VALIDATION PROTOCOL

FOR
DUST EXTRACTOR MACHINE
GMP MODEL
Purchase Order No.: HPP/170291 DATED 11-03-04

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: 91-79-2287 54 10
91-79-2289 25 30
91-79-2297 04 06-7-8
TeleFax: 91-79-2289 14 10
Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-2583 59 08
91-79-2583 53 41-2-3
TeleFax: 91-79-2583 58 53

E-Mail : cipmachad1@sancharnet.in
sales@cipmach.com

Visit us on Internet at : www.cipmach.com / www.roll-compactor.com

OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY

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Table of Content
Section Description
No.
1.0 Title
2.0 Objective
3.0 Scope
4.0 Re – qualification criteria
5.0 Over view of equipments / description
6.0 Definition
7.0 Responsibilities
7.1 Quality Engineering
7.2 Quality Assurance
7.3 Quality Control
7.4 Purchase
7.5 Production
7.6 Engineering
8.0 Indented use of instrument
9.0 Acceptance Criteria
10.0 Reference
11.0 Installation Qualification
12.0 Standard Operating Procedure
13.0 Operation Qualification
14.0 Performance Qualification
15.0 Preventive Maintenance Schedule
16.0 Final Conduction and recommendations
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1.0 Title : Protocol for qualification of Dust Extractor Machine.

2.0 Objective : The objective of this protocol is to define the installation, operation and
performance Qualification requirement and qualifying criteria recommended from its Design
specification.

3.0 Scope : This qualification protocol is applicable to the Dust Extractor Machine.

4.0 Re – qualification Criteria

Re – qualification will be recommended in the following cases:

a. When there is change in location of the equipment.

b. When there is major modification in the equipment.
c. When there is major breakdown, which have direct impact on performance of the
equipment.

Re – qualification shall be recommended by Quality Engineering.

5.0 Overview of Equipment / Description:

The equipment is a self-contained unit for collection of dust from the tableting etc. machine.

6.0 Definition

Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists
of the following:

a. Installation Qualification: A documents verification of the installation in the selected user

environment to comply with the approved design, the manufacturer’s recommendations and or
user requirements.
b. Operation Qualification: A documents demonstration that facilities and operation work to
functional design specifications.
c. Performance Qualification: A documents verification of the performance in the selected user
environment to comply with the approved design, the manufacturer’s recommendations and or
user requirements.
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DUST EXTRACTOR MACHINE

7.0 Responsibilities:

7.1 Quality Engineering:

- Preparation, approval and implementation of the protocol.
- On going compliance of the system.
- Organizing the activities related to qualification.
- Co – ordination with production, engineering purchase department.
- Qualification reports preparation.
7.2 Quality Assurance:
- Review, monitoring and approval of the protocol.
- On going compliance of the quality system.
7.3 Quality Control:
- Analysis of samples if any.
- Recording the QC raw data.
7.4 Purchase:
- Organization Preparation, approval and implementation of the protocol.
- Purchase order preparation.
- Co-ordination with vendor for related activities.
7.5 Production:
- Organizing the activities related to qualification in production area.
- SOP preparation for operation.
- Routine calibration and maintenance implementation.
- Report review and training of users.
7.6 Engineering:
- Providing the design specification.
- Inspection at vendor site.
- Utilities arrangement for equipment.
- Organize the calibration of parts of equipments & instruments as a whole.
- Organizing the activities related to qualification.

8.0 Intended use of the Equipment: The Dust Extractor Machine shall be used for suction of dust.

9.0 Acceptance Criteria:

a. Equipment shall be supplied and installed as per pre – determined specification Purchase Order.
b. Material of construction and finish surface of equipment shall be as per pre – determined
specification.
c. All Utilities connected with the equipment shall be as per requirement.
d. All components of the equipment shall work or function as defined.
e. Equipment shall perform for its intended use as specified.

10.0 Reference:

a. Technical specification / Operation Manual

b. GA drawing / Exploded drawing
c. Purchase order copy
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d. FAT and SAT report recommendation.

11.0 Installation Qualification:

11.1 Equipment Details:

Equipment Name Dust Extractor Equipment Type
Machine
Location (Floor)
Designed By Location (Plant)
Date of Installation

11.2 Major Components & Material of Construction:

Sr. Description Specification Actual Remarks
No.
01 Chamber SS 316
02 Impeller CIP MAKE
03 Cotton Bag CIP MAKE
04 Motor 1 Hp
05 Wheel Pu

11.3 Utility Details:

Sr. Utilities recommended by Specification Utility connected Remarks
No. the vendor with the
equipment
01 Electrical 1 Hp, 3 phase
02 Chilled water NA
03 Cooling water NA
04 Hot water NA
05 Compressed air NA
06 Steam pressure NA

11.4 Installation Checks:

Sr. Test Test Procedure Observation
No.
01 Position as per GA drawing Ensure that position of
equipment is as per the
GA drawing
02 Electrical connection Check 3 phase supply to
starter through a proper
isolator with suitable
backup MCBs.
04 Direction of Motor Check direction of motor
depending upon suction
05 Earthing Check the earthing of
machine
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DUST EXTRACTOR MACHINE
Installation done by: Verified by:

11.5 FINAL REPORT

Summary:

The equipment shall be procured as per specification. Installation is carried out as per
manufacturers recommendations and user applicability. Supporting utilities will be connected.

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. The user shall verify all relevant critical document and
drawing.

Reviewed & Inspected by: ___________________ Date :

Approval:

Area Representative Signature Date

Production
Engineering Services
Quality Engineering
Quality Assurance
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12.0 Standard Operating Procedure:

Draft SOP of the equipment shall be available

SOP No. Title Location Effective Revision Remarks

Date No.
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13.0 Operational Qualification:

13.1 Procedure: The equipment (Dust Extractor Machine) shall be checked for the following
parameters:

13.2 Operational Checks:

Sr. Activity Specification Observation Remarks

No.
01 On / Off Test Machine should be
ON and OFF with
operating buttons
03 Start Machine with proper Smooth running
suction direction
04 Test for vibration No abnormal
vibration
05 Test for noise No abnormal Noise
should be there.
06 Stopping of the Machine Machine should
STOP

13.3 Safety Features:

Sr. Safety features Method of Target Actual Remarks

No. provided with Verification
the equipment
01 Proper earthing to Ensure that there is Complete
the machine no loose earthing earthing
02 Safety interlocks Should work as No deviation
if any designed

13.4 Training:

Following operating / maintenance personnel were trained by the vendor and authorized to operate
or carryout routine maintenance of the equipment.

Name Designation Date of Training Trained by

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13.5 FINAL REPORT

Summary

The operation of the equipment DUST EXTRACTOR MACHINE is 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 confirms to the acceptance criteria.

Equipment: DUST EXTRACTOR MACHINE

Location :

Purpose : Use for suction of the dust.

Frequency of Validation: Validation due on or the event of any change in critical

component of the machine.

"THE EQUIPMENT "DUST EXTRACTOR MACHINE” VALIDATED AND RELEASED

FOR USE.

Approval:

Area Representative Signature Date

Production
Engineering Services
Quality Engineering
Quality Assurance
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14.0 PERFORMANCE QUALIFICATION

14.1 EQUIPMENT VALIDATION

The simulation of the process was carried out by connection with the specific machine.

Simulation of the process consist of the following:

Sr.No. Activity Functional Acceptance Status / Observation

Criteria
01 Proper assembly of cotton bags As per the details given with
the operating manual
02 Position of chamber It should be properly fixed
with machine and fixed with
knobs.
03 Powder suction It should be from the specific
machine with this machine to
be attached.

14.2 PERFORMANCE QUALIFICAION EVALUATION:

NAME OF TABLET:

PERFORMANCE CRITERIA - BEFORE CONNECTING THIS MACHINE:

1. APPERANCE :
2. ANAYALSIS

PERFORMANCE CRITERIA - AFTER CONNECTING THIS MACHINE:

1 2 3
APPERANCE
ANAYALSIS

14.3 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 confirming to the acceptance criteria.

Inspected by: _____________________Date :