ISO 7 Clean Room
With ISO-7 classification, it has 6 injection machines of up to 160 Tm, as well as a serigraphy machine, assembly machines and PP film packaging machines.
We produce different types of products in the Clean Room: nebulisers, medicine cups, dosing syringes and tubes, with CE Certification in all necessary cases.
ISO 7 Clean Room Environmental Control
An essential requirement for the control of product contamination is to establish a controlled working environment. To ensure this, our clean room ventilation system is equipped with high efficiency filters that guarantee that the air entering the manufacturing room meets high standards in terms of the quantity and size of particles in suspension.
The existence of overpressure from inside the manufacturing area to the exchangers (SAS Material and SAS Personal), and from the latter to the outside, prevents the entry of air that has not circulated through the ultra filtration system.
The protocol for personnel access to the manufacturing area includes the use of clothing made of specific materials that contribute to low particle emissions.
Our Clean Room has the ISO 7 / Class C environmental qualification according to the validation protocol carried out in compliance with ISO 14698 on an annual basis.
Microbiological control of the clean room
We perform environmental microbiological controls using sedimentation culture plates. The viability of growth of aerobic and anaerobic pathogenic bacteria as well as yeasts and fungi is analysed.
It is a guarantee that the filtration system is performing correctly and the manufacturing environment is safe.
Protocol for cleaning and disinfection of the Clean Room
Through the involvement of the personnel in the cleaning activities of the facilities, as well as the disinfection of work equipment, it is possible to maintain an awareness of the importance of following the established instructions in order to ensure the good quality of the manufactured product.
Disinfection of work surfaces is validated by microbiological cultures from contact plate sampling.
Highly qualified staff
Training of clean room personnel is also of vital importance to work according to Good Manufacturing Practice (GMP), a basic requirement in the manufacture of medicines and pharmaceutical packaging.
All IP TRIANA staff are involved in continuous training projects.
In this way, by acting on the different critical points of the process according to the risk assessment and analysis carried out, we close the quality assurance cycle of the manufactured product.