Issue date

Installation Qualification Equipment

(Reference SOP: __________)

Project:					Project No:
Equipment Description:									Serial No:
Manufacturer:				Model No:					Equipment No:
Location:					Protocol:

PROGRAM INDEX

1. OBJECTIVE................................ ................................ ................................ ................................ ..3

2. ACCEPTANCE CRITERIA ................................ ................................ ................................ ............ 3

3. QUALIFICATION PROCEDURES ................................ ................................ ................................ 3

4. DEMAND SPECIFICATIONS................................ ................................ ................................ ........4

5. EQUIPMENT - MECHANICAL ................................ ................................ ................................ ......4

5.1. List of drawings................................. ................................ ................................ .................... 4

5.2. List of Supplier Quotes & Purchase Orders for Major Components................................ .......5

5.3. List of Equipment / Maintenance Manuals. ................................ ................................ ........... 5

6. EQUIPMENT FEATURES................................ ................................ ................................ ............. 6

6.1.

6.2. Component Materials in Product Contact................................ ................................ .............. 6

6.3. Component Materials (as detailed in design spec.) not in Product Contact........................... 7

6.4. Filters: ................................ ................................ ................................ ................................ ..7

6.5. Lubricants................................ ................................ ................................ ............................. 8

6.6.

6.7. Spare Parts List Location: ................................ ................................ ................................ ..9

6.8. Can machine adjustment be made without potential for product contamination? .................. 9

7. ELECTRICAL INSTALLATION................................ ................................ ................................ ......9

7.1. Electrical Drawings ................................ ................................ ................................ ............... 9

7.2. Equipment Rating ................................ ................................ ................................ ............... 10

7.3. Supply Wiring ................................ ................................ ................................ ..................... 10

7.4. Distribution Details................................ ................................ ................................ .............. 11

7.5. Instrumentation................................ ................................ ................................ ................... 11

7.6.

7.7. Computerised Systems Verification ................................ ................................ .................... 12

7.8. Spare Parts List:................................ ................................ ................................ ................. 14

8. AUXILIARY EQUIPMENT / SERVICES LIST................................ ................................ ..............14

9. CHANGE PARTS ................................ ................................ ................................ ....................... 15

10. CLEANING PROCEDURES ................................ ................................ ................................ .......15

10.1.

10.2. Cleaning Records ................................ ................................ ................................ ............... 15

11. PREVENTATIVE MAINTENANCE ................................ ................................ .............................. 15

11.1. Preventative Maintenance Program Identification: ................................ .............................. 15

12. TRAINING RECORDS ................................ ................................ ................................ ................ 16

13. ................................ ................................ ................................ ..16

13.1. Equipment Operation................................ ................................ ................................ .......... 16

13.2. Process Operation................................ ................................ ................................ ..............16

14. DISCREPANCIES................................ ................................ ................................ ....................... 16

15. SIGNATURE LOG ................................ ................................ ................................ ...................... 17

16. ATTACHMENTS ................................ ................................ ................................ ......................... 17

TEM 170 Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

1. OBJECTIVE

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2. ACCEPTANCE CRITERIA

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3. QUALIFICATION PROCEDURES

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As Built drawings and equipment specification as quoted in the protocol.

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Prepared by: Date Prepared: Revision No: Page

of 17

Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

1. Piping
2. Pneumatic

Drawing ID	Rev. No.	Description	Location	As Built Verified		Date	Verified by
				Yes	No

Drawing ID	Rev. No.	Description	Location	As Built Verified		Date	Verified by
				Yes	No

1. List of Supplier Quotes & Purchase Orders for Major Components
2. List of Equipment / Maintenance Manuals.

Component	Supplier Quote	Purchase Order No.	Location

Manual ID.	Location

Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

6.2.2. Component Listing

Component Parts	Material of Construction
	Specified	Actual

6.3. Component Materials (as detailed in design spec.) not in Product Contact

Component Parts	Material of Construction
	Specified	Actual

6.4. Filters: This list is based on information from purchase orders and eq uipment specifications. Verify that the items have been delivered as specified

Identifying No:	Size/Porosity (Micron)	Location	Verified		Verified by
			Yes	No

Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

6.7. Spare Parts List Location:

Mechanical: Attach material/component list (attachment)

6.8. Can machine adjustment be made without potential for product contamination ? YES / NO

Write a brief description as to how machine adjustment can be done to no t effect product quality. Include any follow up activities that must occur after machine adjustment .

7. ELECTRICAL INSTALLATION

Complete a list of drawings & manuals associated with the electrical installation of the equipment /system.

Document Location of the latest versions. Verify the accuracy of those drawings which represent the system

7.1. Electrical Drawings

1. Single Line
2. Cables Schedules

Drawing ID	Rev. No.	Description	Location	As Built Verified		Date	Verified by
				Yes	No

Drawing ID	Rev. No.	Description	Location	As Built Verified		Date	Verified by
				Yes	No

		TEM 170
		Issue date
Installation Qualification for Equipment
(Reference SOP: _________)
7.4.	Distribution Details

Main Switchboard:
Sub Board:
Distribution Board:
Circuit Breaker Type:
Circuit Breaker Rating:
Phases:

7.5. Instrumentation

Attach all items requiring calibration. Attach calibration reports for all critical items and non critical items requiring calibration .

1. Critical Instrumentation
2. Non Critical Instrumentation (Convenience)

Description	Manufacturer	Model No.	Serial No.	Equipment No	Previous Maintenance No.

Description	Manufacturer	Model No.	Serial No.	Equipment No	Previous Maintenance No.

Installation Qualification for Equipment

(Reference SOP: _________)

TEM 170 Issue date

Item	Requirement	Details/Function	Sign/Date
PC	Name of manufacturer Record model number Record serial number
Operating system	Record type of Record version of
System configuration files	Record details.(Include printout if available)
Inspection	Visually inspect and confirm that unit is in good condition
Logon	Confirm able to logon to PC and successfully able to call up any critical programs from desktop.

PLC s, PC s, LAN etc.

7.7.3. Computerised System Inventory List

To section should be filled out and submitted to ensure that the site Computerised System Inventory List is maintained as procedure

Information	Equipment		Equipment	Equipment
Proposed SAP Equipment No (EO# etc)
Description (40 char. max.)
Long Text (If needed)
Vendor
Acquisition date
Manufacturer
Manufacture Country
Construction Year
Construction. Month
Model No
Manufacturers Part No
Manufacturers Serial No
Superior Equipment
Functional Location
Technical Identification No
Submitted by		Sign		Date

Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

9. CHANGE PARTS

List below all change parts, quantity, and description for each process requiring a changeover .

Item Description	Quantity	Specification Part No.	ID No. on equipment

10. CLEANING PROCEDURES

10.1.

system. Ensure you reference the current version.

S.O.P. No:	Title	Date Issued

10.2. Cleaning Records

Record in what form cleaning records are to be kept and where e .g. log book, as a part of batch documents.

11. PREVENTATIVE MAINTENANCE

11.1. Preventative Maintenance Program Identification:

Program identification and records. For each piece of equipment list the maintenance Task Number and maintenance period :

Equipment	Task No.	Maintenance Period