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 Blender
Installation Qualification
Prospective Validation

Installation Qualification Protocol for HZD1500 Bin Blender
JN/JS/IQ-HZD1500
version：V01
SAINTYCO INTERNATIONAL GROUP
Writer’s signature
Your signature indicates that the preparation of this file (Edit/Revision) complies with the validation
project of the equipment, installation requirements of GMP and GEP for bin blender. It also fully
reflects the necessary tasks that shall be completed during the validation procedure, and it can
implement 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 and
this document fully reflects the validation tasks, and it can implement the Installation Validation of the
HZD1500 Bin Blender
.
Approver’s signature
Your signature indicates that this document complies with the general plan of enterprise validation, the
technical production standards and all the including files and information are sufficient and can be
directly applied. After the approval, any modification or correction to the aim of this document or to the
validation standard must be done in improving this document, and before the execution of the
modified/corrected document, it must be approved.
0

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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

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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

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1 Purpose
The purpose of this protocol is to provide guiding and technical standards to the installation of the
HZD1500 Bin Blender.
This is to establish the validation protocol in order to obtain a document certifying that the HZD1500
Bin 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 been
implemented according to the approved protocol.
This protocol is the second part of the validation protocol of the HZD1500 Bin Blender: Installation
Qualification (IQ).
2 Validation Scope
Validation scope covers ① the hardware, ② utility system installation (electric power), ③ training
and 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

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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, and
processes the rotation of the frame according to the expected technical parameters, thus it achieves
the blending of the materials inside the bin. It is mainly used in pharmaceutical industries for blending
materials 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

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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：sainty@saintyco.com
Tel：（86）0577-66612826
5.6 Tests procedure
5.6.1 Every validation results shall be truly and integrally filled in the Installation Qualification Report
IQR, 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 shall
clearly indicate whether the validation has been passed. Inspector and checker shall sign and record
the date on the related chapters and sections; putting a tick as signature is forbidden. On places that
are 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 should
be recorded on the inspection file, such as system damages or failures causing the stop of the
inspection.
5.6.4 A group (or a day) of validation accomplished, validation group shall summarize briefly the
formed results or datum and shall conclude it (including inspection datum which are not up to
standard).
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

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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 Installation
Qualification Report. The Report should explicitly mention whether this validation has been passed or
not.
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.

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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.
Qualify the SOP of the blender system have been checked and approved.
Record
6.3 Qualification of the key material
Purpose
Qualify the materials of the blender system which can influence quality of product and safety of utility
system accord with design requirements.
Procedure
Check the manufacturing materials certificates of the following parts of the system; they shall comply
with GMP requirements:
 Bin body
 Bin lid
 Lid seal
 Butterfly valve seal
 Control box
 Machine housing
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.

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Procedure
 According to the instruments and meters list of the blender system, check the calibration
certificates 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 GMP
requirements.
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 GMP
requirements.
Acceptable standard
The lubrication positions and points of the system and the used lubrication complies with GMP
requirements.
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 layout
drawing; 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, observe
the 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.

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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 equipment
requirements 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 model
and No. of the switch cabinet fulfill the requirements of engineering design of the system, operation
conditions of the equipment and system management for electric power.
Acceptable standard
Power of the blender system and installation of the utility services comply with equipment
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 equipment
Procedure
According to product manual, qualify the status of power transmission and signal transmission comply
with 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

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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/FAT
requirements.
Procedure
According to URS /FAT, qualify the following items:

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 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 safety
production.
Procedure
Qualify the following items:
 Electrical safety
 Operation safety
Acceptable standard
The installation of the hardware system of the blender complies with requirements for safety
production.
Record
6.13 Qualification of the equipment appearance
Purpose
Qualify the appearance of the blender system has not been damaged or injured during the installation
process.

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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 clear
indication 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 date
of 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 Report
Collect all records and reports of chapters 6, 7 and 8. Validation group uses procedures below to form
the final validation report:

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 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 changed
files should be archived.

JN/JS/IQ-HZD1500
Installation Qualification Protocol for HZD1500 Bin Blender version：V01
IQR of HZD1500 Bin Blender
Record 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 Checker
Signature
Date

JN/JS/IQ-HZD1500
name：SOP Qualification of SOP feasibility
Item Description Result
SOP
Operation SOP
Has been checked and approved by authorized
personnel
□Yes □NoAll revisions have been checked and approved
It is the current effective version
SOP
Washing SOP
personnel
SOP
Maintenance SOP
personnel
Other：
Recorder Checked Checked Checked
Signature
Date

JN/JS/IQ-HZD1500
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 304
Machine housing 304
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of calibration of instruments and meters（N/A）
Instruments and meters Calibration
No. Name Manufacturer Model
Range/
Precision
Critical?
Y/ N
Calibration
date
Expiry Date
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of system lubrication
NO. Lubrication point Distance to product (materials)
Lubrication
period
Lubrication medium
1 Left/right gearbox
Far from product (medicine), it doesn’t
influence product safety directly
3 months High-quality lubricant
2 Lifting screw-nut pair
3
Bottom guide rod of
the lifting mechanism
4
Left/right bearings of
the rotating body
1 year High-quality lubricant
5 Lifting reducer
Refer to motor
manual
Refer to motor manual
6 Rotary reducer
Refer to motor
manual
Refer to motor manual
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of the installation position and room of the equipment
Item
Result
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：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of the installation of utility engineering
Item Description
Electric power
Power supply：440 V/60Hz/3P
Power：Rotary power：7.5 kW
Lifting 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：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of correct connections of power and signal transmission
Item Description
Result
Yes No
Mixing motor 3x4mm²+1x2.5 mm² □Yes □No
Lifting motor 3x2.5mm²+1x1.5 mm² □Yes □No
PLC
24V
Power supply 24V, actions of I/O are agile and reliable
□Yes □No
Touch panel
DC24V
Power supply 24V, displays data and picture
□Yes □No
Printer 220V Power supply 220V □Yes □No
Various sensors
Sensitive actions of proximity switches/photoelectric
switches/limit switches
□Yes □No
Strong electricity
electric elements of the
control part
Reliable actions of inverters, contactors and relays □Yes □No
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：PLC Qualification of the tests of the PLC Input/Output (I/O)
Item Description
Result
Yes No
Input
Sensors for bin
in position
Mandatory input position, bin in position, signal
light 0.3 of the PLC illuminates
□Yes □No
upper limit
Mandatory input position, bin clamped in position,
signal light 0.4 of the PLC illuminates
□Yes □No
Lower limit
Mandatory input position, bin fallen to ground
position, signal light 0.5 of the PLC illuminates
□Yes □No
Safety barrier
□Yes □No
Emergency
stop
□Yes □No
Output
Lifting sensors
Mandatory output position, bin is lifting, signal light
0.1 of the PLC illuminates
□Yes □No
Falling sensors
Mandatory output position, bin is falling, signal light
0.1 of the PLC illuminates
□Yes □No
Contracting
brake
Mandatory output position, system is braking,
signal light 0.1 of the PLC illuminates
□Yes □No
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：Installation Qualification of the Software
Item 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 200
Qualify the OS of the system is Siemens S7 200
□Yes □No
Backup Set with backup, backup disk No. is □Yes □No
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of the main components of the blender
Item
Description
Conformance
Yes No
Frame body
Installation foundation complies with requirements of user’s
manual
The anchor bolts are reliably locked and loosing prevention
measures are implemented.
The frame body has not been hit during its installation and
the anti-rust layer is kept intact.
□Yes □No
Rotary reducer
Model：DK107-YBEJ7.5KW-4P-96.15-B3B
Power：7.5 kW
□Yes □No
Lifting reducer
Model：YBEJ100L2-4P-3KW-B3+DFAFS67-17.4-B5Ⅱ
Power：3 kW
□Yes □No
Top lid of pharma
bin
No seal leakage of top lid of pharma bin, locked reliable,no
material leakage.
□Yes □No
Electric control
system
Components shall comply with electric parts list
Devices arrangement shall be consistent with lines No. and
electric diagram
No wires loosening
□Yes □No
Operation
terminal
Touch panel has a clear display, it has no distinctness
scratch or spot
□Yes □No
Other:
Signature
Date

JN/JS/IQ-HZD1500
name： Qualification of the safety measures
Item Description
Conformance
Yes No
Electric
safety
Labels
Driving Power connection has “Electricity Danger” label
Protective Earthing label
□Yes □No
Earthing resistance Correct earthing, resistance ≤4Ω □Yes □No
Shell (control box
body)
Only use key or tool to open it □Yes □No
Motor overloading
protection
Designed with motor overloading protection,
when overloaded, system emits overload alarm
signal
□Yes □No
Insulation failure
protection
Designed with system insulation failure
protection (Air switch)
□Yes □No
Operati
on
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 convenient
position(control panel/machine column)
□Yes □Yes
System is designed with optic and acoustic alarm devices alarming
any system failures or malfunctions
□Yes □Yes
Other：
Signature
Date

JN/JS/IQ-HZD1500
name：Qualification of equipment appearance
Item Description
Conformance
Yes No
Labels Without any nick; with clear characters and pattern □Yes □No
External
housing
Flat and smooth surface without obvious concave convex
surface, spot or nick
□Yes □No
Rotate frame
□Yes □No
Pharma Bin
□Yes □No
Electric control
cabinet
Sheet metal parts have not obvious distortion
Door 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：
Signature
Date

JN/JS/IQ-HZD1500
name：Attached page of the Record
Record No. IQR Record name Pages
Total pages:
Page No.:

JN/JS/IQ-HZD1500
name：Deviations list
Deviation No.
Qualification
record No.
Description Date of solution

JN/JS/IQ-HZD1500
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-HZD1500
name： Attachments list
Attachment
No.
Attachment name Page
Application validation record
No./Name

JN/JS/IQ-HZD1500
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-HZD1500
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 IQ
meet equipment requirements, and if the Equipment qualification can be concluded.
2 Scope
 Installation Qualification of the HZD1500 Bin Blender manufactured by SAINTY that is installed
in Room , ID No.
 The making of the IQ tests is to ensure that the complete functions of the installation fully
comply 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 related
approval signature, supporting documents and other documentation will be included. Any
supporting 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 requirements
of the Company (Management regulations of equipment validation), the validation group proceeds
according to the validation protocol of the HZD1500 Bin Blender. The protocol should have the entire
IQ validated and results of the checking listed. By the validation process, the checking and auditing
of 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 Bin
Blender.
5 Confirmed Record Summary

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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 of
the protocol, thus Operational Qualification (OQ) and Performance Qualification (PQ) of the
equipment can be performed.
By the validation process, the checking and auditing of the reports and deviations reports, qualify
that contents related to the IQ of the protocol, during the implementation process, have not been
modified, 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 of
the 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 the
next step activities and equipment validation or equipment trial operation.
7 List of signatures of validation group members (Brief)

JN/JS/IQ-HZD1500
8 Signature
Executed by
Signature
Date
(dd/mm/yyyy)
Checked by
Signature
Date
(dd/mm/yyyy)
Checked by
Signature
Date
(dd/mm/yyyy)

JN/JS/IQ-HZD1500
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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