Construction / Reconstruction

Construction project for a new sterile plant (“Pharma 2020”),
floor space 14.000 square meters with an investment volume of approx. € 23m. Execution of the project within time line and
budget. Production of commercial products 18 months after
completion of foundation.

 

Development of a production site as competence centre for
pharmaceutical packaging including full QC service and with sales releases for pharmaceutical products.
Annual volume of 100m. Blister.

Optimation of economics

Consolidation of several rationalisation measures (re-engineering, redesign, group production, lead-time reduction) into a
lean manufacturing concept, achieving > 10 % cost savings.
 
Development and implementation of a comprehensive Business Excellence Programme (balanced scorecard) with KPI’s for Operations.

 

 

Capital expenditures of manufacturing equipment

Development and implementation of PLC process automation for fluid bed coating, reduction of manufacturing costs by more than 80%.
 
Reduction of manufacturing costs by instalment of a new fully
automated 15.000 L reactor for sterile pharmaceutical and
medicinal products.

Change Management

 

Project management for a production relocation of
„Blow-Fill-Seal“ equipment (Bottelpack®) - technology.
 
Successful integration of two assembly lines following closure of two manufacturing locations in England and Germany, despite limiting cost and time factors.

 

cGMP

Accompany 3 Quality System FDA Audits without #483 deviations for 3 manufacturing locations.
Audit duration: 1-2 weeks/ inspection
No #483 report.
 
Yearly renewals of the manufacturing authorization after governmental audits.