Contract manufacturing of sterile forms

We offer a long-term expertise in  sterile production of

• Formulation of aqueous solutions
• Aseptic filling of aqueous solutions in vials up to 100 ml
• Sterilisation in the final container
• Lyophilisation
• Labelling
• Secondary packaging
  
  
  

• Quality control of sterile dosage forms
• Automatic testing for visible particles and sterility testing according to EP
• Development and optimisation of testing methods

Validation phase:

• Risk analysis for the identification of critical parameters
• Execution of process and method validations
• Preparation of manufacturing and testing instructions

Production phase:

• Transfer into routine production and analysis
• Preparation of Product Quality Reviews

Additional services:

• Cleaning validation and stability studies according to ICH guidelines
• Release for placement on the market

All services can be offered particularly for veterinary products, including vaccines.