In this post Standard Operating Procedure Cleaning and Operation of Blister Pack Machine, Make: Elmach in Pharmaceuticals is describe.
1.0 OBJECTIVE:
1.1 To lay down a procedure for Cleaning and Operation of Blister Pack Machine; Elmach packages.
2.0 SCOPE:
2.1 This procedure is applicable for Cleaning & Operation of Blister Pack Machine in Production
Department.
3.0 RESPONSIBILITY:
3.1 Technical Associate: For cleaning and operation Blister Pack Machine EPI- 500XT.
3.2 Officer and Executive: Production Department- For supervision of Cleaning and Operation of
Blister Pack Machine EPI- 500 XT.
3.3 IPQA: Verification of Cleaning and Operation of Blister Pack Machine EPI-500 XT.
3.4 Head of Department: For compliance of SOP of Cleaning and Operation of Blister Pack Machine
EPI-500 XT.
4.0 DEFINITION (S):
4.1 NA
5.0 PROCEDURE:
5.1 TYPE A CLEANING:
Change over from one batch to next batch of the same product and potency.
5.1.1 Ensure that all the materials of previous batch are removed from the blister packing
cubicle.
5.1.2 Remove ‘EQUIPMENT STATUS’ label and affix “UNDER CLEANING’’ label on the machine with date
and sign of the production officer.
5.1.3 Clean the machine with dry lint free cloth and then by vacuum cleaning.
5.1.4 Clean the channel, feeding assembly, hopper, hopper lid and guide track with a dry lint
free cloth.
5.1.5 Clean the punch tool and forming unit and perforation unit with lint free duster.
5.1.6 Clean the inner and outer surface of the machine, control panel and utility lines with a
lint free duster.
5.1.7 Clean the sealing unit with a brass brush by applying silicon compound.
5.1.8 Replace the “UNDER CLEANING” status label by “CLEANED” status label on the machine with
date and sign of the production officer.
5.1.9 Record the cleaning activity in equipment usage log as per SOP (“Making entries in
equipment usage and cleaning log sheet”).
5.2 TYPE B CLEANING:
This is a cleaning procedure for Changeover of product with different activities
/color/descending potency/ascending potency / same product processed for more than a week or after
maintenance of contact parts.
5.2.1 Replaced the ‘‘EQUIPMENT STATUS’’ status label by ‘‘UNDER CLEANING’’ status label with date
and sign of the production officer.
5.2.2 Ensure that the power supply and compressed air supply are put ‘‘OFF’’.
5.2.3 Dismantle the hopper, hopper lid, feed channel and transfer to washing area in virgin poly
bag for cleaning.
5.2.4 Clean the machine and area with vacuum cleaning.
5.2.5 Scrub the dismantled parts with a nylon scrubber using purified water.
5.2.6 Finally rinse the cleaned parts with 10-20 liters of purified water.
5.2.7 Dry the cleaned parts with a dry lint free cloth.
5.2.8 Wipe the dismantled parts with 70% v/v IPA solution.
5.2.9 Cover the dismantled parts with poly bag and transferred to packing spare cabinet.
5.2.10 Remove the punching tool and guide track, forming plate and clean with dry lint free
cloth.
5.2.11 Remove the sealing unit and clean with a brass brush by applying silicon compound.
5.2.12 Transfer the guide track and sealing and forming unit to packing spare cabinet.
5.2.13 Clean the inner and outer surface of the machine, control panel and utility lines with a
dry duster.
5.2.14 Wipe the machine with 70% v/v IPA solution.
5.2.15 Reassemble the cleaned hopper, channel assembly and hopper lid.
5.2.16 Replace ‘‘UNDER CLEANING’’ status label by ‘‘CLEANED’’ status label with date and sign of the production officer.
5.2.17 After cleaning if machine is idle for more than 72 hrs. re-clean the machine with dry lint
free cloth followed by wiping with 70% v/v IPA solution before using the machine.
5.2.18 Record the cleaning operation time in equipment usage log sheet and check the cleaning
activity as per Annexure- I (“Cleaning and operation of blister pack machine, Make: Elmach
packages, Model: EPI-500 XT” PG/263/F1/00).
5.2.19 Clean the area as per SOP (“Cleaning of Production Area”).
5.3 Machine Setting:
5.3.1 Loading The Change Parts:
5.3.1.1 Procedure for fixing forming plate:
5.3.1.1.1 Switch ‘‘OFF’’ the machine.
5.3.1.1.2 Alu: Slide in the die-set in the guides provided on the moving plate. Fasten plug mount
plate with thrust plate and plug guide plate with the top plate.
5.3.1.1.3 To access mounting holes of thrust plate, pockets are provided in the top plate.
5.3.1.1.4 PVC: Slide in the die set in the guides provided on the moving plate. Fasten the blow
head to the top plate and connect air.
5.3.1.2 Procedure for fixing Counter Sealing Plate:
5.3.1.2.1 Counter Sealing Die is to be placed on dowel pins provided on the moving plate of the
sealing Station and is to be fastened.
5.3.1.3 EMBOSSING/PERFORATION:
5.3.1.3.1 Letter-holding/slotted plate is mounted on the moving plate and hammer and blade holding
plate is mounted on the top plate
5.3.1.4 PUNCH:
5.3.1.4.1 An assembled punch is to be placed on the station and fastened properly. Pneumatic
cylinder is provided with the machine, cylinder is to be mounted on the lower plate and piston is
to be engaged with the moving bracket.
5.3.1.5 Feeding station:
5.3.1.5.1 It consists of hopper, vibrator, tablet level sealing proxy, feeding channel.
5.3.1.5.2 Speed of all the vibrators is controlled independently by the potentiometer provided in
the operator panel.
5.3.2 Equipment Setting:
It consists of two sets of reel support, reel fastening screw, reel adjusting screw, all activities
are controlled by PLC.
5.3.2.1 Switch ‘‘ON’’ the machine.
5.3.2.2 Remove Base film Clamp from the quill by unscrew the socket set screw.
5.3.2.3 Insert the new Real.
5.3.2.4 Position the Real along the quill, in correct location as per Real setting gauge.
5.3.2.5 Tighten screw to clamp Real.
5.3.2.6 Thread the base film all the way up-to the punching station.
5.3.2.7 Engage the index roller.
5.3.2.8 Switch ‘OFF’ all functions on the “Switches” screen of the MMI.
5.3.2.9 Then, put the forming air (only for thermo-formable base film) and set the forming
temperature and wait until the temperature is reached.
5.3.2.10 Set the speed of machine as per requirement.
5.3.2.11 Form the few meters of web. Once the web is punched, thread the trim section.
5.3.2.12 Switch Sealing “ON” and set the required temperature values for upper & lower preheating
plates. Verify that this temperature is reached.
5.3.2.13 Thread the Lidding Foil and bring the Front End of the Lidding Foil under the sealing
station and pull it until it extends a little beyond the sealing station. Fasten to the Base Film
using Adhesive tape.
5.3.2.14 Put the correct values into all the required parameters in all the “SET PARAMETER” screen
on the MMI.
5.3.2.15 If base is Aluminum foil, selection of corresponding option will automatically ‘SWITCH
‘‘OFF’ the platen heaters. For Alu-Alu Base Film, also keep the upper platen open.
5.3.2.16 Check the index setting by actual measurement of advance over 10 repeats, and this must
match with the value per advance from the identification chart, /pack layout.
5.3.2.17 Check that forming & Punching Station positions of the Station match the Pack Layout.
5.3.2.18 If there is any mismatch (sealing crushing, packs punched of set), verify firstly that
the stations are in correct position as per the identification chart and then correct the advance
until the formed web matches in all stations.
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