End-to-end qualification of RTU product containers in packaging suitable for No-Touch Transfer into Grade A filling zones
NTT of pre-sterilized ready-to-use (RTU) containers offers an alternative approach that adheres to Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. The NTT de-bagging process removes contents from secondary bag packaging without direct contact or exposure to environments of a lower grade than the target zone. This method eliminates the need for in-process material disinfection steps when transferring into Grade A environments.
Read the whitepaper now to learn more about the design qualification of pre-sterilized RTU container packaging!
The article was initially published in EJPPS – European Journal of Parenteral and Pharmaceutical Sciences Volume 26 Issue 4.