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Installation Qualification of Capsule Filling Machine

INSTALLATION QUALIFICATION REPORT 

OF 

CAPSULE FILLING MACHINE


Name of the Equipment

 

Name of the Department

 

Equipment Identification No.

 

Protocol No.

 

Issue Date

 

Supersedes

 

Reason for Change

 

Number of Pages

 


 

Prepared By

Checked By

Approved By

Signature

 

 

 

Date

 

 

 

Name

 

 

 

Department

 

 

 


TABLE OF CONTENTS:

Sr. No

Title

1.0

Table of contents

2.0

Objective               

3.0

Scope

4.0

Qualification Team

5.0

Responsibilities      

6.0

Installation Procedure

7.0

Acceptance criteria

8.0

Re-qualification criteria

9.0

FORMS:

FORM A: Details of Equipment

FORM B: Details of main components

FORM C: Utilities requirement

FORM D: MOC of the component

FORM E: Details of change parts if any

FORM F: Lubrication

FORM G: List of manuals

FORM H: List of drawing

FORM I: Deviation Report

10.0

Summary & Approval of Installation Qualification

11.0

Check list for Installation Qualification


OBJECTIVE:
The objective of this protocol is:
  1. To define the Installation Qualification (IQ) requirements for the Capsule Filling Machine.
  2. To ensure that the equipment installed conforms to the purchase specifications & the manufacturers recommendations.
  3. To document the information that the equipment meets the acceptance criteria.

SCOPE:
The scope of this qualification exercise is limited to the installation. The respective protocol defines the procedures, documentation, references, acceptance criteria & re-qualification criteria.

QUALIFICATION TEAM:
Responsible staff from:

NAME

DEPARTMENT

DESIGNATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 




RESPONSIBILITIES:

Responsibilities

Details

Vendor

Supplying drawings, manual and necessary documents for the generation and implementation of this protocol.

Engineering

Initial receipt and inspection of incoming equipment, drawings & certificates.

Preparation of description reports of equipment and its various components.

Preparation of written procedures for preventive maintenance of the equipment and its components.

Engineering Head will check the protocol and report.

QA

Preparation of this protocol in assistance with Engineering department.

Audit & review the data documented during equipment qualification & ensure that it meets the acceptance criteria.

Final approval of Protocol & report.



INSTALLATION PROCEDURE:
Pre-Installation:
  1. Check the installation site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, etc.) and room dimension.
  2. In-house identification No: for the equipment shall be allocated.
  3. Information and general lay out of the equipment.
  4. Location for installation of equipment shall be made ready.

During Installation:
  1. Compare equipment, as received, with purchase order and write the equipment details in FORM-A. Attach a copy of purchase order as annexure.
  2. Check the equipment & its main components (accessories) for any damage. Write the details of main components in FORM-B.
  3. Check the utilities provided are according to the manufacturer’s recommendation. Refer FORM-C.
  4. The material of construction of the components. Refer FORM-D.
  5. Check the change parts if any with the machine supplied. Refer FORM-E.
  6. Details of the lubricants, which should be used in operation of the machine and its specifications. Refer FORM-F.
  7. Check the manuals received for completeness. Mention the equipment manuals in FORM-G.
  8. Check the drawings received for completeness. FORM-H.
  9. Any deviation observed during the qualification study shall be recorded in FORM-I & the manufacturer shall be informed. If the deviation is minor & is not going to affect the routine performance of the equipment, IQ study may be completed with proper justification.
  10. Prepare an IQ report comprising of Observations made, problems encountered, summary of deviation report, results of any tests & any other relevant information.

Acceptance Criteria:
  1. The installation of Capsule Filling Machine fulfills the selection criteria and purpose of application, in accordance with the protocol.
  2. The Capsule Filling Machine is installed and verified as per the procedure given in the protocol.

RE-QUALIFICATION CRITERIA:
Re-qualification of the equipment is applicable when
  1. Modification or change in main component.
  2. Equipment is sent for major repairing.
  3. Equipment is transferred from one location to another.

FORMS:
FORM A

Details of Equipment:

Name of the Equipment

 

Identification No.

 

Manufacturer’s Name & Address

 

Make/Model

 

Overall Dimension in mm (W x L x H)

 

Material of Construction

 

Weight of the Machine

 

Location for Installation

 

Purpose

 

Main Components of the Equipment

 



Description of Equipment:
  1. The machine is best suited to meet the needs of Pharmaceuticals. It serves to specifically reduce fatigue of the operator making it easy to operate with automation of the loading, filling and closing sections.
  2. The Semi-Automatic Capsule Filling Machine is designed to fill Hard Gelatin Capsules. Capsules from size 00 to size 2 can be filled with powder, granules or pellets.
  3. The capsules filling machine operates in the following sequence.
  4. Loading and separation of capsules cap from body.
  5. Powder filling of capsules into the capsule body half.
  6. Rejoining of the capsules cap with the body and ejection of the filled capsules.


FORM B

List of Components

Sr. No.

DESCRIPTION

Checked By

1

 

 

2

 

 

3

 

 

4

 

 

5

 

 

6

 

 

7.

 

 



FORM C

Utilities Requirement

Sr. No.

Utility

Specified

Observed

Engg. Sign & Date

1.

Electric supply

Load

 

 

 

Voltage

 

 

 

Phase

 

 

 

Frequency

 

 

 

2.

Compressed Air

 

 

 

3.

Max. Consumption of Air

 

 

 

4.

Earthing

 

 

 


FORM D

Material of Construction for The Components

Sr. No

Component

MOC

Contact Part Yes/No

Identification No./Sr. No.

Date/Sign (Engg.)

1

 

 

 

 

 

2

 

 

 

 

 

3

 

 

 

 

 

4

 

 

 

 

 

5

 

 

 

 

 

6

 

 

 

 

 


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FORM E

Change Parts Details

Sr. No.

CHANGE PARTS

QUANTITY

CHECKED BY

1.

 

 

 

2.

  

 

 

 

FORM F

Lubricant Chart

Sr. No.

Description

Location

Contact Part

Yes/No

Type of Lubricant

1.

 

 

 

 

2.

 

 

 

 

3.

 

 

 

 

4.

 

 

 

 

5.

 

 

 

 

6.

 

 

 

 

 

FORM G

List of Manuals

Sr. No.

Manual

Manual Recd./

Not Recd.

Date & Signature

(Engg.)

1.

Instruction

 

 

2.

Installation

 

 

3.

Operation

 

 

4.

Maintenance

 

 

 

FORM H

List of Drawing

Sr. No.

Drawing Title

Recd./Not Recd.

File Location

Date & Signature (Engg.)

1.

Electrical Drawing

 

 

 

2.

Schematic Diagram

 

 

 

 

FORM I

Deviation Report

Deviation(s):

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

 Justification for acceptance:

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––


Name

 

 

Signature

 

 

Date

 

 

Department

Engineering

Head Q.A.

 

Prepared By

Verified By

N.A. - = Not Applicable


SUMMARY & APPROVAL OF INSTALLATION QUALIFICATION:

Summary:

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Approval:

Installation Qualification (IQ) is satisfactory                                                              


  
Hence can proceed to Operation Qualification (OQ)                                       

 

Name

 

 

Signature

 

 

Date

 

 

Department

Engineering

Head Q.A.

 

Prepared By

Verified By



CHECK LIST FOR INSTALLATION QUALIFICATION:

Sr. No.

List

Enclosed/Not Closed

Sign/Date Engg.

1.

FORM A: Details of equipment

 

 

2.

FORM B: Details of main components

 

 

3.

FORM C: Utilities requirement

 

 

4.

FORM D: Material of construction

 

 

5.

FORM E: Change parts

 

 

6.

FORM F: Lubrication chart

 

 

7.

FORM G: Details of manuals

 

 

8.

FORM H: Drawings

 

 

9.

FORM I: Deviation report

 

 

10.

Summary & Approval of Installation Qualification

 

 

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