Clean room

Our Clean Room has 6 injection machines of up to 160 Tm, a screen printing machine to decorate dosing syringes and vaginal applicators and a bagger in a PP film flow pack.

In addition to the manufacture and decoration of the pieces, we also have an assembly and handling area for medical devices.

Environmental Control of ISO 7 Clean Room

An essential requirement for the control of product contamination is to establish a controlled working environment. To ensure this aspect, the ventilation system of our clean room has high-efficiency filters that guarantee that the air entering the manufacturing room meets high levels of demand in terms of quantity and size of suspended particles.

The existence of overpressure inside the manufacturing area towards the exchangers (SAS Material and SAS Personal), and of these with respect to the outside, prevents the entry of air that has not circulated through the ultrafiltration 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 the ISO 14698 standard on an annual basis.

Control microbiológico de la Sala Blanca

Microbiological control of the Clean Room

We perform environmental microbiological controls using sedimentation culture plates. The growth viability of aerobic and anaerobic pathogenic bacteria, as well as yeasts and fungi is analyzed.

It is a guarantee that the filtration system is working correctly and the manufacturing environment is safe.

Protocolo de limpieza y desinfección de la Sala Blanca

Clean Room Cleaning and Disinfection Protocol

Through the involvement of the staff 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 to ensure good quality of the manufactured product.

The disinfection of work surfaces is validated by microbiological cultures from sampling with contact plates.

Highly qualified staff

The training of personnel operating in clean rooms is also of vital importance to work according to Good Manufacturing Practices (GMP), a basic requirement in the manufacture of medicines and pharmaceutical packaging.

All 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 cycle of quality assurance of the manufactured product.

Designed and made in Barcelona

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