HERE

The interfaces between pharmaceutical products, production facilities, and building services engineering are demanding and complex. Here, GMP requirements, technical solutions, and regulatory specifications directly converge. What is needed are experienced, communicative engineers who are confident in the GMP environment and speak the language of pharmacists, architects, building services planners, and qualification experts alike. It is precisely at this interface that we apply our expertise – connecting, structuring, and solution-oriented.

Engineering

Layout/Facility Planning

A floor plan does not come about by chance – it is the result of an overall concept precisely tailored to the process. Only when processes, hygiene requirements, technology, and logistics interlock can a layout be created that functions permanently. Whether equipment cleaning takes place in the correct hygiene zone, how media and technical centers need to be dimensioned, or how material and personnel flows are optimally managed – such central questions can only be answered interdisciplinarily.

Together with you, we embark on this journey: architects, process and building services planners, GMP experts, and operators work hand in hand on a solution that is functional, economical, and future-proof. New perspectives are welcome – we consistently keep an eye on optimal personnel and material flow.

Risk Analysis Segregation

A viable layout does not arise by chance – it is based on a thorough analysis of processes, risks, and interfaces. Key questions must be clarified at the very beginning of a project:

Are two processes allowed to take place in one room? Is temporal segregation sufficient? How open can a process be designed?
Without clear answers to these points, no layout will remain stable in the long term. Issues such as cross-contamination, risk of confusion, or impermissible process overlaps must be evaluated early and systematically.
We conduct practical and technically sound risk analyses – with a clear focus on feasibility and economic viability. Interdisciplinarily, we holistically integrate processes, hygiene zones, technical areas, and personnel and material flows.
We rely on understandable, lean methodologies instead of unnecessarily complex documents. The goal is a reliable basis for decision-making – transparent, comprehensible, and directly transferable into a stable layout.

Process/Plant Design

We accompany you from the initial vision to technical implementation. With our expertise, we create process flow diagrams (PFD/P&ID), define requirements in specifications, and develop initial 3D layouts as a basis for informed decisions.

You benefit from our project experience across a wide range of pharmaceutical and technical applications.

Specifications and Tenders, Supplier Selection, and Bid Comparisons

In the GMP environment, a precisely formulated specification is the foundation for successful project implementation and subsequent qualification. We prepare reliable tender documents for you that clearly define all relevant requirements and unambiguously and contractually describe all interfaces – no more and no less.

On this basis, we accompany the entire award process: from structured bid evaluation and technical clarification meetings to well-founded bid comparisons. Thanks to our many years of experience in planning and realizing numerous plants, we support you in finding a technically optimal and economically viable solution – neutrally, independently, and with a clear focus on your requirements.

Calculation of Media Consumption

If simultaneities, actual connection values, or real load profiles are not critically questioned, this quickly leads to oversized and uneconomical supply systems.
We analyze your needs precisely and reliably. If project-specific consumption data is available, we integrate it into our calculations.

If valid values are missing, we draw on reference projects and sound empirical data to make realistic assumptions.
In doing so, we consider not only regular operation but also failure and redundancy concepts – because production processes must run reliably. And for that, they require an optimally designed, secure, and economical media supply.

Calculation and Simulation of Media Systems

Using proprietary or commercial software such as FluidFlow (R) or Inosim (R), we simulate distribution and storage systems. Whether it’s the tank level in the WFI system or the hydraulics after the outlet – we know where to look. Where it is worthwhile to perform complex calculations. And where it is not.

Process Simulation

For production in three-shift operation, crucial questions arise: Will the weighing become a bottleneck? How many buffer tanks are actually required? What impact will delays in cleaning cycles have? And what is the real peak demand for steam or other media?

Depending on the complexity of the task, we answer these questions with the appropriate tool: from a structured analysis using a Gantt chart to detailed, dynamic process simulation – for example, with INOSIM®. We choose not the most elaborate, but the most efficient instrument – tailored to your project and your requirements.

Logistics

How is delivery organized? How many pallets leave production per hour? What size must the buffer area be to ensure stable operation? We analyze goods flows, calculate capacities, and develop reliable logistics concepts – from goods receipt to dispatch.

In doing so, we design buffer zones, storage areas, and material flows to ensure efficiency, transparency, and future viability. For large and complex issues, we conduct detailed logistics simulations in cooperation with specialized partners – always with the goal of realizing an economical and process-safe overall solution.

FAT and SAT, Commissioning

We plan your process and your facilities – and consistently accompany them until successful regular operation. Already during the tendering phase, we assist with initial supplier visits and technical clarifications. From Factory Acceptance Test (FAT) to Site Acceptance Test (SAT) and structured commissioning, we coordinate all steps and interfaces.

We handle the connection of media, accompany functional tests, and support as a neutral instance during Operational Qualification (OQ) – or perform it ourselves if desired. Our goal is a smoothly running, qualified, and documented plant – handed over on time and ready for operation.

Technical Quality Assurance (TQS)

Quality deviations should not become apparent only during assembly or qualification – for example, if a nozzle has warped due to improper welding or unspecified material has been installed. To exclude such risks early on, we rely on structured Technical Quality Assurance. This includes, among other things, supplier audits, material mix-up tests (PMI), weld seam inspections, and accompanying control of manufacturing processes.

Depending on the project scope and complexity, we seamlessly integrate specialized engineers into the project team. This ensures that quality is planned and implemented from the outset – comprehensibly documented and GMP-compliant.

Support for Official Approvals

You know your process best. We both know why the layout was planned this way. What is the material flow? We have a zone jump here. But is that actually a problem? We are happy to accompany you in presenting your project to the authorities even at an early stage. And we stand firmly by your side during the inspection when it comes to granting the manufacturing authorization.

References

Boehringer Ingelheim Pharma GmbH & Co. KG

Upgrade of an existing sterile area (grade A) with implementation of a new RABS vial filling line with semi-automatic tub loading/unloading system

  • Technical planning of a RABS vial filling line and the associated process workflows and support processes
  • Technical construction management
  • Conversion measures
  • Commissioning
View Project

GSK Zoster (GSK Vaccines GmbH)

New facility for the production of cell culture-based vaccines

  • General Planner
  • Construction Management
  • Commissioning (EPCM)
  • Procurement
  • Site Safety
View Project
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