Installation Qualification for Particle Size Analyser (Malvern Instruments)

TABLE OF CONTENTS

1. Protocol Author
2. Protocol Pre – Approval
3. Validation Team
4. Objective & Scope
5. Acceptance Criteria
6. Responsibilities
7. Criteria For Clearance to Installation Qualification
8. Reference Documents
9. Installing Software
10. Installing Machine in Software
11. System Description
12. Major Component List
13. Identification of Instruments to be Calibrated
14. Check For Installation Qualification
15. SOP Identification
16. Preventive Maintenance Programme
17. Change Parts and Spare Parts
18. Safety Features Identification
19. Requalification Criteria
20. Deficiency and Corrective Action Report
21. Summary & Conclusion
22. Installation Qualification Post – Approval
23. Appendix

1. PROTOCOL AUTHOR

Name	Designation	Signature	Date

2. PROTOCOL PRE–APPROVAL

Name	Designation	Signature	Date

3. VALIDATION TEAM: 

Validation team will comprise of representatives form Q.C., Q.A and Malvern.

Function	Name	Signature	Date

4. OBJECTIVE & SCOPE:

4.1 Objective

The objective of this protocol is to establish documented evidence that

• The equipment is installed according to the design specification and manufacturer’s recommendation.
• Each installed subcomponent complies with the specifications.
• SOP’s have been identified and listed.
• All critical instrumentation have been identified for calibration.

4.2 Scope

This installation qualification protocol defines the procedure, checklists, references, acceptance criteria and requalification criteria used in the successful installation of the equipment.

5. ACCEPTANCE CRITERIA

• The equipment shall be installed as per the supplier’s recommendation.
• The installation shall be performed in the close supervision of the validation team.
• All checks of installation qualification shall be found to be in accordance with the desired requirement as mentioned in the specifications for the equipment.

6. RESPONSIBILITIES

• Protocol Development: Representative of Malvern in close co ordination with Q.C. and Q.A. shall develop the protocol.
• Qualification Program: This has been jointly carried out by Q.C., Q.A. & Representative of Malvern.
• Approval of Protocol & Evaluation of Results for Final Approval: The Q.C Head and Q.A Head will evaluate the results and are authorized for final approval.

ALSO READ: Operational Qualification of UV Spectrophotometer UV 1800

7. CRITERIA FOR CLEARANCE TO INSTALLATION QUALIFICATION

7.1 Purchase Order Copy (Annexure)

PARAMETERS	REQUIREMENT	OBSERVATION	CHECKED BY	DATE
® A copy of the duly raised purchase order   ® Check the list of accessories and spares	Should be available   As per purchase order

Any deviation from the purchase order should be informed to supplier through the purchase department for corrective action.

7.2 Details of the Equipment

Equipment Name: PARTICLE SIZE ANALYSER

Vendor’s Name: MALVERN. 

Location of the Equipment: INSTRUMENT ANALYSIS ROOM

7.3 Installation Procedure

Installation of the equipment should be carried out as under :

PARAMETERS	CHECKED BY	DATE
Machine shall be received from the vendor at the factory. All details of delivery shall be checked.   Machine shall be then shifted to the location where it has to be installed in Q.C. department.   Validation team in the presence of a person from the supplier shall perform installation qualification of the equipment.   Utilities should be identified and then connected to the equipment.

7.4 Clearance for Installation Qualification

All the criteria for the acceptance of the equipment for performing of installation qualification have been met.

The equipment is now ready for performance of installation qualification.

Department	PharmaGuide	Q.C.	Q.A.

8. REFERENCE DOCUMENTS

A. Purchase order copy (Annexure – I)

B. Operating and Maintenance manual

Sr. No.	Manual Title	Verified By/Date
1	Operators Guide
2	Installation Guide
3	Hydro 2000 S/G User Manual
4	Sample Dispersion & Refractive Index Guide
5	Scirocco User Manual
6	Health & Safety
7	Compressor Operating Manual
8	Site Requirements

C. Software Details

Sr. No.	Manual Title	Verified By/Date
1	Mastersizer 2000 PSS0002-18
2	Mastersizer 2000 PSS0018-01
3	Mastersizer 2000 PSS0010-04
4	Acrobat 7.0 Standard
5	Floppy for linearity files (System Sr. No. MAL101428)

9. INSTALLING SOFTWARE

Use the following procedure to install Mastersizer 2000 version 5.22

Sr. No.	Specification	Checked by & Date
1	Insert the Software CD into CD-Drive
2	CD autorun.
3	Follow the screen command for installation
4	After successful installation of software, it will display a message saying installation is complete

10. INSTALLING MACHINE IN SOFTWARE

SELECTING COM PORT (RS232-C SERIAL COMMUNICATION PORT) AND CONNECTING TO MACHINE

Sr. No.	Specification	Checked by & Date
1	Click on installation on main menu bar then click on COM Port.
2	Communication port number window will appear. By Default, communication port number is 1. If serial communication port 1 is free and available then click cancel or else type the serial communication port number that is free and then click ok.
3	Now Connect the RS-232-C cable of communication port to the instrument.
4	When instrument is connected all the instrument function enables in the software.

ALSO READ: Installation Qualification of Polarimeter

CONFIGURING SECURITY

Sr. No.	Specification	Checked by & Date
1	Security configuring using Configure - Security Manu.
2	You can allow the different level of access of software to different user.

SETTING COMPANY NAME

Sr. No.	Specification	Checked by & Date
1	Company name is printed on the printouts taken from the software. Default company name is Malvern Instruments.
2	Company name can be change by modifying the report page or making new report from tools - report designer.

Printer for Printing Data:

Description	Specification	Actual	Checked by & Date
Type	HP LaserJet
Connected to	Local PC / Network Printer

Installation verification

Consideration	Yes/No	Checked by / Date
Software installed successfully to PC
Sufficient free space of 15MB is available on Hard disk
Electrical connections have been done according to the drawing
Required electric connections are tight and proofed and grounded.

11. SYSTEM DESCRIPTION

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

12. MAJOR COMPONENT LIST

Identify all the major components and their specification.

Sr. No.	Name of Components / Accessories	Specified Serial No.	Actual	Verified By/ Date
1	Mastersizer 2000 Optical Bench
2	Hydro 2000 S Small volume auto dispersion unit
3	Scirocco 2000 automated dry dispersion unit
4	Vacuum Collation System
5	Air Compressor

13. IDENTIFICATION OF INSTRUMENTS TO BE CALIBRATED

Identify and enlist the instruments to be calibrated, its location, test instrument to be used to calibrate the instrument & its location. This should be signed by along with the date by the engineer.

Sr. No.	Instrument to be calibrated	Location	Test instrument	Identified by & date
1	NA	NA	NA

14. CHECK FOR INSTALLATION QUALIFICATION

A. Physical observation

Item	Requirement		Observation		Verified by / Date
Equipment Appearance check	No Defragmentation, Damages etc.
Part check	Check with standard packing list and confirm that parts are supplied as listed
Installation site check	Check and confirm the following
	Room Temperature of 15°C to   35°C	I		:-
		II		:-
		III		:-
	Humidity of 45% to 70%	I		:-
		II		:-
		III		:-
	Firm, vibration free location, as     level as possible.
	Stability of input power (< ± 10% of 230 V AC 50 Hz with MCB)	I		:-
		II		:-
		III		:-
	Platform level

ALSO READ: SOP for Calibration of Malvern Particle Size Analyzer

B. Apparatus

INSTRUMENT IDENTIFICATION

Sr. No.	Particular	Observation / Requirement	Verified by / Date
1	Equipment Name
2	Manufacturer
3	Model
4	Serial Number
5	Power
6	Frequency
7	Power Consumption

EXPENDABLES / CONSUMABLES

Sr. No.	Description	Part No.	Verified by / Date
1	450mm cell inlet/outlet tube
2	Lens tissues
3	Pair of cell windows and seals
4	Quality audit standard
5	Quality audit standard
6	Vacuum bags

15. SOP IDENTIFICATION

Sr. No.	Particulars	Title of SOP	SOP No.
1.	Operation
2.	Cleaning
3.	Preventive maintenance
4.	Calibration

16. PREVENTIVE MAINTENANCE PROGRAMME

Preventive maintenance schedule has been prepared and this has to be observed by the Malvern.  This has been made based on the recommendation of the Malvern & the user of the equipment.

17. CHANGE PARTS AND SPARE PARTS

Identify and enlist the change parts and spare parts (Expendables/Consumables) for the each module of the equipment.

18. SAFETY FEATURES IDENTIFICATION

Identify all safety features of the equipment, their specified function. Sign the document (By the engineer).

Sr. No.	Safety feature	Function	Identified by / Date
1.

19. REQUALIFICATION CRITERIA

The equipment shall be subjected to installation requalification only under following reasons:

• Change in location of the equipment.
• Shifting out of the equipment for major maintenance or modification & again locating at the same place after completion of work.

20. DEFICIENCY AND CORRECTIVE ACTION REPORT

DEFICIENCY OBSERVED (IF ANY)

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

CORRECTIVE ACTION TAKEN AND CONDUCTED BY

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

CONDUCTED BY: __________          DATE : __________

AUTHORIZED BY: __________          DATE : __________

21. SUMMARY & CONCLUSION

SUMMARY :

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

CONCLUSION :

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

COMMENTS :

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

22. INSTALLATION QUALIFICATION POST – APPROVAL

Q.C. Head and Q.A Head will review the executed protocols and will be authorized to approve the equipment for operational qualification.

APPROVED / NOT APPROVED

Name	Designation	Signature	Date

23. APPENDIX

List of Annexures

Enlist all the annexures to be attached with the protocol.

ANNEXURE-1: Purchase order copy

Abbreviations

Enlist all the abbreviation and their full form used in the Installation Qualification protocol.

Q.C: Quality Control

Q.A: Quality Assurance

ALSO READ: SOP for Operation of Malvern Particle Size Analyzer