Brief Description

This Installation Qualification (IQ) Protocol cum Report is prepared for a 30-inch Vibro Sifter used in pharmaceutical manufacturing. Its main purpose is to confirm that the equipment and all its parts are installed correctly as per approved specifications, design documents, and supplier requirements. The Vibro Sifter is a movable, self-contained machine used for separating fine and coarse materials through a vibrating screen. During qualification, important checks are performed for equipment location, leveling, electrical connections, earthing, working space, illumination, safety guards, and proper installation. The material of construction of product-contact parts, machine dimensions, motor details, screen size, and other components are also verified. Required documents such as design qualification, technical specifications, drawings, and material certificates are checked before execution. Production, Engineering, and Quality Assurance departments jointly perform and review the qualification. Any deviation or change is recorded, reviewed, and approved before final conclusion and recommendation for safe and reliable routine operation.

Impact Assessment

The Installation Qualification of the 30-inch Vibro Sifter will have a positive impact on equipment reliability, product quality, and operator safety. The qualification confirms that the Vibro Sifter is installed correctly as per approved specifications and supplier requirements. Important items such as machine location, leveling, electrical connections, earthing, illumination, working space, and safety guards are checked during qualification.

The material of construction, equipment dimensions, motor details, screen size, and other components are also verified to ensure that they meet the required specifications.
Proper verification helps identify installation problems before routine use. Any deviation found during qualification can be recorded, reviewed, and corrected. This reduces the risk of equipment failure, unsafe operation, and improper sifting. Overall, the IQ activity provides documented evidence that the Vibro Sifter is properly installed and suitable to proceed for further qualification and routine pharmaceutical manufacturing activities.

Questions & Answers

1. What is the purpose of Installation Qualification (IQ) for the Vibro Sifter?
   The purpose is to confirm with documented evidence that the Vibro Sifter and its components are installed according to approved specifications and supplier requirements.
2. Which equipment is covered in this IQ protocol?
   The protocol covers the 30-inch Vibro Sifter, manufactured/supplied by Elicon Pharma.
3. What is the main function of a Vibro Sifter?
   It separates material according to particle size using a vibrating screen. Fine material passes through the mesh, while coarse material remains above the screen.
4. Which departments are involved in the qualification?
   Quality Assurance, Production, and Engineering are involved in reviewing, executing, monitoring, and approving the qualification activity.
5. Which documents should be checked before qualification?
   Design Qualification documents, P&ID, electrical diagrams, equipment technical specifications, and material-of-construction certificates should be checked.
6. What installation conditions are checked?
   Leveling, smooth edges, proper welding, installation location, room condition, illumination, and sufficient working space are checked.
7. What electrical requirements are verified?
   Voltage, phase, frequency, secured electrical connections, tightened terminals, and proper earthing are verified.
8. What is the required electrical supply?
   The equipment requires 415 V, 3-phase, 50 Hz electrical supply.
9. What material is used for major product-contact parts?
   Major product-contact parts such as the top lid, top deck, bottom deck, mesh, base, and clamp are specified as AISI 316 stainless steel.
10. What safety items are checked during IQ?
    Proper equipment installation, electrical wiring, earthing, guards for moving parts, and the Start/On-Off switch are checked for safety.
11. What should be done if a deviation is found?
    The deviation should be recorded and handled through the defined deviation section of the IQ report before final review and conclusion.
12. What happens after completion of Installation Qualification?
    The qualification results are reviewed, a conclusion and recommendation are recorded, and the protocol is finally approved by the concerned departments.
13. Why is Installation Qualification important?
    It provides documented evidence that the Vibro Sifter has been installed correctly and that required installation, component, electrical, and safety checks have been completed before further use.
14. What is the screen diameter of the Vibro Sifter?
    The specified screen diameter is 750 mm.
15. What is the minimum illumination requirement around the equipment?
    The illumination should be not less than 300 Lux.