Clean Room Technologies
The Röchling Medical locations are equipped with clean rooms, to meet the high requirements for production environments in the pharmaceutical and medical sectors. Thanks to a wide variety of blow moulding and injection moulding processing technologies, and downstream assembly processes under clean room conditions, Röchling Medical is able to produce individual components and assemblies for the pharmaceutical and medical sectors, under various clean room classes.
All areas fulfil stringent requirements, are continuously monitored, and are regularly reviewed by internal and external auditors. Systematic training and education programmes ensure that our employees are always kept up to date, and the regulatory requirements are met. Monitoring is an essential element of quality assurance. In particular for demanding production processes, such as manufacture of products for the pharmaceutical and medical sectors, where compliance with operating parameters (including room pressure, particle concentrations, temperature etc.) must be continuously verified and documented in batch documentation.
Röchling Medical currently has over 6,500 m² of clean room space, which is used both for injection moulding and assembly processes. Röchling Medical can currently manufacture products for the pharmaceutical and medical sectors under the following clean room conditions:
- ISO 8 / GMP D
- ISO 7 / GMP C
- ISO 5 / GMP B
- Clean room / controlled area