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Programme Sterilization Course



Medical Device Sterilization info





   

Medical Device Sterilization for Manufacturers

 

Monday 23 April 2012

Time

Subject

Tutor

08:30

Welcome and Registration

Anette Sjögren

09:00

INTRODUCTION

David Allison

09:30

MICROBIOLOGICAL QUALITY

David Allison

 

Introductory microbiology

 

10:15

Coffee/Tea

 

10:30

MICROBIOLOGICAL QUALITY cont..

David Allison

 

Contamination control          

 

 

ISO 11737-1 Bioburden estimation
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements

 

12:00

Lunch

 

13:00

Syndicate exercise

David Allison

13:30

Syndicate feedback

David Allison

14:00

MICROBIAL INACTIVATION KINETICS

David Allison

 

Implications
Sterilization of medical devices – Requirements for a terminally-sterilized device to be labelled “sterile”

 

14:45

Coffee/Tea

 

15:00

GENERAL CONSIDERATIONS

David Allison

 

Sterility testing

Pharmacopoeia 'Test for sterility'

'Test of sterility'
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process

 

16:00

BIOLOGICAL and CHEMICAL INDICATORS

David Allison

 

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

 

17:00

Close

 

Evening

Homework/Individual exercises

Delegates

 

Tuesday 24 April 2012

Time

Subject

Tutor

09:00

RADIATION STERILIZATION

Arne Miller

 

The nature of ionising radiation and the measurement of dose (gamma, electrons, X-rays)

ISO 11137-1, -3 Sterilization of medical devices – Validation and routine control of sterilization by irradiation

 

10.15

Coffee/Tea

 

10:30

RADIATION STERILIZATION

Eamonn Hoxey

 

ISO 11137-2 – Establishing the sterilization dose

 

12:00

Lunch

 

13:00

RADIATION STERILIZATION cont..

Eamonn Hoxey

 14.30

RADIATION STERILIZATION (IQ, OQ and PQ)

Arne Miller

Installation Qualification, Performance Qualification and Routine Control

15.00

Coffee/Tea

 

16:00

RADIATION STERILIZATION (IQ, OQ and PQ) cont..

Arne Miller

17:00

Close

Evening

Homework/Individual exercises

Delegates

 

Wednesday  25 April 2012

Time
Subject
Tutor
08:30
HEAT STERILIZATION
Eric Dewhurst
 
ISO 17665 Sterilization of medical devices – Validation and routine control of sterilization by moist heat
 
09:45
Coffee/Tea
 
10:00
HEAT STERILIZATION cont..
Eric Dewhurst
11.00
ETHYLENE OXIDE
Eamonn Hoxey
 
ISO 11135 Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization
 
12:00
Lunch
 
13.00
ETHYLENE OXIDE cont..
Eamonn Hoxey
13.15
Syndicate exercises
Eamonn Hoxey
13:45
Syndicate feedback
 
14:15
LIQUID CHEMICAL STERILANTS  
Eamonn Hoxey
 
ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilant
 
15:00
Coffee/Tea
 
15:15
LIQUID CHEMICAL STERILANTS  ..cont..
Eamonn Hoxey
16:00

ASEPTIC PROCESSING

Eric Dewhurst
ISO 13408-1 Aseptic processing of health care products – Part 1:General requirements
 
17:00
Close
 

Evening

Homework/Individual exercises

Delegates

 

Thursday 26 April 2012

Time

Subject

Tutor

09:00

CLEAN ROOMS

EN ISO 14644 –x:1999 Clean rooms and associated controlled environments

Charlotte Rudbäck

10:00

Coffee/Tea

 

10:15

GENERAL CONSIDERATION

Eamonn Hoxey

The future direction of sterilization standards.

ISO 14937 General Requirements for Sterilization of Medical Devices

Conclusion of the revision process for EN 550, EN 552 &  EN 554

12:00

Lunch

 

13:00

AUDITING TO THE STANDARDS /
AUDIT PLANNING

Eamonn Hoxey

 13:30

Syndicate exercises

Eamonn Hoxey

14:00

Syndicate Feedback

Eamonn Hoxey

14.30

AUDIT REVIEW

 

15:00

Coffee/Tea

 

15:15

AUDIT REVIEW

 

16:00
 
 
 
QUALITY SYSTEMS LINKS
ISO 13485:2003 Quality management systems – Medical devices – Requirements for regulatory compliance
Poul Schmidt-Andersen
 
 

16:30

REVIEW OF COURSE

Anette Sjögren  & Poul Schmidt-Andersen

17:00

Close

Evening

Individual revision / Preparation for exam

Delagates 

 

Friday 27 April 2012 

Time

Subject

 

 

09:30

EXAMINATION (Optional)

11:30

Close