What is the purpose of the WMF in your fill process and how has it improved your production metrics?
The Low-Loss Fill Process is a recently developed and validated process with the purpose of reducing drug product loss during filtration and filling for high-value and low-volume drug product lots. When the process was first developed, destructive weight checks were still being performed. This would consume filled drug products and add to the loss in the process. By implementing the WMF, we now perform non-destructive weight checks, allowing those filled vials that would otherwise be consumed, to be used in clinical studies and to treat patients. In a recent client fill, we were able to keep the total loss of product, from formulation and filtration through filling, to under 10 g. Non-destructive weight checks have been instrumental in achieving these low losses.
What was your experience integrating the WMF into the fill environment?
The METTLER TOLEDO team continues to be exceptionally helpful. We worked on every detail together from cabling options and the chassis support to software solutions using APW-Link. METTLER TOLEDO representatives from Europe and the US visited BSM to help set up filter characteristics appropriate for the mechanically noisy environment of a Grade A isolator space. The collaboration with Mettler has been productive and fruitful.
One WMF is installed to verify very fine doses of expensive materials. What specific features were of value?
The low cut-off frequencies of the WMF filters allowed us to perform accurate and repeatable readings even in our difficult environment. If the scale could not read accurately within the Grade A space of the isolator, then non-destructive weight checks would not be achievable.
