| Department | Manufacturing | Document no | MAN-095 | ||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Operations Manager
Affected Parties
All Packing operation’s colleagues
Purpose
To describe the method for checking the effectiveness of seals in Blister Packs, Blister-Packed Tablets manufactured in Sydco tablet packing lines.
Scope
The procedure set out in this SOP is to be followed by all Authorised Persons (Operators) when carrying out a Blue Dye Test or preparing the Blue Dye Solution.
Definition
| N/A |
Related Documents
| Form-175 | Vacuum Leak Test – Hourly Form |
| Form-180 | Vacuum Leak Test – New Foil and PVC Roll |
| MAN-010 | Cleaning Responsibilities and Methods for Employees |
| MAN-080 | Example-Manufacturing Instruction for Tablet Packing |
EHS Statement
Safety Glasses and gloves must be worn at all times when testing is done and preparing the Blue Dye Solution.
Inspect the plastic vacuum vessel for cracks prior to use, as a faulty vessel can be dangerous. If the equipment is cracked – do not use it.
Safety Glasses must be worn during the testing of product.
Procedure
1. Leak Test frequency
1.1. For Blister Pack Tablets
Vacuum Leak test of tablet blister packs are to be done at the time of start-up and after maintenance, after changing either lidding or base foil or PVC. VLT to be done on every hour while the machine is running unless otherwise directed by the area Manager to increase the amount of Blister Leak tests. See Form-175 and Form-180.
8 blisters should be leak tested from the shipper which is being packed. These must be the top 4 packs of a bundle to ensure consecutive blisters are taken. The blisters are taken to check that no damage has been done to them during carton loading or while packing in the shipper. Test pressure will be -60 Kpa for 60 seconds.
2.1. Using Desiccator
2.1.1. Place the packs or blisters to be leak tested into the Desiccator containing a Blue Dye solution. Place a wire mesh and a weight on top of the packs ensuring the Blue Dye solution covers the packs. Slide the lid onto the Desiccator.
2.1.2. Turn Vacuum valve “on” of the Leak Tester and ensure Vacuum Regulator valve is fully open.
2.1.3. Close the Vacuum Release valve on the Desiccator.
2.1.4. Use the Regulating valve to adjust the vacuum until the gauge reads minus 60 kPa by slowly closing the Vacuum Regulator valve.
2.1.5. When the correct pressure is reached, maintain for exposure time for 60 seconds, look for telltale bubble flows in the Desiccator, which may indicate leakers.
Turn “OFF” Vacuum valve and fully open the Vacuum Regulator. Release the vacuum on the Desiccator. Turn “OFF” the Vacuum pump.
DO NOT REMOVE SAMPLES YET.
Wait for another 60 seconds as recovery time to allow Blue Dye to enter faulty containers.
Figure: 1 Vacuum Leak Test Apparatus
2.2. Takes samples out and rinse with water.
2.3. Visually inspect each blister and check that none contains Blue dye.
For non-clear tablet blisters, thoroughly dry the external face of the blister with an absorbent cloth, then pop each tablet out and inspect both the tablet and the pocket.
2.4. If there is a Leak Test failure, re-sample and re-test. If further failures occur, stop filling and immediately notify the Fitter and Manager. The product that has gone through up to the point of the last check should be reworked to check for other possible failures.
Note: Blistered products produced with bad blisters are reworked.
2.5. Enter the Leak Test results in the space provided on the Batch Documentation as appropriate. (See SOP MAN-080; Form-175; Form-180)
Notes:
Change the Blue Dye solution for the Desiccator whenever the solution level is too low to carry out a test, or when the solution is dirty.
If the equipment is cracked or faulty, DO NOT USE and notify the Area Manager.
Upon completion of this testing, all product used is to be rejected and disposed of according to SOP MAN-010
A faulty/cracked Vacuum vessel is very dangerous.
3. Preparation of Blue Dye Solution
Place 5mL of 25% commercial Blue Dye into a beaker and dilute with water to 3 litres. Mix and pour into the Desiccator. Do not overfill as this may cause damage to the Vacuum pump during operation. Allow enough gap between the liquid height when covering the product and the Vacuum hose connection point.
4. Summary of Changes
| Version # | Revision History |
| MAN-095 | New |