Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components.

In the biopharmaceutical industry, the observation of a single particle in a vial or syringe may result in entire lots of drug product recalls. U.S. Pharmacopeia <787> and <788> describe light obscuration methods and particle collection (membrane filtration) followed by light microscopy for particle counting of filled drug products. However, there are no corresponding pharmacopeial methods for determining the particle levels of unfilled primary packaging components or their packaging materials (tubs, nests, bags, etc.). This article describes a quantification method to accurately assess the number of particles in primary containers and corresponding closures. As a microscopic method, the size ranges can be set by the user and are limited only by the optical properties of the microscope and analysis time. Particle load is a critical quality attribute that has a direct impact on product safety. Applying a standardized method to compare the effect of process changes on particle load can aid manufacturers in refining their processes to minimize particulates. Described herein are the critical parameters to develop physical rinse methods and the subsequent qualification results to measure the visible particle load of nonsiliconized and siliconized primary packaging systems.

Engaging Older Adults in a Depression Simulation Experience.

BACKGROUND: Clinical simulation has become integral to curriculum development in nursing programs. This innovative intervention was designed to explore the efficacy of high-fidelity standardized patient (SP) simulation to increase students' ability to recognize signs of depression and to improve therapeutic communication. METHOD: During a 12-month period, prelicensure nursing students (n = 136) in a midwestern nursing program participated in this simulation experience. Volunteer retirees residing in the college-affiliated retirement village played the roles of depressed patients. RESULTS: Students' self-evaluations indicated this experience was a positive learning experience. All of the students indicated the experience improved their knowledge about depression; 91% stated their confidence in interviewing improved, and 89.7% indicated improvement in their communication skills. CONCLUSION: Use of SP simulation in mental health nursing is an effective strategy to bolster confidence, improve depression screening skills, and enhance therapeutic communication skills. [J Nurs Educ. 2022;61(4):209-212.].

Pandemic-Related Disruptions in Nursing Education: Zooming Out for an Innovative Interprofessional Simulation.

When the COVID-19 global pandemic began, many higher education systems had to restructure their educational delivery system and transition to online learning. This posed a challenge for students in health professions education programs as it impacted their ability to participate in hands-on learning regarding patient care. As a result, the University of Cincinnati College of Nursing developed and implemented simulation-based learning experiences to allow graduate-level social worker, counselor, and psychiatric-mental health nurse practitioner students the opportunity to learn as an interdisciplinary team in a virtual format. The Opioid Use Disorder Simulation Case Study discussed in this article was developed as part of the Serving At-risk Youth Fellowship Experience Training program with the overarching aim to prepare culturally competent providers to deliver direct patient care and education around prevention and recovery services to individuals with substance use disorders.

Predicting the potential of capacitive deionization for the separation of pH-dependent organic molecules.

One of the main steps in the biotechnological production of chemical building blocks, such as, e.g. bio-based succinic acid which is used for lubricants, cosmetics, food, and pharmaceuticals, is the isolation and purification of the target molecule. A new approach to isolate charged, bio-based chemicals is by electrosorption onto carbon surfaces. In contrast to ion exchange, electrosorption does not require additional chemicals for elution and regeneration. However, while the electrosorption of inorganic salts is well understood and in commercial use, the knowledge about electrosorption of weak organic acids including the strong implications of the pH-dependent dissociation and their affinity towards physical adsorption must be expanded. Here, we show a detailed discussion of the main pH-dependent effects determining the achievable charge efficiencies and capacities. An explicit set of equations allows the fast prediction of the named key figures for constant voltage and constant current operation. The calculated and experimental results obtained for the electrosorption of maleic acid show that the potential-free adsorption of differently protonated forms of the organic acid play a dominating role in the process. At pH 8 and a voltage threshold of 1.3 V, charge efficiencies of 25% and capacities around 40 mmol/kg could be reached for a constant current experiment. While this capacity is clearly below that of ion exchange resins, the required carbon materials are inexpensive and energy costs are only about 0.013 €/mol. Therefore, we anticipate that electrosorption has the potential to become an interesting alternative to conventional unit operations for the isolation of charged target molecules.

Adsorption of organic molecules on carbon surfaces: Experimental data and molecular dynamics simulation considering multiple protonation states.

Owing to their high specific surface and low production cost, carbon materials are among the most important adsorption materials. Novel usages, for instance in pharmaceutical applications, challenge existing methods because charged and strongly polar substances need to be adsorbed. Here, we systematically investigate the highly complex adsorption equilibria of organic molecules having multiple protonation states as a function of pH. The adsorption behavior depends on intermolecular interactions within the solution (dissociation equilibria) and between adsorbed molecules on the carbon surface (electrostatic forces). For the model substances maleic acid and phenylalanine, we demonstrate that a custom-made genetic algorithm is able to extract up to nine parameters of a multispecies isotherm from experimental data covering a broad pH-range. The parameters, including adsorption affinities, interaction energies, and maximum loadings were also predicted by molecular dynamics simulations. Both approaches obtained a good qualitative and mostly also quantitative description of the adsorption behavior within a pH-range of 2-12. By combining the determined isotherms with mass balances, the final concentrations and pH-shifts of batch adsorption experiments can be predicted. The developed modeling tools can be easily adapted to other types of pH-dependent, multispecies adsorbates and therefore will help to optimize adsorption-based processes in different fields.

Maximizing Effectiveness of the Holistic Admission Process: Implementing the Multiple Mini Interview Model.

BACKGROUND: Nursing programs have responsibility to become more holistic in admission practices, ensuring they admit applicants based on more than grades and test scores to determine the best fit for their program. PROBLEM: One frequently cited holistic admissions barrier is incorporating qualitative measurement of applicant characteristics through interviews. Finding the best interview model is a challenge, depending on a program's intent to learn about applicants. APPROACH: This article describes the planning and implementation process for incorporating the Multiple Mini Interview (MMI) model into an existing holistic nursing program admission process. OUTCOMES: MMI model implementation resulted in more congruency in student attributes with the college vision, mission, and values and increased diversity. CONCLUSION: An efficient, well-organized MMI interview model was implemented, allowing achievement of overall admission goals and ensuring selected applicants demonstrate attributes aligned with college values and vision and increased diversity.

Role of the clinical learning environment in preparing new clinicians to engage in quality improvement efforts to eliminate health care disparities.

PURPOSE: The National Collaborative for Improving the Clinical Learning Environment offers guidance to health care leaders for engaging new clinicians in efforts to eliminate health care disparities. SUMMARY: To address health care disparities that are pervasive across the United States, individuals at all levels of the health care system need to commit to ensuring equity in care. Engaging new clinicians is a key element of any systems-based approach, as new clinicians will shape the future of health care delivery. Clinical learning environments, or the hospitals, medical centers, and ambulatory care clinics where new clinicians train, have an important role in this process. Efforts may include training in cultural humility and cultural competency, education about the organization's vulnerable populations, and continuous interprofessional experiential learning through comprehensive, systems-based QI efforts focused on eliminating health care disparities. CONCLUSION: By preparing and supporting new clinicians to engage in systems-based QI efforts to eliminate health care disparities, clinical learning environments are instilling skills and supporting behaviors that clinicians can build throughout their careers-and helping pave the road towards equity throughout the US health care system.