MEDICAL & COSMETIC
PRODUCTS CO.LTD.
P.O.Box 140, Riyadh 11383
Kingdom of Saudi Arabia.
INSTALLATION QUALIFICATION (I.Q.)
CHECKLIST
EQUIPMENT / SYSTEM DELAMA AUTOCLAVE - NEW CONTROL SYSTEM
MODEL DLOV – PL
SERIAL NUMBER 2211
SUPPLIER DELAMA SPA
ASSET NO RP 2 0002
LOCATION STERILE – C CLASS AREA (02 – 105 – C)
PROTOCOL REFERENCE IQ-032A
DOCUMENT REFERENCE
DOCUMENT FORMAT PREPARED BY:
S. No Name &Title Signature Date
1. AMJAD HAWWASH
Production Engineering
DOCUMENT FORMAT VERIFIED BY:
1. FARES AWAD
Production Engineering Manager
2. DHANANJAY KULKARNI
Sterile Department Manager
3. PEER MOHAMED
QA-Validation
DOCUMENT FORMAT APPROVED BY:
1. SARANG ATHAVALE
Approved By Compliance Manager
2. KHALID AL-FHAID
Authorized by Head of Quality Assurance
Page 1 of 4
INSTALLATION QUALIFICATION (IQ) CHECKLIST
EQUIPMENT: DELAMA AUTOCLAVE - NEW
Document Reference
CONTROL SYSTEM.
S. No.: 2211
1. PURPOSE
The purpose of this document is to qualify the installation of DELAMA
AUTOCLAVE - NEW CONTROL SYSTEM According to Installation Qualification
protocol (IQ-032A)
2. UTILITIES & COMPONENT SPECIFICATION
Checked
S. No Description Specification Observation Conclusion
By
Electrical
2.1 23O VAC / 50-60 Hz
Power
Compressed
2.2 5-6 Bars
Air Supply
24 V – DC Power Supply
Siemens PLC CPU 314
2.3
Unit Input/Output Card
(Digital – 16/16)
Analog Input Card
Relays and connectors
Electrical
2.4 for Delama Signals
Panel
Interfacing
Operator Panels with
Siemens OP Communication Code to
2.5
27 PLC Unit for Displaying
Related Process Values
To Print the Process
EPSON
2.6 Values ONLINE while
Printer
Cycles are in Operation
3. INSTALLATION VERIFICATION
The following should be verified and recorded by production engineering. The test will be
considered as ‘pass’ if descriptions meet the acceptance criteria.
Checked
S. No Description Acceptance criteria Observation Conclusion
by
Should be completed & installations
3.1 Electrical & should be done according to
Mechanical Drawings drawing.
Should be free from physical
Physical damage on damage and that component are
3.2
installed component. securely anchored and protected
from shock.
Page 2 of 4
INSTALLATION QUALIFICATION (IQ) CHECKLIST
EQUIPMENT: DELAMA AUTOCLAVE - NEW
Document Reference
CONTROL SYSTEM.
S. No.: 2211
All electrical connections have been
3.3 Electrical connections done according to the drawings and
specifications.
3.4 Access ports Should be free from debris.
Equipment Should be available with all
3.5
identification label informations.
Manufacturer manuals & user
3.6 Manuals
recommendation to be available
3.7 Space for servicing Should be sufficient
4. DOCUMENTS
The following documents should be identified by Sterile Production, Production
Engineering and record reference number.
Checked
S. No Document Requirement Observation Conclusion
by
4.1 Sterile Production
Operation SOP
4.2 Maintenance SOP Production Engineering
4.3 Calibration SOP Facilities Engineering
5. DEVIATIONS
Production Engineering should verify and list down if any unauthorized works are
observed. Deviation should be raised for unauthorized work for assessment and approval
according to Deviation SOP.
Deviation Approval and Conclusion
S. No Description of Unauthorized work Checked by
Deviation Number (Pass / Fail)
Page 3 of 4
INSTALLATION QUALIFICATION (IQ) CHECKLIST
EQUIPMENT: DELAMA AUTOCLAVE - NEW
Document Reference
CONTROL SYSTEM.
S. No.: 2211
6. OUTSTANDING ACTION
Outstanding action Outstanding completion report
Description Sign & Date Description Sign & Date
7. REPORT
The Installation Qualification of DELAMA AUTOCLAVE - NEW CONTROL SYSTEM is
performed accordance with the procedures and standards of Riyadh Pharma.
The Installation Qualification confirms the DELAMA AUTOCLAVE - NEW CONTROL
SYSTEM complies / does not comply to the acceptance criteria stated in Installation
Qualification Protocol (IQ-032A).
S. No Name &Title Signature Date
1. Reviewed By QA - Validation
2 Approved By Production Engineering
Manager
3 Approved By Compliance Manager
4 Authorized By Q. A. Manager
Page 4 of 4
