print - GMP Pharma Consulting

GMP Pharma Equipment and Engineering Ltd.
Die GMP Pharma and Engineering Ltd. bringt über 25
Jahre Erfahrung in der Planung und Umsetzung von
Projekten in der Pharmazeutischen Industrie mit.
Ihr Ansprechpartner ist Herr Hans Knobloch,
Geschäftsführer und Projektmanager des Unternehmens.
Zusammen mit seinen Mitarbeitern und Partnern kann
auf das Know How von kompetenten Pharmazeuten und
Ingenieuren zurückgegriffen werden.
Projekte werden unmittelbar mit dem Kunden vor Ort in
engster Zusammenarbeit mit dem Betreiber
durchgeführt. Damit ist die Umsetzung gemäß
Kundenwunsch gewährleistet. Selbstverständlich werden
alle Maßnahmen im Vorfeld mit den
Genehmigungsbehörden abgestimmt.
GMP Pharma Equipment and Engineering Ltd., being
busy within Europe for more than 25 years, gives you
the experience of a strong network in technical projects
within the Pharmaceutical Industry.
Two years in South Africa we are now devoted to
empower previously disadvantaged women in this
specialised field.
Your partner will be Hans Knobloch as your Lead Project
Manager. In close cooperation with his team of qualified
pharmacists and engineers you get access to almost the
complete KNOW HOW of State of the Art Technology in
the Pharmaceutical Production.
Consultancy and ON-SITE-MANAGEMENT in a trustful
partnership with you as the client guarantees the
successful development and realisation of every project.
Turn Key projects are our speciality.
Hans Knobloch
Services
GMP - Concept Design - Accountabel Overall Planning (all stages) of
-
New production departments / Turn-Key-Solutions
Complete new production facilities
Packaging departments
Realisation of the relocation of production facilities
GMP - upgrades to comply with latest requirements
CLEAN - FLOOR CONCEPTS
Integration of new machinery into existing production facilities
Design of Air Ventilation Systems
Qualification / Validation
GMP - Audit Assistance
Active management and of communication with the local athorities
State of the art production equipment (Fluid Bed Granulator, Coating Machines)
Stainless steel components, -equipment and -furniture.
Field of Business
GMP Pharma Equipment and Engineering is working in the technical part of industry.
We are specialised in:
- Solid Dosage Forms
- Packaging Department
- Sterile Ampoule - and Vial-Filling
- Hormones
- Cytostatics
- Penicillines
- B-Lactame Productions
All projects are done in compliance with the latest regulations
cGMP – FDA – EMEA – DIN EN ISO 14644
References
Dragenopharm
Wyeth
Next Pharma (Pencef)
Haupt Pharma AG
Rhone Poulenc Livron
Pharma Start Kiew
Berlin Chemie
Swiss Caps BA
Eli Lilly
Dragenopharm
New Packaging Department 2006/2007
Integration Coater Technology 2007
Integration of Fluid Bed Granulators 2007/2008
Clean Floor Concept 2006
New Sterile Compartment
New Production Facility Penecillin's / ß-Lactame
Isolator Technology (Ampoule and Vial Filling)
Solid Dosage Form Upgrading
Solid Dosage Production Upgrade
Ampoule Filling Department Upgrade
12 000 m² Production Facility for Solid Dosage Forms
New Production Facility
GMP Upgrade
Regulatory Affairs new Packaging Department
New Sterile Department (Vial Filling)
Complete Production Facility 1997-1998
Contact
For an effective way to contact us, please phone Mr Hans Knobloch, visit our website or just fill in the questionary
below or fax to us. We will contact you ASAP.
Geschäftsführer
Internet
E-mail
Tel R.S.A.
Tel D.
Hans Knobloch
www.gmp-pharma-consulting.com
[email protected]
+27 8292 05645
+49 177 5732 127
Projects
Project 1
Succesful integration of 2 Glatt Fluid Bed Granulators and GMP - upgrade of
the Granulation Department
Whilst the production in the neighbouring departments had to continue the
granulation rooms where dismantled and completely rebuild. A new HVAC System was
installed. Materials of choice were stainless steel and glass for separating walls. The
whole project was completed within 3 months.
Project 2
Design - Delivery and Installation of GMP-Production Equipment
Within the projects for upgrading existing new production departments special
equipment was designed according to the clients requirements. The shown supply
columns with integrated washing basins are custom made with local suppliers.
Project 3
Design and Realisation of a new FilmCoating Department
New Film-Coating Units GLATT GC 1750 had to
be integrated into an existing production
facility. From the first design up to the finished
department the whole project was completed
within 2 months.
Project 4
Realising the GMP-CLEAN-FLOOR-CONCEPT in a State of the Art Packaging
Department
To comply with the latest GMP requirements for the CLEAN-FLOOR-CONCEPT the head
stations of the packaging lines were separated from the secondary packaging. Looking
for the most economic way glass was used as separating walls. This guarantees
transparency and easy validated cleaning.
The department was constructed in a period of about 5 months.