Manufacturing Systems

The basic operations involved in the manufacture of liquid-filled capsules include preparation of the bulk mix, followed by capsule filling and, when required, sealing.

Table 4 Major Factors Contributing to Successful Hard-Capsule Processing, by Process Category

Formulation development

Capsule

Filling machine

Sealing machine

Other

Minimize leak potential by increasing viscosity above 100 cps

Select for compatibility with intended sealing process (in-process (Qualicaps Hicap® or secondary, separate sealing process (Capsugel LEMS®)

Ensure robust system operates for detection of ') missing capsule parts (including "transparent" formats) and related inhibition of the dosing pump/rejection of unfilled capsules

Select formulation proportions, which ensure that the fill quantity is not more than 90% of the selected capsule body volume

Select to minimize intracapsule Pay close attention to the pressurisation, e.g., vented "Qualicaps" or unvented Capsugel "Licaps," according to process equipment Consider (but do not require) use of speciality "liquid-fill"

need for "clean-running"

Avoid "stringing" by nozzle selection and formulation capsule formats (e.g., LiCaps®) de-gassing

Control the amount of sealing solution applied to ensure sufficient is applied for seal integrity but avoiding over-wetting of capsule

Pay close attention to the need for "clean-running"

Control elapsed time between capsule filling and sealing to minimize intra-capsule pressure and formulation seepage between cap and body

Band-sealing (Qualicaps Hicap®): control sealing-solution viscosity to ensure consistent application of gelatin over entire processing period

Table 4 Major Factors Contributing to Successful Hard-Capsule Processing, by Process Category (Continued)

Formulation development Capsule

Filling machine

Sealing machine Other

Select capsule size to avoid

Select injection nozzle

Limit drying temperature

excessive void volume

profile to minimize

to that required for

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