Table of Contents
1.0 OBJECTIVE:-
1.1 To maintain the equipment tidy and clean.
2.0 SCOPE: –
2.1 To prevent cross contamination between different products. To ensure error free operation of the machine. This procedure is applicable for Cleaning & operation compression machine (27 station ).
3.0 RESPONSIBILITY:-
3.1 Execution: operator
3.2 Production officer
4.0 ACCOUNTABILITY :-
4.1 Head of Department
5.0 Procedure compression machine
5.1 : Procedure of cleaning compression machine
5.1.1 Remove “TO BE CLEANED” tag from equipment.
5.1.2 Switch “OFF” the electric supply to the machine & remove plug.
5.1.3 Remove hoppers, feed-frame and worm-guard from the machine.
5.1.4 Loosen ant turning stick and plugs by rotating the screws anticlockwise using a screw driver.
5.1.5 Remove upper punches, lower punches and dies from the turret and keep it a side in punch handling trolley for cleaning as per respective SOP.
5.1.6 Keep all the removed parts in Stainless Steel/plastic container, take it to the washing area and clean it as per respective SOP.
5.1.7 Keep all the cleaned parts in the special SS container and bring it to compression area.
5.1.8 Clean turret, Die holes and worm-teeth with appropriate nylon fiber brush applying Isopropyl alcohol until the adhered mass is removed.
5.1.9 Clean the bottom part (Below the turret) of machine with dry cloth and mop with Isopropyl alcohol to remove powder.
5.1.10 Set cleaning parts on the machines in the reverse order of dismantling.
5.1.11 First clean surrounding area of the machine with dry mopping and then clean with 0.2% Teepol solution.
5.1.12 Record the data in machine cleaning record.(Annex.No.1 of this SOP)
5.1.13 Affix a “CLEANED” tag on the machine.
5.1.14 FREQUENCY : Product to product changes over & batch to batch cleaning.
5.1.15 PRECAUTION: Do not switch “ON” the machine until complete evaporation of Isopropyl Alcohol.
5.2 Procedure of Operation of compression machine
5.2.1 Cleaning the machine and surrounding area as per as per respective SOP and set the dies and punches according to the product which is being compressed in tablet production department.
5.2.2 Affix the stage label
5.2.3 Take Line clearance from Q.A. Department as per respective SOP.
5.2.4 Load the granules in to both hoppers using clean SS scoop (Initially load app. 2 Kg granules in each hopper)
5.2.5 Operate machine manually 2 to 3 rounds to ensure correct setting in areas.
5.2.6 Set “Tablet De dusting Unit” below the tablet delivering chute.
5.2.7 After setting, switch “ON” the machine and collect the tablet from both sides by inching the machine and giving pressure gradually.
5.2.8 Set the in process parameters according to product in-process specification (Average weight, Disintegration tests, hardness, Friability, thickness) mentioned into the respective products Batch Manufacturing record.
5.2.9 After setting the in process parameters give the intimation to Q.A. department for checking the physical parameters of that product.
5.2.10 After approval of Q.A. Dept. set the counter to zero.
5.2.11 Load the granules in both hoppers fully, close the lid as well as also close the compression platform.
5.2.12 Ensure that the oil cups are filled with food grade edible lubrication oil in machine.
5.2.13 Collect the tablet in clean plastic container lined with single poly bag use the double poly bags in case of hygroscopic products
5.2.14 Affix container label on each container in prescribed format.
5.2.15 Record the in-process parameters according to the frequency given in Batch Manufacturing
5.2.16 Record and fill the Temperature and RH readings as per the frequency given in BPR.
5.2.17 Cover the tablet’s container with lid and keep it on a pallet
5.2.18 Weigh the container on calibrated electronic platform balance and note it on to the container label and in the BPR.
5.2.19 Keep the containers in the unchecked quarantine room.
5.2.20 Keep machine setting and in process parameter setting tablets in a separate container with proper identification as recoverable rejected tablets.
5.2.21 Affix a “TO BE CLEANED” tag/label on machine.
6.0 ABBREVIATIONS:
6.1 EFF. : Effective
6.2 SOP : Standard Operating Procedure
6.3 Mfg. : Manufacturing