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Bio-contamination Control & Monitoring Seminar & Workshop

This seminar supports the initiative of Quality Risk Management (QRM) by improving bio-contamination control process knowledge together with an improving understanding in the best practice of environmental monitoring either to meet GMP target levels or control bio-burden to non sterile applications.


Control of Bio-contamination, related total particulate and monitoring for deviation to set trends or levels is a fundamental part of processing pharmaceuticals, bio-pharmaceuticals, radio-pharmaceuticals and in preparation of medicinal / therapeutic prescriptions in Pharmacy aseptic services units.

Out of specification (OOS) excursions in micro-biological levels require root cause analysis (RCA) and corrective and preventative action (CAPA) that can be time and resource consuming, interrupting process operations, product release and potentially put patients at risk.

Registration from 9am
Welcome and start 9.30am
Chairmans welcome and seminar introduction.

9.40am – 10.20am
Changes in ISO standards that impact on contamination control and monitoring in classified areas: Update of progress in changes to ISO14644 and ISO14698.
Tim Triggs, PHSS Management committee - Director DOP Solutions.
• ISO14644 parts 1 to 8 – Cleanrooms and Associated controlled environments current status of changes and potential impact.
• ISO14698 current status of changes to a two part standard: Classification of airborne (part 1) and
surface (part 2) Bio-contamination in cleanrooms, including methods of measurement and their
• Overview of developing PHSS technical monograph on Bio-contamination classification and
monitoring of controlled areas.

10.20am – 11.00am
Gaseous disinfection of Barrier systems.
James Drinkwater, PHSS Chairman, Bioquell process and Compliance Director
• Science and mode of action for the bench mark process: Hydrogen peroxide vapour.
• Gaseous disinfection of Cleanrooms and associated material transfer chambers.
• Gaseous disinfection of Separative barriers, Isolators and RABS (restrictive access barrier systems).
• Validation rationales for Rooms, Barriers and Material transfers.

11.00am – 11.20am
Coffee and viewing Exhibition.

11.20am – 12.00pm
Manual disinfection in Cleanrooms and barrier systems.
Karen Laws. Contec. Marketing Manager
• Science and modes of actions for manual disinfection processes.
• Best practice in Cleanroom disinfection.

• Development of impregnated wipes for improved safety, application and compatibility
with particle monitoring systems.
• Validation requirements and practices.

12.00am – 12.40pm
Environmental monitoring of Barrier systems: Cleanrooms, Isolators and RABS.
Ken McWilliam - Pharmagraph UK.
• Integrated systems for environmental monitoring (EM) programs.
• Continuous monitoring and Classification particle monitoring.
• Active air sampling and integration into barrier systems.
• Trending in environmental monitoring programs.

Lunch served and lunch break and viewing of exhibition until 2.00pm.

2.00pm – 3.00pm
Workshop presentation and discussion: Microbiological deviation management including best
practice in Root cause investigation (RCA) and Corrective and Preventative action (CAPA).

PHSS Bio-contamination monitoring special interest group.
• Risk based review on microbiological out of specification (OOS) results.
• Best practice in managing microbiological deviations.
• ISO14698 is changing to include Classification of controlled areas by microbiology - what does this
mean and what is the impact?

3.00pm – 3.15pm
Afternoon break.

3.15pm – 4.15pm
Workshop: PHSS Publications review
PHSS Bio-contamination monitoring special interest group.
A number of recent publications in the European Journal of Parenteral and Pharmaceutical Sciences
(EJPPS) have an impact on bio-contamination control and monitoring and operations in Cleanrooms and controlled air devices (Isolators and RABS). In addition recent PHSS monographs introduce a new hierarchy of bio-decontamination principles and practice that support initiatives of Quality Risk management (QRM). This session reviews the key issues presented in the scientific articles and monographs and considers their impact.
• Microbial monitoring active air samplers – the D50 rate and collection efficiencies – likely to be
referenced in developing guides and standards.
What is this D50 rate and how is it monitored?
• Airborne Microbial Monitoring in an Operational Cleanroom using an Instantaneous Microbial
Detection (IMD) system and High Efficiency Microbiological Samplers. Overview of experimental
research with operational trials of IMD systems and comparison with traditional, efficient  environmental monitoring systems. Comparison between IMD recorded ‘biological’ particles and microbe-carrying particles (MCPs). Research conclusions on applying microbial monitoring technologies to classified areas.
• Introducing Gaseous Vapour Phase (GVP) decontamination possible to validate to achieve
surface sterilisation of in-direct product contact parts as a Gassing-In-Place (GIP) process.
GVP decontamination taking a place in a biodecontamination hierarchy. Possible other
applications of GVP decontamination in Freeze dryers. First published in the PHSS RABS technical
monograph no.15.

Chairmans closing remarks and seminar.
Seminar close: 4.20pm

For more information contact PHSS Office, download the programme here


Becton Dickinson, Oxford


Tim Triggs - DOP Solutions
James Drinkwater - PHSS Chairman
Karen Laws - Contec
Ken McWilliam - Pharmagraph


June 27, 2012


Please contact the PHSS Office with any questions. Info@phss.co.uk or tel: 01793 824254


Member £ 300.00 + VAT
Non Member £ 400.00 + VAT

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