Production

IQ OF INSPECTION CONVEYOR

INSTALLATION QUALIFICATION OF INSPECTION CONVEYOR

Contents

  • Pre Execution Approval
  • Objective
  • Equipment Description
  • Participants Log
  • Installation Qualification Checklist
  • Sub-Component CheckList
  • Component Location List
  • MOC Verification List
  • Test / Inspection Reports
  • Utility Verification List
  • Attachment Log
  • Summary, Conclusion, and Recommendation
  • Abbreviations
  • Post Execution Approval

PRE-EXECUTION APPROVAL

Prepared by

By signing, the person is responsible for the accuracy of this Installation Qualification and agrees with the content

Approved by

The signature on this page indicates that this document has been reviewed, checked, and approved by the concerned person. It shall be signed and dated.

OBJECTIVE:

Installation Qualification protocol for Inspection Conveyor 3.1/2” x 5 ft Triple Line is written to comply with requirements for Qualification. Qualification of critical equipment is a GMP requirement.

Scope of Qualification:

The scope is limited to Inspection Conveyor 3.1/2” x 5 ft Triple Line.

The purpose of this protocol is as follows:

  • To provide documented evidence that the Inspection Conveyor 3.1/2” x 5 ft Triple Line is installed as per design.
  • To collect the required information for installation of Inspection Conveyor 3.1/2” x 5 ft. Triple Line in order to assure the equipment functions as per the desired operating specifications.

EQUIPMENT DESCRIPTION:

Inspection Conveyor of 3.1/2” x 5 ft Triple Line is used for feeding bottles to the subsequent machine for further operation.

Basic Constructional Features:

  • The Unit is compact, versatile, and enclosed in S.S. elegantly hair finish body
  • SS Slat Conveyor
  • All non-contact parts shall be of SS304 / cladded with SS 304
  • Totally enclosed drive with a gearbox mounted on a structure.
  • No external lubrication is required since gearing is enclosed in the oil bath

Description:

  • The Main Motor drive unit is fitted with a Flange mounted on a reduction gearbox.
  • A separate A.C. frequency drive is fitted with the machine for speed control of the conveyor.
  • The drive assembly with gearbox and motor is mounted on the structure.

PARTICIPANTS LOG:

All persons involved in the execution of this protocol must sign

INSTALLATION QUALIFICATION CHECKLIST:

Checks to be performed
Check for the Dimensional accuracy
Check for the receipt of the consignment in good condition
Check for the Motor and the Gearbox
Check for the alignment of the drive

The purpose of this checklist is to check and document the receipt of equipment and spares as per the Purchase order.

SUBCOMPONENT CHECKLIST:

Sr. No.Component

(Make + Specs.)

Observation
1.       MAIN MOTOR

MAKE : BONFIGLIOLI

0.25HP/0.18KW/1.01A/230V/

1360RPM/3PHASE

SRNO.210380522292

2.       MAIN GEAR BOX

MAKE : BONFIGLIOLI

MODEL : VF44 F120 P63 B5B3

SRNO.09 B03202500180

RATIO : 20:01

3.       MAIN A.C DRIVE

MAKE : ALLEN BRADLEY

MODEL : 22F-A2P5N103

0.5HP/2.5A/230V

SRNO.FA2P5NOW21030279

4.       MAIN SWITCH

MAKE : SCHNEIDER

5.       MACHINE DIMENSION

1520mm L x 850mm W x 1550mm H

COMPONENT LOCATION LIST:

Component
Location
Observation
Main MotorCoupled to the main Gear Box
Main Gear BoxOn the machine structure

MOC VERIFICATION LIST: (REFERENCE TO CERTIFICATES):

ComponentMOCObservation
Machine frame structureSS  304 
ConveyorSS 304 
SprocketNylon 

TEST / INSPECTION REPORTS:

DocumentsType
 MotorTest Certificate
Gear BoxTest Certificate
A.C. DriveTest Certificate

UTILITY VERIFICATION LIST:

Utility ParameterMethod  of VerificationAcceptance Criteria
Electrical power supplyBy Multi meterSingle Phase ,230 to 415 V

ATTACHMENT LOG:

All documents attached to this protocol should be listed in the following log. If the attachment is more than one page then denote the number of pages along with the protocol number, signature, and date on the first page of the attachment.

SUMMARY, CONCLUSIONS, AND RECOMMENDATIONS:

ParameterComment (Yes / No/NA)
Did the IQ Protocol comply with all the parameters laid down in the document?
Did the IQ invite any deviation?
In case of any deviation, is it acceptable?

ABBREVIATIONS:

Abbreviation
Expanded Form

IQ

Installation Qualification

NANot Applicable
GMPGood Manufacturing Practice
SSStainless Steel
RPMRevolution Per Minute
HPHorse Power
VVolts
HzHertz
A.C.Alternating Currant
MOCMaterial Of Construction

POST EXECUTION APPROVAL

Approver’s signature

Approver’s signature indicates all the test mentioned in Protocol has been completed and all the amendment and discrepancies are documented approved attached to the protocol. The signature in the below blocks indicates that the qualification report has been reviewed and found to an acceptable state and all the discrepancies have been satisfactorily resolved.

Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 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, Panacea Biotec Ltd, and Nectar life Science 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