Cleaning and Operation of Tablet Counter Machine

 In this post Standard Operating Procedure Cleaning and Operation of Tablet Counter Machine in Pharmaceuticals is describe.

1.0  OBJECTIVE:

To lay down a procedure for cleaning and Operation of Tablet Counter Machine.

2.0  SCOPE:

This procedure is applicable to the cleaning and operation of Tablet Counter Machine in production 

area.

3.0  RESPONSIBILITY:

Technical Associate: Cleaning and Operation Officer and Executive: Supervision

Head Production: SOP compliance IPQA Person: Line Clearance

4.0  DEFINITION (S):

NA

5.0  PROCEDURE:

5.1  CLEANING:

This is a cleaning procedure applicable for cleaning after completion of every batch/or any maintenance activity.

5.1.1  Ensure that the tablet counter machine is switched off.

5.1.2  Replace “UNDER PROCESS” label with “TO BE CLEANED” status label with date and signature of production officer.

5.1.3  Dry clean the tablet counter machine body, control panel and utility cables using a dry lint free duster.

5.1.4  Remove the hopper and clean it by using a dry lint free duster.

5.1.5  Remove the vibration plate by unscrewing the bolts. Clean the inner part of the powder collection port by using dry lint free duster.

5.1.6  Clean the tablet rotating disc and outer side of machine by using dry lint free duster.

5.1.7  Wipe the all the dismantled parts of machine with 70% v/v IPA followed by clean dry lint free cloth.

5.1.8  Assemble the dismantled parts of the Tablet Counter Machine.

5.1.9  Replace the “TO BE CLEANED” status label with “CLEANED” status label with date and signature of production officer.

5.1.10  If the same product is proceeds for more than one week, then follow the procedure of cleaning as per SOP.

5.1.11  Record the cleaning activity in equipment usage log book as per SOP.

5.1.12   Cleaning is idle for 72 hours, if machine is not used with in 72 hours clean the machine “before use” with lint free duster dipped in 70%v/v IPA solution followed by dry lint free duster and mention the 70% v/v IPA cleaning on the previous “CLEANED” label attached on the machine. And 

record the activity in equipment usage log sheet as per SOP.

5.2  PRECAUTIONS:

5.2.1  Don’t keep the excess tablets in rotating plate.

5.3  OPERATION:

5.3.1  Replace “CLEANED” label with “UNDER PROCESS” status label with date and signature of Production Officer.

5.3.2  Enter the start time in the equipment usage log sheet as per SOP.

5.3.3  Switch “ON” the mains from electrical panel.

5.3.4  Adjust batch counter to fill the required quantity of tablets in container/Triple laminated pouch.

5.3.5  Adjust the width of deflector according to the size of tablet by putting a tablet in to the guide.

5.3.6  Adjust tablet deflector with bottom gap allowing only one tablet to pack.

5.3.7  Adjust outlet of guide set to middle of photocell so that the tablet can be correct counted.

5.3.8  Pour the tablets in to the hopper.

5.3.9  Turn rotary adjuster and vibrant speed adjuster to zero.

5.3.10  Keep two containers/ triple laminated pouches properly under discharge chute.

5.3.11  Turn the rotary adjuster to adjust the speed 2.0 to 6.0.

5.3.12  Adjust the feeding gate to proper position.

5.3.13  Turn the vibrant speed adjuster to proper feeding speed.

5.3.14  Transfer the tablets from container to LDPE polybag / triple laminated bag and pack as per BPR.

5.3.15  After completion of batch enter the completion time in the equipment usage log sheet as per SOP.

5.4.16   Put the “TO BE CLEANED” label dully filled and signed with production officer.

6.0  ABBREVIATION (S):

QA : Quality Assurance

SOP : Standard Operating Procedure v/v : Volume/Volume

LDPE : Low Density Polyethylene

7.0  RERERENCE (S):

Nil

8.0  ANNEXURE (S):

Nil

9.0  DISTRIBUTION:

Master Copy    : Quality Assurance

Controlled copy (S) : Production department, Quality Assurance

Reference copy (S) : Production department