A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis.

An increasing number of pharmaceutical products require deep cold storage at cryogenic conditions, approximately -150°C to -190°C, to maintain stability and/or activity. Previous work has revealed that, at these extreme conditions, a typical pharmaceutical package configuration (vial, stopper, crimp cap) may lose container closure integrity (CCI) due to both the glass transition temperature (-55°C to -70°C) of the rubber stopper used to seal the vial and the different thermal expansion coefficients of the primary packaging components. Importantly, this type of temporary breach in CCI frequently reseals itself when the vial is brought back to ambient temperature.

Comparing Container Closure Integrity Test Methods-Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls.

As described in USP <1207>, the deterministic leak test methods using laser-based gas headspace analysis and helium leakage are those with the highest sensitivities. As stated in the chapter, "no single package leak test or package seal quality test method is applicable to all product-package systems"; therefore, knowing the advantages and disadvantages of both of these techniques, and the extent to which they can be substituted for each other, is valuable. In an effort to begin addressing this issue, a systematic study using these two techniques has been performed.

Revision Rates in Cosmetic Plastic Surgery with and without Resident Involvement.

Background: Changes in surgical education have caused concern over residents' preparedness for independent practice. As the field of otolaryngology requires such a wide breadth of expertise, ill preparation becomes especially costly. This study explores how the presence and participation of a postgraduate year 3 (PGY3) otolaryngology resident in surgery impacts revision rates and operating time as gauges for the resident competency and indirect training costs.

Quality of life, satisfaction with care, and the experiences of adults with intellectual and developmental disabilities before and during COVID-19.

Background: Adults with intellectual and developmental disabilities (IDD) experienced significant disruptions in their access to health care, support services, and essential daily activities such as work, leisure, and routine daily care during COVID-19.

Objective: The purpose of this study was to describe overall experiences related to COVID-19 among adults with IDD, including the vaccination process, quality of life (QoL), and service satisfaction before and during the pandemic.

Methods: A longitudinal statewide survey of adults with IDD receiving long-term care support using a combination of self- and care partner report was completed prior to (2017; n = 331) and during (2021; n = 206) the pandemic.