CLEANROOM PRODUCTION

for you

Grade C & D

Production in the Grade C & D cleanroom according to §13 of the German Medicinal Products Act (AMG) under GMP conditions.

In our cleanroom production, we rely on perfect interaction between technology and people. The production of pharmaceutical media uses technical equipment that meets the highest standards.

Production uses technical equipment that meets the highest standards.

Facts and Figures

  • 800 m2 cleanroom area, divided into liquid and solid areas
  • Clean corridor concept
  • Production facility free of animal components (AOF)
  • Personnel airlocks
  • Weighing of raw materials in cleanroom class C&D
  • Compounding and filling in cleanroom class C&D
  • 3 filling rooms for liquid media cleanroom class C&D
  • 2 filling rooms for solid media cleanroom class C&D
  • Automatic transport conveyor system with integrated weighing technology
  • SIP/CIP system for sanitisation and cleaning with validated cleaning processes
  • In-house quality control including microbiology
  • Washroom to clean production equipment
  • In-process use of nitrogen and ultra-pure steam

Production setup

  • Multipurpose equipment with validated cleaning procedures
  • Stainless steel vessel with integrated double agitator
  • 2,000 L and 5,000 L stainless steel vessels with magnetically coupled agitator, heatable, temperature-regulated, inline pH control
  • 2,000 L and 5,000 L plastic vessels (PVDF)
  • Vessels on integrated scales for direct weighing of raw materials
  • 200 L mobile vessel for pilot or small batches
  • 1.000 L mobile single use mixer for small scale batch production
  • Weighing containers from 100 L - 1,000 L volume

Warehouse

Additional external storage capacities at warehousing service provider
  • 3,200 pallet spaces for packaging materials, raw materials and finished products
  • Temperature and humidity monitoring
  • Pest control
  • Underground stainless-steel storage tank with 30,000 L volume for pharmaceutical solutions
  • Laminar flow sampling cabinet for contamination-free sampling of raw materials

Our Experts For you

 

Our Experts - Your Partners

Overview of key contacts - supported by many more specialists working for our partners and Clients behind the scenes.

Dr. Frank Velte
Head of CG Pharma & Biotech

+49 (0)511 87803-106
+49 (0)152 3466 7631
frank.velte@cg-chemikalien.de

Marco Regel
Head of Sales & Business Development

+49 (0)511 / 87803-146
+49(0)511 / 2516696
marco.regel@cg-chemikalien.de

Thomas Metzger
Sales & Business Development Manager

+49 (0)511 87803-258
+49 (0)79 483 72 81
thomas.metzger@cg-chemikalien.de

Verena Diederich
Head of Quality Management

+49 (0)511 87803-870
+49 (0)173 / 3857408
verena.diederich@cg-chemikalien.de