SOP for the Manual Capsule Machine Operation and Cleaning is split up into 2 main types, semi-automatic and fully automatic. Semi-automatic machines require the operator to assist with production by moving the filling plates between the different production stages. SOP for the Manual Capsule Machine Operation and Cleaning the end of the day or product, changeover remove any visible material from the machine with the help of a nylon brush, vacuum cleaner, and jet of compressed air.

PURPOSE:

To lay down the operating procedure for the Operation and cleaning of the Manual cap machine.

SCOPE:

This shall be applicable to the operation and Cleaning of Manual Capsule machines in the area of Production.

RESPONSIBILITY:

1. Supervisor/ Machine Operator.
2. Production Pharmacist.
3. Manager-Production department

REFERENCE

1. In house

MATERIAL AND EQUIPMENT:

1. Manual capsule machine.

PROCEDURE:

OPERATION:

1. Open Locking Plate (a). Place adapter (b) on Caps Tray. Check that Cam Lever is set to three o’clock.
2. Place CapsiCards® (c) on Adapter with capsule bodies down. Use Pusher (d) to push capsules down into Caps Tray.
3. Remove empty CapsiCards® cardboard and Adapter
4. Close the Filler Locking Plate and secure it by turning the two tabs.
5. Gently pull Cam Lever toward the post to secure bodies in Filler. Capsules should be held firmly but should not be squeezed to an oval shape.
6. To separate capsules, press palms down on handles while lifting Caps Tray (top metal piece) up with fingers. Remove Caps Tray with caps from Filler. If whole capsules are pulled up, the cam lever should be pulled tighter in step 5. If just a few capsules fail to separate, check that they were not already locked.
7. Release Cam Lever to allow capsule bodies to drop into Filler. If some capsules sit higher than others, gently pat them into place.
8. Place Powder Tray onto Filler. Optionally, attach Powder Tray Clamps. For filling sticky powders, see chapter Special Fill Materials, page 14, following these instructions.
9. Pour powder onto Filler. Use Powder Spreader to move powder from center towards all four edges of Powder Tray Frame. Use tapping, vibration or tamping to settle powder. Repeat spreading and tamping as necessary.

Tapping, Vibration& Tamping:

1. Tapping: Pull Cam Lever to gently hold bodies in place. Hold Filler Base Frame and gently tap against table a few times to settle powder. Powder Tray Clamps are recommended when tapping. Do not hold Filler by Lifting Plate (moveable plate) as capsule bodies will be pushed up out of the Filler. Repeat spreading and tamping as necessary.
2. Vibration: Use optional Vibrator as an alternative to or in addition to tamping or tapping (see chapter Optional Accessories, page 5). Powder Tray Clamps are recommended. Repeat spreading and tamping as necessary.
3. Tamping: To fill additional powder, use Tamper. Repeat spreading and tamping as necessary.
4. Remove Powder Tray. Place Caps Tray onto Filler.
5. To lock capsules, press down on Locking Plate with thumbs while pulling up Lifting Plate. Repeat several times, with thumbs positioned in different areas of Locking Plate
6. Remove Caps Tray and turn over onto table. Use Capsule Locker to lock capsules. Apply pressure until you feel capsules snap and lock.
7. Capsules are fully locked. Check that capsules are fully locked using Locked Capsule Indicator. A locked capsule should pass through the Locked Capsule Indicator on Caps Tray.

CLEANING:

1. At the end of day or product changeover remove any visible material from the machine with the help of a nylon brush, vacuum cleaner and jet of compressed air.
2. Dismantle the capsule filling plate and pin plate from the unit.
3. Keep all dismantled parts in a plastic / SS tub containing warm tap water.
4. Remove any visible material from surfaces of all dismantled parts with the help of nylon brush or scrubber and drain the washings.
5. Prepare a Teepol solution (10ml à 10 liters water) or liquid-soap (50gm à 5 liters water) and clean surfaces of dismantled parts by mopping.
6. Wash all dismantled parts with running tap water for 10 minutes and drains the washings. Repeat the procedure for another 5 minutes and again drain the washings.
7. Finally rinse all dismantled parts with purified water and drain it completely.
8. Send the wash water for analysis of residual active ingredients of previous product.
9. Let all the parts dry in air or dry with a clean lint free cloth.
10. Re-assemble all cleaned parts in the reverse order of dismantling and put a label “Clean” or “Ready for use