Issue #8
Redefining aseptic transfer after revision of Annex 1
The latest revision of EU GMP Annex 1 brings aseptic transfer solutions into sharper regulatory focus - and challenges manufacturers to rethink traditional transfer methods. As pharmaceutical manufacturing shifts toward gloveless filling lines, the externally operated Alpha ports enhance sterility assurance and streamline operator workflows.
This white paper explores how technologies like DPTE®-EXO and DPTE®-FLEX align with Annex 1 requirements - from validated leak-tightness and reduced human interaction to enhanced ergonomics and compatibility with automated systems.
Accelerating validation with built-in GAMP 5 compliance
Validating automated equipment is essential in GMP environments — but it often comes at the cost of time, resources, and audit risk. This white paper explores how Getinge’s software for pharmaceutical washers/dryers reduces on-site validation scope through a pre-qualified, modular platform.
Small-scale HEK cultures, scalable insights
HEK293 cells play a key role in gene therapy and vaccine production - but scaling their cultivation could be challenging. This study evaluated batch and fed-batch cultivation in the AppliFlex ST 500 mL bioreactor, revealing high viability and a more than 30% increase in viable cell density when switching to a fed-batch strategy.
The results confirm the system’s reliability for process development and upstream optimization in compact formats.
Did you know…
...that Getinge offers comprehensive solutions to ensure a contamination-free vivarium environment, supporting both research integrity and staff safety? From high-throughput cage and rack washers that automatically clean and decontaminate equipment to fully automated cage handling systems (US only) that minimize operator exposure and improve workflow efficiency. Combined with sterilizers, playing a key role in the facility's containment barrier as pass-through units, Getinge enables laboratories to ensure safe transfer of materials between different zones and consistent hygienic conditions throughout the animal facility.
Any questions or comments? We’d be happy to hear your thoughts on these topics!