Capsules

Question 1

Capsule filling - indirect

Answer 1

Indirect Filling/Independent – Powder measured using dosing device, forms ‘plug’ of powder
Tamp Filling (Dosing-disc and Tamping pins): Powder fed into powder bowl containing a removable dosing disc with dosing stations & dosing holes at each station.
As the dosing disk rotates, the powder flows into each hole. Tamping pins compress the powder to a controlled depth. This process of partially filling and tamping is repeated at each station until the last station is reached.
After excess powder is scraped off, the dosating disc positions the plug of powder over a capsule body and ejects it into the capsule body.
Fill weight control: thickness of dosing-disc, powder bed depth & tamping pressure.
Tamping pins are spring loaded (lab/medium scale) or cushion of compressed air (industrial scale) to minimize tamping force to keep plug density low
Dosator Nozzle/Tube: Nozzle pushed into powder bed and plug of powder filled into the nozzle. This plug of powder is then transferred from the nozzle to capsule body.

Question 2

Capsule filling - direct

Answer 2

Direct Filling/Dependent – Use capsule body to measure powder
Auger filling: Powder in a hopper is filled into capsules continuously by a rotating auger in conjunction with a stirrer. Empty capsule bodies are placed below the auger into a rotating turntable.
Dosed weight dependent on auger speed, the twist angle of the auger and the time the capsule body spends under the hopper outlet.
Fill weight also dependent on powder density.
Thus, fill weight may vary over the course of the filling process.

Question 3

Capsule filling

Answer 3

Orientation
Separation
Filling
Re-joining
Closing

Question 4

Capsule IPCs

Answer 4

Visual Appearance
Weight Variation
Closed length measurements

Question 5

Gelatin Capsules Properties:

Answer 5

Bloom strength determines capsule strength: Capsule shell manufacturers typically blend diff. batches for consistent bloom strength
Viscosity controls thickness of capsule shell
Moisture content of capsule shell critical  HUMIDITY control
Gelatin source: Bovine/Porcine  TSE/BSE considerations

Can also get capsule shells made from HMPC

Question 6

Capsule CQAs

Answer 6

Weight
Appearance
Closed Length
Capsule Condition

Question 7

Capsule CPPs

Answer 7

Machine speed
Tamping Pin Pressure
Dosing Disc Thickness
Powder Bed Depth

Question 8

Soft Gel Capsules

Answer 8

Mainly used for liquid/paste fills
Two ribbons of gelatin brought together on rotary die
Gelatin forced into shape of cavities in rotary moulds
Liquid fill injected as the two die rollers come together
Messy!!
100/200% inspections