Product Definition

“Most of the major pharmaceutical companies rely on us because we offer personalized turn-key solutions.”

New Containment strategies by providing integrated concepts for pharmaceutical production processes while manufacturing solids.

• Chemical Industry Manufacturing (active) compounds.
• Pharmaceutical Industry Manufacturing solids.
• Machine manufacturers of pharmaceutical production machines.

Engineering of integrated production processes for production rooms or production lines
– Overcoming of considering individual machines only, but looking for integrated concepts while

• manual handling and
• machine production of pharmaceutical solids

Integration of HEPA filter units into the pharmaceutical production processes

Grading of HEPA filters according required OEL levels

Guaranteeing of unbroken compliance with:
– Required room pressure in production rooms at any time ( Regulation of in coming and off going air to filter unit)
– OEL values levels 1 – 5 while dust recovery and filter change at any time

Closing the gap in containment..
– Required efficiency values of filter systems : H14 / EN 1822 at any time

Validation of HEPA filter units when integrated into theproduction process
– IQ = Installation Qualification
– OQ = Operation Qualification
– PQ = Production Qualification