Selecting and validating a suitable container closure integrity test method for pharmaceutical ophthalmic bottles
Järvilä, Tiina (2017)
2017
Master's Degree Programme in Materials Science
Teknisten tieteiden tiedekunta - Faculty of Engineering Sciences
This publication is copyrighted. You may download, display and print it for Your own personal use. Commercial use is prohibited.
Hyväksymispäivämäärä
2017-02-08
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tty-201701251085
https://urn.fi/URN:NBN:fi:tty-201701251085
Tiivistelmä
Target of this thesis was to find suitable integrity test method for Santen Oy ophthalmic solution bottles. Suitable integrity test method is able to detect leaking container closure systems which could endanger sterility of the pharmaceutical product or lead to product loss. There are requirements and guidelines set by authorities for pharmaceutical companies regarding integrity of the container closure system. Pharmaceutical companies must follow these while selecting a suitable integrity test method.
Common integrity test methods available are discussed in this thesis. Qualities of those methods, suitability for ophthalmic solution bottles and sensitivity are described. More attention is paid for deterministic methods which generally have better sensitivity and reliability and are recommended by authorities. Basic features of some common probabilistic methods are covered too.
In addition to selecting a suitable test method; this thesis also covers validation of the new integrity test method. The validation phase involves for example qualification of new machinery arriving with the testing method. Validation is critical to ensure that the selected method is functioning as supposed. This phase is done according to the requirements and guidelines set by authorities.
The outcome of this thesis was to recommend Santen Oy to use vacuum decay method as integrity test method for ophthalmic solution bottles. This method was tested in a certain machine manufacturer site with Santen product and it was found to be suitable for Santen container closure system. Method showed good sensitivity and repeatability. In addition it is deterministic and nondestructive, which all are appreciated features for the integrity test method.
Common integrity test methods available are discussed in this thesis. Qualities of those methods, suitability for ophthalmic solution bottles and sensitivity are described. More attention is paid for deterministic methods which generally have better sensitivity and reliability and are recommended by authorities. Basic features of some common probabilistic methods are covered too.
In addition to selecting a suitable test method; this thesis also covers validation of the new integrity test method. The validation phase involves for example qualification of new machinery arriving with the testing method. Validation is critical to ensure that the selected method is functioning as supposed. This phase is done according to the requirements and guidelines set by authorities.
The outcome of this thesis was to recommend Santen Oy to use vacuum decay method as integrity test method for ophthalmic solution bottles. This method was tested in a certain machine manufacturer site with Santen product and it was found to be suitable for Santen container closure system. Method showed good sensitivity and repeatability. In addition it is deterministic and nondestructive, which all are appreciated features for the integrity test method.