Cleaning and Operation of Encapsulation Machine

 

1.0         Purpose

1.1       To established and define the procedure followed in the Operation and Cleaning of Encapsulation machine of Production Area to maintain the machine in proper and in efficient working order.

2.0         Scope

2.1         This procedure is applicable for Encapsulation Machine of production area at “NAME” Pharmaceuticals Ltd.

 

3.0      Responsibility

3.1.       Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains logbook.

3.2.       Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.

3.3        Production and Quality Assurance Officer shall ensure that the procedure is implemented properly.

4.0      Abbreviations and Definitions

4.1          BMR     : Batch Manufacturing Record

4.2          IPA       : Isopropyl Alcohol

4.3          ADU     : Air Displacement Unit

 

5.0       Materials and Equipment

5.1        Tap water

5.2        Hot water (60⁰ c)

5.3        Purified water

5.4        Hand brush / Plastic Brush

5.5        Clean lint free cloth

5.6        Detergent Solution / Cleaning agent: 0.4% (w/v) Sodium Lauryl Sulphate solution ;  4 gm Sodium lauryl Sulphate  is  dissolved in 1.0 liter of portable / tap water to prepare detergent solution.

5.7        70 % Isopropyl Alcohol.

 

6.0      Precaution / Health and Safety Considerations

6   

6.1         Use mask and hand gloves during operation.

6.2        Check the electric connection before operation.

6.3        Cover the electric switch board and motor with polybag during cleaning.

6.4      Do not operate the machine in automatic mode without all the protective guards in the proper closed position.

6.5        Do not by-pass safety switches.

6.6        Do not carry out any additions, deletions, conversions, or modification to the machine.

6.7        Never attempt to repair, adjust, clean, or lubricate any moving part while the machine is in operation.

6.8      The main switch of the machine must be switched “off” during the process of installation, assembly,       disassembly, maintenance, and cleaning.

6.9        Do not deactivate the safety devices installed on the machine.

6.10        Clean the surface, control panels of the machine with soft, dry cloth.

6.11        The checking of the safety devices must be carried out with the machine running on automatic mode.

6.12        The fallowing safety system checks should be carried out once a week.

6.13        The main supply is able to be cut “off” by using the main power switch on the pendant.

6.14        The emergency push button switches on the pendant functions correctly.

6.15        The emergency switch on the rear metallic safety cover of the machine functions correctly.

6.16        The machine should stop when front, rear, left and right safety door is opened.

7.0       Procedure

7.1            Cleaning

7.1.1        Switch “OFF” the main and disconnect the supply card.

7.1.2        Disconnect all line attachment.

 

7.1.3        Air Displacement Unit (ADU 100)

7.1.3.1     Remove suction hose pipe from the cylindrical chamber and open the cover.

7.1.3.2     Detach the filter bag, empty the contents in the polythene bag. Put the filter bag in a clean polythene bag and transfer to general washing area with “To be cleaned” status label.

7.1.3.3     Ensure that all of the Pellets from bag is removed and clean the filter bag with 5 liter potable water followed by detergent solution and then with 10 liter potable water. Finally rinse with 5 liter purified water.

7.1.3.4     Clean the inner portion of the cylindrical chamber with the help of dry clean lint-free cloth.

7.1.3.5      Reassemble the bag and close the cover.

7.1.3.6     Affix “Cleaned” label.

 

7.1.4        Sorter Elevator (SE 100)

7.1.4.1      Ensure that all empty capsule removed from the machine.

7.1.4.2     Clean the inner and outer portion of the sorter elevator with the help of dry lint-free cloth and wipe it with 70 % v/v Isopropyl Alcohol (IPA) solution. 

7.1.4.3     Affix clean label.

7.1.5         Automatic Capsule Filling Machine (AF 90T)

7.1.5.1      Ensure that all the material removed from the machine.

7.1.5.2      Remove the hopper tamping pins, ejection guide plate and closing pins and clean with 70 % v/v Isopropyl Alcohol (IPA).

7.1.5.3     Clean the turret with lint-free cloth and wipe it with 70 % v/v Isopropyl Alcohol (IPA).

7.1.5.4     Clean all the guard with lint-free cloth.

7.1.5.5     Reassemble all the accessories.

7.1.5.6     Affix “Cleaned” label.

7.1.6        Dedusting With Polishing Unit (DP 100)

7.1.6.1      Ensure that entire capsule removed from the unit.

7.1.6.2     Clean the inner portion of dedusting and polishing unit with compressed air and the outer portion with a lint-free cloth and wipe it with 70 % v/v solution of Isopropyl Alcohol (IPA).

7.1.6.3     Affix “Cleaned” label.

7.1.7        Compact Air Displacement Unit (CADU 100)

7.1.7.1     Remove suction hose pipe from the cylindrical chamber and open the cover.

7.1.7.2     Detach the filter bag, empty the contents in the polythene bag. Put the filter bag in a clean polythene bag and transfer to general washing area with “To be cleaned” status label.

7.1.7.3     Ensure that all of the powder from bag is removed and clean the filter bag with 5-liter potable water followed by detergent solution and then with 10-liter potable water. Finally rinse with 5-liter purified water.

7.1.7.4     Clean the inner portion of the cylindrical chamber with the help of dry clean lint-free cloth.

7.1.7.5     Reassemble the bag and close the cover.

7.1.7.6     Affix “Cleaned” label.

7.1.8        Mini Filled Capsule Sorter (MCS 100)

7.1.8.1     Ensure that all capsule removed from it.

7.1.8.2     Remove the plate sorter and drum sorter from it.

7.1.8.3     Clean the plate sorter and drum sorter with detergent solution and then with potable water, finally rinse with purified water.

7.1.8.4     Finally wipe out with 70 % solution of Isopropyl Alcohol (IPA).

7.1.8.5     Affix “Cleaned” label.

7.1.9        Empty Capsule Sorter (ECS 100)

7.1.9.1     Ensure that all capsules removed from it and cleaned with lint-free cloth.

7.1.9.2     Finally wipe out with 70 % solution of Isopropyl Alcohol (IPA).

7.1.9.3      Affix “Cleaned” label.

7.1.9.4     Connect the all-line attachment and affix “CLEANED” label and fill the record “Equipment Log Book”. (Annexure-I)

7.1.9.5     Re-clean if not used within 72 hours.

7.2            Operation Procedure 

7.2.1    Verify the cleanliness of the area and the equipment. Confirm that “CLEANED” label is affixed to the equipment.

7.2.2        Enter the details in the ‘”Machine Logbook”.

7.2.3        Remove the “CLEANED” label and affix the “UNDER PROCESS” label.

7.2.4        Get Line Clearance Certificate from In Process Quality Assurance.

 

7.2.5        Assembling

7.2.5.1     Sorter-cum-Elevator:

7.2.5.2     The capsule Sorter -cum- Elevator is connected to the machine’s capsule hopper.

7.2.5.3     Empty capsules are loaded in the hopper.

7.2.5.4     Sort out diametrically defective capsule and ensure that only capsules of the correct size enter the capsule hopper of machine, ensuring a continuous feed of diametrically correct capsules.

7.2.5.5      Capsule Orienting & Loading:

7.2.5.6      Fix all the cams to the main shaft by means of tightening keys.

7.2.5.7      Adjust the height of the Capsule Release Pin Block in such a way that one Capsule falls into each raceway slot.

7.2.5.8     The capsule moves in 7 vertical tracks in a non-oriented manner. (i.e., either the cap or the body faces downwards). The capsules are then rectified 7 at a time and loaded with the body facing downwards into the bushes in the segments.

7.2.5.9     The capsules are separated by vacuum so that the bodies go into the bushes of lower segment and the caps remain in the bushes of upper segment.

7.2.5.10  Two loading stations load and separate 14 capsules at a time.

7.2.5.11   The Dosing plate and bottom segment should be adjusted in such a way that the holes on dosing plate should be concentric with the holes of the bottom segment for all the positions for proper filling.

7.2.5.12  The Punch Guide Plate should be aligned / adjusted properly to move the punches freely into the holes of the dosing plate.

7.2.5.13  Set the penetration of the Punches in such a way to obtain a desired fill weight.

7.2.5.14  Select the right thickness of the dosing disc to avoid the downtime of the machine.

7.2.5.15  Set the sufficient Air Pressure to push the capsules in the rejection box (Standard: 0.5 to1.0 kg/cm sq.)

 

7.2.6        Optional Pellet Filling Device:

7.2.6.1      The pellet filling is based on the volumetric principle. Adjusting the volume of the dosing chamber helps in obtaining precise fill weights.

7.2.6.2     The dose volume is controlled by fixed dose container and movable slider block. The fill weight can be varied by adjusting a threaded spindle operated by a knob.

7.2.6.3      Displacement of slider block is recorded by a dial gauge having a least count of 1 micron for precise dose setting. The unique design ensures no damage is caused to the pellets during the filling process.

7.2.6.4     Then it passes through polishing and sorter machine (mini capsule sorter, empty capsule sorter) where all the capsules are polished and empty capsules, low weight and damaged capsules are sorted.

 

7.2.7         Capsule Closing & Ejection:

7.2.7.1      The capsules are closed and locked by means of closing pins. The locked length of the capsules can be adjusted with the help of a fine screw arrangement.

7.2.7.2     Change the size of the Closing Pins as and when the size of the capsule is changed.

7.2.7.3     Filled & closed capsules are ejected by ejection pins and come out through the exit chute.

7.2.7.4     After ejection, the empty bushes are cleaned with the help of compressed air and vacuum before the next cycle begins.

7.2.8        Operation

7.2.8.1         Switch on the mains.

7.2.8.2          Before running the machine in auto or manual mode, run the machine for at least one complete rotation of the Turret Assembly by turning the hand wheel provided on the motor shaft.

7.2.8.3         In Auto mode, the machine automatically checks the conditions before starting the machine.

7.2.8.4         In the main screen of the Control Panel, the following options are selected auto, alarm, product, select and sample.

7.2.8.5         In Auto Function Screen, the following options start, stop, Time reset, Alarm status,

7.2.8.6          Product report, Data entry, Weight setting, Sample setting is selected as per the batch requirement.

7.2.8.7         Start: On pressing this key machine starts in auto mode. The vacuum pump and blower re started with the machine.

7.2.8.8         Stop: On pressing this key machine stops functioning.

7.2.8.9         Time Reset: The machine running time can be reset by pressing this key for three seconds.

7.2.8.10      Alarm Status: The alarm status screen is displayed when this key is pressed. The alarm present if any is displayed on this screen.

7.2.8.11      Product Report: On pressing this key, production status screen is displayed showing the total production, day production count and number of capsules per hour.

7.2.8.12      Data Entry: Data entry screen is displayed on pressing this key. The required parameters are fed into this screen.

7.2.8.13      Weight Setting: This screen is displayed when WT SET is pressed on the Data Entry Screen showing the acceptable limit of weight variation, the number of capsules for which average is to be given and the time taken after which sampling is to be carried  out.

7.2.8.14      Sample Setting: On pressing F8 function key, sample setting screen is displayed. On which functional keys Take sample, Auto Manual, Auto, Manual, Tare, Motor ON/OFF are provided. Once the option is selected, sampling followed by the weighing operation starts.

7.2.9        Capsule sorter:

7.2.9.1         The filled capsules are passed through filled capsule sorter.

7.2.9.2         They are two types of sorters: Loose capsule sorter – Plate sorter.

7.2.9.3         Diametrically defective capsule sorting section – Drum sorter.

7.2.9.4         For starting the plate sorter keep the regulator knob at zero position and switch on the “on/off” switch of the plate sorter.

7.2.9.5         Then slowly turning the knob clockwise set it at middle position. The plate sorter starts vibrating. Ensure that the plate sorter does not make rattling noise. If so, decrease the voltage.

7.2.9.6         Similarly for starting the Drum sorter, start green push button. Check the rotation of Drum sorter, which should be clockwise in direction looking from the end.

7.2.9.7         Now, the capsules flow can be started. Start the capsule filling machine.

7.2.9.8         The capsule starts moving forward in the sorting plate. Observe the capsule movement in the sorting plate. If the movement is slow and the capsules start clogging, then increase the vibration slowly by turning the regulator knob clockwise.

7.2.9.9         The capsules move forward the loose caps will fall through the hole in the sorting plate, and the capsule is delivered to the drum sorter, they rotate along with the sorting plate.

7.2.9.10      The capsules are rotated in the drum sorter, capsules of oversize diameter or oval shape get trapped in the sorting plate and the good capsules pass through ECS 100.

7.2.9.11      The good capsule which passes through the sorting plate is delivered to the ECS 100. The defective capsule clogged in the sorting plate, are removed by a nylon bush which is fixed at the top drum sorter in the stainless-steel housing. The defective capsules get collected in a tray, which is to be removed manually at an interval.

 

7.2.10       Affix “TO BE CLEANED” label on the Machine.

7.2.11      Clean the Automatic Capsules Filling Machine as per defined Standard Operating procedure.

 

8.0      Reference Document

8.1        In-house

 

9.0       Annexure       

9.1        Annexure- I   : Format of Machine Log Book

 

10.0    Revision History 

Revision No.	Brief reason for the revision	Effective Date	Remarks
01	New

 

 

11.0     Training 

11.1      Head of Production or his nominee give the training of production operator and worker.