by admin | Dec 20, 2023
When implementing new machines or revalidating processes, care should be taken to determine if the new process introduces a new worst case scenario. In addition, where multiple sealing machines are used, it’s advisable to evaluate and identify a worst case...
by admin | Dec 20, 2023
Packaging materials should not adversely affect the biocompatibility of the device. Care must be taken to ensure that the materials used in the packaging do not react adversely with the device.
by admin | Dec 20, 2023
Multi-component SBS materials can aggregate theoretical microbial loads exceeding 1000 CFU per device, which can complicate sterilisation validation.
by admin | Dec 20, 2023
Pre-contamination refers to the presence of micro-organisms on packaging materials prior to use. It’s recommended to check the microbial load to prevent it from affecting the sterilisation process.
by admin | Dec 19, 2023
Our expertise lies in the development of packaging and the production of prototypes. We can create certain prototypes close to series production in order to carry out an initial performance screening. We work closely with the packaging manufacturers for the final...