VALIDATION PROTOCOL

FOR
MULTI MILL MACHINE
MODEL: CIMM-200
Purchase Order No.: HPP/181439 DATED 06-10-04

Cip Machineries Pvt. Ltd.

Registered Office :
10,11 Umiya Estate,
Nr.Bharat Party Plot, N.H.No.8,
Amraiwadi, Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-287 54 10
91-79-289 25 30
91-79-297 04 06-7-8
TeleFax: 91-79-289 14 10

Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-583 59 08
91-79-583 53 41-2-3
TeleFax: 91-79-583 58 53

E-Mail : [email protected]

[email protected]
Visit us on Internet at :

www.cipmach.com / www.roll-compactor.com

OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY

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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 2 of 32

OBJECTIVE AND SCOPE:

It is the objective of this protocol to describe in detail the methodology to be adopted to qualify the
Multi Mill Machine GMP Model, intended to use in the manufacturing process. It is to establish
confidence that the Multi Mill Machine GMP Model is capable of consistently operating within
established limits and tolerance.
The protocol comprises of the following.
A) Installation Qualification:
It should describe the following:
1. Equipment Features
2. Pre Qualification
3. Statement of Purpose
4. Installation Checklist
5. Drawings
6. Materials of Construction
7. Major components verification
8. Supporting Utilities
9. Manufacturers recommendation for site acceptance test.
10. Supporting certificates and Drawings
11. Final Report
B) Operational Qualification:
It should cover the operating parameters set for the equipment operation. Validation of equipment
against these parameters should also be described.
It should also describe.
01. System description (Pre requisite of operation).
02. Sequential operational aspects.
03. Critical operational aspects.
04. Statement of purpose.
05. Operator training (user).
06. SOP development.
07. Deficiency (if any) and corrective action report.

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VALIDATION PROTOCOL FOR MULTI

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PAGE 3 of 32

08. Final report.

C) Performance Qualification:
It should cover the performance parameters set for the equipment performance. Validation of
equipment against these parameters should also be described.
It should also describe.
01. Equipment validation.
02. Performance qualification evaluation.
03. Final report.
D) Design Qualification:
01. Relevant drawings.
02. Final report.

E) Conclusion:
The Multi Mill Machine meets the acceptance criteria in reference to above parameters are declared
validated and released for use.

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CIP MACHINERIES
PVT. LTD

VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 4 of 32

INSTALLATION QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MANUFACTURER
EQUIPMENT LOCATION

: MULTI MILL MACHINE GMP MODEL.

: CIP MACHINERIES PVT. LTD.
:

TABLE OF CONTENTS
01.0 Equipment Features
02.0 Pre Qualification
03.0 Statement of Purpose
04.0 Installation Checklist
05.0 Drawings
06.0 Materials of Construction
07.0 Major Components Verification
08.0 Supporting Utilities
9.0

Manufacturers recommendation for site acceptance test.

10.0 Final Report

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VALIDATION PROTOCOL FOR MULTI

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PAGE 5 of 32

INSTALLATION QUALIFICATION
01.0 EQUIPMENT FEATURES
EQUIPMENT NAME

: MULTI MILL MACHINE GMP MODEL.

MODEL NO.

: CIMM-200

SERIAL NO.

: 295

DEPARTMENT

PURPOSE

: Milling of powder.

VALIDATION TEAM

NAME
DESIGNATION

SIGNATURE
DATE:

Q.A.
Manager

Production
Manager

Works
Manager

Maintenance
Manager

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VALIDATION PROTOCOL FOR MULTI

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PAGE 6 of 32

INSTALLATION QUALIFICATION
02.0 PRE QUALIFICATION
EQUIPMENT NAME

: Multi Mill Machine GMP Model

OUTPUT

: 50 to 200 kgs. per hour.(Depending on the material

Characteristic)

VENDOR SELECTED

: M/S Cip Machineries Pvt. Ltd.

Ahmedabad.

VENDER'S ADDRESS

: Plot No. 1903, G.I.D.C,

Phase IV, Opp. Maradia Steel Unit No. 3,
Nr. Neeka Tube Bus Stand,
Vatva, Ahmedabad.
Gujarat - 382 445.

MANUFACTURE'S NAME

: Plot No. 1903, G.I.D.C,

Phase IV, Opp. Maradia Steel Unit No. 3,
Nr. Neeka Tube Bus Stand,
Vatva, Ahmedabad.
Gujarat - 382 445.

TEAM INVOLVED IN SELECTION OF

EQUIPMENT

NAME

DESIGNATION

SIGNATURES

DATE

Project Incharge

Works Manager

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VALIDATION PROTOCOL FOR MULTI

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PAGE 7 of 32

INSTALLATION QUALIFICATION

02.1 PRE QUALIFICATION

EQUIPMENT QUALIFICATION

: Multi Mill Machine GMP Model

CERTIFICATION FROM VENDOR FOR

(A)

MATERIAL OF CONSTRUCTION

Contact parts SS 316 L

ACCEPTED FOR INSTALLATION

INSTALLATION TEAM
01.
02.
03.
04.

THE EQUIPMENT INSTALLATION IS CARRIED OUT AS PER GUIDELINES FRAMED BY

THE MANUFACTURER.

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

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PAGE 8 of 32

INSTALLATION QUALIFICATION
03.0 STATMENTS OF PURPOSE
The purpose of this protocol is to provide an outline for the inspection of equipment for
static attributes to verify that:

Each installed sub-component complies with the engineering design and equipment data
sheets / specifications.

The system is installed according to the design specifications and manufacturers

recommendations.

No unauthorized or unrecorded modifications have taken place.

Standard Operating Procedures have been identified and listed.

All supporting utilities are properly connected.

All safety features are accounted for.

All installation-testing reports are available and maintained on file.

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VALIDATION PROTOCOL FOR MULTI

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PAGE 9 of 32

INSTALLATION QUALIFICATION
05.0

INSTALLATION CHECKLIST

It shall be ensured that all civil, mechanical, electrical and instrumental requirement of the
equipment to be installed is fulfill. i.e. as bellow.
Consideration
No.

Statement

01.

Verify that the "As Built" drawings are complete and represent the design
concept.
Verify that major components are securely anchored and protected from
shock.
Verify that there is no observable physical damage

02.
03.
04.
05.
06.
07.
08.
09.

Yes/No

Verify that there is sufficient room for servicing provided

Verify that all piping and electrical connections have been done according
to the drawings.
Required electric connections are tight weather proof and grounded.
Equipment identification nameplate is visible.
Verify that all switches of starter of the machine are working satisfactory.
Proper earthing is made.

Comments: All the above-mentioned consideration is being checked and found satisfactory.

Reviewed & Inspected by: ______________________

Date :

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VALIDATION PROTOCOL FOR MULTI

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PAGE 10 of 32

INSTALLATION QUALIFICATION
06.0

DRAWINGS

Drawings are provided by the manufacturer and are complete.

Supporting relevant drawings / certificates prior to Installation of the equipment.
Sr. No.
01

Details

Ref. Drg.No.

Status

G.A drawing

Reviewed & Inspected by : ______________________

Date :

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 11 of 32

INSTALLATION QUALIFICATION
7.1 MAJOR COMPONENT VARIFICATION
Item
Hopper
Sieve
Beaters
Feed Hopper

Specification
CIP Make
CIP Make
CIP Make
CIP Make

Supporting
Certificates
SS 316 L
SS 316 L
SS 316 L
SS 316 L

Comments: Material of construction of equipment is as specified.

Review & Inspected by: _______________________Date:

Actual

Status

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 12 of 32

INSTALLATION QUALIFICATION
07.2 CONTACT PARTS MATERIALS OF CONSTRUCTION
Item Description
Hopper
Sieve
Beaters
Feed Hopper

Ref. certificate
As per attached herewith.
As above
As above
As above

Comments: Material of construction of equipment is as specified.

Review & Inspected by: _______________________Date:

Material of Construction
SS 316L
SS 316L
SS 316L
SS 316 L

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 13 of 32

INSTALLATION QUALIFICATION
7.3

MAJOR ELECTRICAL COMPONENTS

Item

Supporting Certificates

Motor
Starter

Comments: Material of construction of equipment is as specified.

Review & Inspected by: _______________________Date:

Status

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 14 of 32

INSTALLATION QUALIFICATION
08.0

SUPPORTING UTILITIES

List the supporting utilities and record whether or not they are properly connected and identified.
Utility

Properly Connected and

Identified (Yes/No)

Electrical connection
Water Connection
Air connection to clean the Machine

Comments: Utilities are properly attached.

Reviewed & Inspected by: ______________________

Date :

Checked by

Date

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 15 of 32

INSTALLATION QUALIFICATION
09.0

MANUFACTURERS RECOMMENDATION FOR SITE ACCEPTANCE TEST

Sr.No.
01
02
03
04

Description
Electrical Connection
Water Connection
Foundation
Compressed Air
connection

Specification
Four core cable to be connected to the machine
To clean the machine
Not applicable
Pressure 8 kg/cm2 for cleaning purpose.

Actual

Sign and Date:

Service Engineer

Plant Manager

Quality Engineer

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VALIDATION PROTOCOL FOR MULTI

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PAGE 16 of 32

INSTALLATION QUALIFICATION
10. SUPPORTING CERTIFICATES & DRAWINGS :
Sr. No.
1
2
3

Descriptions
RELEVENT DRAWINGS
MOC CERTIFICATES
BOUGHTOUT ITEMS CERTIFICATES

Actuals

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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 17 of 32

INSTALLATION QUALIFICATION
11.0

FINAL REPORT

11.1

Summary:
The equipment shall be procured as per specification to M/s ALEMBIC LIMITED,
Installation is carried out as per manufacturers recommendations and user applicability.
supporting utilities will be connected.

11.2 Analysis / Evaluation:

The machine shall be installed at the location. Supporting utilities shall be connected and
Used for Functioning properly. Standard operating procedure shall be identified and listed.
History card shall be prepared for the equipment. All relevant critical document and
drawing shall be verified by the user.

Reviewed & Inspected by: ___________________

Date :

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CIP MACHINERIES
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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

OPERATIONAL QUALIFICATION
EQUIPMENT NAME
: MULTI MILL MACHINE GMP MODEL.
EQUIPMENT MAKE
: CIP MACHINERIES PVT. LTD.
EQUIPMENT LOCATION :
TAB LE O F C O N T E N T S
1.0

System Description (Pre requisite of operation)

2.0

Sequential Operational aspects.

3.0

Critical Operational aspects.

4.0

Statement of Purpose

5.0

Operator Training (User)

6.0

SOP Development

7.0

Deficiency (if any) and Corrective Action Report

8.0

Final Report

PAGE 18 of 32

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VALIDATION PROTOCOL FOR MULTI

MILL MACHINE

PAGE 19 of 32

OPERATIONAL QUALIFICATION
01.0 SYSTEM DESCRIPTION
CIP MACHINERIES PVT LTD, Multi Mill Machine is a machine for milling of the powder with
output of 75-100 kg/hour. The unit consists of:

Base Plate

Support Pillar

Motor mounting

Hopper assembly

Sieve

Feed Hopper

The system has utilities like electrical connection and air connection connected to it.

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VALIDATION PROTOCOL FOR MULTI

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PAGE 20 of 32

OPERATIONAL QUALIFICATION
01.1 SYSTEM DESCRIPTION

Item
Base Plate
Support Pillar
Motor mounting

Description

Hopper Assembly

The base plate is mounted on four wheels.

Drive assembly is mounted on the support pillar.
Motor is mounted on the motor mounting plate with the
help of four bolts.
Hopper assembly consists of Rotor assembly, Beaters etc.

Sieve

Sieve is mounted inside the hopper assembly.

Feed Hopper

Feed hopper is mounted on the upper portion of the

hopper.

Status

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VALIDATION PROTOCOL FOR MULTI

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PAGE 21 of 32

OPERATIONAL QUALIFICATION
02.0 SEQUENTIAL OPERATION ASPECTS

Sr.No.
01
02
03

04
05
06

07
08

Operation / Activity
Cable from machine to main switch.

Specification
It should be four core three
phase.
Fix the plug as per the cable and It should be suitable to the
main switch.
three phase supply
To clean the machine
Hopper assembly should be
dismantled to clean the
machine before use and should
be assembled as per the
instruction.
To start the machine.
Starter should be ON to start
the machine.
To stop the machine.
Starter should be OFF to stop
the machine.
Reverse / Forward Direction
Machine should be rotate in
Reverse / forward direction
depend upon the required
milling.
Pour the powder into the feed Powder quantity should be
hopper.
decided depending upon the
characteristic of the same.
Powder Collection after sieving
Powder should be collected
with the suitable drum,
collection bowl, polyethylene
bag etc. from the discharge
chute.

Actual

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VALIDATION PROTOCOL FOR MULTI

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PAGE 22 of 32

OPERATIONAL QUALIFICATION
03.0 CRITICAL OPERATIONAL ASPECTS

Sr.No.
01

02
03

03
04
05

Operation / Activity
To clean the machine

Specification
Hopper assembly should be
dismantled to clean the machine
before use and should be
assembled as per the instruction.
To start the machine.
Starter should be ON to start the
machine.
Reverse / Forward Direction
Machine should be rotate in
Reverse / forward direction
depend upon the required
milling.
To stop the machine.
Starter should be OFF to stop the
machine.
Pour the powder into the hopper Powder quantity should be
assembly.
decided depending upon the
characteristic of the same.
Powder Collection after sieving
Powder should be collected with
the suitable drum, collection
bowl, polyethylene bag etc. from
the discharge chute.

Actual

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VALIDATION PROTOCOL FOR MULTI

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PAGE 23 of 32

OPERATIONAL QUALIFICATION
NAME OF EQUIPMENT: MULTI MILL MACHINE
04.0

STATEMENT OF PURPOSE

The purpose of this protocol is to validate the above equipment for the operational qualification to
1. Demonstrate that the equipment / system will perform reproductively and consistently within its
full dynamic range of operation according to manufacturers specifications.
2. Documents initial performance of the equipment / system.
3. Assure that the equipment / system performance is adequate to support the process for which the
system is designed.
4. Demonstrate the suitability of the SOP is established for the equipment / system.

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PAGE 24 of 32

OPERATIONAL QUALIFICATION
06.0 SOP DEVELOPMENT
Subject

:
: Standard Operating procedure for the operation of
Multi Mill Machine.

Testing Date

Operating Personnel :

Observing Personnel :

Observation

Observation - Yes / No
(If no state why in comments)

Operating Personnel understand and follow SOP

description and requirements.
Most current revision in use
SOP provides adequate direction and control to
ensure uniform equipment operation.
Comments: Machine is operated as per Standard Operating Procedure.

Reviewed & Inspected by: _____________________

Date :

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VALIDATION PROTOCOL FOR MULTI

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PAGE 25 of 32

OPERATIONAL QUALIFICATION
07.0

DEFICEINCY (IF ANY) AND CORRECTIVE ACTIONS REPORT:

Description of deficiency and date observed:

Person responsible for corrective action and date assigned:

Corrective actions taken and date conducted:

Conducted By:

Conducted By:

Date:

Date:

Comments (If any):

Verified By:
Name:

Signature:

Date:

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VALIDATION PROTOCOL FOR MULTI

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PAGE 26 of 32

OPERATIONAL QUALIFICATION
08.0

FINAL REPORT
Summary
Analysis / Evaluation
Certification
The operation of the equipment MULTI MILL MACHINE GMP MODEL. was carried
out as per standard operating procedure.
The equipment performs within the assigned limits when operated as per approved
standard operating procedure.
Operating parameters that have a significant impact on the equipment ability to operate and
achieve the process are satisfactory and conforms to the acceptance criteria.
The equipment: MULTI MILL MACHINE - GMP MODEL.
Model No. CIMM-200
Location
Purpose

Equipment No.: 295

:
:

Use for sieving of the powder.

Frequency of Validation : Validation due on

or the event of any change in
critical component of the machine.
"THE EQUIPMENT "MULTI MILL MACHINE VALIDATED AND RELEASED FOR
USE.
DATE

Q.C. MANAGER
WORKS MANAGER

MAINTENANCE
MANAGER

Q.A. MANAGER

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VALIDATION PROTOCOL FOR MULTI

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PAGE 27 of 32

PERFORMANCE QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MANUFACTURER
EQUIPMENT LOCATION

: MULTI MILL MACHINE - GMP MODEL.

: CIP MACHINERIES PVT. LTD.
:

TABLE OF CONTENTS
01. Equipment Validation.
02. Performance Qualification Evaluation.
03. Data Evaluation And Conclusion:
04. Final Report.

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VALIDATION PROTOCOL FOR MULTI

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PAGE 28 of 32

PERFORMANCE QUALIFICATION
01.0

EQUIPMENT VALIDATION

The simulation of the process was carried out by sieving of the powder from the machine.
Simulation of the process consist of the following:
Sr.No.

Activity

01

Proper assembly of hopper.

02

Position of Sieve

03

Pouring of Powder

04

Powder collection

Functional Acceptance
Criteria
As per the details given with
the operating manual
It should be properly fixed
with the wings nut.
It should from the feed
hopper.
It should be from the
discharge chute.

Status / Observation

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PAGE 29 of 32

PERFORMANCE QUALIFICATION
2.0

PERFORMANCE QUALIFICAION EVALUATION:

NAME OF MATERIAL:
PERFORMANCE CRITERIA - BEFORE MILLING:
1. APPERANCE:
2. SIEVE ANAYALSIS
PERFORMANCE CRITERIA - AFTER MILLING:
1
APPERANCE
SIEVE ANAYALSIS

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PAGE 30 of 32

PERFORMANCE QUALIFICATION
03.0

DATA EVALUATION AND CONCLUSION:

Based on the quality control results generated by simulating the process and its review, it
can be said that machine performs satisfactory and conforming to the acceptance
criteria.

Reviewed by: _____________________Date :

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VALIDATION PROTOCOL FOR MULTI

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PAGE 31 of 32

PERFORMANCE QUALIFICATION
04.0

FINAL REPORT
Summary
Analysis / Evaluation
Certification
The performance of the equipment MULTI MILL GMP MODEL. was carried out as
standard operating procedure.

per

The equipment performs within the assigned limits when operated as per approved
standard operating procedure.
Performance parameters that have a significant impact on the equipment ability to operate
and achieve the process are satisfactory and confirms to the acceptance criteria.
The equipment: MULTI MILL MACHINE - GMP MODEL.
Model No. CIMM200
Location
Purpose

Equipment No.: 295

:
:

Use for milling of the powder.

Frequency of Validation : Validation due on

or the event of any change in
critical component of the machine.
"THE EQUIPMENT "MULT MILL MACHINE VALIDATED AND RELEASED FOR
USE.
DATE

Q.C. MANAGER
WORKS MANAGER

MAINTENANCE
MANAGER

Q.A. MANAGER

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VALIDATION PROTOCOL FOR MULTI

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PAGE 32 of 32