GMP Production

Otorhinolaryngology

Head of Department:
Prof. Dr. med. Dr. h. c. Heinrich Iro

GMP Production

the Pharmacy of the University Hospital Erlangen, Palmsanlage 3

Through close cooperation with our partner, the Pharmacy of the University Hospital Erlangen, we have the opportunity to produce the nanoparticle systems according GMP (Good Manufacturing Practice) guidelines. To analyze the prepared specimens established characterization methods, such as dynamic light scattering (DLS), HPLC - UV or FTIR are used. The Pharmacy of the University Hospital Erlangen has a manufacturing authorization for investigational medicinal products according to §13 AMG for selected drugs (http://www.apotheke.uk-erlangen.de/leistungsspektrum/herstellungsbetrieb-nach-13-amg/). The available manufacturing facility complies with all relevant regulations, such as the EU GMP Guide, the GCP Regulation and the German Pharmaceutical Law.

Mini Pilot Reactor in the clean room

Synthesis reactor MiniPilot 2 special (Büchi AG)

For the upscaling of nanoparticle synthesis from the laboratory level up to the production of small batches a mini pilot reactor for GMP / FDA compliant synthesis is available at the Pharmacy. The reactor meets the current GMP  requirements in all product contact parts.
 
The modular design facilitates the exchange of components to accommodate different synthesis requirements, such as: distillation, evaporation to any desired consistency, multi-component reactions, gas introduction, extraction, crystallization or precipitation.

The system is composed of a cover plate with a metering unit. A hand hole for the addition of starting material, an inert gas connection, an opening for a  stirrer, a reflux condenser, and a pressure gauge for monitoring the pressure are fixed. This allows a small-stage parameterization process for the adaption of synthesis steps from the laboratory scale to larger scale under quality-controlled conditions.

Contact at SEON


Contact at the Pharmacy

Ralph Heimke-Brinck,
Pharmacist
phone: +49 9131/85-39041
e-mail: ralph.heimke-brinckatuk-erlangen.de

Eva Baum
Pharmacist
phone: +49 9131-85-33595/-39042
e-mail: eva.baumatuk-erlangen.de

http://www.apotheke.uk-erlangen.de/



 
News

Potenziale der Nanomedizin
Europaabgeordnete Monika Hohlmeier
besucht SEON

Erlangen soll Leuchtturm werden
Oberbürgermeister Florian Janik sagt
Unterstützung zu

First poster award: Dr. Ralf Friedrich
16th Ferrofluid-Workshop 2017, Dresden, Germany

Second poster award: Dr. Marina Pöttler
10th International Conference CLINAM 2017, Basel, Switzerland

Highlights

Forschung mit anziehender Wirkung
Manfred-Roth-Stiftung unterstützt SEON-Turmorforschung der HNO-Klinik mit 50.000 Euro

Physik-Nobelpreisträger Prof. Dr. Gerd Binnig zu Gast in der HNO-Klinik

Donations account

Forschungsstiftung Medizin at the University Hospital of Erlangen

Sparkasse Erlangen
IBAN: DE 69 76350000 0000062000
Intended use:
Nanomedizin Prof. Alexiou

Certifications
Text TÜV Süd auf weißem Grund umgeben von achteckigen blauen Ring in dem in weißer Schrift ISO 9001 steht
 
 
 
 
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Summary