Installation Qualification for Vibratory Sifter (Single Deck)

Installation Qualification for Vibratory Sifter (Single Deck)

TABLE OF CONTENTS

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 

EQUIPMENT LOCATION 

Facility: Oral Cephalosporin’s Facility

Floor: Ground Floor

Area: Process Area

Room Name: Wet Granulation

DOCUMENTATION:- 

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 

Inspection Check List 

Leveling and alignment 

 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 

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 

• Drawings Execution
  

Identification of Standard Operating Procedures 

Supporting Utilities Check 

Identification of Critical Instruments for Calibration / Testing 

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 

REVALIDATION CRITERIA

Installation Qualification to be re-qualified on

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: 

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._________________.

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