SOP Operation of compression machine 35 stations.
1. OBJECTIVE:1.1. Objective of this Standard Operating Procedure (SOP) is to give the procedures for Operation of compression machine 35 stations.
2. SCOPE
2.1. This SOP is applicable for operation of compression machine 35 stations with ID No.: P/PR/TC-35/001.
3. RESPONSIBILITY
3.1. Operator – Production shall responsible for operation of compression machine 35 stations.
3.2. Officer – Production / his or her designee shall be responsible for supervise the operation of compression machine 35 stations.
3.3. Officer – In Process Quality Assurance (IPQA) / his or her designee shall be responsible for verification of operation of compression machine 35 stations.
4. PROCEDURE
4.1. Check the status label and ensure the 35 station tablet compression machine is clean.
4.2. Update the status label by entering details of product being processed.
4.3. Obtain the area line clearance from Quality assurance person and subsequently record the details in Batch Manufacturing Record (BMR).
4.4. Setting of machine:
4.3.1 Close the safety guards of machine and rotate turret by using hand wheel to ensure that all moving parts of machine are free.
4.3.2 The turret must not be rotated backwards when tooling is in position, otherwise punches and cam may be damaged. Clockwise rotation of hand wheel rotates the turret in correct direction.
4.3.3 Take the punch set as per specified in respective Batch Manufacturing Record (BMR).
4.3.4 Wipe the punches and dies with lint free cloth.
4.3.5 Fitting of Dies:
4.4.1 Ensure that the machine turret die pockets are thoroughly cleaned.
4.4.2 Press the die down with fingers and ensure the die is accurately located in the pockets.
4.4.3 Once the die is located, enter the die bar through the upper punch guide hole and allow dropping on to the die face till the die fits in cavity, from a height of approximately 3 inches.
4.4.4 When the die is fitted correctly, the top face must be perfectly flush with the die table.
4.4.5 Fit the die screw in to the die screw holes with the dowel located in keyway of the die screw.
4.4.6 Note: No excessive force is used in tightening the die screws. Also die screws should be tightened after mounting all dies perfectly.
4.4.7 After tightening the die screw check that all top face of die has remained flush with die table.
4.3.6 Fitting of punches:
4.4.1 Slacken the screws retaining the anti-tuning springs before inserting the lower punches.
4.4.2 Insert lower punches one by one in its sockets on turret through a hole for lower punch insertion by rotating the hand wheel manually and close the hole with the help of plug provided.
4.4.3 Tight the lower punch slightly with Nylon plugs and Anti turning plates.
4.4.4 Place the feed-frame at the position and tight the screws.
4.4.5 Insert the upper punches in the guide hole and push the punch to its highest position and ensure its drops freely under its own weight.
4.4.6 Rotate the turret slowly with the help of detachable hand wheel so that the punch guide hole is exactly aligned above the punch loading port. Replace the punch loading plug and tighten the punch holding plug.
4.4.7 After setting of dies and punches rotate the turret by hand with the help of hand wheel to ensure smooth movement of the punches and dies.
4.4.8 Ensure that lower punch tip protrude only slightly above the top face of dies at ejection point, use ‘Pull down cam’ to adjust the same.
4.4.9 The lower face of the feed frame should be just clear of turret face and only scraper plate should be in actual contact.
4.4.10 The take off plate should be positioned to just clear the lower punch faces as they pass underneath.
4.3.7 Mount the hopper of machine at specified place and adjust the height properly with the help of hopper height adjusting screws and tight with the help of locking knob.
4.3.8 Adjust hopper in such way that it should deliver the lubricated granules to the front part of the feed frame for recirculation.
4.3.9 Load the lubricated granules manually or position the bin of lubricated granules over the compression machine by using elevator and open the valve of bin to fill the granules in hopper of machine.
4.3.10 Rotate turret manually with the help of hand wheel manually to fill the dies uniformly.
4.3.11 Observe that when die cavity reach at scraper plate the lower punches pass over the weight adjusting cam.
4.3.12 Scrapper plate shall scrap the excessive material and direct it to the inner part of the turret, then again to feed frame.
4.3.13 When material filled die comes under pressure wheel, increase the pressure on punches by rotating pressure adjusting hand wheel, clockwise to produce a tablet with desired hardness.
4.3.14 Adjust the pressure and weight as per requirement as follows;
4.4.1 To increase the pressure turn the pressure adjustment wheel clockwise.
4.4.2 To decrease the pressure turn the pressure adjustment wheel anticlockwise.
4.4.3 To increase the weight turns the weight adjusting cam anticlockwise.
4.4.4 To reduce the weight turns the weight adjusting cam clockwise.
4.3.15 Check the thickness and weight of tablets.
4.3.16 Tablets compressed during initial 2 rotations shall be rejected.
4.3.17 Make necessary adjustment for weight, pressure, hopper, blend level sensors and speed of machine so that physical parameters (i.e. appearance, weight, thickness, friability, hardness, disintegration time) of core tablets complies with limits present in Batch Manufacturing Record (BMR).
4.3.18 Check the physical parameters of tablets and record the same in BMR. All observed physical parameters of core tablets shall be complies with specification for the same mentioned in BMR.
4.3.19 Tablets compressed while initial setting shall be treated as rejected and destroyed before proceeding for the compression activity.
4.5. Operation:
4.4.1 After obtaining the parameters clearance from Quality Assurance person, compression activity should be started.
4.4.2 Engage the clutch of machine and continue the activity with set machine parameters.
4.4.3 Increase the speed to the output required. When output is increased or decreased compensating adjustments will have to be made to each weight control and material flow from each hopper.
4.4.4 Perform the In-process checks as per frequency defined in BMR and subsequently record the observations in respective BMR.
4.4.5 Collect the tablets polythene lined HDPE drum and label the drum properly.
4.4.6 After completion of compression activity update the status label as ‘To be cleaned’ on equipment status label, which is already affixed on machine.
4.4.7 Record details in the ‘Area use logbook’ (Format No.:PRP/F/008) and ‘Equipment use logbook’ (Format No.:PRP/F/001).
5. FREQUENCY
5.1. Operation: As and when required.
6. ACCEPTANCE CRITERIA
6.1. All physical parameters of compressed tablets should be complies the limit mentioned in BMR.
7. RELATED DOCUMENTS
7.1. Format No.:PRP/F/010: Section label
7.2. SOP No. SOP/PTN/PR/022: Issue, receipt, storage and destruction of tablets punches and dies.