UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA

COLLEGE OF PHARMACY

EXERCISE NO.11
Name : UNLAYAO, DIANA MAE
LEAKER’S TEST Date :______________________
Rating :______________________

I. Objective
To acquaint the students with the basic skill in pharmaceutical analysis through leaker’s
test in finished product dosage form

II. Pre-Laboratory Discussion

Leaker’s test

III. Materials
Sealed 3 bottles of 30mL paracetamol syrup or any liquid solution whose cap seals are
not yet opened.

IV. Procedure
1. Select at least 3 bottles of sealed 30mL paracetamol syrup or any liquid solution
whose cap seals are not yet opened.
2. Place them in inverted position for 60 minutes and observed any leakage around the
sealed cap.
See pictures below
or

PHARMACEUTICAL ANALYSIS 2
 UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA
COLLEGE OF PHARMACY

V. Answer the following questions.

A. Give other methods of leaker’s test.

Leak testers are also used to test the integrity of the blister packs, packed strips,
small sachets containing tablets, liquids and so on. In addition to package testing,
time and money can be lost if product is manufactured while there is a leak or
occlusion in the process equipment such as a production pipe. 

1. Vacuum leak method- this method of leak test of the colored vial in
pharmaceutical manufacturing usually used for pharmaceutical blister packaging. It
uses methylene blue dye or another colored chemical liquid to determine whether
there is a leak or not. The test is done by placing the pack of blister into a container
of vacuum leak detector which has been filled with methylene blue dye mixed with
water. Suppose there is a leakage, the liquid will seep into the blister package
thereby giving visual proof.

2. Automated vacuum leakage method - this is usually used for vial, blisters and
ampoules. When conducting a leak test of the colored vial in pharmaceutical
manufacturing, a vacuum chamber is filled with water after which a blue dye is
added. Thereafter, the package is submerged in the chamber and then the chamber
is closed by a lid.

The test begins by creating a vacuum inside the chamber, the packs remain in the
methylene blue dye under atmospheric pressure for a specific period of time. After
the chamber is vented, if there is a leakage in the package, the dye filled with water
will penetrate the specific cell. When the test is concluded, the inspection of the
blister pack will immediately produce a visual result and the result can be exported
to a printer or a PC.

3. Internal pressure method - this method is typically used for larger flexible or
semi-rigid packages such as bottles, bags, containers, or tubes among many other.
It uses a hermetically-sealed septum or package adopter, which is adhered onto the
package and a probe that is used to insert the air.

PHARMACEUTICAL ANALYSIS 2
 UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA
COLLEGE OF PHARMACY

B. Is leakage in seal or caps form a critical defect? Explain your

answer.

Having a defect in a packaging affects mainly the quality of the product.

It is important that care should be taken to avoid it. A leakage in seal or
caps is a form a critical defect because it prevents the package doing its
main function, which is to protect its content that may cause safety
hazards in handling, use or disposal. A container should be rejected if
there is a critical defect.

I. DATA AND RESULTS:

LIQUID SOLUTION

Brandname: Yakult Manufacturer: Yakult Philippines Incorporated

Lot No. DRP-670 Batch No. I2058
Expiry date: January 07, 2021 Manufactured date: November 23, 2020

Number of trials
Bottle No. 1 2 3
1 60 minutes 60 minutes 60 minutes
2 60 minutes 60 minutes 60 minutes
3 60 minutes 60 minutes 60 minutes
Disposition Passed Passed Passed

REFERENCES:

https://www.pharmaguideline.com/2017/10/leak-detection-of-colored-vials.html

https://www.slideshare.net/radhipatel05/defect-of-packaging

II. Lab Performance :

PHARMACEUTICAL ANALYSIS 2
 UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA
COLLEGE OF PHARMACY

Performance Criteria Student’s Score Instructor’s Score

Punctuality in Lab
2 - Came to class on time
1- Came to class after 10 minutes
0 - Absent in class
Proper Lab Attire during class
2 - Wears complete and proper lab attire
1 - Is not wearing the complete lab attire
0 - Wears no lab attire during class
Preparation of Materials
2 - Prepare the materials needed
1 - Present but did not prepared the materials needed
0 – Did not prepare at all
Performance of the Exercise
2 – Performs the exercise correctly and properly
1 – Did not perform the exercise correctly and properly
0 – Did not perform the exercise at all
Clean-up
2 – Performed clean-up of materials and work area
after the exercise
1 – Present but did not clean the materials and work
area after the exercise
0 – Did not clean at all
TOTAL (100%)
Lab Instructor’s Signature
Legend: 2 = 20%, 1 = 10%,

http://www.tmelectronics.com/industries-and-applications/pharmaceutical-leak-flow-
testers.cfm#:~:text=Leak%20testers%20are%20also%20used,such%20as%20a%20production%20pipe.

PHARMACEUTICAL ANALYSIS 2