MAN-115 Machine Start up Challenges and In-Process Testing Procedures

1. Overview

This SOP explains the procedure for all Start-Up and In-Process Tests required to be conducted by Production Operators in the Tablet areas.  You WILL NOT use all of these tests for a batch.  The MI Sheet will guide you through which needs to be done for a batch.

2. Operators Names in MI Sheet Logbook

At the start of the shift, or at the start of a batch, operators are to enter their initials into the table provided in the MI sheet Logbook.  The table format is as follows:

a. Time/Date:   Time date must be in the format hh.mm/dd.mm.yyyy

b. Initial:          Initials of all operators come in contact with this BPN.

c. Work title:    e.g. Operator, Dispenser etc.

If operators are attending the line to cover breaks, it is to be noted they were on the line by entering their name in the table in the MI sheet Logbook.

This applies to ALL tablet lines and is required for traceability purposes.

The Maintenance System is utilised to ensure, that if any work by maintenance staff is performed on the line, that the type of work, time and date will be recorded.

3. Tablet Sampling

Please refer to SOP WAR-080 for the procedure on tablet sampling.

4 Machine Line Opening Challenges and In-process Checks

A. Protruding Product Sensor Test (see Part C of topic 1)

This test is performed at the start of every batch.

Procedure

Operator will rotate one tablet from its blister pocket so that protrudes from its pocket and start the machine. The tablet should be detected and the machine should stop. Again place on tablet on the web, not in a pocket and start the machine. The tablet should be detected and the machine should stop. If any of these tests fails, operator should readjust the Protruding Product sensor (item18) and repeat the test.

B. Pin Hole Detector Test (Part B of topic 1)

The Pin Hole Detector (item 13) is only used for Aluminum base foil.  It is designed to detect if the cold forming of the blister pockets has created a hole or crack greater than 100 microns, which may limit the life of the product to be packed inside the blister.  This test should be done at the start of each batch.

Procedure

Operator will use an acupuncture needle to create a hole in the base aluminum foil.  Repeat making holes in different locations on the blister web.  Mark the base foil to indicate the locations of the holes.

When these blisters will pass the Pin Hole sensor, the machine will reject the marked blisters and stop. If the test fails, operator should readjust the sensor and repeat the test.

C. Vision Camera System Challenge (see Part C, item 19 of topic 1, for missing, broken or rouge tablets)

The purpose of this test is to validate the Vision system that it is working correctly. This test is performed at the start of every batch, start of day, and every time the vision system is re-learnt.

Procedure

Start to make up a blister set with missing tablets like Set 1 in Figure 3.1, the next set of blisters   should have full blisters, the last set of blisters will have broken tablets like Set 2 in Figure 3.1

Let the blister run under the vision system. The first and the last set (set 1 & 2) of blisters should be rejected.  The middle set should be passed onto the carton conveyor. If this test fails investigate the system.

Figure: 1 Vision Camera System Challenge

D. Vacuum Leak Test

Vacuum Leak test of tablet blister packs should to be done at the time of start-up and after maintenance, after changing either lid or base foil and on every hour while the machine is running for a batch production.

Procedure

Place the packs or blisters to be leak tested into the Desiccator containing a Red or Blue Dye solution.  Place a wire mesh and a weight on top of the packs/blisters ensuring the dye solution covers the packs.  Slide the lid onto the Desiccator.

Turn Vacuum valve “on” of the Leak Tester and ensure Vacuum Regulator valve is fully open. Close the Vacuum Release valve on the Desiccator. Use the Regulating valve to adjust the vacuum until the gauge reads minus 60 KPa by slowly closing the Vacuum Regulator valve.

Figure: 2 Vacuum Leak Test Apparatus

When the correct pressure is reached, maintain for exposure time for 60 seconds, look for telltale bubble flows in the Desiccator, which may indicate leaks.

Turn “OFF” Vacuum valve and fully open the Vacuum Regulator.  Release the vacuum on the Desiccator.  Turn “OFF” the Vacuum pump. Wait for another 60 seconds as recovery time to allow dye to enter into faulty blisters/packs.

Takes samples out and rinse with water. Visually inspect each blister and check that none contains dye.

If there is a Leak Test failure, re-sample and re-test.  If further failures occur, stop filling and investigate.

E. Barcode Sensor Test for Cartons and Leaflets (Part G of topic 1)

The Code Sensor (item 36) operates by using optical scanning heads that translate a printed signal (a bar code) into a series of electronic signals.  These signals are compared with the Reference Code or commonly called “Pharmacode” loaded into the Code Reader. If an incorrect bar code is encountered, the carton will be rejected.

Figure: 3 Typical Bar Code

Procedure

The optical scanning head must be focused so that it is able to distinguish the code. Barcode reader should be challenged at the start of the operation and after any maintenance operation is done on the sensor.

Modify a bar code by changing a thin bar to a thick bar or add a bar by using a Blue or Black pen.  Clearly mark “Reject” on the carton. Place the modified bar code in the in-feed magazine (item 32 of Part G) within the first three cartons or leaflets. Start the machine, allow the modified bar code to pass under the sensor (item 36) and allow the carton/Leaflet to be rejected. The component with the faulty bar code should be rejected.

If the bar code reader fails the challenge, investigate if the bar code has been entered correctly or the led sensor has been set-up correctly. Repeat the test.

F. Print Presence Sensor Test for Variable data on Carton (item 38 of part G)

The Print Presence Sensor (item 38) operates by comparing the variable data entered into it as a program with the variable data coded on the carton, using an optical scanning head. If an incorrect or missing data is encountered, the carton will be rejected. This challenge is to be done before the batch start and once a day while the machine is running.

Procedure

Operator has to remove the coding Block (item 37 of part G).  Start the machine and run two un-coded cartons through the sensor and record that the machine rejects the cartons.  On completion of the test, reset the coding block on the line and confirm a good coded carton is accepted by the sensor. In case of a fail test, investigate and repeat the test.

G. Checkweigher Challenge (Part H)

The Checkweigher is used to detect finished cartons having under or over weight due to missing or extra component in the carton. So the cartons can be rejected before further processing.

This is to be performed at the start of each batch.

Procedure

Produce a schedule to add the average weight of each component required to make the finished carton. For instance, if a finished carton will contain one tablet filled blister, one leaflet and the carton itself, than take ten of each component and determine the average weight. This can be done using calibrated Laboratory scales.  Add the average weights together to get the average weight of one finished carton. Determine a limit by using + 2% of the average weight. Ensure that this fractional weight must be less than the average of each component. Program the checkweigher by using the weight range.

Run a set of faulty product through the Checkweigher one at each time. For example,

A full carton, less one blister

A full carton with one extra blister

A full carton, less one leaflet

A full carton with one extra leaflet

Ensure that on each occasion the carton is correctly rejected. In case of a fail test, investigate and repeat the test.

H. Blister Appearance and Correct Information Check

This is an in-process check and should be carried out by the blister process operators in every half an hour. The purpose of this check is to make sure that all blisters have correctly embossed data and printed information.

Procedure

Collect one blister from the blister conveyor line as shown in picture Part F and open two packs from the stretch bender as shown in the picture Part I.

Figure

Check for the following on the blister:

Correct print registration

Correct and legible batch number

Correct and legible Expiry date

General appearance (i.e. good, bad, stretched foil, pinch mark of the foil or printed side of the foil)

All empty inspected blisters should be rejected and filled blisters should be de-blistered to recover the tablets. For any non conformance investigate immediately.

I. Carton Coding Appearance and Correct Information

This is an in-process check and should be carried out by the packing process operators in every half an hour. The purpose of this check is to make sure that all cartons have correctly embossed data and printed information.

Procedure

Collect one bundle of cartons from the stretch bender as shown in the picture Part I.

 Figure

Check selected bundle for:

Correct and legible batch number and expiry date embossed on the carton.

Cartons folder neatly with no creases or dents and facing the same way

Correct number of cartons in bundle

Possible damage may be pinholes in foil side of blister.

Crushed blisters

Some Examples of Opening Components for Tablet Packing Line

5. Leak Test or Vacuum Leak Test

Which lines conduct this test?	All Tablet packing lines.
How often is the test conducted?	See SOP MAN-095.
Where are the results recorded?	In the relevant batch documentation (MI sheet). One table for entering hourly VLT results. Another table for New foil and PVC rolls.
How do I do it?	See SOP MAN-095.
What do I do if Leak test fails?	See SOP MAN-095.
What do I do with all In-Process Samples after testing?	All empty cartons are to be rejected. Blisters are to be rejected.

6. Humidity Temperature Test

How often is the test conducted?	At the start of batch and every four (4) hours.
Where are the results recorded?	In the relevant batch documentation (MI sheet).
How do I do it?	Use the Standard calibrated Aspirated Psychrometer
What do I do if test fails?	Re-test again.  If humidity is still out of parameters, stop the line and consult Manager.

7. Blister Appearance and Correct Information

Which lines conduct this test?	All tablet packing line
How often is the test conducted?	Every half hour. NOTE: Operators should check Appearance/Quality every 5 minutes but only record results every half hour.
Where are the results recorded?	Relevant batch documentation (MI sheet).
How do I do it?	1.     Select one blister from each of the three or four lanes and 2 packs from after the End of Process. 2.     Check selected blisters for: ·         Correct print registration ·         Correct BPN ·         Correct Expiry date ·         General appearance ·         Perforation (if applicable) Tear test.
What do I do if appearance of information is incorrect?	Immediately stop the line.  Contact Fitter to rectify problem and inspect finished goods to make sure no reject blisters have been packed. Refer to relevant QA personnel to decide if a rework is necessary.
What Do I do with all In-Process Samples after testing	All empty cartons are to be rejected. Blisters are to be De-blistered.

8. Carton Coding Appearance and Correct Information

Which lines conduct this test?	All tablet packing line
How often is the test conducted?	Every half hour. NOTE: Operators should check Appearance/Quality every 5 minutes but only record results every half hour.
Where are the results recorded?	In the relevant batch documentation (MI sheet).
How do I do it? Leak Test Samples: Take the top two (2) cartons from a carton bundle. These must be checked for damage during cartoning.	1.     Select one bundle of cartons. 2.     Check selected bundle for: ·         Correct BPN and expiry date ·         Cartons folder neatly with no creases or dents and facing the same way ·         Correct number of cartons in bundle ·           Possible damage may be pinholes in foil side of blister. ·           Crushed blisters.
What do I do if appearance or information is incorrect?	Immediately stop the line.  Contact Fitter to rectify problem and inspect finished goods to make sure no reject cartons are packed. Refer to relevant QA personnel to decide if a rework is necessary
What do I do with all In-Process Samples after testing?	All empty cartons are to be rejected. Blisters are to be De-blistered.

 

9. Print Presence Detector on Cartons

Which lines conduct this test?	All tablet packing line
How often is the test conducted?	Once a day or at Line Opening.
Where are the results recorded?	In the relevant batch documentation (MI sheet).
How do I do it?	Stop the line and remove the embossing roller (coding Block).  Start the machine and run two cartons through and record that the machine rejects the cartons.  On completion of the test replace the Embossing roller (coding block) and confirm a good code is being accepted.
What do I do if the Print Presence Detector is not working correctly?	Immediately stop the line.  Re-Test again.  If problems persist, contact Fitter to rectify problem.
What do I do with all Cartons after testing?	All empty cartons are to be rejected. Blisters are to be De-blistered.

10. Vision System Camera Test

Which lines conduct this test?	All tablet packing line
How often is the test conducted?	At the start of a new batch or start of each day batch is running
Where are the results recorded?	In the relevant batch documentation (MI Sheet)
How do I do it?	See SOP  MAN-075
What do I do if the Vision System is not adjusted correctly?	Immediately stop the line.  Contact Fitter to rectify problem and inspect finished goods to make sure no reject blisters are packed.
What do I do with all Vision System test samples after testing?	All blisters to be De-blistered.

11. Summary of Changes

Version #	Revision History
MAN-115	New