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Requirements of effective contamination control
and the appropriate steps to manage deviations
DATE: Thursday 18th February 2015
VENUE: Four Pillars Hotel, Abingdon
PRICE: 350 Members, 450 Non Members*


Tim Sandle
Jenni Tranter
Synergy Health
Alan Heavey
Sterilisation Solutions Ltd
Alison Livsey

09.30 Registration
10.00 Welcome & Programme Overview: Jenni Tranter, Chair
10.15 -11.30 Sterilisation Technologies Overview
An Insight into the Sterilisation Methods
Jenni Tranter, Synergy Health

Technology overview & comparison

Achieving the desired SAL
Concept to market for Sterilisation process
Key considerations

Moist Heat Sterilisation - Overview

Alan Heavey, Sterilisation Solutions Ltd

What are we trying to achieve?

The Autoclave
Steam supply
Cycle Design

11.50 - 12.25
Disinfection/Sanitisation Processes;
Semi and Automated: cGMP for Cleaning and Disinfection
Tim Sandle, BPL

Regulations relating to cleaning and disinfection

Selection of detergents
Selection of disinfectants (manual and automated systems)
How disinfectants kill microorganisms
Disinfectant rotation
Orientating the environmental monitoring programme to assess cleanroom cleanliness
Disinfectant field trials: what do we want to achieve?
Key audit points relating to cleaning and disinfection (including FDA warning letters)

12.25 - 13.00
Disinfection Application Techniques & The Science of Wiping
Alison Livsey, Contec

Manual application techniques

Benefits of wiping - why wipes are so effective
Advantages of presaturated wipes
Potential issues with disinfectant wipes
Manual application best practice
Typical manual disinfection programme


14.00 -15.45 Interactive Workshops covering challenges to industry,

the practical elements. Delegates will need to pre-register for their
preference when booking.
OPTION 1 Sterilisation;
Moist Heat Sterilization of Porous Load/Hardware Loads - Best Practice & Pitfalls
Alan Heavey, Sterilisation Solutions Ltd

Acceptance Criteria best practice; global possibility?

Equilibration Time the why, the how and the, Why does it fail?
Wet loads when is wet, well wet? Why does it happen, how can we fix it?
Loads packaging, preparation and failures
Quality, risk and commercial rationale how did we get to this place?

OPTION 2 Sterilisation;
How to decide which option is most suitable - Best Practice and Pitfalls
Jenni Tranter, Synergy Health

Importance of R&D assessment - when and what to trial

Process validation / performance qualification / dose mapping / sterilisation validation what is required and when?
Deviations - they do happen, understanding why
Importance of consistency and maintaining this
Routine processing & monitoring, what is involved

OPTION 3 Automated Processes;

Meeting Regulatory Expectation for Cleaning and Disinfection
Tim Sandle, BPL

Key points for a disinfection rationale

Key points for cleaning and disinfection SOPs
How to approach the disinfectant rotation question?
Key environmental monitoring points
Strategies for disinfection field trials
Semi and automated disinfection foggers and gaseous: strategies for qualification

OPTION 4 Manual Procedures;


Microscopic view of wipes and mops

Capabilities of different wipes to attract and retain contaminants
Repeatability of wipe saturation
Effective repeatable surface wiping
Best practice mopping

15.45 - 16.00 Summary & Close; Jenni Tranter, Chair

The aim of this one day conference is to provide delegates with an overview of all key elements
together with the opportunity to network with industry experts. The day will start with presentations
covering everything from the sterilisation options available, best practice approach to manual and
automated disinfection/sanitisation procedures. The afternoon will feature workshops giving delegates
the opportunity to focus on specific topics of interest relating to overcoming some of the challenges
faced in managing deviations.


Microbiology, R&D, Quality, Technical, Validation, Regulatory, Engineering, Process Development,
Planning, Procurement, anyone involved in the Sterilisation, Sanitisation & Disinfection process,
there will be something for everyone.

To book online and go to EVENTS

(or click on the left hand side)

or call +44 1793 824254 to discuss further
* VAT applicable for UK invoice addresses