An Overview of USP 1207: A Guidance Chapter

Historically, container closure integrity testing was largely treated as a formality; a check-box to be ticked before submission. After all, to a company which had just gone through the intense process of developing a drug to bring to market, the package is just something to put it in. Even within the field of container testing, the regularity and scientific rigor with which integrity testing was pursued paled in comparison to other container tests, such as chemical characterization, moisture permeation, and light transmission.

An Overview of USP 1207: A Guidance Chapter

Historically, container closure integrity testing was largely treated as a formality; a check-box to be ticked before submission. After all, to a company which had just gone through the intense process of developing a drug to bring to market, the package is just something to put it in. Even within the field of container testing, the regularity and scientific rigor with which integrity testing was pursued paled in comparison to other container tests, such as chemical characterization, moisture permeation, and light transmission.

An Overview of USP 1207: A Guidance Chapter

Historically, container closure integrity testing was largely treated as a formality; a check-box to be ticked before submission. After all, to a company which had just gone through the intense process of developing a drug to bring to market, the package is just something to put it in. Even within the field of container testing, the regularity and scientific rigor with which integrity testing was pursued paled in comparison to other container tests, such as chemical characterization, moisture permeation, and light transmission.

An Overview of USP 1207: A Guidance Chapter

Historically, container closure integrity testing was largely treated as a formality; a check-box to be ticked before submission. After all, to a company which had just gone through the intense process of developing a drug to bring to market, the package is just something to put it in. Even within the field of container testing, the regularity and scientific rigor with which integrity testing was pursued paled in comparison to other container tests, such as chemical characterization, moisture permeation, and light transmission.