Engineering precision. GMP standards. Full control of the process
The production of medicines requires not just equipment, but a systematic approach, where each unit operates in a validation logic and under regulatory control. At Steiner Ukraine, we design and supply complete solutions for pharmaceutical production - taking into account GMP requirements, product specifics and cleanliness class of the premises.
We work with solid, liquid and soft forms, aseptic filling, serialisation - and cover the entire cycle from raw material preparation to packaging and aggregation.
What is included in our solution:
Lines for different forms: syrups, solutions, ointments, gels, aseptic products - each line is configured for a specific technology.
Clean rooms: ventilation, filtration and air parameter control systems for classes A-D.
Track&Trace: integration of serialisation and aggregation solutions in line with EU-FMD and DSCSA requirements.
Documented conformity: all equipment comes with a validation package.
Inspection readiness: technical solutions that take into account the requirements of supervisory authorities at the design stage.
Full support - from technical specifications to launch:
Analysis of production needs and cleanliness requirements
Line design with GMP and flow logic in mind
Equipment selection and integration of control systems
Commissioning, FAT, SAT, staff training
Service support and system upgrades
Are you preparing to launch a pharmaceutical production facility or expand your capacity? Get a project feasibility study from Steiner Ukraine with a clear roadmap to implementation.