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HZD 1500 IBC Bin Blender IQ Documents -SaintyCo

HZD series Bin Blender can automatically finish the whole process of clamping, lifting, mixing and falling, etc. Equipped with one set of HZD series Bin Blender and applying some different models of bins, pharmaceutical enterprises can satisfy with the mixing demands of large output and diversity products. It’s the desirable final mixing equipment for pharmaceutical factories. Meanwhile, it can be widely used in such areas as raw medicine material industry, chemical industry, foodstuff industry, etc.

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HZD 1500 IBC Bin Blender IQ Documents -SaintyCo

  1. 1. 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
  2. 2. 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 . Name Title Name Date Unit 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. Name Title Name Date Unit 0
  3. 3. 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
  4. 4. 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
  5. 5. 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 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
  6. 6. 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, 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
  7. 7. 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: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
  8. 8. 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 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.
  9. 9. 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 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 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.
  10. 10. 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 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 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 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 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 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.
  11. 11. 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 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 requirements 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 equipment requirements and management requirements of the utility engineering. 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 Record the validation result in IQR08;
  12. 12. 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/FAT requirements. Procedure According to URS /FAT, qualify the following items:
  13. 13. 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 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 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 installation process.
  14. 14. 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 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:
  15. 15. 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 changed files should be archived.
  16. 16. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP 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
  17. 17. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:02 Manufacturer Saintyco Record/Date Check/Date 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 Has been checked and approved by authorized personnel □Yes □NoAll revisions have been checked and approved It is the current effective version SOP Maintenance SOP Has been checked and approved by authorized personnel □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 Checked Signature Date
  18. 18. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record 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 304 Machine housing 304 Other: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  19. 19. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record 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 Calibration date Expiry Date Other: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  20. 20. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:05 Manufacturer Saintyco Record/Date Check/Date 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 Far from product (medicine), it doesn’t influence product safety directly 2 months High-quality lubricant 3 Bottom guide rod of the lifting mechanism Far from product (medicine), it doesn’t influence product safety directly 2 months High-quality lubricant 4 Left/right bearings of the rotating body Far from product (medicine), it doesn’t influence product safety directly 1 year High-quality lubricant 5 Lifting reducer Far from product (medicine), it doesn’t influence product safety directly Refer to motor manual Refer to motor manual 6 Rotary reducer Far from product (medicine), it doesn’t influence product safety directly Refer to motor manual Refer to motor manual Other: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  21. 21. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:06 Manufacturer Saintyco Record/Date Check/Date 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  22. 22. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record 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 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  23. 23. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:08 Manufacturer Saintyco Record/Date Check/Date 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  24. 24. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:09 Manufacturer Saintyco Record/Date Check/Date 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 Mandatory input position, bin fallen to ground position, signal light 0.6 of the PLC illuminates □Yes □No Emergency stop Mandatory input position, bin fallen to ground position, signal light 0.7 of the PLC illuminates □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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  25. 25. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:109 Manufacturer Saintyco Record/Date Check/Date 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  26. 26. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:11 Manufacturer Saintyco Record/Date Check/Date 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  27. 27. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:12 Manufacturer Saintyco Record/Date Check/Date 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  28. 28. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:13 Manufacturer Saintyco Record/Date Check/Date 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 Flat and smooth surface without obvious concave convex surface, spot or nick □Yes □No Pharma Bin Flat and smooth surface without obvious concave convex surface, spot or nick □Yes □No Electric control cabinet Flat and smooth surface without obvious concave convex surface, spot or nick 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: Any deviation? □(YES) □(NO) Deviation recorded in DR, DR No. is:DR Recorder Checker Checker Checker Signature Date
  29. 29. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:14 Manufacturer Saintyco Record/Date Check/Date name:Attached page of the Record Record No. IQR Record name Pages Total pages: Page No.:
  30. 30. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:15 Manufacturer Saintyco Record/Date Check/Date name:Deviations list Deviation No. Qualification record No. Description Date of solution
  31. 31. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record 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
  32. 32. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record No. IQR:17 Manufacturer Saintyco Record/Date Check/Date name: Attachments list Attachment No. Attachment name Page Application validation record No./Name
  33. 33. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP IQR of HZD1500 Bin Blender Record 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
  34. 34. JN/JS/IQ-HZD1500 Installation 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 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
  35. 35. JN/JS/IQ-HZD1500 Installation 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 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)
  36. 36. JN/JS/IQ-HZD1500 Installation Qualification Protocol for HZD1500 Bin Blender version:V01 SAINTYCO INTERNATIONAL GROUP 8 Signature Executed by Signature Date (dd/mm/yyyy) Checked by Signature Date (dd/mm/yyyy) Checked by Signature Date (dd/mm/yyyy)
  37. 37. JN/JS/IQ-HZD1500 Installation 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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  • TonyZeng6

    Apr. 14, 2017

HZD series Bin Blender can automatically finish the whole process of clamping, lifting, mixing and falling, etc. Equipped with one set of HZD series Bin Blender and applying some different models of bins, pharmaceutical enterprises can satisfy with the mixing demands of large output and diversity products. It’s the desirable final mixing equipment for pharmaceutical factories. Meanwhile, it can be widely used in such areas as raw medicine material industry, chemical industry, foodstuff industry, etc.

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