VALIDATION PROTOCOLFOR MULTI MILL MACHINE MODEL: CIMM-200 Purchase Order No.: HPP/181439 DATED 06-10-04 Cip Machineries Pvt. Ltd. Registered Office : 10,11 Umiya Estate, Nr.Bharat Party Plot, N.H.No.8, Amraiwadi, Ahmedabad 380 026. Gujarat, INDIA. Phone: 91-79-287 54 10 91-79-289 25 30 91-79-297 04 06-7-8 TeleFax: 91-79-289 14 10 Works : Plot No.1903, Phase IV, Opp. Maradia Steel Unit-3, G.I.D.C., Vatva, Ahmedabad 380 026. Gujarat, INDIA. Phone: 91-79-583 59 08 91-79-583 53 41-2-3 TeleFax: 91-79-583 58 53 E-Mail : [email protected][email protected] Visit us on Internet at : www.cipmach.com / www.roll-compactor.com OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY Confidential CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 2 of 32 OBJECTIVE AND SCOPE: It is the objective of this protocol to describe in detail the methodology to be adopted to qualify the Multi Mill Machine GMP Model, intended to use in the manufacturing process. It is to establish confidence that the Multi Mill Machine GMP Model is capable of consistently operating within established limits and tolerance. The protocol comprises of the following. A) Installation Qualification: It should describe the following: 1. Equipment Features 2. Pre Qualification 3. Statement of Purpose 4. Installation Checklist 5. Drawings 6. Materials of Construction 7. Major components verification 8. Supporting Utilities 9. Manufacturer’s recommendation for site acceptance test. 10. Supporting certificates and Drawings 11. Final Report B) Operational Qualification: It should cover the operating parameters set for the equipment operation. Validation of equipment against these parameters should also be described. It should also describe. 01. System description (Pre requisite of operation). 02. Sequential operational aspects. 03. Critical operational aspects. 04. Statement of purpose. 05. Operator training (user). 06. SOP development. 07. Deficiency (if any) and corrective action report. Confidential CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 3 of 32 08. Final report. C) Performance Qualification: It should cover the performance parameters set for the equipment performance. Validation of equipment against these parameters should also be described. It should also describe. 01. Equipment validation. 02. Performance qualification evaluation. 03. Final report. D) Design Qualification: 01. Relevant drawings. 02. Final report. E) Conclusion: The Multi Mill Machine meets the acceptance criteria in reference to above parameters are declared validated and released for use. 0 Statement of Purpose 04.0 Major Components Verification 08.0 Drawings 06. : CIP MACHINERIES PVT.0 Installation Checklist 05.0 Manufacturer’s recommendation for site acceptance test.0 Equipment Features 02.0 Materials of Construction 07.0 Supporting Utilities 9. 10.0 Pre Qualification 03.0 Final Report . : TABLE OF CONTENTS 01.Confidential CIP MACHINERIES PVT. LTD. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 4 of 32 INSTALLATION QUALIFICATION EQUIPMENT NAME EQUIPMENT MANUFACTURER EQUIPMENT LOCATION : MULTI MILL MACHINE GMP MODEL. A. : 295 DEPARTMENT : PURPOSE : Milling of powder. MODEL NO. Manager Production Manager Works Manager Maintenance Manager .Confidential CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 5 of 32 INSTALLATION QUALIFICATION 01. : CIMM-200 SERIAL NO.0 EQUIPMENT FEATURES EQUIPMENT NAME : MULTI MILL MACHINE GMP MODEL. VALIDATION TEAM : NAME DESIGNATION SIGNATURE DATE: Q. D. Ltd. Ahmedabad. Vatva.0 PRE QUALIFICATION EQUIPMENT NAME : Multi Mill Machine GMP Model OUTPUT : 50 to 200 kgs. per hour.C. Nr. Gujarat . Maradia Steel Unit No. 1903. 3.I. Ahmedabad. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 6 of 32 INSTALLATION QUALIFICATION 02. MANUFACTURE'S NAME : Plot No. Phase IV. Phase IV. 1903. VENDER'S ADDRESS : Plot No.382 445. TEAM INVOLVED IN SELECTION OF EQUIPMENT : NAME : DESIGNATION : SIGNATURES : DATE : Project Incharge Works Manager .C. Vatva. Maradia Steel Unit No. Nr. Neeka Tube Bus Stand.I.D. G. Opp. G.Confidential CIP MACHINERIES PVT. Neeka Tube Bus Stand. Opp.382 445. 3.(Depending on the material Characteristic) VENDOR SELECTED : M/S Cip Machineries Pvt. Gujarat . Ahmedabad. 03. THE EQUIPMENT INSTALLATION IS CARRIED OUT AS PER GUIDELINES FRAMED BY THE MANUFACTURER. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 7 of 32 INSTALLATION QUALIFICATION 02.Confidential CIP MACHINERIES PVT. 04. 02.1 PRE QUALIFICATION EQUIPMENT QUALIFICATION : Multi Mill Machine GMP Model CERTIFICATION FROM VENDOR FOR : (A) : MATERIAL OF CONSTRUCTION Contact parts SS 316 L ACCEPTED FOR INSTALLATION INSTALLATION TEAM 01. . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 8 of 32 INSTALLATION QUALIFICATION 03.Confidential CIP MACHINERIES PVT. The system is installed according to the design specifications and manufacturers recommendations. All installation-testing reports are available and maintained on file. All supporting utilities are properly connected. All safety features are accounted for. No unauthorized or unrecorded modifications have taken place. Standard Operating Procedures have been identified and listed.0 STATMENTS OF PURPOSE The purpose of this protocol is to provide an outline for the inspection of equipment for static attributes to verify that: Each installed sub-component complies with the engineering design and equipment data sheets / specifications. . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 9 of 32 INSTALLATION QUALIFICATION 05.e. Comments: All the above-mentioned consideration is being checked and found satisfactory. as bellow. Yes/No Verify that there is sufficient room for servicing provided Verify that all piping and electrical connections have been done according to the drawings.Confidential CIP MACHINERIES PVT. Statement 01. Equipment identification nameplate is visible. Required electric connections are tight weather proof and grounded. 07. 09. Proper earthing is made. Consideration No. Verify that all switches of starter of the machine are working satisfactory. Verify that the "As Built" drawings are complete and represent the design concept. 03. Reviewed & Inspected by: ______________________ Date : .0 INSTALLATION CHECKLIST It shall be ensured that all civil. 06. mechanical. electrical and instrumental requirement of the equipment to be installed is fulfill. Verify that there is no observable physical damage 02. 04. 08. Verify that major components are securely anchored and protected from shock. i. 05. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 10 of 32 INSTALLATION QUALIFICATION 06. Supporting relevant drawings / certificates prior to Installation of the equipment.A drawing Reviewed & Inspected by : ______________________ Date : . Status G. Sr. 01 Details Ref.Confidential CIP MACHINERIES PVT. Drg. No.No.0 DRAWINGS Drawings are provided by the manufacturer and are complete. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 11 of 32 INSTALLATION QUALIFICATION 7.Confidential CIP MACHINERIES PVT.1 MAJOR COMPONENT VARIFICATION Item Hopper Sieve Beaters Feed Hopper Specification CIP Make CIP Make CIP Make CIP Make Supporting Certificates SS 316 L SS 316 L SS 316 L SS 316 L Comments: Material of construction of equipment is as specified. Review & Inspected by: _______________________Date: Actual Status . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 12 of 32 INSTALLATION QUALIFICATION 07.Confidential CIP MACHINERIES PVT. certificate As per attached herewith. Review & Inspected by: _______________________Date: Material of Construction SS 316L SS 316L SS 316L SS 316 L . As above As above As above Comments: Material of construction of equipment is as specified.2 CONTACT PARTS MATERIALS OF CONSTRUCTION Item Description Hopper Sieve Beaters Feed Hopper Ref. Confidential CIP MACHINERIES PVT. Review & Inspected by: _______________________Date: Status .3 MAJOR ELECTRICAL COMPONENTS Item Supporting Certificates Motor Starter Comments: Material of construction of equipment is as specified. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 13 of 32 INSTALLATION QUALIFICATION 7. 0 SUPPORTING UTILITIES List the supporting utilities and record whether or not they are properly connected and identified. Reviewed & Inspected by: ______________________ Date : Checked by Date .Confidential CIP MACHINERIES PVT. Utility Properly Connected and Identified (Yes/No) Electrical connection Water Connection Air connection to clean the Machine Comments: Utilities are properly attached. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 14 of 32 INSTALLATION QUALIFICATION 08. No.Confidential CIP MACHINERIES PVT. Actual Sign and Date: Service Engineer Plant Manager Quality Engineer . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 15 of 32 INSTALLATION QUALIFICATION 09. 01 02 03 04 Description Electrical Connection Water Connection Foundation Compressed Air connection Specification Four core cable to be connected to the machine To clean the machine Not applicable Pressure 8 kg/cm2 for cleaning purpose.0 MANUFACTURER’S RECOMMENDATION FOR SITE ACCEPTANCE TEST Sr. 1 2 3 Descriptions RELEVENT DRAWINGS MOC CERTIFICATES BOUGHTOUT ITEMS CERTIFICATES Actuals . SUPPORTING CERTIFICATES & DRAWINGS : Sr.Confidential CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 16 of 32 INSTALLATION QUALIFICATION 10. No. Confidential CIP MACHINERIES PVT. 11.2 Analysis / Evaluation: The machine shall be installed at the location. Supporting utilities shall be connected and Used for Functioning properly. Reviewed & Inspected by: ___________________ Date : .1 Summary: The equipment shall be procured as per specification to M/s ALEMBIC LIMITED. Installation is carried out as per manufacturers recommendations and user applicability. Standard operating procedure shall be identified and listed. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 17 of 32 INSTALLATION QUALIFICATION 11. History card shall be prepared for the equipment.0 FINAL REPORT 11. supporting utilities will be connected. All relevant critical document and drawing shall be verified by the user. LTD. 4.0 System Description (Pre requisite of operation) 2.0 Operator Training (User) 6.Confidential CIP MACHINERIES PVT. EQUIPMENT MAKE : CIP MACHINERIES PVT.0 SOP Development 7.0 Deficiency (if any) and Corrective Action Report 8.0 Statement of Purpose 5.0 Final Report PAGE 18 of 32 . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE OPERATIONAL QUALIFICATION EQUIPMENT NAME : MULTI MILL MACHINE GMP MODEL. EQUIPMENT LOCATION : TAB LE O F C O N T E N T S 1. 3.0 Sequential Operational aspects.0 Critical Operational aspects. The unit consists of: Base Plate Support Pillar Motor mounting Hopper assembly Sieve Feed Hopper The system has utilities like electrical connection and air connection connected to it.0 SYSTEM DESCRIPTION CIP MACHINERIES PVT LTD. .Confidential CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 19 of 32 OPERATIONAL QUALIFICATION 01. Multi Mill Machine is a machine for milling of the powder with output of 75-100 kg/hour. Status . Drive assembly is mounted on the support pillar. Beaters etc. Feed Hopper Feed hopper is mounted on the upper portion of the hopper.1 SYSTEM DESCRIPTION Item Base Plate Support Pillar Motor mounting Description Hopper Assembly The base plate is mounted on four wheels.Confidential CIP MACHINERIES PVT. Sieve Sieve is mounted inside the hopper assembly. Hopper assembly consists of Rotor assembly. Motor is mounted on the motor mounting plate with the help of four bolts. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 20 of 32 OPERATIONAL QUALIFICATION 01. 0 SEQUENTIAL OPERATION ASPECTS Sr. Powder Collection after sieving Powder should be collected with the suitable drum.No. polyethylene bag etc. collection bowl. Specification It should be four core three phase. Fix the plug as per the cable and It should be suitable to the main switch. decided depending upon the characteristic of the same. 01 02 03 04 05 06 07 08 Operation / Activity Cable from machine to main switch. Reverse / Forward Direction Machine should be rotate in Reverse / forward direction depend upon the required milling.Confidential CIP MACHINERIES PVT. To stop the machine. Actual . Pour the powder into the feed Powder quantity should be hopper. Starter should be OFF to stop the machine. To start the machine. three phase supply To clean the machine Hopper assembly should be dismantled to clean the machine before use and should be assembled as per the instruction. from the discharge chute. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 21 of 32 OPERATIONAL QUALIFICATION 02. Starter should be ON to start the machine. polyethylene bag etc. Actual . Reverse / Forward Direction Machine should be rotate in Reverse / forward direction depend upon the required milling. Pour the powder into the hopper Powder quantity should be assembly.No.Confidential CIP MACHINERIES PVT. To stop the machine. collection bowl. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 22 of 32 OPERATIONAL QUALIFICATION 03. decided depending upon the characteristic of the same. from the discharge chute. Starter should be OFF to stop the machine. To start the machine.0 CRITICAL OPERATIONAL ASPECTS Sr. 01 02 03 03 04 05 Operation / Activity To clean the machine Specification Hopper assembly should be dismantled to clean the machine before use and should be assembled as per the instruction. Powder Collection after sieving Powder should be collected with the suitable drum. Starter should be ON to start the machine. 0 STATEMENT OF PURPOSE The purpose of this protocol is to validate the above equipment for the operational qualification to 1. Demonstrate the suitability of the SOP is established for the equipment / system.Confidential CIP MACHINERIES PVT. Documents initial performance of the equipment / system. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 23 of 32 OPERATIONAL QUALIFICATION NAME OF EQUIPMENT: MULTI MILL MACHINE 04. 4. Demonstrate that the equipment / system will perform reproductively and consistently within its full dynamic range of operation according to manufacturers specifications. . Assure that the equipment / system performance is adequate to support the process for which the system is designed. 3. 2. 0 SOP DEVELOPMENT Subject : : Standard Operating procedure for the operation of Multi Mill Machine. Most current revision in use SOP provides adequate direction and control to ensure uniform equipment operation. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 24 of 32 OPERATIONAL QUALIFICATION 06. Comments: Machine is operated as per Standard Operating Procedure. Reviewed & Inspected by: _____________________ Date : .Confidential CIP MACHINERIES PVT.Yes / No (If no state why in comments) Operating Personnel understand and follow SOP description and requirements. Testing Date : Operating Personnel : Observing Personnel : Observation Observation . 0 DEFICEINCY (IF ANY) AND CORRECTIVE ACTIONS REPORT: Description of deficiency and date observed: Person responsible for corrective action and date assigned: Corrective actions taken and date conducted: Conducted By: Conducted By: Date: Date: Comments (If any): Verified By: Name: Signature: Date: . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 25 of 32 OPERATIONAL QUALIFICATION 07.Confidential CIP MACHINERIES PVT. MANAGER . was carried out as per standard operating procedure. CIMM-200 Location Purpose Equipment No.C. The equipment performs within the assigned limits when operated as per approved standard operating procedure.Confidential CIP MACHINERIES PVT. DATE : Q. Operating parameters that have a significant impact on the equipment ability to operate and achieve the process are satisfactory and conforms to the acceptance criteria.: 295 : : Use for sieving of the powder.0 FINAL REPORT Summary Analysis / Evaluation Certification The operation of the equipment MULTI MILL MACHINE GMP MODEL. MANAGER WORKS MANAGER MAINTENANCE MANAGER Q. The equipment: MULTI MILL MACHINE .GMP MODEL. Frequency of Validation : Validation due on or the event of any change in critical component of the machine. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 26 of 32 OPERATIONAL QUALIFICATION 08. Model No. "THE EQUIPMENT "MULTI MILL MACHINE VALIDATED AND RELEASED FOR USE.A. Performance Qualification Evaluation.Confidential CIP MACHINERIES PVT. : TABLE OF CONTENTS 01. Data Evaluation And Conclusion: 04. .GMP MODEL. Equipment Validation. 03. Final Report. : CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 27 of 32 PERFORMANCE QUALIFICATION EQUIPMENT NAME EQUIPMENT MANUFACTURER EQUIPMENT LOCATION : MULTI MILL MACHINE . LTD. 02. Confidential CIP MACHINERIES PVT. Activity 01 Proper assembly of hopper. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 28 of 32 PERFORMANCE QUALIFICATION 01.0 EQUIPMENT VALIDATION The simulation of the process was carried out by sieving of the powder from the machine. It should from the feed hopper. It should be from the discharge chute. 02 Position of Sieve 03 Pouring of Powder 04 Powder collection Functional Acceptance Criteria As per the details given with the operating manual It should be properly fixed with the wings nut. Simulation of the process consist of the following: Sr.No. Status / Observation . Confidential CIP MACHINERIES PVT. APPERANCE: 2. SIEVE ANAYALSIS PERFORMANCE CRITERIA .AFTER MILLING: 1 APPERANCE SIEVE ANAYALSIS 2 3 . LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 29 of 32 PERFORMANCE QUALIFICATION 2.BEFORE MILLING: 1.0 PERFORMANCE QUALIFICAION EVALUATION: NAME OF MATERIAL: PERFORMANCE CRITERIA . 0 DATA EVALUATION AND CONCLUSION: Based on the quality control results generated by simulating the process and its review. Reviewed by: _____________________Date : .Confidential CIP MACHINERIES PVT. it can be said that machine performs satisfactory and conforming to the acceptance criteria. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 30 of 32 PERFORMANCE QUALIFICATION 03. was carried out as standard operating procedure. Performance parameters that have a significant impact on the equipment ability to operate and achieve the process are satisfactory and confirms to the acceptance criteria. The equipment: MULTI MILL MACHINE . Frequency of Validation : Validation due on or the event of any change in critical component of the machine.: 295 : : Use for milling of the powder.GMP MODEL. MANAGER . "THE EQUIPMENT "MULT MILL MACHINE VALIDATED AND RELEASED FOR USE. Model No.C. CIMM200 Location Purpose Equipment No. per The equipment performs within the assigned limits when operated as per approved standard operating procedure. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 31 of 32 PERFORMANCE QUALIFICATION 04. MANAGER WORKS MANAGER MAINTENANCE MANAGER Q.0 FINAL REPORT Summary Analysis / Evaluation Certification The performance of the equipment MULTI MILL GMP MODEL.A. DATE : Q.Confidential CIP MACHINERIES PVT. LTD VALIDATION PROTOCOL FOR MULTI MILL MACHINE PAGE 32 of 32 .Confidential CIP MACHINERIES PVT.