Considerations in Qualifying Critical Suppliers.

The impending updates to United States Pharmacopeia Chapter <797> and Chapter <795> specify that compounders must obtain active pharmaceutical ingredients and should obtain excipients from FDA-registered facilities. Additionally, the U.S.

Advanced Compounding; How to Investigate Microbiological Excursions at a Sterile Compounding Facility.

Per United States Pharmacopeia Chapter <797>, effective November 1, 2023, uncovering non-conforming cleanroom microbiological conditions must be investigated thoroughly and in a timely manner. This article's objective is to outline the basic elements in investigating microbiological excursions at a sterile compounding facility, which models the use of an Ishakawa diagram to conduct a root cause investigation and discusses important concepts such as: product impact analysis, corrective and preventive action effectiveness checks, trend analysis, and investigational pitfalls to avoid. While this article focuses on investigating microbiological excursions, the concepts can be applied to investigating an out-of-range temperature, relative humidity, pressure differential, total particle count, or compounded sterile preparation failure.

Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control.

Whether sterile compounds are prepared in a brand new state-of-the-art cleanroom suite or in an aging space, compounders rely heavily on their primary and secondary engineering controls when sterilizing or maintaining sterility of the final preparation. With the release of the latest revision to United States Pharmacopeia Chapter <797>, organizations that prepare sterile compounds must now sample and test each classified area for the presence of microbiological contaminants at a higher frequency. Facilities that are not purpose-built, as well as those that do not operate within a state of control, are predicted to repeatedly exceed action levels as set by the United States Pharmacopeia Convention, Inc.

Sterile Basics of Compounding: Contamination Control Strategies, Part 2.

Compounded sterile preparations are required to be at the very least sterile. If not, the parenteral administration of such a preparation can cause serious patient harm, even death. Therefore, cleanroom contamination-control strategies must be employed to protect the final preparation and the patient.

Sterile Basics of Compounding: Contamination Control Strategies, Part 1.

Compounded sterile preparations are required to be at the very least sterile. If not, the parenteral administration of such a preparation can cause serious patient harm, even death. Therefore, cleanroom contamination control strategies must be employed to protect the final preparation and the patient.

Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program.

Dispensing compounded sterile injectable drug preparations that contain particulates can have serious patient-safety implications. While there is a lack of controlled human studies to demonstrate the clinical concerns that particles can be carriers for microbiological contamination, they have been shown to potentially block blood vessels. Anecdotal studies found that foreign body emboli and granulomas are the most common result of particulate matter present in intravenous solutions.

Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2.

Container-closure integrity provides assurance that compounded sterile preparation quality attributes are met throughout its shelf life. Since compounded sterile preparations lacking container-closure integrity are considered adulterated as per the Federal Food, Drug and Cosmetic Act and are therefore unsafe for patient use, compounders must be able to produce a well closed sealed vial. Furthermore, 503B outsourcing facilities must qualify the capping process as described by the proposed "Current Good Manufacturing Practice - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act Guidance for Industry.

Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 1.

Container closure integrity provides assurance that compounded sterile preparation quality attributes are met throughout its shelf life. Since compounded sterile preparations lacking container-closure integrity are considered adulterated as per the Federal Food, Drug and Cosmetic Act and are therefore unsafe for patient use, compounders must be able to produce a well-closed sealed vial. Furthermore, 503B outsourcing facilities must qualify the capping process as described by the proposed "Current Good Manufacturing Practice - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act Guidance for Industry.

Interdisciplinary Education Apartment Simulation (IDEAS) Project: An Interdisciplinary Simulation for Transitional Home Care.

Introduction: Home-based care (HBC) is a valuable tool to provide care to rural, medically underserved populations. By mitigating geographic and transportation barriers for vulnerable populations, HBC is a promising modality of health care delivery. Interprofessional education has become an integral part in undergraduate and professional curricula; however, applications of team-based training in HBC are often missing from curricula.

Draft Genome Sequences of Klebsiella pneumoniae Clinical Type Strain ATCC 13883 and Three Multidrug-Resistant Clinical Isolates.

Klebsiella pneumoniae is a Gram-negative human pathogen capable of causing hospital-acquired infections with an increasing risk to human health. The total DNA from four clinically relevant strains was sequenced to >100× coverage, providing high-quality genome assemblies for K. pneumoniae strains ATCC 13883, KP4640, 101488, and 101712.

AB5075, a Highly Virulent Isolate of Acinetobacter baumannii, as a Model Strain for the Evaluation of Pathogenesis and Antimicrobial Treatments.

Unlabelled: Acinetobacter baumannii is recognized as an emerging bacterial pathogen because of traits such as prolonged survival in a desiccated state, effective nosocomial transmission, and an inherent ability to acquire antibiotic resistance genes. A pressing need in the field of A. baumannii research is a suitable model strain that is representative of current clinical isolates, is highly virulent in established animal models, and can be genetically manipulated.

Detection of qacA/B in clinical isolates of methicillin-resistant Staphylococcus aureus from a regional healthcare network in the eastern United States.

We describe the clinical, microbiologic, and molecular features of the first series of qacA/B-containing strains of methicillin-resistant Staphylococcus aureus from infected US patients. All qac-carrying strains were clonally diverse, and qacA strains exhibited increased tolerance to chlorhexidine as measured by minimum inhibitory concentrations, minimum bactericidal concentrations, and postexposure colony counts.

High incidence of multidrug-resistant gram-negative bacteria recovered from Afghan patients at a deployed US military hospital.

Objective: To investigate potential sources and risks associated with multidrug-resistant (MDR) bacteria in a deployed US military hospital.

Design: Retrospective analysis of factors associated with recovery of MDR bacteria, supplemented by environmental sampling.

Setting: The largest US military hospital in Afghanistan.

Capsular serotype of Staphylococcus aureus in the era of community-acquired MRSA.

Capsular polysaccharide (CP) plays an important role in the pathogenicity and immunogenicity of Staphylococcus aureus, yet the common serotypes of S. aureus isolated from US pediatric patients have not been reported. We investigated capsular serotype as well as methicillin susceptibility, presence of Panton-Valentine leukocidin (PVL), and clonal relatedness of pediatric S.

In vitro activity of the aminoglycoside antibiotic arbekacin against Acinetobacter baumannii-calcoaceticus isolated from war-wounded patients at Walter Reed Army Medical Center.

We determined the in vitro MIC of arbekacin against 200 Acinetobacter isolates recovered from wounded soldiers. The median MIC was 2 microg/ml (range, 0.5 to > 64 microg/ml).

Natural history of colonization with gram-negative multidrug-resistant organisms among hospitalized patients.

Objective: To determine the anatomic sites and natural history of colonization with gram-negative multidrug-resistant organisms (MDROs).

Design: Prospective, longitudinal cohort study.

Setting: Walter Reed Army Medical Center, a 236-bed tertiary care center in Washington, DC.

Ertapenem susceptibility of extended spectrum beta-lactamase-producing organisms.

Background: Infections caused by multiply drug resistant organisms such as extended spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae are increasing. Carbapenems (imipenem and meropenem) are the antibiotics commonly used to treat these agents. There is limited clinical data regarding the efficacy of the newest carbapenem, ertapenem, against these organisms.