Pappas Michael (pumaside3)

In the past decades, the silicone layer thickness and its distribution on the inner glass barrels of prefilled syringes have been characterized in several studies. However, the limited number of adequate methods to characterize thin baked-on silicone layers and the destructive nature of some analytical techniques imply challenges on the inter-lab reproducibility of some methods. In this study, the measured silicone layer thickness of baked-on siliconized syringes was compared between two laboratories both equipped with white light reflectometry coupled to laser interferometry instrumentation (Bouncer, LE UT 1.0, LE UT 2.0). The quantity of silicone oil of a subset of those syringes was measured by Fourier transformed infrared spectroscopy. Glide force tests were realized as complementary measurements on both syringes analyzed by white light reflectometry coupled to laser interferometry instrumentation and on non-analyzed identical syringes from the same lot. The mean layer thickness was found to be slightly tature up-to-now.The assessment of substances that can be extracted (extractables) or leached (leachables) from the materials that contact pharmaceutical products often starts with a general screening of these substances in relevant samples. Although such screening studies may be of a qualitative and semi-quantitative nature, the data they generate are critical in ensuring the suitability of the system(s) used to manufacture, store, and/or administer the product. As such, it is important they are designed using appropriate analytical techniques and methodologies so that representative and reproducible data are obtained. The goal of this commentary is to provide insight into several, but by no means all, good practices for the preparation and analysis of samples in extractable and/or leachable screening studies in order to help ensure representative and reproducible results are ultimately obtained. The specific topics covered are extraction stoichiometry, the importance of verifying method performance, assessing the need for incorporating derivatization in gas chromatography based analyses, and properly accounting for analytical uncertainty when calculating the analytical evaluation threshold.Two statistically based testing procedures, a zero-failure test and a one-failure test, are proposed for demonstrating that a vial capping process has an acceptably low rate of failed seals, i.e., non-integral container closures, or leaky vials. These tests are developed for use with the standard helium-leak test method that measures the amount of escaped helium from a capped vial. The amount of escaped helium is a continuous measurement and a vial is said to be leaky if the measurement exceeds a threshold and not leaky if it does not. Not leaky measurements are often less than the lower limit of validation, i.e., left-censored. By using the continuous measurements that describe the extent of leaking instead of the binary measurements, leaky or not leaky, the proposed tests are able to reach similar conclusions as tests using binary measurements but with much smaller sample sizes. The proposed tests can handle any number of measurements less than the lower limit of validation.To develop a guide of best practices for establishing appropriate controls on nonsterile manufacturing environments for pharmaceutical manufacturers, the Kansai Study Group of the Parenteral Drug Association Japan Chapter explored relevant issues in-depth and published the results of their study, ″Manufacturing Environmental Control for Non-sterile Drug Products″ in the PDA Journal of GMP and Validation in Japan (1). This review summarizes the background of that study and the structure of the published article and, to help readers make the most of the contents, provides a table displaying the category, subject, Problem Statement, and points to consider of each topic discussed in the article, as well as examples of central topics (Appendices 1-3).Forecasts of the