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VHP/ vH202 has been used in the Pharmaceutical industry for many years initially in Isolator barrier technology but now in Cleanrooms but the science and process have not always been fully understood or applied correctly. This lack of knowledge has led to increasing regulatory observations and a Blog from the MHRA considering the Fragility of VHP that has challenged the Pharma industry.
 

This workshop closes the knowledge gap in science and requirements for CGMP compliance and explains current
developments to meet process challenges for aseptic processing of biological products where H202 residuals may impact at low levels.
 

This workshop would benefit;
• Biological product development specialists who need to consider H202 residuals that apply in environmental control
of processing areas hence may impact product.
• Microbiologists involved in environmental control of CGMP
classified/ controlled areas
• Validation/ qualification specialists involved in VHP cycle development and qualification
• Process engineers that need to consider the technical
integration of VHP bio-decontamination
• Production operations that need to consider how to achieve short robust VHP cycles for effective operations.
 

Key Job Titles:

Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeial Scientist, Analytical Standards Specialist

Global Presence:

Attendees from all over the world attend our events. Gain insight from representatives from the USA, UK and Europe.
 

Workshop programme

13:30 Registration and Coffee

14:00 Opening remarks and introductions

14:10 Key points on Science of VHP bio-decontamination

James  Drinkwater

James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

• Vaporisation of H202, control of condensable vapor and impact on cycle time
• Hydrogen bonding characteristics and impact on gas distribution
• Scientific comparison of VHP and Dry Fog using H202 for applications in
Isolators and Cleanrooms.
• Applied science at each cycle phase to optimise overall cycle time and efficacy
 

14:50 Addressing regulatory concerns in ‘Fragility of VHP’

James  Drinkwater

James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

• Limitations of VHP penetration through protective layers/ spore clumps and impact on cycle Fragility if not properly managed.
• MHRA Blog on Fragility of VHP – key considerations and discussion
• PHSS Clarity on GMP Guidance note: Assurance of Sterility for surfaces that contact product contacts parts; relates to MHRA Blog
• Managing limitations of VHP and using the strengths for a robust CGMP
compliant process.

 

15:30 Afternoon tea

16:00 Application of VHP bio-decontamination in Filling line barriers

James  Drinkwater

James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

• Process integration of a VHP bio-decontamination process into a Filling line
Isolator to achieve total cycle times less than 2 hours to 1ppm level.
• Biological indicator pre-use qualification to reduce risks of unexpected BI
positive growth because of BI quality issues.
• VHP cycle development – improved practice to make the process efficient and with reduced risks of issues at site qualifications
• VHP bio-decontamination of material loads in support to Filling lines.
 

16:40 H202 residual biocompatibility with biological products

James  Drinkwater

James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

• Oxidizing potential of H202 and possible impact on biological products.
• DoE: Design of Experiment studies to assess VHP/H202 residual impact on biological products.
• Analytical methods (Amplex Red) applied in H202 residual transfer studies
• Examples from VHP/H202 residual studies and product impact.
 

17:20 Closing remarks

17:30 End of workshop

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Battery Wharf Hotel

3 Battery Wharf
Boston 02109
USA

Battery Wharf Hotel

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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