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Validation Protocol for Dust Extractor Machine


Table of Content

Section No.

Description

1

Title

2

Objective

3

Scope

4

Re – qualification criteria

5

Overview of equipments / Description

6

Definition

7

Responsibilities

7.1

Quality Engineering

7.2

Quality Assurance

7.3

Quality Control

7.4

Purchase

7.5

Production

7.6

Engineering

8

Indented use of instrument

9

Acceptance Criteria

10

Reference

11

Installation Qualification

12

Standard Operating Procedure

13

Operation Qualification

14

Performance Qualification

15

Preventive Maintenance Schedule

16

Final Conduction and recommendations



Title:
Protocol for qualification of Dust Extractor Machine.

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


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

Re–qualification Criteria:
Re – qualification will be recommended in the following cases:
  1. When there is change in location of the equipment.
  2. When there is major modification in the equipment.
  3. When there is major breakdown, which have direct impact on performance of the equipment.
Re – qualification shall be recommended by Quality Engineering.

Overview of Equipment / Description:
The equipment is a self-contained unit for collection of dust from the tableting etc. machine.

Definition:
Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists of the following:
  1. 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.
  2. Operation Qualification: A documents demonstration that facilities and operation work to functional design specifications.
  3. 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.

Responsibilities:
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.
Quality Assurance:
  • Review, monitoring and approval of the protocol.
  • On going compliance of the quality system.
Quality Control:
  • Analysis of samples if any.
  • Recording the QC raw data.
Purchase:
  • Organization Preparation, approval and implementation of the protocol.
  • Purchase order preparation.
  • Co-ordination with vendor for related activities.
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.


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.

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

Acceptance Criteria:
  1. Equipment shall be supplied and installed as per pre – determined specification Purchase Order.
  2. Material of construction and finish surface of equipment shall be as per pre – determined specification.
  3. All Utilities connected with the equipment shall be as per requirement.
  4. All components of the equipment shall work or function as defined.
  5. Equipment shall perform for its intended use as specified.

Reference:
Technical specification / Operation Manual
GA drawing / Exploded drawing
Purchase order copy
FAT and SAT report recommendation.

Installation Qualification:

Equipment Details:

Equipment Name

Dust Extractor Machine

Equipment Type

 

 

 

Location (Floor)

 

Designed By

 

Location (Plant)

 

 

 

Date of Installation

 


Major Components & Material of Construction:

Sr. No.

Description

Specification

Actual

Remarks

1

Chamber

SS 316

 

 

2

Impeller

CIP MAKE

 

 

3

Cotton Bag

CIP MAKE

 

 

4

Motor

1 Hp

 

 

5

Wheel

Pu

 

 



Utility Details:

Sr. No.

Utilities recommended by the vendor

Specification

Utility connected with the equipment

Remarks

1

Electrical

1 Hp, 3 phase

 

 

2

Chilled water

NA

 

 

3

Cooling water

NA

 

 

4

Hot water

NA

 

 

5

Compressed air

NA

 

 

6

Steam pressure

NA

 

 



Installation Checks:

Sr. No.

Test

Test Procedure

Observation

1

Position as per GA drawing

Ensure that position of equipment is as per the GA drawing

 

2

Electrical connection

Check 3 phase supply to starter through a proper isolator with suitable backup MCBs.

 

3

Direction of Motor

Check direction of motor depending upon suction

 

4

Earthing

Check the earthing of machine

 



Installation Done By:                                                  Verified By:


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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

 

 



Standard Operating Procedure:
Draft SOP of the equipment shall be available

SOP No.

Title

Location

Effective Date

Revision No.

Remarks

1

 

 

 

 

 

2

 

 

 

 

 

3

 

 

 

 

 



Operational Qualification:

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

Operational Checks:

Sr. No.

Activity

Specification

Observation

Remarks

1

On / Off Test

Machine should be ON and OFF with operating buttons

 

 

3

Start Machine with proper suction direction

Smooth running

 

 

4

Test for vibration

No abnormal vibration

 

 

5

Test for noise

No abnormal Noise should be there.

 

 

6

Stopping of the Machine

Machine should STOP

 

 



Safety Features:

Sr. No.

Safety features provided with the equipment

Method of Verification

Target

Actual

Remarks

1

Proper earthing to the machine

Ensure that there is no loose earthing

Complete earthing

 

 

2

Safety interlocks if any

Should work as designed

No deviation

 

 



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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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

 

 



Performance Qualification:

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 Criteria

Status / Observation

1

Proper assembly of cotton bags

As per the details given with the operating manual

 

2

Position of chamber

It should be properly fixed with machine and fixed with knobs.

 

3

Powder suction

It should be from the specific machine with this machine to be attached.

 



Performance Qualification Evaluation

Name of Tablet:

 

Performance Criteria - Before Connecting This Machine:

 

1. Appearance:

2. Analysis

 

Performance Criteria  - After Connecting This Machine:

 

1

2

3

Appearance

 

 

 

Analysis

 

 

 



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 satisfactorily and confirming to the acceptance criteria.

Inspected by: _____________________           Date :


Final Report:

Summary
The performance of the equipment DUST EXTRACTOR MACHINE was carried out as per standard operating procedure.
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.


Equipment: DUST EXTRACTOR MACHINE

Location :

Purpose : Use for suction of the dust.

"THE EQUIPMENT "DUST EXTRACTOR MACHINE VALIDATED AND RELEASED FOR

USE.

Approval:

Area Representative

Signature

Date

Production

 

 

Engineering Services

 

 

Quality Engineering

 

 

Quality Assurance

 

 



On – going Activities:

Preventive Maintenance Schedule:

Sr. No.

Preventive maintenance details

Any major change

Performed by

Remarks

 

 

 

 

 

 



Change in the History card:

New equipment installed on: Date - 

Sr.

No

Change recommended by

Reason for change

Modification Details

Re-qualification

Remark

 

 

 

 

 

 

 



Modification with recommendation for re – qualification:
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


Final Conclusion and Recommendation:
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


Approval:

Area Representative

Signature

Date

Production

 

 

Engineering Services

 

 

Quality Engineering

 

 

Quality Assurance

 

 



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