Brief Description

This Design Qualification for Vibro Sifter 30″ is prepared for a 30-inch Vibro Sifter used in pharmaceutical manufacturing. Its purpose is to confirm that the equipment design meets the User Requirement Specification, cGMP, process needs, and safety requirements. The Vibro Sifter is a compact and movable machine mounted on castor wheels. It is used for sifting raw materials, APIs, and excipients during manufacturing. The machine works through vibration, allowing fine material to pass through the selected mesh while coarse material remains above. The document checks important points such as equipment size, electrical supply, motor, screen diameter, materials of construction, room conditions, and safety features. Product-contact parts are mainly stainless steel 316, while non-contact parts are stainless steel 304. Safety features include MCB, mechanical guards, proper earthing, smooth metal surfaces, balancing, noise control, and an emergency switch. The protocol also defines responsibilities of Quality Assurance, Production, and Engineering during qualification.

Impact Assessment

This Design Qualification of the 30-inch Vibro Sifter will have a positive impact on equipment quality, safety, and manufacturing activities. It confirms that the machine design meets the User Requirement Specification, cGMP needs, process requirements, and safety expectations. Checking the material of construction, motor, screen size, electrical supply, room condition, and equipment dimensions helps ensure that the Vibro Sifter is suitable for its intended use. Product-contact parts made of stainless steel 316 help reduce contamination risk, while proper guards, earthing, MCB, balancing, and an emergency switch improve operator safety. Verification of drawings, specifications, utilities, and vendor details also improves equipment control and documentation. Clear responsibilities for Quality Assurance, Production, and Engineering support proper review and approval. Overall, this qualification helps prevent design-related problems, supports reliable sifting of raw materials, APIs, and excipients, and provides confidence that the equipment can be installed and used safely for routine pharmaceutical manufacturing site operations.

Questions & Answers

1. What is Design Qualification (DQ)?
   Design Qualification is documented verification that the equipment design meets the User Requirement Specification, cGMP, process, and safety requirements.
2. Which equipment is covered in this document?
   The document covers the 30-inch Vibro Sifter.
3. What is the main use of a Vibro Sifter?
   It is used for sifting raw materials, APIs, and excipients during the manufacturing process.
4. How does a Vibro Sifter work?
   A vibrating motor creates vibration. Fine material passes through the screen mesh, while coarse material remains above the screen.
5. Can the Vibro Sifter be moved from one area to another?
   Yes. It is mounted on castor wheels and may be moved as required without changing its performance.
6. What material is used for product-contact parts?
   Product-contact parts are specified as SS316, with major contact components such as the top lid, decks, and mesh listed as AISI 316L.
7. What material is used for non-contact parts?
   Non-contact parts are specified as SS304.
8. What is the screen diameter of the Vibro Sifter?
   The screen diameter is 750 mm.
9. What type of motor is used?
   A vibratory motor of 0.5 HP and 1440 RPM is specified.
10. What departments are responsible for Design Qualification?
    Quality Assurance, Production, and Engineering are responsible for review, verification, coordination, and qualification activities.
11. What safety features are checked during DQ?
    Safety checks include MCB, mechanical guards, smooth joints, proper balancing, electrical wiring, earthing, noise level, and an emergency switch.
12. What should be the noise level of the equipment?
    The noise level should be below 80 dB.
13. Why is proper earthing required?
    Proper earthing helps provide electrical safety for the machine and operator.
14. What should be done if the agreed equipment design is changed?
    The change should be handled and documented through the change control procedure.
15. What documents should be attached with the DQ report?
    Technical equipment details, engineering drawings, approved design and specifications, and other relevant documents should be attached.