Biomaterial Database

[Hygienic precautions and microbiological quality control during the manufacturing of sterile drugs]. 1982

R Züge

By the use of an example such as the production of a sterile solution, the hygienic precautions and control procedures required in the pharmaceutical industry are described. Starting materials should be free of germs and pyrogens. During production experimentally tested cleaning procedures for equipment are to be observed. A critical production step is the filtration. The time limits between starting and sterilizing the solution as well as the leakproofness of the filters have to be tested microbiological. --Special microbiological requirements exist for rooms, surfaces and clothes. Process-sterility control is carried out by periodic filling of ampules with nutrient broth. After running through the "compact unit" of the aseptic filling line the ampules contaminated before with endotoxin, are free of pyrogens. --Sterility depends on the count and kind of germs before sterilization procedure. The probability of survival of microorganismen should be less than 1:1 million.

UI	MeSH Term	Description	Entries
D011749	Pyrogens	Substances capable of increasing BODY TEMPERATURE and cause FEVER and may be used for FEVER THERAPY. They may be of microbial origin, often POLYSACCHARIDES, and may contaminate distilled water.	Pyrogen
D011786	Quality Control	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)	Control, Quality,Controls, Quality,Quality Controls
D004345	Drug Industry	That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.	Industries, Pharmaceutic,Industry, Drug,Industry, Pharmaceutic,Industry, Pharmaceutical,Pharmaceutical Industry,Drug Industries,Industries, Drug,Industries, Pharmaceutical,Pharmaceutic Industries,Pharmaceutic Industry,Pharmaceutical Industries
D004349	Drug Packaging	Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.	Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D005374	Filtration	A process of separating particulate matter from a fluid, such as air or a liquid, by passing the fluid carrier through a medium that will not pass the particulates. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)	Filtrations
D001419	Bacteria	One of the three domains of life (the others being Eukarya and ARCHAEA), also called Eubacteria. They are unicellular prokaryotic microorganisms which generally possess rigid cell walls, multiply by cell division, and exhibit three principal forms: round or coccal, rodlike or bacillary, and spiral or spirochetal. Bacteria can be classified by their response to OXYGEN: aerobic, anaerobic, or facultatively anaerobic; by the mode by which they obtain their energy: chemotrophy (via chemical reaction) or PHOTOTROPHY (via light reaction); for chemotrophs by their source of chemical energy: CHEMOLITHOTROPHY (from inorganic compounds) or chemoorganotrophy (from organic compounds); and by their source for CARBON; NITROGEN; etc.; HETEROTROPHY (from organic sources) or AUTOTROPHY (from CARBON DIOXIDE). They can also be classified by whether or not they stain (based on the structure of their CELL WALLS) with CRYSTAL VIOLET dye: gram-negative or gram-positive.	Eubacteria
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.