Any pharmaceutical manufacturer who is concerned about the shelf-life and efficacy of the product they produce must make a leak test a mandatory part of the manufacturing process. Because anytime there is any sort of physical breach of the packaging structure, the integrity of the product is greatly compromised. By using a validatable leakage detection instrument, efficacy and safety of the product will not be negatively impacted.
This method of leak test of the colored vial in pharmaceutical manufacturing usually used for pharmaceutical blister packaging. This simple visual test is the oldest of the three testing methods. 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.
Advantages:
a) It is the least expensive process among the three.
b) It does not need major investment in equipment.
Disadvantages:
a) No validation
b) Destructive test
c) Involves manual documentation only which consumes a lot of time
d) Results generated are operator subjective
e) Not possible to determine quantifiable leak statistics
f) It is not suitable for pouches
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 operator then enters parameters for vacuum, test, and penetration time into a console. Alternatively, the parameters can be pulled from the previously stored, password protected database which actually minimizes human error.
The test begins by creating a vacuum inside the chamber. the packs remain in the methylene blue dye under atmospheric pressure. for a specific time. After the chamber is vented, if there is a leakage in the package, then the dye-filled 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 PC
Advantages:
a) Low price
b) Well defined method
c) Saves time and labor
d) Provides exact leakage detection data
Disadvantages:
a) Destructive test
b) Not suitable for products
Advantages:
a) It provides precise leak detention data
b) Results are not operator-oriented
c) Controlling pressure level is easier
d) Computer-based data analysis is possible
Disadvantages:
a) Destructive test
b) Not suitable for pharmaceutical blister packaging
1. Vacuum Leak Method:
This method of leak test of the colored vial in pharmaceutical manufacturing usually used for pharmaceutical blister packaging. This simple visual test is the oldest of the three testing methods. 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.Advantages:
a) It is the least expensive process among the three.
b) It does not need major investment in equipment.
Disadvantages:
a) No validation
b) Destructive test
c) Involves manual documentation only which consumes a lot of time
d) Results generated are operator subjective
e) Not possible to determine quantifiable leak statistics
f) It is not suitable for pouches
2. Automated Vacuum Leakage Method:
This method automates the classic methylene blue dye test and provides detailed documentation. It 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 operator then enters parameters for vacuum, test, and penetration time into a console. Alternatively, the parameters can be pulled from the previously stored, password protected database which actually minimizes human error.
The test begins by creating a vacuum inside the chamber. the packs remain in the methylene blue dye under atmospheric pressure. for a specific time. After the chamber is vented, if there is a leakage in the package, then the dye-filled 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 PC
Advantages:
a) Low price
b) Well defined method
c) Saves time and labor
d) Provides exact leakage detection data
Disadvantages:
a) Destructive test
b) Not suitable for products
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.Advantages:
a) It provides precise leak detention data
b) Results are not operator-oriented
c) Controlling pressure level is easier
d) Computer-based data analysis is possible
Disadvantages:
a) Destructive test
b) Not suitable for pharmaceutical blister packaging
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