Cleanroom capabilities at Berry PET Power
Berry PET Power produce under high standards of cleanliness with a Certified Clean Room, GMP Class C. This means we are able to help our customers who are looking for products that require a specialist environment for their production. We conform to IS09001:2015 and the Cleanroom is validated according to IS014644-1.
About the cleanroom
The GMP Class C Cleanroom is 1,200 square metres and produces all of the PET healthcare packaging produced at the Etten Leur site, with the ability to produce injection moulding, injection blow moulding and injection stretch blow moulding. We pack the bottles inside the GMP Class C area using PE film which is heat-sealed, preventing microorganisms from entering the pack. Additional layers of heat-sealed PE film bags may be added, if required to form a triple brick pack providing microbial barriers and ensuring the pack is suitable for gamma irradiation which can be managed by Berry PET POWER through an external service provider.
Specialist Air Control
The air pressure in the cleanroom is higher than the ambient air pressure. Meaning there is only a unidirectional, outgoing airflow, which means that there is no incoming unmonitored airflow. The monitored incoming airflow is filtered with a High-Efficiency Particulate Air (HEPA) filter. This filter removes more than 99% of particles larger than 0.3 µm. For Class 7 cleanroom, the maximum allowable concentration of particles is no more than 352 000 particles of a particle size ≥0.5µm.
In addition to controlling the particles, we also perform temperature and humidity control to keep the production process as stable as possible.
Contact our team to find out about any current capacity available in our clean room and how we can support you in creating the products you require.