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.
Name Title Name Date Unit
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.
Name Title Name Date Unit
0
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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.
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Record the validation result in IQR03;
Record deviation appeared during the qualification process in the deviation report.
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.
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Record the validation result in IQR04;
Record deviation appeared during the qualification process in the deviation report.
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
Record the validation result in IQR05;
Record deviation appeared during the qualification process in the deviation report.
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.
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
Record
Record the validation result in IQR06;
Record deviation appeared during the qualification process in the deviation report.
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
Record the validation result in IQR07;
Record deviation appeared during the qualification process in the deviation report.
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
Record the validation result in IQR08;
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
Record deviation appeared during the qualification process in the deviation report.
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
Record the validation result in IQR09;
Record deviation appeared during the qualification process in the deviation report.
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
Record the validation result in IQR10;
Record deviation appeared during the qualification process in the deviation report.
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:
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Record the validation result in IQR10;
Record deviation appeared during the qualification process in the deviation report.
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
Record the validation result in IQR12;
Record deviation appeared during the qualification process in the deviation report.
6.13 Qualification of the equipment appearance
Purpose
Qualify the appearance of the blender system has not been damaged or injured during the installationprocess.
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
Record the validation result in IQR13;
Record deviation appeared during the qualification process in the deviation report.
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:
Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version:V01
SAINTYCO INTERNATIONAL GROUP
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
SAINTYCO INTERNATIONAL GROUP
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
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:02 Manufacturer Saintyco
Record/Date Check/Date
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
Has been checked and approved by authorizedpersonnel
□Yes □NoAll revisions have been checked and approved
It is the current effective version
SOPMaintenance SOP
Has been checked and approved by authorizedpersonnel
□Yes □NoAll revisions have been checked and approved
It is the current effective version
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checked Checked CheckedSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:03 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:04 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:05 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:06 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:07 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:08 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:09 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:109 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:11 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:12 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:13 Manufacturer Saintyco
Record/Date Check/Date
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:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker CheckerSignatureDate
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:14 Manufacturer Saintyco
Record/Date Check/Date
name:Attached page of the Record
Record No. IQR Record name PagesTotal pages:Page No.:
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:15 Manufacturer Saintyco
Record/Date Check/Date
name:Deviations list
Deviation No.Qualificationrecord No.
Description Date of solution
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:16 Manufacturer Saintyco
Record/Date Check/Date
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
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:17 Manufacturer Saintyco
Record/Date Check/Date
name: Attachments listAttachment
No.Attachment name Page
Application validation recordNo./Name
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
IQR of HZD1500 Bin BlenderRecord No. IQR:18 Manufacturer Saintyco
Record/Date Check/Date
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
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
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
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
No. Item Evaluation and analysis
1 IQR1: PASS□ FAIL□ N/A□
2 IQR2: PASS□ FAIL□ N/A□
3 IQR3: PASS□ FAIL□ N/A□
4 IQR4: PASS□ FAIL□ N/A□
5 IQR5: PASS□ FAIL□ N/A□
6 IQR6: PASS□ FAIL□ N/A□
7 IQR7: PASS□ FAIL□ N/A□
8 IQR8: PASS□ FAIL□ N/A□
9 IQR9: PASS□ FAIL□ N/A□
10 IQR10: PASS□ FAIL□ N/A□
11 IQR11: PASS□ FAIL□ N/A□
12 IQR12: PASS□ FAIL□ N/A□
13 IQR13: PASS□ FAIL□ N/A□
14 IQR14: PASS□ FAIL□ N/A□
15 IQR15: PASS□ FAIL□ N/A□
16 IQR16: PASS□ FAIL□ N/A□
17 IQR17: 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)
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
8 Signature
Executed by
SignatureDate
(dd/mm/yyyy)Checked by
SignatureDate
(dd/mm/yyyy)Checked by
SignatureDate
(dd/mm/yyyy)
JN/JS/IQ-HZD1500Installation Qualification Protocol for HZD1500 Bin Blender version:V01
SAINTYCO INTERNATIONAL GROUP
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
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