The planning and realization of a modern plant for the production of APIs (Active Pharmaceutical Ingredients) is more than ever a complex task in which problems from the most diverse areas have to be solved. This applies not only to the construction of new production plants - whether multipurpose or mono plants - but also to the conversion or repurposing of existing facilities and the necessary infrastructure systems, e.g. for the generation of ultra-pure media or waste gas treatment.
Thanks to a structured and methodical approach, we can determine your individual requirements and implement them precisely. We work closely with you in all planning phases to determine the essential information on the manufacturing process and product requirements. Our experts have in-depth knowledge in all relevant specialist areas and bring the experience of many successfully implemented projects to you.
"Invented Here" is no longer in
The know-how about the manufacturing process and the specific product requirements usually lies with the operator, who has developed the synthesis process and sells the product himself or has it sold. However, the implementation of an investment project requires experience and skills from many different disciplines, which are often not (or no longer) sufficiently available in the manufacturing industry today. In most cases, planning begins with the process and the technical equipment required for it.
What is not directly part of this, e.g. energy supply, waste disposal facilities, sometimes also questions of safety and occupational hygiene, are usually treated rather neglected in the early project phase and lag behind the planning progress, although these aspects are just as important. When it comes to important milestones, it is precisely these planning results and reliable information that are missing in order to make fundamental decisions. Not infrequently, there is also a certain blinkered thinking within the company, which benefits from fresh impetus from outside.
Consult specialists at an early stage
The project initiation and concept phase requires an energetic team of experienced experts to tackle all relevant aspects and issues in an environment that encourages creativity. Depending on the available personnel resources of the investing company, it is sensible and expedient to call in external support for individual special topics or for the entire project. Chemgineering has already carried out such assignments for various renowned customers.
We either make individual specialists available as consultants for subtasks, or Chemgineering takes the lead and integrates the customer's specialists into its own project team. In this way, we ensure that not only the process-related problems are addressed, but also all other relevant aspects.
Our experts have in-depth, tried-and-tested knowledge in all key disciplines and specialist areas: Process engineering, biotechnology, sterile technology, I&C and electrical engineering, clean room technology, ultra-pure media, safety technology, etc.
Speaking the same language, thinking entrepreneurially
Chemgineering has a methodical approach in which its requirements are determined and described in close cooperation with the future operator.
A major advantage is that some of our seniors used to work "on the other side" and therefore speak the language of chemists and operators and understand their needs. On the other hand, we have sufficient entrepreneurial thinking skills to be able to evaluate requirements and wishes from an economic point of view.
By focusing on a limited industry segment in particular, we can exploit the synergies that arise from processing orders for pharmaceuticals, fine chemicals, vitamin production or diagnostics. This gives us a broad overview of proven technical solutions that we can adapt to new problems. The handling of highly potent substances, whose production share is increasing due to the ever-increasing effectiveness of pharmaceuticals, is a current topic in this context.
We know what your API facility is all about
We have acquired the know-how that we bring to bear in the preliminary planning phases through the successful realization of many investment projects. Our project engineers, who are deployed in concept planning or basic engineering, are generally also responsible for commissioning the systems. This motivates them to teach their "baby" to run. The experience gained flows into the next planning phase.
Good ideas and cost-effective solutions are worth nothing without professional project management and efficient tools - especially when it comes to detailed planning, which we carry out using modern 3D CAD tools as well as conventional methods. Chemgineering has a unique selection of technical experts and generalists who are highly motivated to turn your ideas and requirements into modern and economical systems that comply with the applicable rules and regulations.
We plan your API synthesis facility
and coordinate the professional implementation of:
Production of active ingredients
Highly potent drugs
Biotechnology
Process engineering
Infrastructure facilities
GMP upgrades
Safety
Environmental protection
Process simulation
Process development
Project management
Relevant Projects
Expansion of Production by Two Glass-lined Reactors
New Facility HD15
F/3000 DSP Cystine León
Recombinant Ebola Vaccine Production
Requalification of a Vitamin Production Plant
Conversion of a multi-purpose system for HAPI operation
Esteve Química
Pharmachem
Sintenovo
Building 50 MZ 170
Expansion of Production by Two Glass-lined Reactors
Planning of two glass-lined reactors, including all connections for steam, air, cooling water, exhaust air, vacuum, nitrogen.
Customer
Biosynth AG
Location
Staad, Switzerland
Budget
1.7 Mio CHF
Year
1 Year
Mandate
Planning
Services
Process Design: Detail Design
Plant Design: 3D Laser Scanning, Layout Equipment, 3D Piping
Qualification: DQ, IQ, OQ
Commissioning: Control of Mechanical Completion
New Facility HD15
Planning and execution of a new plant (4 floors) for the production of natural products under high pressure conditions (supercritical CO2 up to 1,000 bar).
Customer
Hopfenveredelung St. Johann GmbH
Location
Wolznach, Germany
Budget
6 Mio. EUR (excl. Engineering Fees)
Year
3 Years
Mandate
General Planner
Services
Basic & detail engineering, support of the procurement process (tendering procedure, contract negotiations), construction management, support of commissioning
Chemical engineering departments: project management, HVAC incl. automation, process planning (building services, packaging unit, piping, 3-D model)
Special features: Process automation of the customer, relocation of existing process equipment (e.g. extraction system)
F/3000 DSP Cystine León
Downstream process for the production of cystine powder.
Customer
Wacker
Location
León, Spain
Budget
10 Mio. EUR
Year
2 Years
Mandate
Engineering, Procurement and Construction Management (EPCM)
Services
Basic and detail engineering
3D planning
Purchasing
Construction management
Support during commissioning
Recombinant Ebola Vaccine Production
Conversion of a production facility, USP and DSP, for cell culture-based vaccine production, including adaptation of media, clean rooms, HVAC and chemical wastewater inactivation.
Customer
Janssen Vaccines AG (J&J, ex. Crucell)
Location
Bern, Switzerland
Budget
8. Mio EUR
Year
2 Years
Mandate
General Planner
Services
Concept design, process layout, basic design, incl. HSE and GMP reviews, detail design
Disposable equipment installation
Conversion of ventilation & media supply
Construction management and commissioning
Planning and implementation of chemical wastewater inactivation
Requalification of a Vitamin Production Plant
Requalification of an existing plant for the production of vitamins. Customer conclusion: "With this project, we were able to show the site management that it is possible to efficiently qualify an old plant with calculable costs and in compliance with the planned timelines."
Customer
DSM Nutritional Products GmbH
Location
Grenzach-Whylen, Germany
Budget
Confidential
Year
8 Months
Mandate
Qualification
Services
Development of qualification concept
Creation of URSs
Creation of risk analyses
Creation of superordinate qualification documents (QMP, QMB)
Qualification: DQ, IQ, PQ (implementation incl. test plan creation, report)
Conversion of a multi-purpose system for HAPI operation
Evaluation & preliminary planning of technical and organizational measures for the operation of an existing multi-purpose facility with highly active substances.
Customer
Siegfried AG
Location
Zofingen, Switzerland
Budget
10+ Mio. CHF
Year
1 Year
Mandate
Concept Study
Services
Requirements analysis, process analysis, variant study
Zone and airlock concept
Layout and equipment planning
Personnel and material flow planning
Concept development for process, TGA, HVAC & safety
Cost estimate +/-30%, rough schedule
Esteve Química
New API production plant, new production facilities, new research center, offices, warehouse and logistics center.
Customer
Esteve Química
Location
Shaoxing, China
Budget
Confidential
Year
4 Years (Phase I) & 2 Years (Phase II)
Mandate
Confidential
Services
Design of all production units
R&D center
Laboratories for quality control
Support in technical project development
Pharmachem
Construction of a production building for APIs and intermediates; 100 m3 reaction capacity, batch process.
Customer
PharmaChem Technologies
Location
Freeport, Bahamas
Budget
Confidential
Year
3 Years
Mandate
General Planner
Services
Basic Design
Detail Design
Support with construction management (Structural and civil engineering, process and operating technology)
Sintenovo
New production unit for active pharmaceutical ingredients (APIs) and intermediates, warehouse and services. Hall II - Production of active pharmaceutical ingredients (1st phase).
Customer
Sintenovo
Location
Jiutepec, Morelos, México
Budget
Confidential
Year
1 Year
Mandate
Confidential
Services
Master Plan
Basic Design
Detail Design
Building 50 MZ 170
Multi-purpose plant for the production of final & finishing steps for active pharmaceutical ingredients 3 HC-22 reactors of 6.3 m3 each, HC-22 centrifuge, infrastructure.
Customer
F. Hoffmann-La Roche AG
Location
Basel, Switzerland
Budget
30 Mio. CHF
Year
2 Years
Mandate
Detail Planning
Services
Support for VT engineering
Basic and detail engineering
CAD 3D planning (PDS)
Coordination of the construction/containment, steel construction and HVAC trades in the 3D model
Support for assembly and commissioning
If you have any questions about API synthesis facilities, please contact us
We help you to successfully implement your project.
With professionally planned API synthesis facilities.