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Bio-contamination Control & Monitoring Seminar Dublin

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.

Schedule
Registration from 9.00am
Welcome and start 9.30am
Chairmans welcome and seminar introduction.

9.35am – 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
validation.
• Overview of developing PHSS technical monograph on Bio-contamination classification and
monitoring of controlled areas.

10.20am – 11.00am
Environmental monitoring of Barrier systems: Cleanrooms, Isolators and RABS.
Ken McWilliam, Pharmagraph UK & PHSS special interest group
• 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.

11.00am – 11.20am
Coffee and viewing Exhibition.

11.20am – 12.10pm
Regulatory perspective of Bio-contamination control, monitoring and deviation investigations.
IMB GMP Inspector

• Typical inspection observations relating to Bio-contamination control & monitoring.
• Regulatory expectations.
• Q&A session.

12.10pm – 12.55pm
Airborne Microbial Monitoring in an Operational Cleanroom using an Instantaneous Microbial Detection (IMD) system and High Efficiency Microbiological Samplers.
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca, UK Operations
• 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.

1.00pm
Lunch served and lunch break viewing of exhibition until 2.00pm.
2.00pm – 2.40pm
Rapid Sterility Test by Solid Phase Cytometry and comparison with other RMM technologies together with Isolator technology RMM & Validation.
Kevin Breesch, Toxikon Europe
• Why Rapid Microbiology?
• Available RMM Technology
• Rapid Sterility Test in an Isolator: Solid Phase Cytometry
• Validation of RMM
• Case Study
• Considerations on presented validation approach.

2.40pm – 3.20pm
Manual disinfection in Cleanrooms and barrier systems.

Karen Rossington / Alison Livsey, Contec Inc
• 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.

3.20pm – 3.30pm
Afternoon break.

3.30pm – 4.15pm
Gaseous disinfection of Barrier systems.
James Drinkwater, PHSS Chairman, Bioquell process & 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.

Chairmans closing remarks and seminar.
Seminar close: 4.20pm

To download the programme, please click here

Venue

The Red Cow Inn, Dublin, IRELAND

Speakers

Tim Triggs - DOP Solutions, PHSS Management Committee Member
Ken McWilliam, Pharmagraph UK
IMB GMP Inspector
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca, UK Operations
Kevin Breesch, Toxikon Europe
Karen Rossington / Alison Livsey, Contec Inc
James Drinkwater, PHSS Chairman, Bioquell process & Compliance Director

Date

July 4, 2012

Enquiries

Please contact the PHSS office with any questions.

Costs

Member £ 300.00 + VAT
Non Member £ 400.00 + VAT

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