Location

Thermal Compliance , North Yorksire, UK

Course Leader

Chris Maughan
Duration

3 Days

Advanced Autoclave Validation

In Person 'Advanced Autoclave Validation' 3 Day Training held at our North Yorkshire, UK Training Centre.

In this three day course you will learn how to perform validation on Porous and Fluids load autoclaves, from autoclave design and control through to rectifying common failure modes. The modules covered in this course are:

Introduction to Autoclaves

We start with a basic introduction to how autoclaves work, the different types and a general overview of validation.

Regulations and Guidance

Overview of current regulations including EN285, IS0 17665, ISO 11138, PDA Technical Report 1, PDA Technical Report 48 and EU GMP Annex 1.

Introduction to Microbiology

Basic introduction to microbiology for sterilisation including methods of kill and an introduction to biological indicators.

Routine Testing

Standard routine tests including Warm Ups, Leak Rate Tests, Bowie Dick Tests and Air Detector Function Tests. Why do we perform them? How do they work?
With practical demonstrations of routine tests.

Anatomy of an Autoclave

Walkthrough a porous and fluids load autoclave design explaining how the autoclave operates.

Cycle Design and Development

How to design robust and repeatable autoclave cycles and how to perform comprehensive Cycle Development of loads.

Load Orientation and Wrapping

How to orientate load items to optimise the sterilisation process and prevent wet loads. Considerations for process specific load wrapping and the impact of different load wrapping wet loads.
With Practical modules on load orientation, wrapping and load placement.

The Steam Path

What is the steam path and why we should consider it when placing temperature sensors and biological indicators.
Practical session on the criticality of steam penetration and how to identify failures using thermal data and biological indicators.

Critical Control Parameters

Identifying, monitoring and trending the critical control parameters for your autoclave cycles can help predict and therefore prevent failures.

Autoclave Loading Patterns

Autoclave Loading Patterns help ensure the load is setup in a repeatable manner. These are normally developed during cycle development and fixed for the performance qualification. We demonstrate how to ensure autoclave loading patterns are clear helping to ensure repeatability.

Sensor Selection, Insertion and Placement

Ensure you are using the most suitable sensor for your application. Whether it is thermocouples or dataloggers, ensure you use compliant systems and that there use minimises the impact to the process.

Biological Indicators

This modules provides an in depth look into biological indicators for porous and fluids loads. Covering Direct Inoculation, Biological Indicator Selection, Occluded Surfaces, Rapid BIs and unique BIs.

Porous Load Acceptance Criteria

A detailed look at validation acceptance criteria for porous/hard goods loads autoclaves. With examples of how to perform calculations and a look at where these criteria originate.

Common Autoclave Failure Modes and how to resolve them

Failures such as Wet Loads, Superheat and Equilibration Time are very common and easily resolved. With knowledge and planning a lot of issues can be prevented through cycle design and knowledge. This modules provides the tools to resolve these issues if they do occur.

Introduction to Air Detectors

Air Detectors act as an process control device (PCD) detecting air within the autoclave chamber. In this modules we explain the different types, how they function and how to set them up correctly.

EN285 Thermometric Testing

How to perform thermometric testing to EN285 including setup of the Standard Towel Pack, Small and Full Load Thermometric Test, Small and Full Load Air Detector Test, Air Detector Function Test and textiles and metal load dryness tests.
With practical demonstrations.

Steam Quality Testing

How and when to perform steam quality testing including Superheat, Dryness and Non Condensable Gases tests.

Fluids Loads Sterilization

How to perform fluids loads sterilization including cycle design, cycle development, sensor placement, biological indicators and acceptance criteria.

Steam, Air Steam Mix and Cascade Autoclaves

Alternative methods for fluids loads sterilisation and when you would use them and how to qualify them.

Lethality

What is lethality/Fo, how it is calculated, lethality as a method of cycle control and when to use it.

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Autoclave Design

Learn how autoclave design can impact the validation of loads. How to specify Cycle Design for User Requirement Specification.

Routine Testing

Routine Testing is in place to detect failures in the process. Setup correctly this can help predict, detect and prevent common failures.

Validation

Provide robust and repeatable cycle design, qualify loads in compliance with international standards and regulations

Failure Modes

If failures occur understand how to perform effective investigations to identify root causes and provide solutions.

Autoclave Validation Specialist and Course Leader

Chris Maughan, Managing Director and Founder of Thermal Compliance Ltd. (established 2007). His career within the life sciences sector spans over 20 years specialising in validation compliance, consultancy and training. He is a validation professional skilled in the Validation of Sterilisation processes.

Throughout the course Chris is happy to answer any questions you may have, please leave comments or contact Chris directly by email chrism@thermalcompliance.co.uk

“The key to successful autoclave validation is in robust and repeatable cycle design”

Chris Maughan

Autoclave Validation Specialist

Advanced Autoclave Validation

Any Questions?

Please let us know if you have any questions, require a group booking or a bespoke course delivered at your facility.

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18 Harelands Courtyard Offices, Richmond, North Yorkshire, DL10 5NY UK
info@thermalcompliance.co.uk
01748327247

Thermal Compliance , North Yorksire, UK

Chris Maughan

3 Days

Advanced Autoclave Validation

Next Course: 12th to 14th November 2024

Day 1

Introduction to Autoclaves

Regulations and Guidance

Introduction to Microbiology

Routine Testing

Anatomy of an Autoclave

Cycle Design and Development

Day 2

Load Orientation and Wrapping

The Steam Path

Critical Control Parameters

Autoclave Loading Patterns

Sensor Selection, Insertion and Placement

Biological Indicators

Porous Load Acceptance Criteria

Common Autoclave Failure Modes and how to resolve them

Day 3

Introduction to Air Detectors

EN285 Thermometric Testing

Steam Quality Testing

Fluids Loads Sterilization

Steam, Air Steam Mix and Cascade Autoclaves

Lethality

Download our course brochure!

Autoclave Design

Routine Testing

Validation

Failure Modes

Autoclave Validation Specialist and Course Leader

Chris Maughan

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