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This 2-part series discusses quality-control and quality-assurance issues along with physical and chemical analytical methods and microbiological testing related to both sterile and nonsterile compounded preparations. This second part covers microbiological testing, including sterility, bacterial endotoxins, preservative effectiveness, and microbial limit testing, along with continuous quality improvement, sample selection and requirements, out-of-specification results, and cost factors associated with testing.
This article was published in the following journal.
Name: International journal of pharmaceutical compounding
The July-August 2019 issue of the International Journal of Pharmaceutical Compounding includes part 1 of a 3-part article on the topic of excipients used in nonsterile compounding. This article, which...
Pharmacogenetic (PGx) testing is increasingly available from clinical and research laboratories. However, only a limited number of quality control and other reference materials (RMs) are currently ava...
In pharmaceutical compounding, strict adherence to a protocol for hand hygiene and glove sanitizing is essential to ensure the purity, safety, and effectiveness of sterile preparations; reduce patient...
Applications of immunophenotyping using flow cytometry offer precise and accurate means for providing information used to both diagnose and monitor disease; they serve as a standard platform for many ...
Establishing and maintaining a sterile field to help prevent surgical site infections requires specific knowledge and skills and is among the most important responsibilities of the perioperative RN. P...
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions. Sterile...
The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was adminis...
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment...
This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in p...
Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B, HsCRP(High-sensitiv...
A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)
A putative protein interaction module, approximately 70 amino acids long, that forms a small five-helix bundle with two large interfaces which may homo- and hetero-oligomerize, or bind non-sterile-alpha motif targets. The sterile alpha motif is present in a wide variety of eukaryotic proteins that function in diverse biological processes.
Detection of or testing for certain ALLELES, mutations, genotypes, or karyotypes that are associated with genetic traits, heritable diseases, or with a predisposition to a disease, or that may lead to the disease in descendants. It includes prenatal genetic testing.
Testing in which the source of the specimen or the person being tested is not individually identified.
Indolesulfonic acid used as a dye in renal function testing for the detection of nitrates and chlorates, and in the testing of milk.