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Containment of Highly Potent APIs
17 March 2015
Containment of Highly Potent APIs

A significant proportion of new drugs under development contain high-potency active pharmaceutical ingredients (HPAPIs), which is leading to explosive growth in demand for their production. The cytotoxicity of HPAPIs, however, presents handling challenges and requires heavy investment in specialized containment to ensure that employees and their environment are protected from exposure. This article examines the planning, equipment, and facility design of chemical and biologic HPAPIs as well as biologic–HPAPI conjugate manufacture. It also outlines the efforts made by the pharmaceutical industry to develop voluntary standards for HPAPI production and handling.

Five years ago the drivers for containment was almost strictly for protecting the operators for exposure of the compound, equally important, appreciation of containing the product so the risk of cross contamination in the facility. This Masterclass will assess how to improve understanding on containment and identifying how to minimise the risks of exposure.
 

Masterclass agenda

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8:30

Registration & Coffee

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9:00

Welcome and Introduction

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9:10

It All Starts with the Hazard!

  • An accurate understanding of pharmaceutical compound hazards is critical as it underpins design parameters
  • Get it wrong and you over-or under-design; both are bad for business
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    9:50

    The Process should be the "Driver";

    Containtment should be designed to fit the process-not the other way around

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    10:30

    Morning Coffee

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    11:00

    Flexible vs. hard wall performance

  • An area where keen comparisons can be made and enough data is available to make compelling arguments
  • Comparison of hard wall vs disposable
  • Assessing the challenges of containment and propoer monitoring, eurgonomics and engineering control
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    11:40

    Practical Case Studies

    Using different containment methods, due to the need to create standardisation - when under audit constantly

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    12:20

    Practical examples of companies who have gone through to meet requirements for high containment

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    13:00

    Networking Lunch

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    14:00

    Facility Design Elements

  • Layouts
  • HVAC Air Pressure Regimes
  • Reviewing the whole concept and data collected from containment studies
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    14:40

    When should you dispose of a flexible system or quality system?

  • Understand more about this and the difference in technology and how to validate the cleaning of hard wall and flexible containment
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    15:10

    Afternoon Tea

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    15:40

    Confidence

    Assessing the occupational hygiene piece on seeking confidence that design and containment objectives have been met? Control performance envelopes, etc SafeBridge

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    16:20

    Closing Remarks and end of the Masterclass

    VENUE

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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, SAE Media 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.

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    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@saemediagroup.com

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