Qualifications & Validations

IQ of AUTOMATIC AIRJET BOTTLE AIR AND VACUUM CLEANING MACHINE

INSTALLATION QUALIFICATION of AUTOMATIC AIRJET BOTTLE AIR AND VACUUM CLEANING MACHINE

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

OBJECTIVE:

Installation Qualification protocol for Automatic Air jet bottle air& vacuum cleaning Machine with 30” dia. Turn Table is written to comply with requirements for Qualification. Qualification of critical equipment is a GMP requirement.

Scope of Qualification:

The scope is limited to Automatic Air jet cleaning & vacuum cleaning Machine with 30” dia. Turn Table

The purpose of this protocol is as follows:

  • To provide documented evidence that the Automatic Air jet bottle air & vacuum cleaning Machine with 30” dia. Turn Table is installed as per design.
  • To collect the required information for installation of Automatic Air jet bottle air& vacuum cleaning Machine with 30” dia. Turn Table in order to assure the equipment functions as per the desired operating specifications.

EQUIPMENT DESCRIPTION:

Automatic Air jet Cleaning & vacuum cleaning Machine is used to clean the Bottle with air & vacuumed to the subsequent machine for further operation.  It is for 80-120 Bottles per minute.

Basic Constructional Features:

  • The Unit is compact, versatile, and enclosed in S.S. elegantly hair finish body.
  • All non-contact parts shall be of SS304 / cladded with SS 304.

Description:

  • The Main Motor on the gear box.
  • The Blower Motor.
  • C. frequency drive is provided for speed control.

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

SUBCOMPONENT CHECKLIST:

  • Component (Make + Specs.)
  • MAIN MOTOR:1HP/0.75KW/3A/230V/1415,RPM/3PHASE
  • BLOWER MOTOR:0.5HP/0.37KW/0.85A/415V/ 2815RPM/3PHASE
  • TURN TABLE GEARBOX
  • MAIN GEARBOX
  • MAIN A.C DRIVE
  • SOLENOID VALVE
  • PRESSURE GUAGE
  • AIR FILTER REGULATOR
  • AIR FILTER
  • AIR SWITCH
  • CONTACTOR
  • OLR
  • MCB
  • SMPS

COMPONENT LOCATION LIST:

Main Motor: Coupled to the main Gear Box

Main Gear Box: On the machine structure

Blower Motor: On the machine structure

MOC VERIFICATION LIST: (REFERENCE TO CERTIFICATES):

ComponentMOC
Machine frame structure (Square pipe)SS 304
Star PlateNylon
Air jet NozzleSS 304
Guide RailSS 304
Turn TableSS304 cladding

TEST / INSPECTION REPORTS:

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

UTILITY VERIFICATION LIST:

Utility ParameterMethod  of VerificationAcceptance Criteria
Electrical power supplyBy Multimeter3 Phase,415 ± 5%
FrequencyBy Multimeter50 Hz
Output Voltage from TransformerBy Multimeter230  ± 5%

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:

Parameter
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
IQInstallation 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 and 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.

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