1.0 Objective: To describe the procedure for operation and cleaning of capsule filling machine.
2.0 Scope: This procedure is applicable to capsule filling machine
3.0 Responsibility: Operator / Production Officer / Executive
4.0 Accountability: Department Head shall be accountable for the compliance of the system.
5.0 Procedure:
5.1 Operation:
5.1.1 Check the cleanliness of the machine as well as the area. There should not be any remainants of the previous product.
5.1.2 Check and ensure that all the parts which were dismantled from the machine for cleaning are fitted properly, Take line clearance from Q.A.
5.1.3 Switch ‘ON’ the main power and vacuum supply to the machine.
5.1.4 Pull out the hand wheel and ensure the free operation of the machine, then push the wheel.
5.1.5 Load the empty hard gelatin capsules (as specified in BMR) in hopper.
5.1.6 Load the powder in SS hopper.
5.1.7 Attach the loading plate and empty capsule filling unit and air displacement unit to the machine.
5.1.8 Set the rectifier unit, magazine and right side hopper (for empty capsule).
5.1.9 Put a cleaned doubled polybag in HDPE drum and place the drum under the empty capsule sorter unit with proper label as specified in BMR.
5.1.10 Fill the empty capsule in the right side hopper and switch on the machine to fill the empty capsule in the loading plate.
5.1.11 Separate the body and cap from the capsule loading plate with the help of vacuum.
5.1.12 Separate the body part of capsule loading plate set in the powder table.
5.1.13 Set the capsule weight by the weight adjustment hogger. Start the hopper left side, fill the powder / pellets in the capsule.
5.1.14 Capsule body (Filled weight) and Cap part of capsule loading plate both set in the locking pin – enter the loading plate in to air cylinder jackets and locked the cap and body part of capsules properly with help of air pressure.
5.1.15 Check the capsule locking length.
5.1.16 Out the loading plate from air cylinder jacket and capsule separate by rotating the loading plate.
5.1.17 Keep the filled capsules separately in drum with “REPROCESSIBLE RECOVERY “label on it, during machine setting.
5.1.18 After completion of the operation put “TO BE CLEANED “ label on it.
5.1.19 Record the activity in log book.
5.2 Cleaning: (For Batch Change Over)
5.2.1 Disconnect the power supply.
5.2.2 Clean the outer surface of the machine, loading plate empty capsule unit (Rectifier, magazine, hopper, loading plate for empty capsule).
5.2.3 Clean the surplus powder from hopper, pin plate and air displacement unit with vacuum cleaner.
5.2.4 Wipe out the body and all the parts with lint free cotton cloth.
5.3 Cleaning: (For Product Change Over)
5.3.1 Switch off the main power supply.
5.3.2 Dismantle the rectifier assembly, hoppers and powder tube, loading plate, pin plate and filter bag of air displacement unit.
5.3.3 Place the rectifier assembly on the stand and dismantle the pin plate, loading plate.
5.3.4 Put all the parts in polybag, affix “TO BE CLEANED” label on it and send it to washing area.
5.3.5 Unlock the capsule body plate and cap plate from the body and cap holding plate.
5.3.6 Keep the all part in SS vessel and soaked in isopropyl alcohol.
5.3.7 Wipe out the outer parts of the machine and turret with isopropyl alcohol and followed by dry lint free cloth.
5.3.8 Clean the surrounding area with vacuum cleaner and mope the area with 2.5 % dettol or savlon.
5.3.9 Clean the all parts with dry lint free cloth and put it into designated box.
5.3.10 Clean all the dismantled parts with purified water.
5.3.11 Dry the parts with lint free cloth.
5.3.12 Affix “CLEANED” label on it.
5.3.13 Record the activity in log book.
5.4 At the Shift End:
5.4.1 Clean all the parts of the machine with vacuum cleaner.
5.4.2 Wipe out all the exposed parts of the machine with dry lint free cloth.
6.0 Abbreviations:
| Abbreviation | Expanded Form |
| SOP | Standard Operating Procedure |
| PR | Production |
| QA | Quality Assurance |
| SS | Stainless Steel |
| BMR | Batch Manufacturing Record |
7.0 Forms and Attachments:
Annexure – 1: Equipment Log Book
8.0 Distribution List:
| S. No. | Department Name | No. of Copy |
| 1. | Quality Assurance | 01 |
| 2. | Production | 01 |
9.0 References:
In – House
Annexure – 1
| Department: | Page No.: |
| Name of Equipment | Equipment ID No.: |
Equipment Usage Log Book
| S. No. | Date | Product Name | B. No. | B. Size | Operation Time | Cleaning
Time |
Done By | Ckd. By | Brk. Down Time | Done By | Remarks | |||