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Installation Qualification for Vibratory Sifter (Single Deck)

TABLE OF CONTENTS

1.0 Approval
2.0 Objective
3.0 Responsibility
4.0 Equipment Identification
5.0 Equipment location
6.0 Documentation
7.0 Pre-requisite of Installation Qualification
8.0 Installation Qualification Procedure
9.0 System Description
10.0 Procedure
10.1 Installation Check List
10.2 Inspection Check list
10.3 Leveling and Alignment 
10.4 Material of Construction Check Points 
10.5 Guarantee / Warrantee Certificates
10.6 Drawing Execution
10.7 Identification of Standard Operating Procedures 
10.8 Supporting Utilities Check
10.9 Identification of Critical Instruments Calibration/Testing
11.0 Deviation and Corrective action
12.0 Change Control Proposal
13.0 Revalidation Criteria
14.0 Acceptance Criteria
15.0 Summary
16.0 Conclusion
  • APPROVAL
Prepared By Signature Date
[Sr. Officer Production]
Checked By Signature Date
Manager – Production
Manager – Engineering
Approved By Signature Date
[Manager – Quality Assurance]
Authorized By Signature Date
[GM – Formulations]
  • OBJECTIVE: –

The purpose of this protocol is to provide an outline for the inspection of equipment for static attributes to verify that:

  • The system meets the Design Specification / Qualifications.
  • The system is installed according to the manufacturer’s recommendations.
  • The system meets the current Good Manufacturer’s Practice (cGMP) requirements.
  • All supporting utilities are properly connected.
  • All critical components have been identified and calibrated.
  • No unauthorized or unrecorded modifications have taken place.
  • The equipment operation has been verified for its intended use.
  • Standard Operating Procedure have been identified and listed.
  • RESPONSIBILITY: –  

The validation group comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol:

  • Engineering Department
  • Production Department
  • Quality Assurance Department

The Manager Plant shall be responsible for providing the area meant for the installation of the equipment. The Production and Engineering shall be responsible for checking the installation and recording installation data as per the procedures outlined in this protocol. The Manager Engineering shall be responsible for verifying the data recorded in the Installation Qualification Protocol.

The Quality Assurance Department shall be responsible for the final review of the qualification documents and its compliance to meet the acceptance criteria of the Installation Qualification protocol.

The final authorization of the document shall be done by the General Manager – Formulations.

  • EQUIPMENT IDENTIFICATION 
The Equipment is identified  as : Vibratory Sifter (Single Deck)
Model No. : Single Deck
Serial No. :
Tag No. :
Name of the Supplier : SAINATH BOILER & PNEUMATICS
Purchase Order Number / Date :
  • EQUIPMENT LOCATION 

Facility                            :                  Oral Cephalosporin’s Facility

Floor                               :                  Ground Floor

Area                                :                  Process Area

Room Name                   :                  Wet Granulation

Room ID                         :                  _______________

  • DOCUMENTATION:- 
S. No. Document Name Annexure No.
1 Data Sheet / User Requirement Specification
2 Purchase Order Copy
3 Design Qualification

 

  • To check the leveling and alignment as per the procedure and record the observation.
  • To verify the proper assembly of the components as per the equipment drawings and  record the installation location and verification of assembly.
  • To verify the location of installation as per the equipment layout.
  • Check the installation of equipment :
  • Instructions:
  • Installation Qualification Procedure 
  • Ensure the other supporting utilities required for Installation. 
  • Ensure the Electric connections required for installation.
  • Check for correctness of mounting of equipment with respect to manufactures recommendation.
  • Check the correctness of location of the equipment to be installed with respect to layout &
  • Ensure the cleanliness of the area.
  • Machine should be open in front of validation Team.
  • PRE REQUISITE OF INSTALLATION QUALIFICATION: –
  • Identify the critical components of equipment and verify that the components are complying as per desired specifications and record the observations.
  • Check the MOC of the component and record the observation of the MOC.
  • Identify the utility supplies required for equipment operation and verify that utilities are as per the specification and record the observation.
  • Identify the critical instruments supplied with the equipment or installed on the utility supply line. Verify that instruments are as per the desired specifications. Review the calibration status of the instruments & record the status.
  • List the available drawing and record the Ref. No. for their location / availability.
  • Identify the SOPs and assign SOP Numbers, record the SOP Title and Number.
  • Record the deviation (if any) and report the details of action taken.
  • SYSTEM DESCRIPTION

Vibro sifter works on gyro principle. The required gyratory motion is obtained from specially designed gyro motor, which is fitted underneath the vibrating assembly. The complete vibrating assembly is isolated from the base by means of specially designed rugged springs. Gyro-motor is fitted with the top & bottom eccentric weights designed as per required centrifugal force. This whole assembly is covered by S.S. plate. The deck hopper is fabricated from S.S. 316 sheet. To collect the discharge tangential, discharge port is provided on the hopper. Conical shape top lid is provided with charging port. Screen is fitted in between the hopper & top lid. The machine inner & outer surfaces are mirror polished.

  • PROCEDURE 
  • Installation Check List 
S. No. Statement Y/ N / NA Checked By

Sign & Date

Verified By

Sign & Date

  Fitting of castor wheel.      
  Vent  filter connection      
  Electrical supply.      
  • Inspection Check List 
S. No. Description Specification Observation Checked By

Sign & Date

1 Overall Dimension in mm. (H x W x B) 455 x 1550 x 800
2 Diameter of sifter. 750mm  
3 Castor wheel 4  No’s  
4 Sieve diameter 750mm  
5 Gasket Silicon ,2 No’s  
6 Main  motor (Gyratory) Make: Phoenix

415V, NFLP, 0.5 HP,1440 RPM

 
7 Control panel. Flame proof  
8 Hopper S.S 316  
9 Rugged  springs Sp. Steel hard chrome plated  
10 Castor wheels PU Wheel with SS baskets & locking facilities  
11 Vent  filter 1½” Trichlover type  
  • Leveling and alignment 
S. No. Item Description Leveling / Alignment

OK / Not OK

Mode of Verification Checked By

Sign / Date

1 Level of Vibro Sifter Water Level
  •  Method for checking the Leveling of the Equipment
  • Using Spirit Level Indicator
  • Place the spirit level indicator at different points on the machine frame.
  • Acceptance Criteria:

The air bubble of the spirit level indicator shall be observed in the center.

  • Using Water Level Indicator
  • Place transparent tube filled with water of suitable length at various corners. Compare the levels of water and align the equipment
  • Acceptance Criteria:

The water level at both the locations should match with the edges of those locations, if required should be repeated for other edges of the equipment on same plane.

  • Method for checking the Alignment
  • Dial Indicator Method
  • Place the dial indicator on the coupling.
  • Rotate the shaft slowly by hand.
  • Observe the indicator reading on both sides’ rotation of the shaft.
  • Acceptance Criteria:

The total indicator reading should not be more than 0.305 mm.

  • Straight Edge Method
  • Place the straight edge along the circumferences of both driver and driven pulleys simultaneously.
  • Shift the motor base so as to adjust the gap between the straight edge and the circumferences of both the pulleys
  • Check the gap with filler gauge.
  • Acceptance Criteria:

The gap between the straight edge and pulleys should not be more than 1.0 mm

  • Material of Construction 
S. No. Name of Components MOC Mode of verification Annexure No. Checked By

Sign & Date

1 Hopper SS 316 Lab test report / Confirmed By Molybdenum Test
2 Top lid SS 316 Lab test report / Confirmed By Molybdenum Test
3 Screen SS 316 Lab test report / Confirmed By Molybdenum Test
4 Body SS 304 Lab test report / Confirmed By Molybdenum Test
5 Gasket Silicon / Neoprene Lab test report

    

  • Method for checking Material of Construction (MOC) of Stainless Steel (SS) material (Molybdenum Test):
  • Put 1 drop of electrolyte solution of the Molybdenum test kit on clean metal surface, which is to be tested.
  • Switch ON the detector and touch the metal tip of the detector on metal surface and carbon point in electrolyte.
  • Do not pass the current for more than 3 to 4 seconds.
  • If the red color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 316
  • If the solution remains colorless or green color appears then it can be concluded that the material of construction of the part being tested is S.S. 304.
  • If the Black color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 302.
  • Guarantee / Warrantee Certificate for Motors 
S. No. Component / Sub Component Report No. Annexure No.
1 Main Motor Not Available Annexure – 6
  • Drawings Execution
Name of Drawings Drawing No. Annexure No. Checked By

Sign & Date

Approved By

Sign & Date

G.A. Drawing Vibro sifter single deck
Electrical
  • Identification of Standard Operating Procedures 
S. No. SOP’s SOP’s No. Title Identified By / Date
1 Operating SOP for Operation of Vibratory Sifter (Single Deck)
2 Cleaning SOP for Cleaning of Vibratory Sifter (Single Deck)
3 Preventive Maintenance SOP for Preventive Maintenance of Vibratory Sifter (Single Deck)
  • Supporting Utilities Check 
S. No. Utility Specification Observation Checked By

Sign & Date

Approved By

Sign & Date

1 Power 2.5 mm² , 3 Phase,415 V,  50 Hz.  
  • Identification of Critical Instruments for Calibration / Testing 
S. No. Component Parameter/ Function Instrument Details Checked By

Sign / Date

1 Not Applicable Not Applicable Not Applicable
  • DEVIATION AND CORRECTIVE ACTION

Description of deviation and date observed

Person responsible for corrective action and date assigned

Corrective action taken and date conducted

  • CHANGE CONTROL PROPOSAL 
Sr. Change Observed / Made Reason Verified By (Production)

Sign & Date

Approved By (Q.A.)

Sign & Date

  • REVALIDATION CRITERIA

Installation Qualification to be re-qualified on

Replacement of major component of the equipment with a new component.
Any major modification in the existing equipment.
Shifting of the equipment from one location to another.
  • ACCEPTANCE CRITERIA   

Installation Qualification shall be considered acceptable when all the conditions specified above table have been met.

Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component.

  • SUMMARY: 
Checks Observations Remarks
Whether acceptance criteria of the protocol and Specific check points are met.
Yes/No

CONCLUSION 

Vibratory Sifter [Single Deck]  Is / Is Not qualifying the installation qualification test as per the guideline described in this Protocol No. IQ / ________________. Vibratory Sifter [Single Deck] can Be / Not Be tested for its operational qualification as per Protocol No._________________.

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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