Installation Qualification

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT----------------------------------------------------------------------------------------------------------------------

VIBRO SIFTER VIBRO SIFTER 30” DIA. (GMP MODEL)

INSTALLATION QUALIFICATIONINSTALLATION QUALIFICATION

CLIENT

P.O. NO.

LOCATION

OUR REF. NO.

MODEL NO.

JOB NO. /S.R.NO.

Please read and understand the installation, operation and maintenance manual carefully. In case of any doubt please feel free to write us.Contents are subject to revision without any notice.CautionFailure to comply with the instructions in this manual may result in damage to equipment and personnel.

Office & Factory Address:

Allied MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

Unit No. 17, Param Industrial Estate, Naik Pada, Waliv, Vasai (East), District Thane- 401 208, Maharashtra, India. Fax: 0250 –: 2451675 Tel : 6451697, 6454301, 2451674

Email: [email protected]

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

INSTALLATION QUALIFICATION PROTOCOL

Name of the Equipment : VIBRO SIFTER 30” Dia.

Name of the client :

Name of Manufacturer : ALLIED. Unit No. 17, Param Industrial Estate, Naik Pada, Waliv, Vasai (E).

District Thane- 401 208, Maharashtra, India.

PROTOCOL APPROVAL COVER

Name Department Sign / Date

Initiated by: Documentation

Reviewed by: (Quality Assurance Dept.)

Approved by: (Project Dept.)

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CONTENTS

SR. NO. TITLE1 Unpacking & Checking 2 Introduction & Working principles3 Instruction before Operating the machine4 Angles can be adjusted by following method

5.0 Introduction (Operating Procedure)5.1 Objective5.2 Background5.3 Scope5.4 Acceptance Criteria5.5 Exceptional Conditions and Deviations5.6 Validation Approach6.0 Evaluations6.1 General6.2 Equipment and System Utilities6.3 Maintenance Program6.4 Lubricants6.5 Engineering Drawings6.6 Controls, Alarms and Interlocks6.7 SOP Identification7.0 Revalidation Criteria8.0 Deficiency and Corrective Action Report9.0 Attachments

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1. UNPACKING AND CHECKING

a) Unpack the cases and the crates carefully under the supervision of a responsible person and remove the contents without trying to force open any package.

b) Check the contents with the packing list.

c) Should any shortage be observed in the first check, the case, individual packages, also the packing materials should be thoroughly searched for a second time in the presence of person who will certify the shortage report. Similarly, for any wrong supply of parts and components, the matter should be immediately brought to the notice M/s. Bombay Pharma Equipments Pvt. Ltd. giving full reference of supply.

d) In case of breakage or damage, the nature and extent of each article, component or equipment should be documented in clear and precise terms and the report sent to the supplier within a week of the receipt of the supply.

e) All the parts and components should be thoroughly cleared of packing materials before assembly with particular reference to moving parts.

f) All contact parts should be washed thoroughly with warm water and soap before the equipment is put in production.

2. INTRODUCTION & WORKING PRINCIPLES

a) Vibro Sifter is a self-contained unit ideally suited for sieving dry, wet powders, Granules etc. We are manufactured in 12”, 20” Dia., 30” Dia., 36” Dia. & 48” Dia. in single as well as multiple deck arrangements.

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b) It uses principle of powder trumbling and interacting because of specially designed vibrating motor with adjustable petals directly mounted on a top plate, which is rested on spring pad to achieve continuous vibrations. The vibrating energy screen unit consisting of circular pretightened screen causes vibration in the vertical tangential axis and top petals causes vibration in the horizontal plain to move the material across the screen towards the discharge spot.

c) The time required for screening the powder of each batch is to be established by trial depend on the mesh used, but keeping upper limit of 250 Kgs. /hr. 2, 3 Decks may be provided for differential screening of powder.

All products contact parts of machine are made of stainless steel 316 quality & non-contact parts depending upon requirement.

3. INSTRUCTION BEFORE OPERATING OF MACHINE

The machine is made out of self-contained cylindrical ring frame.

a) Ensure that the frame is perfectly level.

b) Connect 3 Phase AC, 415 V, 50 cycle electric supply through a suitable isolator & starter.

c) Tighten all nuts and bolts (there is possibility of their getting loosened during transportation)

d) Ensure effective earthling to the equipment.

e) Electrical:i) All the electrical connections should be tightened and properly

connected.ii) Motor connections should be maintained to give clockwise rotation.

f) Charge the material in to the screen for screening.

g) Run the machine for desired screening time to be established on trial.

CAUTION:

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Insulate all electrical switches before cleaning / removing the screen.

5.0 INTRODUCTION (OPERATING PROCEDURES)

5.1 OBJECTIVE

The objective of this is to provide guidelines for the installation of the installation of Vibro sifter.

To ensure that the equipment and system are installed in the granulation area and meet the specification as set out in the design qualification document.

To ensure that the various SOPs related to the system have been identified and listed.

To ensure that all the critical instruments have been identified and documented for calibration.

5.2 BACKGROUND

Vibratory sifter is a self contained unit suited for sifting of raw materials or dry granules. The design of the equipment includes feature to assure GMP operations and easy cleaning. Safety during operation has also been considered.

Equipment Name Vibro Sifter

All Products contact parts are of S.S. 316 quality material and non-contact parts are of S.S.304 or cladded with S.S.304 quality material.

5.3 SCOPE

This report will define the procedures, documentation, acceptance criteria and revalidation criteria to establish that the equipment has been installed as required in the processing environment.

5.4 ACCEPTANCE CRITERIAThe successful execution of this report in accordance with the desired requirement as mentioned in the specification of the equipment will verify that the Vibro sifter has been installed as per GMP requirements and is ready for operation.

5.5 EXCEPTIONAL CONDITIONS AND DEVIATIONS

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Any minor changes of deviations that are necessary to comply with this report will be documented in the final report.

5.6 VALIDATION APPROACHResponsibility: Vendors (BOMBAY PHARMA) IQ Validation team Ensure that:

1. Purchase order copy is available.2. Factory Acceptance Test (FAT) document is approved and is in

place.3. Personnel responsible for installation have undergone proper

training to install the equipment.4. Required utilities are installed in right capacities.5. Following drawing are in place.

a) General Arrangement Drawing b) Electrical circuit diagramc) Location layout drawing

6. All documents like equipment manual, list of spare parts, list of lubricants etc. are available.

7. Certificates of M.O.C. are in place.8. Cleaning procedures are developed and approved.9. All materials and tooling are available for installation of the

equipment.

The equipment was installed as per the installation procedure provided in the equipment was cleaned, tagged with equipment number and was included in the preventive maintenance schedule.

Installation documents were reviewed by validation team and a report was generated for approval.

7.0 EVALUATIONS

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7.1 GeneralComplete data sheets in Attachments 1 and 2 including:

Equipment and System Description Manufacturer’s Specifications Purchase Orders Materials in Product Contact

7.2 Equipment and System UtilitiesComplete data sheets in Attachment 3 including:

Following utilities shall be required for installation of the equipment.

Electrical

7.3 Maintenance ProgramComplete data sheets in Attachment 4 including:

Equipment Maintenance Program

7.4 LubricantsComplete data sheets in Attachment 5 including:

Non In Product/Critical Component Surface Contact

7.5 Engineering Drawings7.5.1 Complete data sheets in Attachment 6 including:

Engineering Drawings

7.6 Controls, 7.6.1 Complete data sheets in Attachment 7 including:

Controls

7.7 SOP IdentificationComplete data sheets in Attachment 8 including:

Initial Cleaning

8.0 REVALIDATION CRITERIA

The equipment shall be subjected to installation, requalification only under following reasons:

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8.1 Change in location of equipment

8.2 Change in the source of any of the utilities being supplied to the equipment

8.3 Shifting of the equipment for major maintenance or modification and again location at the same place after completion of work

9 DEFICIENCY AND CORRECTIVE ACTION REPORT

.

ATTACHMENTS

IQ Data Sheets

ATTACHMENT 1IQ Data Sheets - General

EQUIPMENT AND SYSTEM DESCRIPTION

Identify and document all equipment associated with the system undergoing IQ. Add additional pages if necessary.

TECHNICAL SPECIFICATION

Sr. No. Name of Components MakeModel No. /

Part No.1 Main Motor (0.5 HP) 2 Gasket

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Contd….

ATTACHMENT 1IQ Data Sheets - General

LIST OF SPARE PARTSList all the spare parts with their manufacturer.

DESCRIPTION MANUFACTURERDust over Bombay Pharma Equipments Pvt. Ltd.Top deck Bombay Pharma Equipments Pvt. Ltd.Bottom Deck Bombay Pharma Equipments Pvt. Ltd.Sieves with Mesh Frame Bombay Pharma Equipments Pvt. Ltd.‘C’ Clamps Bombay Pharma Equipments Pvt. Ltd.Bottom deck Bombay Pharma Equipments Pvt. Ltd.Spring Bombay Pharma Equipments Pvt. Ltd.Spring locating bush Bombay Pharma Equipments Pvt. Ltd.PU Coating Wheel with Break Bombay Pharma Equipments Pvt. Ltd.

PURCHASE ORDERS

Identify all purchase orders associated with the system.

Vendor Name PO # Description

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CHECKS FOR INSTALLATION QUALIFICATION

Sr. No.

ParametersAcceptance

CriteriaObservations

Checked by

Date

1Horizontal

leveling of the equipment

Perfectly Horizontal

2Positioning of the equipment

Aligned vertically straight with

sufficient space for maintenance

3Floor

balancingNo vibrations

4Identification

PlateManufacturer’s Name

5 Surface Finish Smooth & matt

6

Any physical damage to the equipment /

floor or room walls

No scratches or damage should be

observed

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OBSERVATIONS FOR ALL ELECTRICAL CONNECTIONS PROVIDED TO THE EQUIPMENT

Sr. No.

Parameters Acceptance Criteria ObservationChecked

byDate

1

General method of the electrical wiring

A. No loose hanging cablesB. Well-insulated electrical wiring.C. Located in a safe place well protected from water seepage during machine or floor cleaning and also safe for operator during operation

2Electrical drawing

A. Electrical drawing available either pasted in the inside of the circuit box or as in the manual.

3

Switches for electrical operation of the equipment

There should be one machine switch for operating and one separate power main switch.

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ATTACHMENT 2IQ Data Sheets

PRODUCT CONTACT PARTSList all materials in the equipment that come in product contact:

Part MaterialMOC

Certificate Available?

Checked by

Date

Dust Cover SS 316 Yes / NoTop Deck SS 316 Yes / NoMesh Frame SS 316 Yes / No‘C’ clamps SS 316 Yes / NoBottom deck SS 316 Yes / No

PRODUCT NON- CONTACT PARTSList all materials in the equipment that do not come in product contact:

Part Material Checked by Date

Spring S.S.

Eccentric top weight M.S.Gasket SiliconAuxiliary top weight M.S.Base plate S.S.304 Quality

Note: Please ensure that all the certificates are available and traceable to national standards.

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UTILITIESIdentify and document the installation’s utility requirements.

Service RequirementsActual Supply

Checked By

Electrical Voltage 415 V + 10% , - 10%Phase 3Amperage 0.8 (no load)Frequency 50 Hz + 5 % - 5 % Supply wiring 2.5 sq.mm. 4.0 core Earthing Available

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EQUIPMENT MAINTENANCE PROGRAM

Sr. No.

Name of ComponentParameters to be

checkedFrequency

1 Dust cover Cleanliness Daily2 Top Lid Cleanliness Daily3 Discharge Deck Cleanliness Daily4 Sieves / Mesh Cleanliness Daily5 Gasket Cleanliness Daily6 “C” clamp Cleanliness Daily7 Shell Cleanliness Daily8 PU Coated wheel with break Check/tighten Monthly9 Bolt of base and motor Cleanliness & tighten Monthly10 Grease motor bearing Lubrication Monthly11 Motor terminal Check/tighten Monthly


LUBRICANTS NOT IN PRODUCT/CRITICAL COMPONENT SURFACE CONTACT

List lubricants that do not come in product contact.

Name Description Used ForGrease Sentinel Grease Motor bearing

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ENGINEERING DRAWINGS

Identify engineering drawings that are associated with the equipment being validated

Drawing # and Storage Location Title

Manager, Formulation Development Location Drawing

Manager, Formulation Development Equipment Drawing

Manager, Formulation Development Electrical Drawing


CONTROLS, ALARMS AND INTERLOCKS

Identify controls that are associated with the item being validated. Enter the name of the control, alarm or interlock in “Name”, describe what it does in “Function Description”

NameFunction Description Identified By / Date

Electrical Insulation Avoid accidental hazard

Earthing To avoid the shock

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SOP IDENTIFICATION

Sr. No.

ParticularsTitle of SOP SOP

Available?Checked

by

1 OperationSet up and Operation of the

Machine Yes / No

2 Cleaning

Cleaning of the Machine (Passivation Cleaning

Procedure For Equipment) Yes / No

3Preventive

Maintenance

Preventive Maintenance of the Machine Yes / No

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Documents

Installation Qualification