Manual Capsule Filling Machine operation SOP

Standard Operating Procedure of Manual Capsule Filling Machine operation SOP is describe in this post.

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1.0 OBJECTIVE:

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

2.0 SCOPE:

This SOP shall be applicable for the operation of manual capsule filling machine

for filling of capsule in Capsule Section at Production department.

3.0 RESPONSIBILITY:

3.1 Supervisor/ Machine Operator.

3.2 Production Pharmacist & above.

4.0 ACCOUNTABILITY:

4.1 Manager-Production department.

5.0 MATERIAL AND EQUIPMENT:

5.1 Manual Capsule Filling Machine.

6.0 PROCEDURE:

6.1 Open Locking Plate (a). Place adapter (b) on Caps Tray. Check that Cam Lever is set to three o’clock.

6.2 Place CapsiCards® (c) on Adapter with capsule bodies down. Use Pusher (d) to push capsules down into Caps Tray.

6.3 Remove empty CapsiCards® cardboard and Adapter

6.4 Close the Filler Locking Plate and secure it by turning the two tabs.

6.5 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.

6.6 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.

6.7 Release Cam Lever to allow capsule bodies to drop into Filler. If some capsules sit higher than others, gently pat them into place.

6.8 Place Powder Tray onto Filler. Optionally, attach Powder Tray Clamps. For filling sticky powders, see chapter Special Fill Materials, page 14, following these instructions.

6.9 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.

6.10 Tapping, Vibration & Tamping:

6.10.1 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.

6.10.2 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.

6.10.3 Tamping: To fill additional powder, use Tamper. Repeat spreading and tamping as necessary.

6.11 Remove Powder Tray. Place Caps Tray onto Filler.

6.12 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.

6.13 Remove Caps Tray and turn over onto table. Use Capsule Locker to lock capsules. Apply pressure until you feel capsules snap and lock.

6.14 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.