CE process for an automated (catheter) packaging line in a cleanroom
Machine safety
A medical manufacturer built an automated packaging line in a cleanroom environment. Prohead Engineering guided the CE assembly from risk assessment to validation, with particular attention to safety and traceability. The result: a robust, audit-ready and easy-to-maintain system.
About the case
Context:
A medical device manufacturer installed an automated packaging line in a cleanroom. The line combines several standard machines (sealing, labelling/printing, vision, weighing and reject stations) and conveyors into a single assembly of machinery. Prohead Engineering guided the CE process.
Approach:
- Risk assessment (EN ISO 12100) focusing on cleanroom interaction, hot surfaces, trapping/shearing points and electrical safety.
- Safety concept: access monitoring (EN ISO 14119), light curtains and safety distances (EN ISO 13857), shared emergency stop architecture with clear zoning and reset.
- Electrical equipment (EN 60204-1): separation of control and power, optimised earthing/equipotential bonding, unambiguous marking.
- Functional safety: safety functions at PLr (Performance Level required, EN ISO 13849-1) and validation (EN ISO 13849-2).
- Interfaces & quality: quality stations (vision/weighing/labelling) logically separated from the safety chain.
Important detail:
Fail-safe rejects: in the event of a detection error, the line comes to a safe stop without loss of product traceability via UDI (Unique Device Identification) and serialisation (unique serial numbers per package for full supply chain traceability).
Result:
- CE-compliant assembly with an audit-ready file and demonstrable PL validation.
- Operational: fewer unwanted stops and safe, ergonomic interaction in the cleanroom.