SGH Medical Pharma, an international group specialising in the design and manufacture of medical devices aimed at key players in the pharmaceuticals, life sciences and diagnostic markets, has achieved ISO 22000 certification for its Eskiss plant, based in the Allier area. This comes in addition to its existing ISO 13 485, 15 378 and 14 001 certifications for its facilities in the Isère and Ain regions.
An ISO 22000 certified process
The group made a conscious decision to be certified to ISO 22000, which “sets out the requirements for a food safety management system and can be certified to it”. At its plant in the Allier region, SGH Medical Pharma designs and manufactures a wide range of bottles (and their associated caps) and pill dispensers, but also Unicadoses, a type of packaging that is used to replace double-tip glass ampoules.
As a result, the regulatory experts at SGH Medical Pharma identified the risks in the production process with the aim of deploying the necessary resources to manage them over time. Among other things, they examined how production was organised and the manufacturing procedures used to demonstrate SGH Medical Pharma’s ability to control risks and supply safe products that are suitable for their intended use. This involved, for example, carrying out regular analyses to prove that there was no migration of the packaging materials into the products themselves.
Pharmaceutical-grade raw materials
Beyond the quality of its process guaranteed by this certification, SGH Medical Pharma offers a range of primary packaging made with pharmaceutical and/or food-grade materials. Some products are therefore compliant with the European Pharmacopoeia 2.9.27 and suitable for contact with medicines. Others, such as HDPE pill dispensers, are suitable for contact with food and solely compliant for use with food supplements, vitamins and nutritional cosmetics.
“Obtaining the certification once more confirms the excellence of our production process. We do our utmost to supply high-quality products and are committed to responding to current challenges, particularly environmental ones. Accordingly, as well as traditional products made from PET, PP and HDPE, we offer an alternative with our environmentally responsible Greenov packaging range. This consists of primary packaging made from recycled and/or bio-based plastics and is part of our CSR strategy. In fact, the group has set itself a target of contributing to replacing fossil fuel-based raw materials with recycled and/or bio-based materials, whenever the regulations it must comply with allow it." explains Olivier Derouard, sales and marketing director.