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

OBJECTIVE

To lay down a procedure for the operation and cleaning of the PAM automatic capsule filling machine (AF90T).

SCOPE

This procedure shall apply to the operation and cleaning of PAM automatic capsule filling machine (AF90T).

RESPONSIBILITY

Production Operator/ Chemist/Officer

IPQA chemist/Officer

ACCOUNTABILITY

Head - Production

PROCEDURE

Pre-Startup

• Wear a clean nose mask and hand gloves.
• Check the availability of compressed air.
• Check the previous status label.
• Check the area & machine for cleanliness.
• Ensure the temperature (NMT 25˚C) & RH (NMT 55%) and record the same in BPR.

• Ensure the line clearance from Q.A.
• Ensure the machine for proper settings.
• Ensure the label of the blend to be filled.
• Ensure the status label of upcoming products.

Operation

• Turn the machine 2-3 cycles manually after setting the hand wheel for the correct position to make sure all moving parts work properly before turning it on by power.
• Turn the valve in “ON” of the main compressed air supply.
• Turn the main switch “ON”.
• Turn the machine 12-20 cycles without capsules and powder for the initial start-up.
• Fill the powder hopper with the blend material by turning the main switch “ON” of the Powder loader.
• Fill the dosing chamber with the blend material by pressing the button for manual feeding.
• Fill the capsules into the hopper & reservoir by capsule loader switch “ON”
• On PLC, keep it on Auto mode & press the “ON” position.
• Keep ”0” in counting mode before starting the machine.
• Ensure when all parameters like powder supply, capsule supply, vacuum supply, capsule shutter, dust collector, and buzzer sound are on, it shows a green color
• Set the Polishing machine & Mini filled capsule sorter at the end of the discharge unit.
• Set the proper level of the powder bed height by the powder sensor. Check the capsule fill weight and adjust the fill weight, if needed, by decreasing or Increasing the penetration of the tamping pin.
• Check the required locking length as per BPR by using a vernier caliper.
• Collect the good capsule in a cleaned container at the discharge of the sorter.
• Record the operational details in the Equipment Log Book.

ALSO READ: SOP for Cleaning Validation of Empty Capsule Loader

Caution

• Ensure that air handling units and dust extraction units are always ON during the entire operation of capsule filling activity. In case the air handling units and dust extraction units stop functioning, stop the machine immediately and inform the engineering department for corrective actions.

Cleaning

For the same product

• Clean the empty capsule hopper, powder hopper, screw feeder, tamping pins, scraper plate, dosing disc, upper and lower segment magazine, rectifier blocks, brass plate, discharge unit, locking unit, faulty capsule ejection unit, segment cleaning assembly, vacuum bush, by using vacuum cleaner followed by dry and clean duster.
• Clean all the viable surfaces with the help of a Vacuum cleaner.
• Ensure complete removal of powder & capsules from the platform of the machine.
• Wipe & clean with a dry and clean duster or lint-free cloth.
• Affix the “CLEANED’’ label on the machine.
• Record the cleaning details in the Equipment Log Book.

For the different product

Note : While washing, remove sensors from peripheral parts of the minimum and maximum powder level

• Ensure complete removal of powder & capsules from the platform of the machine.
• Dismantle the empty capsule hopper, Powder hopper, screw feeder, tamping pins, scraper plate, dosing disc, upper and lower segment magazine, rectifier blocks, brass plate, discharge unit, locking unit, Faulty capsule ejection unit, segment cleaning assembly, vacuum bush and wash it approx 50-60 liter of portable water. Rinse all washed parts with approx 40 liters of Purified water and dry by using a jet of air.
• Vacuum clean all the viable surfaces.
• Wipe the tower portion with a cloth damped with Purified water.
• Blow with oil, moisture & dirt-free compressed air.
• Clean the lower portion similarly with the cloth damp it with Purified water and dry by blowing with oil, moisture & dirt-free compressed air.

• Assemble the empty capsule hopper, Powder hopper, screw feeder, tamping pins, scraper plate, dosing disc, upper and lower segment magazine, rectifier blocks, brass plate, discharge unit, locking unit, faulty capsule ejection unit, segment cleaning assembly, vacuum bush and check the machine for correct setting by an empty run.
• Send Swab/rinse sample for analysis to QC.
• Affix the “CLEANED’’ tag on the machine.
• Record the cleaning details in the Equipment Log Book.

REFERENCE

In house

ANNEXURE

Nil

ABBREVIATION

SOP: Standard Operating Procedure

No.: Number

BPR: Batch Production Record

REVISION HISTORY

Nil

ALSO READ: SOP for Disposal of Tablets and Capsules after In-Process Checks