The bench-top, at-line minispec CCW instrument utilizes Time Domain (TD) NMR technology. TD-NMR is a fast quantitative technique for analyzing in-package products across various application fields.
In the pharmaceutical industry processed powders and solutions are filled into vials and syringes, but it is critical to carefully control the filling load.
Weighing is traditionally a two-step process, but the minispec’s TD-NMR technology offers a much more convenient and quick, one-step solution. Within seconds the filling load is determined to high precision, and without the need for the sample to be removed from the vial.
Calibration of the instrument is achieved by simply using empty vials or syringes and adding different amounts of the product of interest (see figure 1). The calibration curve is highly linear in nature, since the higher the mass, the higher the signal of the minispec.
Roche Diagnostics GmbH in Mannheim, Germany, is one of our main reference customers in this application field and they have collected various experiences with CCW over the years.
Roche has established a minispec CCW at-line process control procedure for different vials and syringes. The company uses CCW to measure, non-destructively, the filling weight of parenteral drug product solutions in vials and syringes.
The filling weight of pre-filled syringes without staked-in needles for different drug product solutions was validated by Roche Diagnostics GmbH according to ICHQ2(R1).
The results of these validation and optimization experiments for solid and liquid samples, including crimped and non-crimped vials as well as syringes, were published in the following two articles by the corresponding author Dr. Tobias Posset:
In recognition of their work and the ultimate strength of CCW, Kristina Witt and Dr. Tobias Posset were awarded with the “Preis für Pharma Technik” in 2012.
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