All the personnel we employee receive in-house training on safety and accident prevention standards, as well as instruction on all current health and hygiene standards, with regard to both the handling of Medical Devices and/or Pharmaceuticals and the cleaning and sanitisation of the rooms and equipment used in the sterilisation validation process. Our professionalism is guaranteed by years of experience and by continuous training through attendance at annual theoretical and practical courses, and also through validation tests and training provided by manufacturers of sterilisation equipment and air handling units.
SDS was established in December 2004 with the aim of providing clients with the benefits of our experience and know-how in the field of sterilisation and in the validation of processes and equipment. Our members together bring several years experience in a range of different disciplines related to the provision of services to the pharmaceutical, biomedical and healthcare industries.
In just a few years, the company structure was expanded to comprise more than 20 people (including both employees and collaborators) divided among our two operational sites:
- Urgnano (BG) – Via Ignazio Silone 81, with our technological laboratory for materials testing
- Spresiano (TV) – Via Galvani 9/G
Operating within the framework of an ISO 9001 and 13485 certified quality system (CERTIFIED BY IMQ), SDS provides VALIDATION services (IQ_OQ_PQ_RPQ) for the following equipment/environments/processes:
- Sterilisation systems using Steam, Ethylene oxide, Peracetic Acid and Hydrogen Peroxide;
- Depyrogenation Tunnels and Ovens;
- Steam Quality Analysis in compliance with UNI EN 285 and ISO 17665;
- Thermal disinfectors (instrument washers, endoscope washers, bedpan washers, hospital footwear washers);
- Operating Theatres and Clean Rooms (including Emery testing, Smoke testing and Recovery time);
- Extractor hoods, Glove Boxes and Isolators;
- Chemical, physical and microbiological analyses;
- Media Fill testing;
- Functional testing and calibration of control and measuring instruments.
2010 saw the foundation of STEROX Srl, a technologically advanced Ethylene Oxide sterilisation centre, based on modern quality standards with minimum environmental impact, situated in Castelfranco di Sopra, in the province of Arezzo.
The plant consists of twin autoclaves, each with a capacity of 44 m3, both of which can accept up to 16 europallets, with a maximum height of 2,400mm; the plant has an overall sterilisation capacity of 120 m3/day. Sterox is ISO 9001 and ISO 13485 certified by IMQ and offers all its clients validation services (physical and microbiological qualification) in compliance with the technical standards of the sector: UNI EN 1422, ISO 11135 and ISO 10993.
Company growth continued in 2011 with MANAGEMENT OF THE STERILISATION CENTRE at the San Rocco di Ome clinical institute in the province of Brescia, which is part of San Donato Hospital Group, where surgical instruments for around 7,800 operations are processed each year.
In 2012 SDS obtained ISO 13485 certification for the Ome sterilisation centre.
The company obtained the updated 2015 version of ISO 9001 certification and the 2016 version of ISO 13485.