Who is bio-steril ?

Bio-Steril was founded in 2004 with the main aim of offering outsourced sterilisation services for healthcare establishments. The company rapidly broadened its field of activity by diversifying into the sterilisation of medical devices in 2008, and then by obtaining ISO 13485 certification from LNE-GMED in 2009, an important recognition of the quality of its sterilisation processes.

Bio-Steril's major turning point came in 2010 with the development of filling for complex aesthetic medicine products based on hyaluronic acid (or biopolymer). This marked the start of strong growth for the company. The same development dynamic led to the introduction of Ethylene Oxide (EtO) sterilisation in 2014, with the integration of two sterilisation chambers, expanding Bio-Steril's technical capabilities.

2017 and 2018 saw significant investment in new equipment, such as a second syringe blister machine and the automation of automatic canning lines. These improvements have helped to optimise production processes and respond more effectively to growing market demand.

Bio-Steril has also undertaken initiatives to strengthen its infrastructure. In 2019, a second ISO 7-certified 70 m² clean room was created for custom product formulation and automatic vial production. That same year, the company was acquired by INDICIA PRODUCTION and integrated into the PROTEX INTERNATIONAL group, opening up new opportunities for synergy and growth.

In 2020, Bio-Steril consolidated its presence in Saint Germain Nuelles by becoming the owner of the entire site, and continued its expansion in 2021 with the creation of a fourth ISO 7/8 ZAC, including a steam sterilisation autoclave for ultra-short cycles, an ISO 8 laundry, and two ISO 7 laboratories available on a daily basis for start-ups and customer projects.

To meet its logistical needs, Bio-Steril built a new temperature-controlled storage area of almost 550 m² in 2022. That same year, an automatic syringe filler was commissioned, increasing the company's production capacity.

ANVISA certification, obtained in 2023, enabled Bio-Steril to comply with Good Manufacturing Practices for healthcare products in the Brazilian market, opening up new international prospects. In 2024, new investments were made, including an automatic candling machine for vials and a mobile ISO 8 ZAC, boosting production quality and flexibility.

With a history marked by constant growth, strategic investment and diversification of its services, Bio-Steril has firmly established itself as a key player in the field of sterilisation and the production of medical devices.