SOP for Operation of Auger Filler Machine

OBJECTIVE

To lay down a procedure for the operation of the auger filler machine.

SCOPE

This procedure applies to the Beta-Lactam production department in Pharmaceutical Manufacturing Facilities.

RESPONSIBILITY

The Dry syrup filling operator is responsible for the implementation of the process.

The Beta-Lactam In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

• Switch on the main switch, then momentarily switch on and off the conveyer. The conveyer should move from left to right. If it moves from right to left just interchange any one of the phase wire connections. Before starting the machine fill the gearbox with oil and check on the lubricant point.
• Switch on the stopper motor switch and adjust the stopper motor control knob (speed) so that the fork-type bottle holder makes 20 strokes in a minute. The number of strokes the fork makes is the output of the machine.
• Switch on the turntable and conveyer and adjust the conveyer speed by operating the hand wheel provided in front of the machine base so that the bottles are perfectly held by the fork for filling and released without knocking the bottles. Perfect synchronization can be achieved by minutely adjusting the stopper motor knob (speed). Also, adjust the turntable speed for proper in-feed of bottles.

• Now charge the hopper with powder. Switch off the turn table and conveyer. Switch on the auger motor and keep the feeder motor feed rate knob in full, make sure that there is a bottle below the filling nozzle. Turn the fill switch (center off two ways) from the off to the feed position.
• Now the feeder motor operates at full speed and transfers the powder from the hopper to the fill cylinder. The level of powder in the felt cylinder should always be from the center of the view gate to the lowest level of the view gate.
• Since the powder inside the fill cylinder at the start of the day remains in a slanting position, to ascertain the level of powder momentarily switch on and off the fill switch. By the operation of the stirrer inside the fill cylinder the powder will be leveled. If it is less shift the fill switch to the feeding position to charge more powder. Never overcharge the fill cylinder.
• Set the weight control counter (on the control box panel) to 70 digits (070) by operating the thumbwheel. Set the number of bottles and a number of fill sensors to sense the neck of the bottle just 4mm from the top of the bottle.
• Keep the fill switch and feeder motor switch in the OFF position. Switch on the topper motor, as per the setting made earlier will make 20 stops per minute approximately. Switch on the conveyer and turntable. Minutely adjust if required the speed control of (the stopper motor speed regulator), to synchronize the bottle movement with the conveyer speed.
• Switch on the fill switch to fill the position when the fork just starts to hold the empty bottle. Switch on the feeder motor and keep the feeder rate knob in 5 or 6th position.
• To get acquainted with the machine operation, set the machine to work at a slow speed and at a small quantity of fill weight. You will now observe that as soon as the bottle is held below the nozzle the power is (small quantity) filled. After filling the bottle remains in the filling station for more time and by the backward motion of the fork the filled bottle is released and another empty bottle is held below the nozzle.
• Take 10 filled bottles and switch off the fill switch, and weigh the content of the bottle to evaluate the filling accuracy of the machine. Though you have set the counter to 70 digits the display will show more or less 85. The variation in the display can be + 3 to 4 digits and still you will get the powder weight variation within ± 1.5%. Under proper setting of all controls and sensors the digit variation will be only ± 2 digits by looking at the display digit the operator can operate the machine with full confidence about the accuracy of the filled weight. Weight setting:

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• For example, you have a filling range of 15g, 25g, and 40g. The machine will be supplied with 3 sets of Auger and Nozzle (change parts) to fill the above-specified ranges. If you use 15g auger to fill 25 g the output of the machine will be less and if you use 25g auger to fill 15g, you will get more speed whereas Accuracy in filled weight will be less which will not be permissible so it is always advisable to use separate auger and nozzle for each range.

• The machine has be fitted with 15g auger and the sample took were weighing only say 12g. Now we have to increase the weight by 3g. Set the counter thumbwheel digit to 102 and start the machine as explained earlier and take readings and weigh the content.
• Say you got a weight 14g increase the thumbwheel to 104 to 106 you will get 15g. Once the weight is OK run the machine continuously.
• To increase the output of the machine, increase the conveyer speed and stopper motor speed to the maximum but not overshoot the range.
• The speed selection should be that soon the fork holds the empty bottle the filling operation should commence and after filling the required set quantity the fork should immediately release the filled one and hold the next empty bottle. Always set the speed a bit less to avoid powder dripping. After the filling is over the bottle should remain in the station for a fraction of a second more and then be released by the fork for the operator to work at ease. Feeder Controls:
• The machine is equipped with an automatic feeder mechanism to refill the fill cylinder. The mechanism takes care of maintaining a constant powder level in the filled cylinder, and essential parameters to get the perfect fill weight. Suppose you are filling 15g at a speed of 50 fills/minute, 600g of powder from the fill cylinder will be filled in bottles and accordingly level of powder will fall down in the fill cylinder by setting the feeder controls, every minute 600-605 g of powder should be transferred from hopper to fill cylinder to maintain the level. This input should be always a few grams more so that the level in the fill cylinder gradually increases to the maximum points in about 30 minutes or so. When the level touches the maximum points just switch off the feeder motor switch for few minutes and switch on while the machine is working.
• By mistake, you have adjusted the input so that is instead of 600g only 595g comes to fill the filing operation and manually readjust the feeder to change (refer to initial powder charging) the powder to fill cylinder which will reduce your per day output requirement.

• This feeder motor is intermittently operated by a sensor-fixed stopper mechanism, which works at 1/5 speed of the reset cam. The feeder's basic operation is such that for every 5-filling operations this operates once. According to the requirement the feeder motor speed and operating time are to be set from the knobs over the panel indicated by feeder rate and feed time.
• All the operation details shall be entered in the equipment usage log book.

ABBREVIATION

Q.A - Quality Assurance

BL - Beta-Lactam

SOP - Standard Operating Procedure

No. - Number

PVC - Polyvinyl chloride

ANNEXURE

Nil

REVISION HISTORY

Nil

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