Quality

Sterilization

The sterilization process is performed with an ethylene oxide gas sterilizer/aerator system which is designed to be used with cartridges of ethylene oxide (100% EO). The EO is very precisely pre-dosed, according to the volume of the chamber, ensuring optimum sterilization.

Accuracy and reliability

The solid state electronic design provides accuracy and dependability. The electronic controller automatically stops the cycle and displays the error code if errors detected.

The sterilization process is validated according SR EN ISO 11135:2014 (ISO 11135:2014) “Sterilization of healthcare products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”

For routine monitoring purposes, we are using biological indicators which comply with SR EN ISO 11138-2:2009 (ISO 11138-2:2006) “Sterilization of healthcare products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes” clause 9 and 5, and chemical indicators which comply with SR EN ISO 11140-1:2015 (ISO 11140-1:2014) “Sterilization of healthcare products – Chemical indicators – Part 1: General requirements”.







News

What our clients say

News

  • BioSintex will be attending Medica and Arab Health

    BioSintex will be attending two of the most important medical exhibitions, in the next months. From November 14th untill 17th 2016, our company will be at Medica, in Dusseldorf, Germany. Please, v ...

What our clients say

  • We appreciate BioSintex sutures for their quality. We found the sutures safe and effective, with superior handling characteristics, providing a good knot security and minimal tissue reaction. Our clients are pleasantly surprised especially by the non-absorbable range, such as Biopro, Bioster, Biosilk. However, BioSintex has a complete portfolio – absorbable and non-absorbable sutures - which allows us to further meet all the needs of our healthcare professionals. At the same time, we want to thank and appreciate BIOSINTEX team, who have shown maximum professionalism and reliability during our collaboration.

    Bercha Valeriy, Director, Medical Service Ukraine
  • The standards of Romanian Students' Society of Surgery’s workshops are maintained at a high level, thanks to the BioSintex sutures, which help us meet the expectations and demands of our teachers, from whom we have received rave reviews regarding our partnership with BioSintex. The quality of BioSintex sutures leads to a high level of professionalism, wich is necessary for the future doctors. We are grateful to BioSintex team for their professionalism, compassion and interest in supporting the continuous medical education.

    Romanian Students' Society of Surgery
  • When in the middle of surgery and all manoeuvres are vital for the pacient, the assurance of quality materials is a must in order to sustain a correct surgical procedure. With BIOSINTEX, we have that assurance.

    Florin Săvulescu, Col, MD, PhD, Head of Department of Surgery, Central Military University Emergency Hospital ”Dr. Carol Davila”
  • We are satisfied of our relationship with BioSintex, based on good quality of device, services and delivery time.

    Benedetta Moroni, Quality Assurance, Fazzini SRL, Italy
  • BioSintex products are of very high quality, on a par if not better than many other established brands. We have no hesitation in recommending them in every way possible. They make us look good with our clients, and this means increased business for us in our very difficult market. A client for BioSintex is not just a client, but a friend.

    Mario Debono, Director Alphafarma

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