*Guest blog by Eramol. If you would like to submit a guest blog please email [email protected].
Written by David Cox, Site Director at Eramol
David has more than 20 years’ experience across engineering, technical functions, sterile manufacturing, technology transfer and pharmaceutical site operations.
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Across a career spanning engineering, technical functions, sterile manufacturing, technology transfer and site operations, one pattern becomes difficult to ignore.
When a sterile fill-finish programme runs into trouble, the cause can often be traced to a much earlier decision.
A programme may look ready. Drug substance has been manufactured, equipment selected, a quotation approved and a filling date discussed.
But are the foundations really in place?
Can the formulation pass through the proposed equipment without changing? Has the sterilisation route been justified? Is the container suitable? Are the analytical methods ready? Has enough material been allowed for testing, stability and process losses?
A programme can resemble a facility fitted out before the process has been fully understood. Everything looks complete, but the weaknesses appear once operations begin.