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| Compounding and subsequent manufacturing steps
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Many pharmaceutical manufacturing process steps are standardised procedures for which
Valicare offers user specific qualification and validation packages.
Equipment and processes applied during the different compounding steps of
liquid dosage form, utilities, cleaning
solutions, and fermentation media are subject to qualification and validation like all following manufacturing processes leading to the finished product.
Mixing represents the central manufacturing step for solid and
semi-solid products. Valicare qualifies your mixing equipment and validates the correspondent processes according to international guidelines.
Granulating represents a critical manufacturing step for solid drugs due to the requirement for homogeneity of grading. Granulates are the basis for the following pressing step forming
tabletting paste by kneading humid powder mixtures, dry compacting , extrusion, or pelleting.
Valicare offers comprehensive qualification of your granulating equipment and GMP compliant validation of the corresponding processes.
Coating means covering of a tablet core, e.g. by a coloured pH resistant finish. Qualification of reproducible application of a suspension
comprises testing of the function,
e.g. the transportation rate, the vaporisation rate, and drying time on the
coater.
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