GMP test rooms

New Service at Höfliger – over 450 qm of laboratory space for tests under controlled climatic conditions

Strategy as a success formula
Nowadays innovative corporations use strategic alliances to minimize development costs and the time to market. This is where it is advisable to have Harro Höfliger as your development partner for product-specific and process-specific lines.

For example, as an introduction to a joint powder project Harro Höfliger offers a comprehensive analysis of the products on the basis of which a preselection of the dosing system can be performed. Further optimization of the system selected can be performed in Höfliger’s own laboratory area together with the customer using original product under controlled conditions.

At the end of the multistage development ranging from the pilot installation to the production line the possibility exists of already producing time-saving stability samples with the qualified machine at Harro Höfliger and of operating the complete line with verum under production conditions.

The 4 GMP test rooms and the pharmaceutical laboratory open up new possibilities.
Service & Consulting:

• Analysis and classification of powder formulations
• Process development and optimization
• Support in formulation and packaging development
• Qualification and GMP training sessions

Tests under controlled environment:

• Testing of customer-specific trial aggregates (“POPs”)
• Line run in with “true” product (Verum) instead of placebo
• Optimization of process parameters and machine settings
• FAT and qualification runs based on future production conditions

The customer benefits of a widespread service performance:

• High efficiency due to direct availability of development and manufacturing
• Time savings, for example by producing the first stability samples onsite
• Well-coordinated team with pharmaceutical-technological know-how:
  • pharmacist with many years of industrial experience
  • engineers from the internal development department
  • experts from the qualification department
  • well-trained and experienced installation, assembly and service staff
• Availability of machine modules / test systems for:
  • dosing of micro volumes of powder
  • thermoforming / cold-forming / sealing of innovative films and foils
  • feeding / dosing of liquid and non-liquid components
  • laminating and delaminating
  • punching and cutting
  • forming