We have produced a new application note focused around moisture determination in lyophilised drug and vaccine products utilising the Aquafast automated moisture analyser from a1-envirosciences GmbH.
Lyophilisation is a common step in drug and vaccine product manufacturing to improve stability of the formulation. Optimisation of the lyophilisation cycle for each formulation/fill combination includes assessment of the residual moisture level of the lyophilised cake.
The Aquafast Automated moisture analyser from a1- envirosciencs GmbH consists of a Nittoseiko (formerly Mitsubishi) coulometer and Gilson GX-271.
An automated coulometric Karl Fischer titration method was developed to address moisture determination in hygroscopic lyophilised biological materials. Advantages include:
- Process is more environmentally friendly
- Many more samples can be tested before the KF cell must be cleaned
- Multiple samples could be processed unattended after dispensing of the dry solid
- Applicable to difficult samples which would foul the KF and make manual testing impossible
To read more about automated Karl Fischer moisture determination in lyophilised drug & vaccine products and receive a copy of the full application note, email email@example.com.