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Sunday, April 26, 2009

CLEANING OF COMPRESSION MACHINE (27 STATION)

1.0 SCOPE:
Applicable to Compression machine manufactured by Cadmach Machinery Company Pvt. Ltd.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER/ AT THE END OF SHIFT
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Verify that the machine is switched ‘OFF’.
3.1.3 Change the status board of the cubicle.
3.1.4 Open the acrylic covers of the machine and suck the accumulated powder from the
feed frame and other contact parts of the machine with the help of vacuum cleaner.
3.1.5 Open the cover of the De duster and clean it with vacuum cleaner.
3.1.6 Remove both the hoppers. Clean them with the help of vacuum cleaner followed by dry lint free cloth.
3.1.7 Suck the accumulated powder on the machine platform with the help of vacuum cleaner and clean the same with dry lint free cloth.
3.1.8 Remove both the feed frame and clean them using vacuum cleaner.
3.1.9 Remove the upper punches individually and wipe them with dry lint free cloth.
3.1.10 Refit the upper punches properly.
3.1.11 Fix the feed frames to their respective positions. Place both the hoppers properly.
3.1.12 Clean the acrylic covers, frames and the body part of the machine using dry lint free cloth.
3.1.13 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.1.14 Fill the Equipment Cleaning Checklist
3.1.15 Enter the details in the ‘Equipment usage log’
Note: If jamming of lower punches observed then remove and clean them using lint free cloth.
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Verify that the machine is switched ‘OFF’.
3.2.3 Release the compression pressure by turning the lever in Anticlockwise direction.
3.2.4 Remove hoppers, feed frames, tablet discharge chute and transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.5 Clean the parts using about 20 kg of potable water followed by scrubbing with nylon scrapper dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.6 Wash the parts with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.7 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.8 Remove the dust extraction nozzles, dust extraction pipes, and transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.9 Clean the parts using 15 kg of potable water followed by scrubbing with nylon scrapper dipped in0.1% Sodium Lauryl sulphate solution.
3.2.10 Wash the parts with 20 kg of potable water and finally rinse with 15 kg of Purified water.
3.2.11 Wipe the parts with a dry lint free cloth and then using compressed air.
3.2.12 Remove the powder adhered to the turret and the machine using vacuum cleaner.
3.2.13 Remove all the upper punches and collect them in a tray. Clean all the upper punches with the help of dry clean lint free cloth. Wiping with a lint free cloth dipped in 70% Isopropyl alcohol followed by dry lint free cloth.
3.2.14 Lubricate the punches using food grade oil/grease and place them to their holder.
3.2.15 Release the screws holding the anti-turning screws.
3.2.16 Carefully unscrew the lower punch inserting assembly remove the punch inserting block. Remove all the lower punches one by one and collect them in a clean tray.
3.2.17 Clean all the lower punches with the help of dry clean lint free cloth. Wiping with a lint free cloth dipped in 70% Isopropyl alcohol followed by dry lint free cloth. Lubricate the punches using food grade oil/grease and place them to their holder.
3.2.18 Clean all the upper and lower shank holes with soft nylon brush dipped in 70 % Isopropyl Alcohol. Clean these shank holes with dry lint free cloth.
3.2.19 Unscrew the die-locking screws and remove the dies one after other by pressing from bottom with the help of die rod. Collect the dies in a clean tray.
3.2.20 Clean all the dies with the help of dry clean lint free cloth. Wiping with a lint free cloth dipped in 70% Isopropyl Alcohol followed by dry lint free cloth. Lubricate the dies using food grade oil/grease and place them to their holder.
3.2.21 Clean all the shank holes and die holes with soft nylon brush dipped in 70 % Isopropyl Alcohol followed by dry lint free cloth.
3.2.22 Clean the powder from the turret with the help of vacuum cleaner.
3.2.23 Clean the upper cam track and the lower cam track assembly using soft nylon wire brush soaked in 70% Isopropyl alcohol followed by wiping with dry clean lint free cloth.
3.2.24 Clean with the help of dry clean lint free cloth the upper pressure assembly, turret cover, top and bottom side of the machine and acrylic safety guards followed by cleaning with wet lint free cloth dipped in purified water. Clean the same with dry lint free cloth.
3.2.25 Open the side guards of the machine and clean the bottom side of the machine to remove the adhered powder dust with the help of vacuum cleaner.
3.2.26 Check the bottom floor below the machine and remove and clean any left over of the previous product.
3.2.27 Check and ensure that difficult to clean parts, grub screws, are free from any
accumulated powder dust. Remove it with the help of fine pointed needle and wipe with dry lint free cloth.
3.2.28 Clean the motor cover, the variable pulley cover, clutch drive, front operating panel and clean them using clean soft dry cloth.
3.2.29 Bring the punches and dies of the specified size and shape as mentioned in the Batch Manufacturing Record (BMR).
3.2.30 Clean the dies and punches with a lint free cloth followed by wiping with lint free cloth dipped in 70% Isopropyl alcohol.
3.2.31 Place the dies one after another in to the die pockets, initially press with thumb and finally fix them using tommy till the upper surface of the dies flushes with turret surface.
3.2.32 Tight the die screw properly.
3.2.33 Remove the punch-inserting block, rotate the turret slowly with the help of hand wheel so the punch guide hole is exactly aligned above the punch-loading hole.
3.2.34 Insert the lower punch into the guide hole. Push the punch to its highest position and ensure it drops freely under its own weight. Insert the nylon plug into the lower punch-locking hole and fix the anti turning spring strip. Carefully rotate the turret and fix the remaining lower punches in the same way.
3.2.35 Fix both the feed frames and hoppers properly and connect the dust extraction ports.
3.2.36 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.2.37 Fill the Equipment Cleaning checklist
3.2.38 Enter the details in the ‘Equipment usage log’

5 comments:

manoj said...

Upon reading sop guideline about 'Cleaning of compression machine( 27 station )' it is found fruitful to us. We have small pharma plant at Vapi and would like to have further assistance of your faculty to guide. As we want to face WHO audit, prompt reply from your faculty is appriciated.
Thanks,
manoj.dorlikar@gmail.com

snehal said...

ur guideline for cleaning is very useful to us. I m M.Pharm student.Can you provide SOP for cleaning validation of the same.

abhishikth said...

the information which you provide is very useful and one can easily understand. Thank you

bhavdip said...

DIESEL CAN BE USED INSTEAD OF IPA?

balasaheb jadhav said...

i think, punches and dies cleaning after use we can use 0.1% teepol solution with hot purified water for 2 to 3 times. and also disinfectant can be done 70% IPA.