Medical Technology

New building for the production and packaging of solid dosage forms and inhalation products.

Planning of a filling line for pre-filled syringes in Switzerland, including planning of all process systems and building infrastructure through to commissioning.

Planning and qualification of a complete filling line for vials using isolator technology, including automatic loading and unloading. General planning and qualification of the new system.

Planning of a plasma fractionation with 650,000 l / 1 million l (expansion) per year; basic fractionation, purification, fill & finish, products: IVIG, albumin, FVIII, each in different concentrations. Planning as a "sandwich concept", production-centered arrangement with the supply below and HVAC above.

Planning of a production plant for endoglycosiadases (and in future also mRNA). Microbiological plant (yeasts and bacteria) with 30l / 300l (after expansion) fermentation volume. Planning as a classic upstream-downstream plant with single-use technology for fermentation and purification.

New planning of standard laboratories, extension of 2^nd floor of an existing laboratory building during ongoing production.

Cell therapy laboratory with various clean room zones incl. storage/logistics and technical areas. Development of the user requirements and the optimum room concept in close cooperation with six different user groups (different processes / laboratory requirements). Total area of 1,000m².

Renovation and extension (new building) of the east operating wing at Basel University Hospital. Assumption of all qualification activities, risk analyses and documents. Overall quality coordination of construction with all trades.

Creation of a CSV framework, an SOP for the software development cycle and a validation strategy for the control software for 3D printers used to manufacture medical devices.

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).

Downstream process for the production of cystine powder.

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.

Implementation and support of internal audits at the company's locations (worldwide) in a team with the customer.

Creation of a system to assess the appropriate GMP level of excipient suppliers.

Against the backdrop of regulatory changes (MDD to MDR), the requirements for various customers were determined and compliance with the new regulations was checked and documented.

Against the backdrop of regulatory changes (IVDD to IVDR), the requirements for various customers were determined and compliance with the new regulations was checked and documented.

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."

Transport validation of the world's first approved COVID-19 vaccine from BioNTech. Transportation at -70°C ±10°C and seamless compliance with the cold chain were essential for the rapid and safe delivery of this important vaccine.

Design of a new laboratory, microbiology laboratory, extension of an existing building during ongoing production.

New production plant, research center and offices. Extended warehouse in reception, dispatch and picking areas.

Thermo (Vapor) Compression WFI-Erzeuger-, Lager- und Verteilsystem für WFI, Reindampf.

Planning, execution and commissioning of GMP production rooms and laboratories including process media.

Tank farm for waste solvents.

Disposal of solvent-containing exhaust air, 12`000 Nm3/h Regenerat. therm. Oxidation (RTO): Process and source exhaust air, exhaust air from waste water treatment plant and industrial waste water systems.

Fine chemicals multi-purpose plant with stirred tank, centrifuge, dryer, rectification, (corrosion-resistant).

Expansion of energy supply: Waste combustion chamber with steam generation (10MW), cooling generation (-25°C, 2,000 kW), factory water with heat recovery, factory distribution networks (steam, cooling, contaminated exhaust air, waste water).

Production plant for the manufacture of neodymium catalysts.

Planning and execution of customer-specific in-house training courses, topics as required, e.g: CSV, GMP basics, data integrity.

Development of a new primary packaging material for parenteral application.

GMP-compliant conversion of plasma processing (10,000 m²) incl. PM for new sterile filling.

Evaluation & preliminary planning of technical and organizational measures for the operation of an existing multi-purpose facility with highly active substances.

New API production plant, new production facilities, new research center, offices, warehouse and logistics center.

Construction of a production building for APIs and intermediates; 100 m³ reaction capacity, batch process.

New production unit for active pharmaceutical ingredients (APIs) and intermediates, warehouse and services. Hall II - Production of active pharmaceutical ingredients (1st phase).

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.

Planning of a new FFF line, incl. construction and complete building services (HVAC + EMSR).

Laboratory for cell and gene therapy, total area approx. 1800 m². Process transfer USA - Switzerland.

Replacement control (Hardware and Software) of two autoclaves, Siemens S5 to Siemens S7: Qualification of the new control (access protection, audit trail, monitoring, process) of a small autoclave as a pilot project. Analog implementation of a large autoclave.

Procurement of new PW generators, adaptation of automation incl. connection to BMS + MAS, dismantling of existing generators.

Feasibility study for conversion of existing personnel and material locks, filling and packaging lines, conveyor technology.

Facility for the production of blisters for medical products.

Evaluation of the hygienic design, GAP analysis and strategy development for cleaning validation.

Renovation of old building and planning of new building. Concept study of old building and new building for Pharmaceuticals, diagnostics, cosmetics.

Support of the project management in the remediation project.

New research and development laboratories and new offices.

Two-storey refurbishment in an office building. Updated and customized design for offices, showrooms, laboratories, meeting rooms and services.

New construction of offices and laboratories for research and development.

New offices and laboratories for research and development.

Production plant for the manufacture of animal feed.

Design review and qualification of the HVAC systems in the new building for oral solid and liquid dosage forms (production and packaging).

New construction of a factory for the production of food supplements; microbial fermentation, DSP, media & infrastructure.

Concept design and engineering for a new production facility for cell therapies on an area of 1,000 m² (brownfield). Production of dendritic cells, CAR-T cells and lentiviral vectors. Main features: Flexible production - cell suites, production area for lentiviral vectors, QC labs, storage, cold chain management.

Design of a modular and standardized production line for cosmetic products. The production line was integrated into an existing building at the site.

Concept study for a production line for Algae (Chlorella Vulgaris) as food supplement.

Planning of two glass-lined reactors, including all connections for steam, air, cooling water, exhaust air, vacuum, nitrogen.

Centrifuge plant. Upgrade of a cone Dryer, GMP cabin for big bag filling

Green field production of chemicals: Process euipment, process and building services, utilities and clean rooms.

Planning, procurement and installation of a new packaging system. The packaging system is used for secondary packaging with shipping carton labeling of filled and checked sachets.

Conceptual design for the implementation of an upstream and downstream process in an existing building. The project included a 90m² clean room, 270 m² fermentation area (60 ³ capacity), a tank farm and utilities.

Planning, procurement and construction management of the new Roche Diagnostics office building in Spain. Offices, training rooms, demonstration rooms, dining room and auditorium were planned by Chemgineering and implemented in detail, including architecturally, and managed during construction.