Teilnahme an den Konferenzen des Kongresses - Pharma Kongress ...
Teilnahme an den Konferenzen des Kongresses - Pharma Kongress ...
Teilnahme an den Konferenzen des Kongresses - Pharma Kongress ...
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In Kooperation mit<br />
ECA<br />
EUROPEAN COMPLIANCE<br />
ACADEMY<br />
Objectives<br />
Case studies from various pharmaceutical comp<strong>an</strong>ies deal with the implementation <strong>an</strong>d qualification of barrier systems<br />
You get to know the current state of the art as well as future technological developments in the field of barrier systems<br />
Which are the weak points of the systems – which operational experience has been gathered? Experts from pharmaceutical<br />
comp<strong>an</strong>ies share their experience with you<br />
Discuss which points have not yet been m<strong>an</strong>aged satisfactorily or need to be improved?<br />
Background<br />
Conference Barrier Systems<br />
Bild: OPTIMA pharma<br />
Especially in connection with sterile medicinal products produced by aseptic processing, protection<br />
against microbial contamination increases in import<strong>an</strong>ce. In case of new facilities for sterile m<strong>an</strong>ufacturing,<br />
the classical cle<strong>an</strong>room c<strong>an</strong>not be considered as the state of the art <strong>an</strong>y longer. Today the supervisory<br />
authorities require a more strict separation between staff <strong>an</strong>d product in the form of <strong>an</strong> access barrier –<br />
RABS (Restricted Access Barrier System) or isolator. The level of contamination safety as well as that of personnel<br />
protection is clearly higher in both systems. This conference focuses on topical questions on barriers<br />
systems in detail from the perspective of pharmaceutical operators, pl<strong>an</strong>ners <strong>an</strong>d engineers.<br />
Target Audience<br />
The event is directed at decision-makers from pharmaceutical production, development <strong>an</strong>d quality assur<strong>an</strong>ce/control, at engineers <strong>an</strong>d pl<strong>an</strong>ners<br />
who need to be well informed about current developments in the field of barrier systems.<br />
Moderator<br />
Jörg Zimmerm<strong>an</strong>n, Vetter <strong>Pharma</strong>-Fertigung<br />
Programme 19 March<br />
9:00 h <strong>Pharma</strong> M<strong>an</strong>ufacturing 2020: Development <strong>an</strong>d Investment Strategy – The View of <strong>an</strong> aseptic filling Comp<strong>an</strong>y<br />
using Platform Technologies<br />
 Udo J. Vetter, Vetter <strong>Pharma</strong>-Fertigung<br />
What are the trends in aseptic m<strong>an</strong>ufacturing<br />
Success factors for a growth strategy<br />
Extension of capacity <strong>an</strong>d the practical implementation<br />
Technical <strong>an</strong>d regulatory challenges for the upcoming years<br />
Expectations with regard to pl<strong>an</strong>ning <strong>an</strong>d engineering comp<strong>an</strong>ies<br />
9:45 h Case study: How to run a RABS cle<strong>an</strong> room successfully<br />
 Jörg Zimmerm<strong>an</strong>n, Vetter <strong>Pharma</strong>-Fertigung<br />
Aseptic Process Design<br />
Cle<strong>an</strong> Rooms – RABS – Isolator: Adv<strong>an</strong>tages <strong>an</strong>d Disadv<strong>an</strong>tages<br />
Types of RABS <strong>an</strong>d implications<br />
Mock-up studies<br />
Daily operations of a RABS<br />
Glove integrity testing / Media fills / Monitoring<br />
Case studies from real life<br />
11:00 h Pros <strong>an</strong>d Cons of Isolator <strong>an</strong>d Cle<strong>an</strong>room based on 10 years of operating experience in sterility testing<br />
 Dr. Timo Krebsbach, Labor L+S<br />
Practicability / Reliability / Costs<br />
Practical problems <strong>an</strong>d solution strategies<br />
11:50 h Aseptic tr<strong>an</strong>sfers across a barrier<br />
 Benoit Verj<strong>an</strong>s, Aseptic Technologies<br />
Crossing a wall has been very challenging during m<strong>an</strong>y years<br />
New tr<strong>an</strong>sfer solutions, called Rapid Tr<strong>an</strong>sfer Ports (RTP) have been initially developed for solid tr<strong>an</strong>sfer whereas the complex<br />
“Cle<strong>an</strong> in Place – Steam in Place” (CIP-SIP) remained the leading solution for liquid tr<strong>an</strong>sfer<br />
Some RTP solutions are now applied for liquid tr<strong>an</strong>sfer<br />
A case study is shown with a small <strong>an</strong>d rapid disposable solution, the SART connector<br />
14:05 h Special considerations in Aseptic processing of Biological-Toxic products in Isolators<br />
 James Drinkwater, Bioquell / PHSS<br />
Challenges of processing Aseptic – Biological <strong>an</strong>d Toxic products<br />
Control logic to provide aseptic environment, prevent operator exposure <strong>an</strong>d cross contamination<br />
M<strong>an</strong>aging compatibility between disinfection agents <strong>an</strong>d Biological products<br />
Reducing risk with single use disposable technologies but underst<strong>an</strong>ding the process challenges<br />
Applying environmental monitoring systems together with contamination risk m<strong>an</strong>agement<br />
14:55 h A day in the life of <strong>an</strong> isolator glove: Glove testing <strong>an</strong>d glove lifetime study:<br />
 Joh<strong>an</strong>nes Rauschnabel, Robert Bosch<br />
M<strong>an</strong>ual interventions with gloves<br />
Glove testing / Simulation of glove use<br />
Particle measurement<br />
Lifetime study<br />
Exch<strong>an</strong>ge intervals<br />
i<br />
Gesamt-Zeitpl<strong>an</strong> am Ende <strong>des</strong> Programms. Änderungen von Inhalten und Zeiten vorbehalten. Aktuelle Infos auf www.pharma-kongress.de.
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