Reducing the Risk of Contamination of Sterile Parenteral Products …
WEBNov 6, 2010 — The preparation of sterile parenteral products requires careful control of all ingredients, materials, and processes to ensure the final product has the identity and strength, and meets the quality and purity characteristics that it purports to possess.
A systematic review and meta-analysis of microbial contamination …
WEBJan 25, 2019 — Preparation of parenteral medication in hospitals is a complex process with a risk of microbial contamination of the product, especially when inappropriately prepared. Contaminated parenteral medications can cause severe complications to patients and increase morbidity in hospitals.
Visible particles in parenteral drug products: A review of current ...
WEBJan 1, 2024 — Particles are regarded as contamination representing safety risk to patients. •. There are no regulatory limits to qualify visible particles. •. Particle safety is impacted by various particle factors. •. Particles may cause physical, microbiological, and chemical adverse effects. •.
Particulate Matter in Parenteral Products: A Review
WEBA variety of methods have been utilized for the measurement of subvisible particulate matter, including microscopic, electrical zone-sensing, light blockage, light scattering, and holographic techniques. Each of these particle counting methods is described.
Particulate Matter Contamination of Intravenous Antibiotics …
WEBThrough the increased use of less expensive and counterfeit medicines, the contamination of parenteral fluids and drugs by particulate matter poses an increasing health hazard worldwide.
Parenteral Drugs: Ensuring Sterility and Minimizing Risks During ...
WEBContamination-free and closed sampling. High recovery and low cost of goods. Filling. Improve manufacturing flexibility. Increase productivity. Meet evolving manufacturing needs. Parenteral Drugs are High-Risk Applications.
Compounding Parenteral Products in Pediatric Wards—Effect of ...
WEBAug 10, 2021 — Administration of a contaminated parenteral product can cause the patient significant harm, including bloodstream infections, sepsis, meningitis and death [2,3,4,5,6]. Pediatric patients are particularly vulnerable to contaminated parenteral products due to their undeveloped immune systems .
Particulate Matter in Sterile Parenteral Products
WEBJan 1, 2013 — Particulate matter, visible or subvisible, in sterile parenteral products is regarded as a critical quality attribute, impacting safety of the product. Particles can arise from many sources foreign, intrinsic, or inherent to the product, the latter having particular emphasis for biopharmaceuticals. This chapter discusses the nature of these ...
Sterile Basics of Compounding: Particulates in Parenteral
WEBIn addition to inspection and analysis of the parenteral solutions for the presence of foreign particulate matter, particulate matter testing includes procedures for removing, counting, and sizing contaminants in injections and ophthalmic solutions.
Particulate Matter in Injectable Drugs: Evaluation of Risks to …
WEBJun 1, 2016 — In a study based on children receiving parenteral fluids, Puntis et al. confirmed that pulmonary granulomata could be found in small proportions, related to particulate contamination of IV solutions. More than 30,000 particles of between 2 and 100 µm in size were detected during a one-day infusion.