HERE

The term pharmaceutical technology encompasses a wide range of processes and forms of representation. However diverse the process engineering behind them may be, they all share a high standard of quality and complex regulatory backgrounds. Whatever your concern may be – we are confident that we have a reference for it.

Fields

Sterile Manufacturing

Whether open or closed, sterile or aseptic. Together with the client, we define the process and layout. From selecting the appropriate hygiene zone and defining the changing process to final process validation – we are with you every step of the way until implementation.

Solids / Semi-Solids / Liquids

When granulators, ointment processors, and comparable equipment are deployed, large-scale components are typically required. How is the installation carried out? Where is the equipment positioned?
From initial planning through installation to professional piping of individual components, we handle the complete implementation – reliably, precisely, and from a single source.

High Potents

High-potent active pharmaceutical ingredients place the highest demands on safety, containment, and process control. Where the smallest quantities produce significant effects, well-conceived concepts and precise implementation are critical. We support you in the planning, integration, and installation of equipment in high-potent environments – taking into account all relevant safety and GMP requirements. From the installation of sensitive components through closed transfer systems to quality-compliant piping and assembly, we ensure maximum safety for personnel, product, and environment. With technical expertise and a clear understanding of regulatory requirements, we create safe and efficient solutions for demanding production environments.

API / Active ingredients

Stirred-tank reactors, filter centrifuges, and drying systems – chemical active ingredient synthesis places the highest demands on technology, safety, and process control. Hazardous areas, demanding piping concepts, and complex automation solutions characterize this specialized production environment. We support your project holistically: from the process flow diagram (PFD/P&ID) through 3D planning to detailed execution planning. In doing so, we consider regulatory requirements, explosion protection specifications, as well as operational safety and quality standards. In addition to planning, we also handle professional assembly, coordination of all trades, and structured commissioning – for safe, efficient, and on-schedule implementation of your API production.

Fill & Finish

Whether RABS or isolator, freeze dryer with 40 m² footprint, or manual filling for clinical trials – we develop customized fill-&-finish concepts together with our clients. From initial media and capacity estimation through the preparation of comprehensive tender documents to structured bid comparisons, we create a reliable decision-making basis. We also stand by your side during the implementation phase: from detailed planning through realization to successful Site Acceptance Test (SAT), we support your project reliably and systematically.

Logistics

How many pallets leave production daily? What does the optimal material flow look like? Which storage system is economical and future-proof – and which regulatory requirements, such as GSP, must be considered? Even in early concept and feasibility studies, we analyze material flows, define capacities, and develop viable logistics and storage concepts. In doing so, we always view production, packaging, and shipping as an integrated overall system. For detailed material flow or warehouse simulations, we collaborate with specialized partners as needed. At the same time, we always maintain focus on the overarching layout and process design – for a consistent, efficient, and scalable logistics solution.

References

Analytics Laboratory (Qmedis Analytics GmbH)

Planning and implementation of an analytics and galenic development laboratory with sterile and controlled substances room

  • Preparation of an extended preliminary design for 370 m²
  • turnkey implementation of
  • building services engineering
  • interior fit-out
  • laboratory furnishings
View Project

Extension K505 (Bayer Bitterfeld AG)

Expansion of production building K505 by adding a two-storey extension with a rooftop technical penthouse, providing 2,990 m² gross floor area for OSD manufacturing & packaging

  • Extended design and permitting planning
  • Turnkey implementation of the following trades
    • Extended structural shell
    • Interior fit-out
    • MEP
    • Cleanroom interior fit-out
    • EMS; BMS
    • Process media
  • Qualification through to the end of OQ
View Project

Next Pharma

Expansion of an OSD production & packaging facility to approx. 1,000 m² across all trades (shell/interior construction, HVAC, black/pure media, I&C/BMS, monitoring, electrical) as well as complete qualification (VMP + SIA, DQ/RA/IQ/OQ).

Preparation of the advanced design planning for all trades including building permit, followed by the realization of the project as general contractor.

View Project

Production Modernization (Dr. Kade Pharmazeutische Fabrik GmbH)

Modernization of the entire production area for ointments, gels, and suppositories, GFA 1,700 m²

Preparation of extended design planning for the modernization of the entire production facility as well as the turnkey implementation of the following trades:

  • technical building services
  • cleanroom interior fit-out
View Project

Solid Dosage Production Expansion (NextPharma / allphamed)

Expansion of an OSD manufacturing & packaging facility across approximately 1000m² for all disciplines (shell & core/interior fit-out, HVAC, black/clean utilities, I&C/BMS, monitoring, electrical) including complete qualification (VMP + SIA, DQ/RA/IQ/OQ)

Preparation of the extended design planning for all disciplines, including building permit, followed by project realization as general contractor

View Project

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Thorsten Kulik

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Konstantinos Baltzis

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Lukas Mayer

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Stefan Stemmle

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