OBJECTIVE

       The Objective of this document is to provide Operating and cleaning procedure for Encapsulation   

      Machine.  

• RESPONSIBILITY

All Production Officer / Chemist and operators are responsible to follow this standard operating      Procedure.

Quality assurance is responsible for the compliance of this standard operating procedure.

Head Production is responsible for the implementation of this standard operating procedure.

ACCOUNTIBILITY

     Head – Production  

PROCEDURE

•    Operating Procedure :

Check status label “CLEANED” on encapsulation Machine.

Take the approval for Cleanliness from in-process quality assurance.

Check and ensure that temperature and relative humidity of the encapsulation machine room are in  Limit as per specified in respective product batch processing and control record.

Before starting the encapsulation machine check and ensure that lubrication oil is 2/3 of the tank      Height in the roller (Left and Right).

Switch “ON” the main electrical supply and encapsulation machine.

Check and ensure that the lubrication system is in normal operation.

Mould /Die Rolls Installation:

Set the Die rolls / Mould as per specified in respective product batch processing and control record.

Adjustment the alignment of die of die rolls properly by pills press inching, repeat the adjustment so  that the mark lines at the pin holes of the left and right and right moulds are aligned.

Set the temperature of spreader box as per specified in respective product batch manufacturing record.

   Open the valve of gelatin mass and allow filling the both spreader box.

Release the gelatin mass from the both spreader box to the both drums of encapsulation machine       through operate the screw of both spreader box.

Take the both side gelatin ribbon to the die roll & apply the pneumatic pressure to rolling moulds.

If there is no gelatin ribbon between two rolling moulds, it is forbidden strictly to apply pressure to         the rolling moulds by using pneumatic clamping mould, so as to avoid damage to moulds.

Set the temperature of segment as per specified in respective product batch processing and control     Record.

When the rolling moulds are turning, do not press the wedge nozzle directly on the rolling moulds.

It is strictly for bidden that hard things fall in between two rolling moulds.

It is strictly for bidden to power On the electric heater in case lack of water in jacket of segment. (If applicable).

Periodic adjustment of rolling moulds and feed pump.

Disengage the idler at the rear of encapsulation machine head from the translating gear. Use  wrench to turn the drive shaft of feed pump so that 12 piston rods at the left side of feed pump are located at extremely left or extremely right pistons .

Use inching method of pill press , make the left and right rolling moulds move slowly , when the nozzles are at operating pistons, make the timing mark line of nozzle to be 2-2.5mm lower than one pair of the nearer timing mark lines on the rolling mould end surface , for different shapes and loading moulds , this value will have a little change .

During adjustment, make sure that the feed liquid spread out from nozzle can get in to cavity of capsule completely.

Engage the idler on the translating gear plate with the translating gear.                  

Preparation and adjustment of gelatin ribbon

Adjust the front plate of gelatin box at two sides of pill press so that it contains fully with gelatin ribbon wheel.

Connect the gelatin Pipe with gelatin box its exterior is wrapped with heating jacket.

Set the temperature of spreader box as per specified in respective product batch processing and control record

Let the temperature stabilized then start the encapsulation machine, adjust the pressure of pneumatic pressure reducing valve on the ground gelatin pipe until the gelatin mass gets in to spreader box.

Turn the adjusting screw at two sides of spreader box. Lift the front plate to increase its gap with gelatin wheel , let the gelatin mass flowing out , and adjust the thickness of gelatin ribbon as per specified in respective product batch processing and control record.

Measure the thickness of two gelatin ribbon with a feeler, according to the result of measurement,     Adjust the clearance between the front plate of spreader box and gelatin wheel.

Ensure that the thickness of gelatin ribbon is as per specified in respective product batch processing and control record.

Capsule Pressing

Feed both gelatin ribbon respectively in to the driving shaft and oil roller shaft at both sides of encapsulation machine head, and through a guide shaft, get in between two rolling die rolls / moulds, and then pass the clearance between two hexagon shafts of pill unit and between net –pulling shafts, let the gelatin ribbon get in to gelatin residual. 

Turn the switch on the panel of pneumatic clamping mould system to “pressurization” position so that the left and right rolling moulds joint together , adjust the pressure knobs of the front and rear cylinders.

 CAUTION : In order to premature wear of the machine , and to delay the first time overhaul , Make sure that the RPM of rolling mould for a long time operation is not exceed  3.0 RPM , especially for new encapsulation because it is not -in completely.     

Replacement of Die Roll / Rolling Mould     

The die rolls / rolling moulds with different specifications has to be used as per respective product batch processing and control record with different shapes and sizes.

At the same time it is necessary to replace the translating gears, wedge / segment that match with the die roll / rolling mould, shunt plates and its suitable sealing gasket.

ELECTRIC CONTROL OPERATION DESCRIPTION            

Open the control box at the rear of pill head, check all connecting wires on the electric control box   for loose, disconnection and then ensure integrity of all connection of encapsulation machine.

Under the condition of no mistakes, close the air switch, the encapsulation machine is powered-on. Turn on the master power switch at this time, use a special key to turn rightwards to turn on the key switch on the operating panel , the touch screen is lit , after automatic initialization , display the menu of machine operation.

Check the parameters of various units on encapsulation machine menu mainly include: temperature and RPM

Operating the different units of encapsulation machine mainly according to the following descriptions:              

There is the operation button of main encapsulation machine at the lower left corner of the main operation menu. Click it to make the main encapsulation machine ON or OFF.

ON/OFF button for heating is available at the lower left corner of main operating menu. Click it to heat the different units of main encapsulation machine or to stop heating automatically.

At the middle of main operating menu, there are schematics of nozzle, left and right spreader boxes, air conditioning and gelatin mass tank. There are two groups of temperature parameters for catch unit. The upper is the measured parameter and the lower is the set parameter. Click the setting, a small keypad is sprung out , you can change the value of setting . The default values for nozzle, left and right spreader boxes are respectively as per respective product batch manufacturing record.

There is schematic conveyor at the lower part of main operating menu. Click the left and right arrows here, the conveyer will operate leftwards or rightwards.

There is schematic of rolling mould / die roll operation at the middle part of main operating menu. Click RPM display key, a keypad is sprung out, it can be used to change the RPM of main encapsulation machine.

There is schematic of gelatin ribbon wheels at the middle part of main operation menu. Click the value setting key of the left and right gelatin ribbon wheels, speed of gelatin ribbon wheels is adjustable.

CAUTION: The speed setting values of the left and right gelatin ribbon wheels are the plus and   minus difference values based on the RPM of main encapsulation machine.

There is switch of “Feeding Punch wall” on the main operation menu. Click it to turn ON or OFF the automatic feeding system

Manually adjust the menus can also operate the rotary caging of main encapsulation machine and auxiliary machine.

Main encapsulation machine inching, click “Main Encapsulation Machine Inching”. The rolling mould / die rolls of main encapsulation machine will have inching movement. This function is mainly used for mould / dies rolls adjustment.

The speed regulation of the net-pulling shaft is to plus or minus based on the rotating speed of main encapsulation machine.

Frequency conversion cooling air, the volume of cooling air can be adjusted arbitrary.

Defrosting control can set the heating time and stop time of defrosting.

Click “System Arrangement” button of main menu, get in to “System Arrangement” menu. 

In this menu, can clean the touch screen. Click the button of “CLEANING SCREEN” to stop the   scanning of screen control for a short time and use this time to clean the surface of touch screen.

Click “PASSWORD LIST” key can get in to code distribution and to display the menu.

In this menu, we with high grade of code can distribute the code grade operation authority to operators.

In this system adjustment menu, click the button of “MESSAGE DISPLAY” to get in to alerting menu, can inquire about the whole encapsulation machine if there is failure alerting thus providing reference for trouble shooting.

ENCAPSULATION MACHINE SHUT DOWN: After making sure that all the units stop running and all indications on menu are in OFF conditions; turn the key switch leftwards to run thick enough

Under the condition that the AC power supply is not stable or there is big load interference to electrical network nearby , a AC voltage stabilizer and isolation filter device is added to ensure that no interference to the operation of encapsulation machine (Especially PLC, Touch Screen, Frequency Converter and their communications ) .

After completion of the process affix the “TO BE CLEANED” label on encapsulation machine duly filled and signed by competent technical staff.

Record all the observations in machine log book.

TROUBLE SHOOTING

Common – met troubles and their remedy are as shown in table below, for reference only.

S. No.	Phenomenon	Cause	Remedy
1	Gelatin ribbon is cut or has groove.	Hard gelatin or other sundries at outlet of gelatin liquid of spreader box.	Remove hard gelatin or sundries (not necessary to stop encapsulation machine).
2	The thickness of gelatin ribbon is uneven or it shows wave lines.	Oil or foreign substance on gelatin ribbon wheel.	Clean gelatin ribbon wheel.
3	Pile up of gelatin ribbon between oil	Improper nozzle position or loose	Adjust the nozzle piston and tighten the net pulling shaft.

Cleaning Procedure:

Disconnect the main electrical switch of encapsulation machine. 

Affix “UNDER CLEANING” label on the encapsulation machine duly filled and signed by competent Technical staff.

Check and ensure that there is no previous product residue in hopper of encapsulation machine.

Dismantle the following parts from the encapsulation machine

 (a) Segment

 (b)Spreader Box                     

 (c) Die Roll

 (d)Medicament Basket        

 (e) Tumble Dryer                   

Transfer all the dismantle parts to the washing area.

Clean the above dismantled parts by 2 % Liquid soap solution, scrubbing with soft nylon brush/ lint      free cloth

Wash with sufficient quantity of potable water and rinse by purified Water.

For removing of sticky adhere material use hot water along with 2 % liquid soap solution.

Wash with sufficient quantity of potable water and rinse by purified water.   

Dry all the parts with lint free cloths.

Clean the outer surface with lint free cloth.

Send the intimation to the quality control department through in-process quality assurance for wash  water analysis.

After getting passes report from control department through assemble all the parts respectively.

Affix “CLEANED” label on encapsulation machine duly filled and signed by competent technical staff.   

Record the cleaning observation in Equipment / Machine Log Book, Annexure-1.

 TRAINING

      Trainer   : Head – Production Department

      Trainees : Staff and machine operator of production  and QA chemist.

DISTRIBUTION

      Master copy                  :     Quality Assurance

      Controlled Copy           :     Production Department

      Display Copy                : Production Department (If Required)

ATTACHMENTS

       Nil.

  REFERENCES  

       In-house

ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.