Home
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

clock

8:30

Registration & Coffee

clock

9:00

Welcome and Introduction

clock

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
  • clock

    9:50

    The Process should be the "Driver";

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

    clock

    10:30

    Morning Coffee

    clock

    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
  • clock

    11:40

    Practical Case Studies

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

    clock

    12:20

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

    clock

    13:00

    Networking Lunch

    clock

    14:00

    Facility Design Elements

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

    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
  • clock

    15:10

    Afternoon Tea

    clock

    15:40

    Confidence

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

    clock

    16:20

    Closing Remarks and end of the Masterclass

    MSE Meeting Rooms

    103a Oxford Street
    London
    United Kingdom

    MSE Meeting Rooms

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    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.

    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@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.