We are compliant with the quality standards applicable to the production of primary plastic packaging and Class I medical devices for the pharmaceutical industry.
A product traceability system allows for documented, full batch histories for each production run. The traceability covers all production steps, from raw materials used and machine and operator identification, up to product output and delivery.
Statistical batch-control and online checking during the production process is accomplished using the most recent technologies.
Visual inspections and several parameters, such as weight control, torque force and leakage testing, are continuously checked and documented during production.
The critical functional dimensions are monitored and documented using a fully automated visual inspection machine.
Monitoring of temperature, pressure and humidity control in the cleanroom is fully documented for each production batch.
All these records are kept for a minimum of 5 years.