ºC Degrees Celsius

DQ Design Qualification

IQ Installation Qualification

OQ Operational Qualification

PQ Performance Qualification

FAT Factory Acceptance Test

SAT Site Acceptance Test

DQR Design Qualification Report

IQR Installation Qualification Record

OQR Operational Qualification Record

PQR Performance Qualification Record

DR Deviation Report

N/A Not Applicable

SOP Standard Operating Procedure

RSD Relative Standard Deviation

Health & Medicine

HZD 1500 IBC Bin Blender IQ Documents -SaintyCo