SOP for Semi Automatic capsule filling machine

GENERAL REQUIREMENT:

1.1 The environment condition in which filling of hard gelatin capsule should be normally carried out is:

                        Humidity:                 Not more than 35% RH

                        Temperature:         Not more than 25%

            These conditions should be maintain even work has stopped at the end of   working day and during                                    the week- ends.

1.2 The area around machine should be kept clean at all times. Spillage should be cleaned up promptly.

       The machine must be thoroughly cleaned during the week –ends and when there is a product change –    over.

1.3 The speed gear should not be adjusted when the machine is running on power,

1.4 Operator should wear rubber gloves, nose mask and head covers when the machine is operated for filling.

PRELIMINARY OPERATIONS

2.1 The RH in the room or area should be checked and recorded on manufacturing sheet. Filling should not  be started if humidity is more than 35%.

2.2 The compressed air supply should be turned on and regulator set at about 5 psi.

2.3 The vacuum pump should be turned on with vacuum hole blocked and the vacuum adjusted to not less than 600 mm Hg.

2.4 At a time on one container each of the blended product to be filled and of the             empty hard gelatin capsule should be brought into the room and placed on either side of filling machine.

LOADING AND RECTIFICATION

3.1 The setting of the loader and rectifier is checked by rotating the machine manually with the clutch in the ON position and the adjustments should be made.

3.2 The bag of empty capsule shells should be opened and with a clean scoop, capsules should be loaded into the hopper of the rectification assembly.

3.3 The capsule holding ring should be placed on the turn – table and turned clock wise until it stops firmly against the drive pin.

3.4 The machine should be run manually to check if the capsules enter the ring correctly. If not, the necessary adjustments should be made.

3.5The main switch of the machine should be switched on and the vacuum pump started. The vacuum should not be less than 600 mmHg.

3.6 The machine should be started and the clutch lever moved to the right to bring the capsule loader into action. It should be checked whether the          capsules are loaded properly. If the loading is satisfactory, the loading of the disc should be completed.

3.7 As the last row of empty capsules is deposited into the ring, on the turn – table should be stopped by moving the clutch lever to the left.

3.8 The ring assembly should be subjected to two or three revolutions on the turn- table in an anti clockwise direction to provide the capsules additional   exposure to vacuum for effective separation of the bodies from the caps.

3.9 The ring assembly should be removed from the table slowly taking care to avoid spilling the capsule; if then be placed on the ring of the machine.

3.10 The top half of the ring should be separated vertically and held chest high to see whether all the capsules have been separated , defective ones should be rectified the hand and the bodies of such capsules should be positioned inside the bottom hold of the ring  if too many capsules bodies        are found unseparated, the vacuum should be increased.

3.11 If the loading and rectification of he capsules are satisfactory the process should be repeated with another ring assembly.

FILLING OF POWDER

4.1 The bottom half of the ring assembly should be placed on the left turntable near the drug hopper and positioned.

4.2 The operator should run his hand lightly over the ring to ensure that all the capsules arte below the ring surface,

4.3 The speed of the turntable should be adjusted to the pre-determined rate. This should not be adjusted while the machine is running on power.

4.4 The drug hopper should be filled with the powder up to the stirring arm.

4.5 The machine should be switched on and the drug hopper pulled over the face of the moving ring until the stirrer start moving and the powder fills the capsule bodies.

4.6 At the end of one revolution of the ring should be pushed back smartly in        order to avoid double feeding of powder,

4.7 Excess powder from the surface of the ring should be scraped off with a small PVX sheet or Teflon scraper and the powder should be collected in the dust tray,

4.8 The body ring with the capsules filled with powder should be removed and  the cap ring placed on it and positioned so that the two rings are joined.

SEALING OF CAPSULES

5.1 The pressure of the compressed air supply should be checked and adjusted if necessary to between 5.5 kg/sq.cm to 6.5 kg/sq.cm. The air supply valve should be opened.

5.2 The sealing position should be adjusted by means of a venire so that the sealed capsules co, ply with the limits specified.

5.3 The complete ring assembly containing the filled capsules should be lifted and held in a slightly inclined position with the cap half facing the operator, and then positioned on the joiner or sealing device.

5.4 The joiner plate should be swung downwards into position and the ring assembly should be pulled snugly against it.

5.5 The peg ring assembly should be pulled, rotating if necessary to align the pins with the holes the peg pins should be eased into the ring assembly until the capsule have started to join.

Note:-

Ø  The ring assembly must be kept firmly against the joiner plate to prevent the capsules from being pushed before joining.

Ø  The ring assembly along with the joiner plate should be held firmly and the air control foot pedal pressed in order to seal the capsules with air pressure.

Ø  The ring assembly should be turned along with the joiner plate by approximately 180^o  and the pedal pressed again to repeat the sealing process.

Ø  The ring assembly should be pushed back completely on to the peg ring in order to eject the capsules.

Ø  The capsules should be collected in a container placed below the joiner.

Ø  The joiner plate should be swung upwards and the ring assembly should be removed.

Ø  The ring should be removed and knocked against the rubber bumper to remove excess powder.

Ø  The drug hopper rotary table should be cleaned before repeating the filling cycle.

Ø  The weight of the filled capsules should be determined and the weight of contents should bin adjusted, of necessary, by altering the speed of the machine.

Ø  The capsules should be checked for proper sealing and the necessary adjustments to the joiner plate, made, if required.

Ø  Machine adjustments should be made until the weights are found to be within specified limits.

Ø  Capsule produced until these limits are reached should be segregated and stored separately until they are taken up for reprocessing.

CLEANING OF AUTOMATIC CAPSULE FILLING MACHINE

A.   PROCEDURE FOR PRODUCT TO PRODUCT CHANGE OVER

Dedusting external surface – Use a clean nylon brush and vacuum cleaner.

Dismantling- Remove 

A. Filling and Loading turn- tables

B. pusher slide

C. Rectifier, raceway with guide block

D. Magazine

E. Drug hopper, auger and stirrer

F. Peg ring plate

G. Partial fill attachment

Ø  Collect all these parts in a suitable SS container.

Ø  Cleaning of parts – clean the above parts by washing with 0.1%Teepol solution and scrubbing with soft clean nylon brush. Rinse with jet of potable water followed by rinsing with 5 micron filtered water.

Ø  Cleaning of capsule plates-capsule plates are soaked in hot 5 micron filtered water for 5-1min. The holes are cleaned using 0.1% Teepol solution. Rinse with jet of potable water by dipping in 5 micron filtered water.

Ø  Cleaning of machine body- clean with 0.1% Teepol solution and scrubbing with soft nylon brush. Clean with potable water.

Ø  Conforming effectiveness of cleaning- the DM water rinse of product hopper and capsule plates is sent to QC department to confirm absence of previous product.

Ø  Drying – the cleaned dried parts as mentioned in step 2 are wiped and dried using a clean lint free duster. The capsule plate has air-dried and stored in a SS trolley.

Ø  Assembling – Ressemble all the parts of machine carefully checking for correctness of assembling and free motion of moving parts. Replace the filter bag in the vacuum can below the machine with a clean filter bag.

Note

Ø  Step 6 is a validatoty exercise to be conducted once in six month at the time of product changeover.

Ø  Fix the cleaned tag with date, previous product and initials.

Ø  Replace vacuum filter bag from vacuum can behind machine every day at the start of filling.

B.   PROCEDURE FOR BATCH-TO-BATCH CHANGEOVER

Ø  Remove powder below the powder-filling turntable.

Ø  Dedust external surface of machine with vacuum cleaner.

Ø  Dry clean the machine with clean lint free duster.

Ø  Oil the different moving parts of machine on loading side.

Ø  Dry clean the partial fill attachment by wiping with a clean lint free duster.

C.PROCEDURE TO BE FOLLOWED FOR CLEANING AT END OF SHIFT:

Ø  Remove empty capsule from capsule hopper.

Ø  Remove blend from powder hopper.

Ø  Dedust external surface with vacuum cleaner and clean lint free duster.

Ø  Clean the capsule loading plate as per procedure A step 4.

Ø  Clean the partial fill attachment as per procedure A step 3.

Ø  Cover the machine with suitable cloth cover.

If machine is to be kept for, more than 2 days without operation follow procedure B.