SOP for Operating Procedure of Manual Capsule Filling Machine

OBJECTIVE

To lay down a procedure for the operation of a manual filling machine.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of PharmaInfo Limited.

RESPONSIBILITY

The capsule-filling operator is responsible for the implementation of the process.

The In-Charge is responsible for the execution of the procedure.

PROCEDURE

• Load empty capsules into the loading plate by means of the autoloader.
• Remove the loading plate from the autoloader and fit it above the powder tray.
• Turn on the capsule lock (pull backward), press down the hand lever, and remove the plate to separate the capsule cap and body. Put the cap holding plate aside and set the body halves in position by releasing the lock and lever.

• Make certain that the body halves are all well seated and none is protruding above the powder tray. This can be done by trapping with a scraper.
• Fit the sliding plate and pour a weighed amount of powder (as indicated on the B.M.R) on the powder plate.

ALSO READ: SOP for Operation and Cleaning of PAM Automatic Capsule Filling Machine (AF 90T)

• Spread the powder uniformly to fill the capsules and force in the excess amount by lowering the sliding attachment plate and then turning its knob clockwise. The latter step is done after removing the sliding plate.
• Once the powder has been filled, place the capsule plate back above the filled capsule body halves, lower the closing plate above it and clamp it into position.
• Turn clockwise the knob on the left-hand side and press down the hand lever to close the capsules. Turn the knob anti-clockwise and press down the hand lever again, this time to eject filled capsules from the powder tray into the capsule plate.

• Remove the capsule plate and pour filled capsules into a polythene-lined drum labeled appropriately.
• In-process checks must be carried out in the manner stipulated in the B.M.R
• All the operation details shall be entered in the equipment usage and cleaning log book.

REFERENCE

SOP: Preparation, Approval, and Control of Standard Cleaning Procedures for equipment.

Operation of autoloader

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

B.M.R: Batch manufacturing record

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Operation of Capsule Polishing Machine