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

 

Dr. sc. hum. Tobias Borst
Pharmacist Pharmacist
Tel: 09131-85-33595/-39285
Email:  Tobias.Borstatuk-erlangen.de

www.apotheke.uk-erlangen.de



 
News

DFG fördert 15 neue
Sonderforschungsbereiche

SEON an SFB/Transregio
"BioFab" beteiligt

Magnetpartikelforschung will Patienten
ihre Stimme zurückgeben

Manfred-Roth-Stiftung und
Forschungsstiftung Medizin spenden
50.000 Euro für die Entwicklung
von Stimmlippentransplantaten

Potenziale der Nanomedizin
Europaabgeordnete Monika Hohlmeier
besucht SEON

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
 
 
 
 
Please insert your name and correct email addresses!
X zum Schließen

Summary