For products with special application, such as silicone medical devices, it is necessary to pay attention to a controlled environment. In order to provide this atmosphere for our customers, Siltec qualifies its own clean room for the packaging of silicone articles according to ISO 14644-1 class 8. Siltec controls and packages silicone molded parts, silicone seals, medical silicone tubing and other silicone products of any kind for our customers under constant conditions. Among other things, parameters such as temperature, illuminance and humidity are permanently monitored.
To keep the quality of the clean room packaging high, the number of airborne particles is regularly checked. The load and size of these particles define the class of the cleanroom and a defined threshold value must not be exceeded. For the qualification of Siltec’s clean room, all necessary measurements are completed and it will meet the conditions for Class 8 of ISO 14644-1 and GMP Class D.
In addition, discontinuous air and surface measurements are performed to ensure that the microbial load is also low. To prevent contamination of the clean room, silicone products are transferred via an annealing oven. This excludes the possibility of processing microbially contaminated silicone parts.
With this qualification, we offer our customers further opportunities to add value to their products. Customers can have silicone products packaged manually or automatically under clean room conditions, directly at Siltec without risking contamination on transport routes. In addition, we subject your silicone tubing, silicone seals and silicone molded parts to a final visual inspection in this controlled environment.
Do you need clean room packaging for silicone items with special quality requirements? Our sales department looks forward to your inquiries and will help you specify your requirements.