Installation Qualification for Vibratory Sifter (Single Deck)
TABLE OF CONTENTS
| Approval | |
| Objective | |
| Responsibility | |
| Equipment Identification | |
| Equipment location | |
| Documentation | |
| Pre-requisite of Installation Qualification | |
| Installation Qualification Procedure | |
| System Description | |
| 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 |
| Deviation and Corrective action | |
| Change Control Proposal | |
| Revalidation Criteria | |
| Acceptance Criteria | |
| Summary | |
| Conclusion | |
APPROVAL
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 of Engineering shall verify 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
DOCUMENTATION:-
| Document Name |
| Data Sheet / User Requirement Specification |
| Purchase Order Copy |
| 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 the 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 the required centrifugal force. This whole assembly is covered by S.S. plate. The deck hopper is fabricated from S.S. 316 sheet. A discharge port is provided on the hopper to collect the tangential discharge. 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
| Statement |
| Fitting of castor wheel. |
| Vent filter connection |
| Electrical supply. |
Inspection Check List
| Description | Specification |
| Overall Dimension in mm. (H x W x B) | 455 x 1550 x 800 |
| Diameter of sifter. | 750mm |
| Castor wheel | 4 No’s |
| Sieve diameter | 750mm |
| Gasket | Silicon ,2 No’s |
| Main motor (Gyratory) | Make: Phoenix
415V, NFLP, 0.5 HP,1440 RPM |
| Control panel. | Flame proof |
| Hopper | S.S 316 |
| Rugged springs | Sp. Steel hard chrome plated |
| Castor wheels | PU Wheel with SS baskets & locking facilities |
| Vent filter | 1½” Trichlover type |
Leveling and alignment
| Item Description | Leveling / Alignment
OK / Not OK |
Mode of Verification |
| 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 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
| Name of Components | MOC | Mode of verification |
| Hopper | SS 316 | Lab test report / Confirmed By Molybdenum Test |
| Top lid | SS 316 | Lab test report / Confirmed By Molybdenum Test |
| Screen | SS 316 | Lab test report / Confirmed By Molybdenum Test |
| Body | SS 304 | Lab test report / Confirmed By Molybdenum Test |
| 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 |
| 1 | Main Motor |
- Drawings Execution
| Name of Drawings | Drawing No. |
| G.A. Drawing Vibro sifter single deck | |
| Electrical |
Identification of Standard Operating Procedures
| SOP’s | Title | Identified By / Date |
| Operating | SOP for Operation of Vibratory Sifter (Single Deck) | |
| Cleaning | SOP for Cleaning of Vibratory Sifter (Single Deck) | |
| Preventive Maintenance | SOP for Preventive Maintenance of Vibratory Sifter (Single Deck) |
Supporting Utilities Check
| Utility | Specification | Observation |
| Power | 2.5 mm² , 3 Phase,415 V, 50 Hz. |
Identification of Critical Instruments for Calibration / Testing
| Component | Parameter/ Function | Instrument Details |
| 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
| Change Observed / Made | Reason |
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 the decision should be taken for the rejection, replacement or rectification of the equipment/component.
- SUMMARY:
| Checks | Observations |
| 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 Protocol No. IQ / ________________. Vibratory Sifter [Single Deck] can Be / Not Be tested for its operational qualification as per Protocol No._________________.
