Subject Issue date: 01/01/2012

Issue/Modification: 1/3
Sterilization Process Validation
Modification date: 10/5/2020
No.: QP-022 Page: 1 of 2

1- Purpose:
This procedure is to:
Define the method of the Sterilization Process Validation and Re-validation.

2- Scope of Application:
Production Department and Quality Department.

3- Responsibility:
Production Manager, Sterilization Supervisor, Sterilization Manager and Quality Manager.

4- Abbreviations & Definitions

None.
5- Work Instructions
None.

6- Forms and Enclosures

None.

7- Procedure:
7-1 The validation of the chamber will be based on the validation protocol issued after chamber
installation. This protocol is defining the exact work to be performed and the format of the report.
7-2 The Validation will contain the following:
7-2-1 Thermal Profile of Empty Chamber (Commissioning).
7-2-2 Temperature Increase of Standard Load.
7-2-3 One Short Cycle.
7-2-4 Three Half Cycles.
7-2-5 One Full Cycle.
7-2-6 Full Microbiological Tests Results.
7-2-7 Eto Degassing Study.
7-3 This protocol will be updated and reviewed by the Quality Manager to accommodate any new
Sterilization Plants and/or cycles.
7-4 The process is subjected to Re-Validation Annually with reviewing and approved from Quality
Manager or if it was subjected to major maintenance or change. The Re-Validation will contain
the following:
7-4-1 Temperature Increase of Standard Load.
7-4-2 One Short Cycle (Every Two Years).
7-4-3 One Half Cycles.
7-4-4 One Full Cycle.
7-4-5 Full Microbiological Tests Results.
 Subject Issue date: 01/01/2012
Issue/Modification: 1/3
Sterilization Process Validation
Modification date: 10/5/2020
No.: QP-022 Page: 2 of 2

7-4-6 Eto Degassing Study.

7-5 The validation Protocol will be reviewed and amended if any of the regulatory requirements are
changed substantially.
7-6 Revalidation Process is conducted by certified services provider

8- Reference Documents
8-1 EN ISO 13485:2016
8-2 ISO 11135-1 : 2014
8-3 ISO 11135-2 : 2008

9- Change History:
Issue/ Issue/
Modified
Modificatio Modification Nature of Modification
pages
n Date No.
01/01/2012
1/0 First issue according to 13485 :2003 All pages
26/05/2014 1/1 Improvement
26/05/2018 1/2 Change according to update ISO
Modify the Procedure according to new
document "Document Control Procedure
10/5/2020 1/3 All pages
(QP-001)"

10- Approvals:
Prepared by Approved by Stamp
Name: Name:
Title: Title:
Sign./Date: Sign./Date: