Quality Assurance
Validation at HA2The objective of validation is to establish, through verification, a sterilization process that ensures reliable and reproducible sterilization results in every cycle under consistent operating conditions. As part of the validation process, the process parameters are determined and established in such a way that they enable the safe sterilization of the respective medical device.
Technology
State-of-the-art plant technologyReliable sterilization requires modern, high-performance, and precisely controlled equipment. HA2 operates one of the most advanced gas sterilization systems in Europe, providing the technical foundation for safe, reproducible, and scalable sterilization processes.
FAQ
Answers on Validation and ProcessesHere you will find answers to frequently asked questions about our validation processes and system technology.
Before products can be routinely sterilized, it must be ensured that the process used reliably achieves the required sterility under defined conditions. Validation serves to establish and verify the necessary process parameters. It is thus a central component of quality assurance and the foundation for reproducible sterilization success.
Reliable sterilization requires high-performance, precisely controlled equipment. At HA2, all relevant process parameters are automatically controlled and continuously monitored. In addition, state-of-the-art measurement and documentation systems ensure transparent, traceable, and reproducible process control.
HA2 is equipped with modern sterilization chambers of various sizes, with capacities ranging from 4 to 20 pallets. This allows for flexible processing of both smaller batches and high-volume throughput. This technical infrastructure is complemented by specialized environmental and safety technology that supports controlled gas flow, minimized emissions, and high safety standards.
