5.3.1 Collect purified water and ensured it has <25 oC as it affects in the test.

5.3.2 Verify the physics conditions equip, if detect abnormalities inform to area
responsible.
5.3.3 Verify identification and cleaning of equip.
5.3.4 Verify the instruments of equip are calibrated actually, if not are
calibrated inform to validation department.
5.3.5 Record the use of equip in the log book. Indicate following information:
date, product name, batch packing, starting hour, activity, who realize and
process stage.
5.3.6 Prepare the 0.1% Methylene Blue solution enough to half-filled the
desiccator and cover the Nylamid plate.
5.3.7 Take the samples and check visually the strips/blisters/bottles and try to
detect problems of leaks and sealed.
5.3.8 Verify valve is open to apply vacuum.
5.3.9 Ensure the strips/blisters/bottles are submersed in the 0.1% Methylene
Blue solution.
5.3.10 Cover the desiccator it must not have leaks.
5.3.11 Apply vacuum 10mm Hg/second speed until 300 mm Hg of differential
pressure.
5.3.12 Once the differential pressure have been 300mm Hg close the valve to
prevent the increase of differential pressure.
5.3.13 Maintain the correct vacuum one minute and verify this time with the
timer.
5.3.14 When alarm activate to indicate the process end switch off equip.
5.3.15 Remove the valve plug to enter slowly air until equalizes pressure.
5.3.16 Put strips/blisters/bottles in a water filled tray to eliminate the
methylene blue excess.
5.3.17 Remove water excess of strips/ blisters/bottles with the wiper.
5.3.18 Log the process ending hour.
5.3.19 Check the presence of methylene blue on the product content in
strips/blisters/bottles tested in following way:

Blisters: if its possible check the content visually into blister if the product has
blue marks or wetness. If it is not possible see the product into blister open
pack to see the product and identify if the product has blue marks or wetness.
If it hasnt marks check the product present stickiness.
Bottles: If its possible check the content into the bottle blister if the product
has blue marks or wetness. If it is not possible see the product into blister open
pack to see the product and identify if the product has blue marks or wetness
(be careful to open the bottle to avoid a false-positive).
5.3.20 Test accomplish if any container hasnt penetration of methylene blue.
5.3.21 If any container has methylene blue penetration realize another
sampling of 150 units/dose and do again the test. The result o fail must be less
0.5%.
5.3.22 Record the results in the current format. Indicate the following
information: product name, batch packing, primary packaging, number of
pieces contented, date, samples number, hour of ending process, vacuum
applied, process time, results, who test, who verified, and number page.
Note: If primary packaging fails in leak test inform to production responsible in
case of test in conditioning stage and verify sealed conditions and material of
sealed. In case of test in stability test stage if primary packaging fails inform to
QA responsible.
Note 2: Its necessary check the results of test at the end of this in the moment
of eliminate the water excess with the wiper.
5.3.23 Put the capsules/tablets in a tray with water to dissolve and inactivate.
Add the inactivating solution according the active principle if test a cytotoxic
product.