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Installation Qualification Report of Capsule Polishing 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 DETAILS:

 

Prepared By

Checked By

Approved By

Name

 

 

 

Signature

 

 

 

Date

 

 

 

Designation

Production Manager

Engineering Manager

QA Manager


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:
  • To define the Installation Qualification (IQ) requirements for the Capsule Polishing Machine.
  • To ensure that the equipment installed conforms to the purchase specifications & the manufacturers recommendations.
  • To document the information that the equipment meets the acceptance criteria.

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

QUALIFICATION TEAM:
Responsible staff from:

NAME

DEPARTMENT

DESIGNATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RESPONSIBILITIES:

Responsibilities

Details

Vendor

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

Engineering

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

Ø  Preparation of description reports of equipment and its various components.

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

Ø  Engineering Head will check the protocol and report.

QA

Ø  Preparation of this protocol in assistance with Engineering department.

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

Ø  Final approval of Protocol & report.

INSTALLATION PROCEDURE:

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

DURING INSTALLATION:
  • Compare equipment, as received, with purchase order and write the equipment details in FORM-A. Attach a copy of purchase order as annexure.
  • Check the equipment & its main components (accessories) for any damage. Write the details of main components in FORM-B.
  • Check the utilities provided are according to the manufacturer’s recommendation. Refer FORM-C.
  • The material of construction of the components. Refer FORM-D.
  • Check the change parts if any with the machine supplied. Refer FORM-E.
  • Details of the lubricants, which should be used in operation of the machine and its specifications. Refer FORM-F.
  • Check the manuals received for completeness. Mention the equipment manuals in FORM-G.
  • Check the drawings received for completeness. FORM-H.
  • 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.
  • Prepare an IQ report comprising of Observations made, problems encountered, summary of deviation report, results of any tests & any other relevant information.

ACCEPTANCE CRITERIA:
  • The installation of Capsule Polishing Machine fulfills the selection criteria and purpose of application, in accordance with the protocol.
  • The Capsule Polishing Machine is installed and verified as per the procedure given in the protocol.

RE-QUALIFICATION CRITERIA:
Re-qualification of the equipment is applicable when
  • Modification or change in main component.
  • Equipment is sent for major repairing.
  • Equipment is transferred from one location to another.
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 Automatic single brush capsule polishing machine is designed basically to polish the capsules after inspection of capsules prior to final packing. Various sizes of capsules can be polished very well. The rotary spiral principle of polishing ensures a high gloss finish.
  2. Inspected capsules are entering to the inlet funnel of the capsule polishing chamber which is provided with the top cover of the polishing chamber.
  3. Capsules travel from the polishing chamber in spiral motion with taper direction and get thoroughly polished by nylon bristles spiral brush. All capsules are coming out from the outlet chute of the capsule chamber. Loose powder which is deposited in the polishing chambers is sucked by the vacuum blower.

FORM B: LIST OF COMPONENTS

Sr. No.

Description

Qty.

Checked By

1

Trolley                                      

 

 

2

Bracket

 

 

3

Nylon net

 

 

4

Compression spring

 

 

5

Flange

 

 

6

Polishing brush

 

 

7

Ball bearing

 

 

8

Bearing housing

 

 

9

Timer belt

 

 

10

Base frame

 

 

11

Timer pulley

 

 

12

Motor

 

 

13

Top cover

 

 

14

Top cover-perforated

 

 

15

Bottom cover-perforated

 

 

16

Bottom cover

 

 

17

Suction tray

 

 

Empty capsule ejection unit

18

Stand

 

 

19

Empty capsule collection box

 

 

20

Outlet chute

 

 

21

Rectification box

 

 

22

Rectification hopper

 

 

23

Hopper

 

 

24

Acrylic top cover

 

 

Air Displacement Unit

25

Structure

 

 

26

Blower

 

 

27

Extension piper for blower

 

 

28

Two-way flange for hose pipe.

 

 

29

Gasket for flange

 

 

30

Filter tank

 

 

31

Filter bag

 

 

32

C-section rubber ring

 

 

33

Ring for filter bag

 

 

34

Tie rod for compression spring

 

 

35

Compression spring

 

 

36

Conical ring for filter bag

 

 

37

Lock nut for shaking rod

 

 

38

Compression spring

 

 

39

Bed shaking rod

 

 

40

Lock nut for guide bush

 

 

41

Lid for filter tank

 

 

42

Hex bolt for tie rod

 

 

43

Rubber washer for guide bush

 

 

44

Guide bush for shaking rod

 

 

45

Knob for bag shaking rod

 

 

46

Hose pipe for filter tank

 

 



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

Impeller of ECE unit

 

 

 

 

2

Fan assembly of ECE unit

 

 

 

 

3

Empty capsule ejection body

 

 

 

 

4

Impeller of ADU

 

 

 

 

5

Fan assembly of ADU

 

 

 

 

6

ADU Body

 

 

 

 

7

Filter bag

 

 

 

 


FORM E: CHANGE PARTS DETAILS

List down the Change Part Details


FORM F: LUBRICANT CHART

Sr. No.

Description

Location

Contact part

Yes/No

Type of lubricant

1.

 

 

 

 

2.

 

 

 

 

3.

 

 

 

 

4.

 

 

 

 

5.

 

 

 

 


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

No.

Drawing Title

Recd./Not Recd.

File Location

Date &

Signature (Engg.)

1.

Electrical drawing

 

 

 

2.

Schematic diagram

 

 

 


FORM I: DEVIATION REPORT

Deviation / OOS: 

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


Justification & Impact:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Name

 

 

Signature

 

 

Date

 

 

Department

Engineering

Head Q.A.

 

Prepared By

Verified By


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:

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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