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About the Workshop
Rapid
Prefilled syringes are of growing importance in the pharmaceutical manufacturing. Silicone oils are usually applied to the containers to form lubricating films on the inner surface of prefilled syringes or to gain hydrophobic container walls.
However, there are several issues related to the interaction of silicone oil and particular protein based formulations like agglomeration (of the active) and absorption of the API in the silicon layer
In order to control the siliconization process methods like weighing of silicone oil or the determination of silicone oil by extraction and measuring the content with AAS (atomic absorption spectroscopy) are currently used. But these technologies are very time consuming and not able to give an information about the silicone oil distribution within the barrel of the syringe.
Recently white light interference was developed as a technology which is able to measure reliably the silicone layer thickness in a syringe in a few seconds. The accuracy can be verified with known standards. Data will be shown for the  correlation of this technology with  data as force displacement measurement and extraction results.  Furthermore the influence of different kinds siliconization of the silicone layer will be presented. The application of the technique in the analysis of failures and process variations will be shown.
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About the workshop Leader
Dr. Markus Lankers is one of the co-founders of rap-ID Particle Systems GmbH a company that develops manufactures and sales rapid particle identification and siliconization measurement systems. Within rap.ID Dr. Lankers is responsible for research and development of specific solution of particulate analysis. Prior to this position he worked as scientist in different development departments with Schering AG, Berlin, Germany. He has published and presented work in the field of analytical methods for particle analysis and spectroscopic analysis.
He helped to establish the Visual Inspection of Parenterals Interest Group in Europe and to setup the first company independent vis. Inspection trainings course. He served as program cochair for Scientific Conference on Visual Inspection of Partenterals 2001-2007  in Europe and USA.

Workshop programme

13:00 Registration

13:30 Reasons, types and methods of siliconization

14:10 Test Methods

14:50 Afternoon Tea

15:20 Influence of process parameters on silicone layer

16:00 Characteristics of silicone oil layers in dependence of siliconization process

16:40 Summary and Close of Workshop

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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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