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References

Our customers are our reference!

We will be pleased to name you personally an approved reference or a contact person from our clientele for your planned project. In doing so, we have to consider the confidentiality of information. We ask for your understanding.

Listed are selected references from the areas of aseptic production, production of liquids, production of solid forms, chemistry & production of active ingredients as well as utilities.

Planning of a facility for the aseptic production of freeze-dried injection preparations in vials (isolator technology)

Project

Planning of a facility for the aseptic production of freeze-dried injection preparations in vials (isolator technology)

Project stage

Conceptual design, basic/detail design, start-up & qualification

Tasks D&B

  • Consulting in the conceptual phase
  • Extended Basic Engineering filling lines and isolators
  • Preparation of URS (User Requirement Specifications)
  • Support of process engineering
  • Support of risk analysis
  • Support mock-up studies for isolators
  • Interface support media
  • Participation FATs and production start

Miscellaneous

Key equipment: vial filling line, freeze dryer, loading/unloading systems isolators

Extension freeze drying – Conceptual, basic and detail design, IBN and qualification

Project

Extension freeze drying – Conceptual, basic and detail design, IBN and qualification

Project stage

Conceptual design, basic/detail design, start-up & qualification

Tasks D&B

  • Concept Study – IBN/Qualification
  • Extended Basic Engineering/Detail Engineering filling line, freeze dryer with semi-automatic loading and unloading and RABS
  • Preparation of URSen (User Requirement Specification)
  • Support of process engineering/clean room
  • Support risk analysis
  • Support mock-up studies RABS
  • Technical site management, interface support process, media, building/clean room
  • Participation in FAT’s/SAT’s
  • Support for qualification (IQ, OQ, PQ)

Miscellaneous

Key Equipment: Vial filling line, freeze dryer, loading/unloading systems, RABS

Pilot plant for active ingredient production – Plant for the production of active pharmaceutical ingredients (GMP) on a pilot scale

Project

Pilot plant for active ingredient production – Plant for the production of active pharmaceutical ingredients (GMP) on a pilot scale

Project stage

Conceptual design, start-up

Tasks D&B

  • Conceptual design (layout, process technology and pure media) incl. off-gas cleaning, hydrogenation pilot plant; tank farm, plant safety concept; personal and product protection
  • Support of automation and start-up incl. preparation of VT control descriptions as well as
  • Concept for Simatic Batch

Miscellaneous

Key equipment: chemical reactors, centrifuges, dryers, CatOx, cryogenic condensers, Siemens PCS 7/SIMATIC Batch control system

Design and construction of a plant for the production of pellets (pharmaceutical)

Project

Design and construction of a plant for the production of pellets (pharmaceutical)

Project stage

Basic & detail engineering, start-up, commissioning, qualification

Tasks D&B

  • Engineering to commissioning, then qualification
  • Basic Engineering/Detail Engineering
    Pellet production, grinding, mixing, extruding, rounding, drying, coating
  • Preparation of User Requirement Specifications (URS)
  • Support for award of contract
  • Process engineering/clean room
  • Support risk analyses
  • Technical site management, interface support process, media, building/clean room
  • Participation in FATs/SATs
  • Support of qualification (IQ, OQ, PQ)

Miscellaneous

Key Equipment:
Fine impact mill, high shear mixer, powder batching, ploughshare mixer, circular, fluid bed dryer, screens, fluid bed granulator.

Plant for the production of pharmaceutical disinfectants

Project

Plant for the production of pharmaceutical disinfectants

Tasks D&B

  • Conceptual design (layout and process technology, clean media and clean room)
  • Development and coordination of a hygiene concept
  • Risk analyses GMP
  • Support of the project management

Key Equipment

Weighing center, preparation and supply tanks, mixing technology, pump technology, valve technology, pure media, plant automation, explosion protection, conveying technology

Tank farm for pharmaceutical starting materials and bulk products

Project

Tank farm for pharmaceutical starting materials and bulk products

Tasks D&B

  • Conceptual design
    Development and coordination of an operational and hygiene concept
  • Risk analyses GMP
  • Support of the project management

Key Equipment

Staging tanks, pump technology, explosion protection, plant automation

Wastewater treatment for pharmaceutical wastewater

Project

Wastewater treatment for pharmaceutical wastewater

Project stage

Conceptual Design

Tasks D&B

  • Selection of suitable processes with regard to technical and economic aspects
  • Proposal of suitable supplier
  • Preparation of tender specification, compilation of URS

Key Equipment

Reverse Osmose, UV-Wet Oxidation, Adsorption

Qualification of clean media (compressed air and aqua purificata)

Project

Qualification of clean media (compressed air and aqua purificata)

Project stage

Qualification

Tasts D&B

  • Inventory of each system
  • Support in qualification planning
  • Preparation of qualification documents
  • GMP risk analysis
  • Implementation of qualification
  • Preparation of qualification reports

Miscellaneous

QMP, GMP Risk Analysis (FMEA), Traceability Matrix

Plant for physical processing of active pharmaceutical ingredients, chemical weighing center

Project

Plant for physical processing of active pharmaceutical ingredients, chemical weighing center

Project stage

Feasibility Study, Conceptual Design, Extended Basic Design

Tasks D&B

  • Feasibility study, layout development
  • Conceptual Design (layout, process technology, clean media and clean room)
  • Extended Basic Design and contract preparation process technology and clean media
  • Risk analysis GMP and EHS (High Potent APIs)
  • Preparation of process technology award
  • Support and consulting project management

Key Equipment

Milling and sieving systems, mixers, dosing systems, containment systems (isolators and workbenches)

Clean media systems (compressed air, nitrogen, AP)