1.0 Objective: To describe the procedure for operation and cleaning of tablet compression machine
2.0 Scope: This procedure is applicable to compression machine
3.0 Responsibility: Operator / Production Officer / Executive
4.0 Accountability: Department Head shall be accountable for the compliance of the system.
5.0 Procedure:
5.1 Operation:
5.1.1 Check the cleanliness of the machine as well as the area. There should not be any remainants of the previous product.
5.1.2 Check and ensure that all the parts which were dismantled from the machine for cleaning are fitted properly.
5.1.3 Ensure that punches are free in punch guide and upper punches drop under their own weight.
5.1.4 Ensure that punches are freely moving through the cam track by rotating the hand wheel.
5.1.5 Switch on the main power supply to the machine.
5.1.6 Set the suction nozzles of dust extractor after feed frame of each part.
5.1.7 Keep the pressure and weight adjustment at its lowest position.
5.1.8 Set the feed frame of both the side so that punch tips must not touch to it.
5.1.9 Set the hopper of both the side of the machine.
5.1.10 Set the tablet dedusting machine to the both side of chute followed by a tablet collecting drum to both the side, affix container label on it.
5.1.11 Fill hopper with blend from the drum by SS scoop.
5.1.12 Rotate manually by rotating the wheel for one complete round. Discard the first round tablets as reprocessible recovery tablet.
5.1.13 Switch “ON” the main switch.
5.1.14 Press start button and disengage the clutch to run the machine.
5.1.15 Use food grade oil for lubrication of punches interminently whenever required.
5.1.16 Adjust the weight of tablet by rotating the adjusting dial located on front middle of machine. Clockwise rotation increase tablet weight and vice versa as mentioned in batch manufacturing record.
5.1.17 Adjust the tablet thickness using the tablet thickness adjusting dial located at the front left hand side of the machine. Tablet thickness decreases by rotating the dial clockwise & vice versa as mentioned in batch manufacturing record.
5.1.18 Record the weight & other parameters like friability, thickness and hardness as per the frequency mentioned in the Batch Manufacturing Record.
5.1.19 After completion of the compression, switch off the main power supply of the compression machine.
5.1.20 Record the details in the Logbook.
5.2 Cleaning: [For Batch Change]
5.2.1 Switch off the main power supply.
5.2.2 Clean the internal and external surface of the compression machine to the maximum possible extent in order to remove residue of previous batch with the designated vacuum cleaner.
5.2.3 Wipe all the contact parts of the machine with a clean dry lint free cloth till no visible residue of the previous batch remains.
5.2.4 Clean the tips of the punches using clean dry lint free cloth.
5.2.5 Open the cover of deduster, remove all the product remnants and clean using clean dry lint free cloth.
5.2.6 Check that there is no previous product remainants left inside chutes.
5.2.7 Clean the surrounding area.
5.2.8 Record the activity in logbook.
5.3 Cleaning:[For Product Change]
5.3.1 Switch off the main power supply.
5.3.2 Clean the internal and external surface of the compression machine to the maximum possible extent in order to remove residue of previous product with the designated vacuum cleaner.
5.3.3 Dismantle the deduster and transfer it to washing area.
5.3.4 Dismantle the parts like chutes, hoppers, suction nozzles, feed frames, scrappers, turret covers, side guards and suction nozzles of the compression machine.
5.3.5 Put all the parts in polybag, affix “TO BE CLEANED” label and transfer to washing area through trolley.
5.3.6 Remove the flight control plate and the upper punches one by one by rotating hand wheel manually and collect all the punches in die punch trolley.
5.3.7 Unscrew the die locks with the help of Allen key and press the dies with the help of die bar and remove all the dies and collect in the die punch trolley.
5.3.8 Remove the lower punch guide plug and remove all the lower punches and collect it in the die punch trolley.
5.3.9 Clean the shank holes of upper punch, lower punch and dies with the help of nylon brush soaked in isopropyl alcohol, ensure perfect cleaning of the corners of the dies seat to remove the traces of the powder and solvent use clean lint free cloth.
5.3.10 Wipe out the total body of the machine with the help of lint free cloth soaked in isopropyl alcohol.
5.3.11 Wash the chutes, hoppers, feed frames, suction nozzles and other parts with purified water using nylon brush till no visible residue of the previous product remains.
5.3.12 Dry the hopper, delivery chutes, feeding chute with clean dry lint free cloth.
5.3.13 Transfer these parts in polybag and affix “Cleaned Label” on it. Keep this bag on pallet and store it in cleaned equipment area of washing area.
5.3.14 Clean the guards with lint free cloth soaked in isopropyl alcohol and followed by dry lint free cloth.
5.3.15 Clean the punches and dies using an Isopropyl Alcohol.
5.3.16 Apply a smear of food grade oil on the punches and dies and store them in their defined place.
5.3.17 Affix “CLEANED” label.
5.3.18 Enter the details in the Logbook.
5.4 Cleaning at the End of Shift :
5.4.1 Switch off the power supply.
5.4.2 Ensure that the safety guards are closed.
5.4.3 Clean the out side of the machine parts and control panel with dry lint free cloth.
5.4.4 Clean the surrounding area.
5.5 Assembling:
5.5.1 Bring the cleaned die-punch in S.S. trolley Set as mentioned in the batch manufacturing Record to the machine cubicle.
5.5.2 Fix the die by tightening the die lock and repeat the procedure for all the dies.
5.5.3 Fix the upper punches through the upper punch guiding holes and if the shape of the punch is other than round shape, match the tip of the punch with the die before locking the die locks.
5.5.4 Uncover the front guard and open the plug on the lower side of the rotor plate.
5.5.5 Slide the lower punch through the lower punch-guiding hole and fix into the die.
5.5.6 Fasten the anti turning strip and repeat the procedure for all the lower punches.
5.5.7 Rotate the flywheel manually to ensure free rotation.
5.5.8 Bring the cleaned dismantled parts from washing area to cubicle on pallet.
5.5.9 Fix the side guard, feed frame etc. to the machine.
5.5.10 Fix the hopper and the tablet delivery chutes.
5.5.11 Bring the deduster in the cubicle and set it under the delivery chute.
6.0 Abbreviations:
| Abbreviation | Expanded Form |
| SOP | Standard Operating Procedure |
| PR | Production |
| QA | Quality Assurance |
| SS | Stainless Steel |
l
7.0 Forms and Attachments:
Annexure – 1: Equipment Log Book
8.0 Distribution List:
| S. No. | Department Name | No. of Copy |
| 1. | Quality Assurance | 01 |
| 2. | Production | 01 |
9.0 References:
In – House
Annexure – 1
| Department: | Page No.: |
| Name of Equipment | Equipment ID No.: |
Equipment Usage Log Book
| S. No. | Date | Product Name | B. No. | B. Size | Operation Time | Cleaning
Time |
Done By | Ckd. By | Brk. Down Time | Done By | Remarks | |||
