Sterile Product Manufacture

sterile product manufactureA client wanted to get a sterile wound dressing product to market quickly. With help from OpenWater throughout the entire product’s life cycle, the client produced a product that not only succeeded in the market, but was ultimately sold on as a lasting investment.

In its early stages, the full marketing potential of this product was uncertain, so we advised erecting a temporary clean room structure. For a company who had no past experience making sterile products, this was an ideal way to economically adopt the culture change needed for their research. OpenWater undertook the entire project – we helped build the room, and were involved in validation, microbiology, writing clean room procedures and staff training, designing equipment and installation, and dealing with all the consumables and maintenance. We also compiled the technical files and took care of the CE marking.

product testing and managementThanks to our professional, procedural testing and management, the product proved success at market and was soon adopted by another business. We assisted in placing it with a contract manufacturer, and worked with them to develop its required processes, set up the supplier chain and establish the quality criteria. In addition, we completed the higher class CE marking necessary within a 6 month period, and provided full staff training, to the great satisfaction of our client.