Biomaterial Database

Method for determination and element analysis of particulate contamination in injectable solutions. 1976

O Winding, and B Holma

A method for sampling and evaluating the chemical and physical composition of particles in injectable solutions was developed. The technique facilitates detection of the particles' sources and possible medical hazards. Particles exceeding 0.2 mum are collected on a membrane filter sized for direct application in a scanning electron microscope (SEM). The sampling device shortens the distance between filter and solution and minimizes contamination from the filter holder. Following coating of the membrane filter with gold, the particles are counted by screening at a magnification of 5,000 x in the SEM. Both unused membrane filters and filters through which a solution of 0.9% sodium chloride had been passed were analyzed. X-ray analysis of particles on the clean filter revealed silicon, aluminum (artifact from the stud) and calcium. X-ray analysis of the filter after passage of 1 liter normal saline revealed chromium, copper, iron, magnesium, manganese, aluminum (from study), calcium chlorine, sodium and silicon. Recommendations for standard procedures for particle detection in large-volume injectables are given.

UI	MeSH Term	Description	Entries
D008722	Methods	A series of steps taken in order to conduct research.	Techniques,Methodological Studies,Methodological Study,Procedures,Studies, Methodological,Study, Methodological,Method,Procedure,Technique
D008855	Microscopy, Electron, Scanning	Microscopy in which the object is examined directly by an electron beam scanning the specimen point-by-point. The image is constructed by detecting the products of specimen interactions that are projected above the plane of the sample, such as backscattered electrons. Although SCANNING TRANSMISSION ELECTRON MICROSCOPY also scans the specimen point by point with the electron beam, the image is constructed by detecting the electrons, or their interaction products that are transmitted through the sample plane, so that is a form of TRANSMISSION ELECTRON MICROSCOPY.	Scanning Electron Microscopy,Electron Scanning Microscopy,Electron Microscopies, Scanning,Electron Microscopy, Scanning,Electron Scanning Microscopies,Microscopies, Electron Scanning,Microscopies, Scanning Electron,Microscopy, Electron Scanning,Microscopy, Scanning Electron,Scanning Electron Microscopies,Scanning Microscopies, Electron,Scanning Microscopy, Electron
D010316	Particle Size	Relating to the size of solids.	Particle Sizes,Size, Particle,Sizes, Particle
D004340	Drug Contamination	The presence of organisms, or any foreign material that makes a drug preparation impure.	Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D004364	Pharmaceutical Preparations	Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.	Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical
D012996	Solutions	The homogeneous mixtures formed by the mixing of a solid, liquid, or gaseous substance (solute) with a liquid (the solvent), from which the dissolved substances can be recovered by physical processes. (From Grant & Hackh's Chemical Dictionary, 5th ed)	Solution
D014462	Ultrafiltration	The separation of particles from a suspension by passage through a filter with very fine pores. In ultrafiltration the separation is accomplished by convective transport; in DIALYSIS separation relies instead upon differential diffusion. Ultrafiltration occurs naturally and is a laboratory procedure. Artificial ultrafiltration of the blood is referred to as HEMOFILTRATION or HEMODIAFILTRATION (if combined with HEMODIALYSIS).