DQ OF TURN TABLE

TURN TABLE DESIGN QUALIFICATION

Stainless steel Scrambler & Unscrambler, which is familiar as turn table. This is built on MS Square frame, solid guide rail & reduction gear box for jerk less & noiseless performance. Turntable is useful to ensure total synchronization, uniform flow of container and to take a turn at 90 degree to suit different machines and purposes for automatic transfer of container for further operation

TABLE OF CONTENTS

  • Objective
  • Scope
  • Responsibilities
  • Machine Description
  • Technical Specification
  • Material of Construction
  • Change Control Procedure
  • Reference Documents
  • Abbreviation
  • Approval Sheet
  • Customer Approval Sheet

OBJECTIVE:

  • To design, engineer, and supply the 30” dia. Turn Table.
  • To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document is the same at utmost transparency

SCOPE:

The scope of this qualification document is limited to the Design Qualification of 30” dia. Turn Table of containers for next operation. This qualification document is part of a validation activity for the 30” dia. Turn Table.

Qualification of support utilities is not within the scope of this qualification documents

The equipment shall be used for store and feeding containers for varies operation. The equipment shall operate under dust free environment & conditions as per the GMP requirement.

RESPONSIBILITIES:

Client:

  • To provide the URS for the equipment.
  • To perform the Factory Acceptance Test (FAT).

Manufacturer:

  • To provide the complete technical details of the equipment pertaining to its design, comprising of the following:
  • Machine Description
  • Technical Specifications for bought-out items
  • Product Contact Parts
  • Brief Process Description
  • To facilitate the client for the Factory acceptance test of the machine at their works/ site.
  • If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.

MACHINE DESCRIPTION:

Stainless steel Scrambler & Unscrambler, which is familiar as turn table. This is built on MS Square frame, solid guide rail & reduction gear box for jerk less & noiseless performance. Turntable is useful to ensure total synchronization, uniform flow of container and to take a turn at 90 degree to suit different machines and purposes for automatic transfer of container for further operation.

Process:

Container loaded on turn table manually or automatically will rotate on disc of turn table.  During rotation of turn table, the container will be guided by a SS strip towards outlet path. The output of turn cable can be maintained by A.C. Frequency drive.

TECHNICAL SPECIFICATION:

Sr. No.DescriptionSpecifications
1.                  ModelPTT-30
2.                  MAIN MOTORMAKE : BONFIGLIOLI

0.5HP/1.75A/0.37KW/1397RPM/3PHASE

3.                  MAIN GEAR BOXMAKE : FENNER

MODEL : FW-63-FL

4.                  MAIN A.C DRIVEMAKE : ALLEN BRADLEY

MODEL : 22F-A2P5N103

5.                  MAIN SWITCHMAKE : SCHNEIDER

 

6.                  MACHINE DIMENSION850mm L x 780mm W x 1040mm H

MATERIAL OF CONSTRUCTION:

Sr. NoComponentMOC
Machine frame structureMS Angle Size:40×40

Powder Coated

External claddingSS 304

CHANGE CONTROL PROCEDURE:

Any modification arising in the design at a later stage, shall be incorporated only after due authentication of Change Control Procedure. The client and the Manufacturer should authenticate the Change control procedure.

REFERENCE DOCUMENTS – ANNEXURE:

Sr. No.Documents
1.       Equipment Brochure
2.       Operational and Instructional Manual
3.       General Arrangement Drawing
4.       Electrical Circuit Diagram

ABBREVIATIONS:

Abbreviated FormExpanded Form
NANot Applicable
DQDesign Qualification
GMPGood Manufacturing Practice
URSUser Requirement Specification
HPHorse Power
RPMRevolution Per Minute
HzHertz
MOCMaterial Of Construction
SSStainless Steel
MSMild Steel

APPROVAL SHEET:

Prepared by: 

The signature below claims to have compiled the protocol with respect to the User Requirement Specification

Reviewed by:

The below signatory claims to have verified the specifications as laid in the defined qualification protocol.

Approved by:

The below signatory authenticates the protocol to have met with the specifications and that the machine is as per the defined protocol.

CUSTOMERS APPROVAL:

Reviewed by:

The Reviewer’s signature claims to have verified the specifications as laid in the defined qualification protocol.

Approved by:

The Approver authenticates the protocol to have met with the specifications as laid in the User Requirement Specification and that the machine is as per the defined protocol.

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits 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. She 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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