Contex

The GEMÜ 490 series butterfly valve is suitable for pharmaceutical manufacturing applications involving freeze-drying processes with critical operating conditions.

Challenge

Many pharmaceutical manufacturing procedures are based on bio-technological processes. Often, their molecular structure is extremely complex and their liquid form is unstable, which is why many bio-pharmaceuticals cannot be stored directly. Freeze-drying is the gentlest procedure for conserving the active ingredient solution.

Solution - dynamic freeze drying in bulk

To overcome the disadvantages of conventional freeze-drying processes, Meridion developed a technology for freeze-drying pharmaceuticals in bulk, which has several steps:

  • Transfer of spray liquid
  • Drop formation
  • Freezing the droplets to microspheres
  • Freeze-drying
  • Draining/filling

Advantages of dynamic freeze-drying

  • Dust-free product with good flow characteristics
  • Higher drying speed
  • Variable batch quantities
  • Flexibility in production, with primary packaging materials (e.g. vial) and during formulation
  • No handling of vials
  • Combination of different lyophilized products

GEMÜ 490 valves

The GEMÜ 490 butterfly valve plays a key role in the process. It is based on the design of concentric soft seal valves and is lined with PFA or PTFE. After the frozen globules have fallen through the cooling tower and are collected in the freeze-dryer, the butterfly valve closes upwards and the vacuum can be applied.