Production environments where compliance is a given.
Pharmaceutical production runs in highly regulated environments. We bring those plants into operation production-ready and fully evidenced — with production IT, commissioning and qualification.
In pharmaceutical production, a plant is only as good as its evidence.
From black utilities and building services, clean utility and disposal systems, media preparation systems, biotech and chemical API production through to cleanroom and monitoring systems — we bring your production environment into regulated operation.
To do that we deliver services from our four fields — production IT & automation, commissioning, qualification and special hardware — plus lifecycle support in routine GMP operation.
Every plant. Across all four fields.
From aseptic filling and diagnostics lines to cleanroom and monitoring systems: we cover what pharmaceutical production demands across production IT, commissioning, qualification and special hardware.
From concept design into GMP operation.
We support pharmaceutical plants across the full lifecycle — from concept design through basic and detail design and commissioning to qualification, handover and routine operation. Evidence and availability build up with the project instead of being assembled at the end.
What we work to.
EU-GMP Annex 1
Sterile manufacturing
FDA & EMA
Regulatory compliance
21 CFR Part 11
Data integrity
The systems we work with.
Control systems
Siemens PCS 7 · DeltaV · Siemens SISTAR
SCADA & HMI
WinCC · WinCC Unified · WinCC flexible · TIA Portal · iFIX · InTouch
PLC
SIMATIC S7 · SIMATIC S5 · SIMATIC S7-1500 · Honeywell · B&R
Data & interfaces
MES · Historian · OPC UA · MQTT · MTP
Common questions.
Do you build the cleanroom and filling equipment yourselves?
No. We do not build the production machinery — filling, cleanroom, diagnostics. Our contribution is the engineering: automation, production IT, commissioning and qualification — through to production-ready handover.
How do you keep the project GMP-compliant?
We work to EU GMP Annex 1 and 21 CFR Part 11 and support qualification (DQ/IQ/OQ/PQ) and data integrity across the project. Your SOPs remain authoritative.
At what point should we bring you in?
Ideally from concept design or basic and detail design — that way compliance, qualification and IT questions are settled early rather than surfacing at handover.
Do you also support the plant in operation?
Yes. Technical service and lifecycle support are part of it. Operation keeps generating change and optimisation work on production plants — and that, too, has to be carried out under regulated conditions.
- →High-specification food production — Production IT, commissioning and qualification for dairy and food plants — from raw milk intake to cheese ripening, aligned with the IFS Food Standard.
Your pharmaceutical project.
Diagnostics, filling, cleanroom or operation — tell us what you are planning. You will get a straight technical assessment.
Enquire about a project or directly: kontakt@group-ecc.com