Installation Qualification for Vibratory Sifter (Single Deck)

Installation Qualification for Vibratory Sifter (Single Deck)


Equipment Identification
Equipment location
Pre-requisite of Installation Qualification
Installation Qualification Procedure
System Description
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



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.


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.


The Equipment is identified  as Vibratory Sifter (Single Deck)
Model No. Single Deck
Serial No.
Tag No.
Purchase Order Number / Date


Facility: Oral Cephalosporin’s Facility

Floor: Ground Floor

Area: Process Area

Room Name: Wet Granulation


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 :


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.


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.


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.


Installation Check List 

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

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


Description of deviation and date observed

Person responsible for corrective action and date assigned

Corrective action taken and date conducted


Change Observed / Made Reason


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.


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.

Checks Observations
Whether acceptance criteria of the protocol and Specific check points are met.


 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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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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