[Microorganisms in drugs and cosmetics - occurrence, harms and consequences in hygienic manufacturing (author's transl)]. 1976

J Grigo

The quantity of pharmaceutical and cosmetic products with different composition and the diversity of contaminating microorganisms set up special problems for each product with its specific field of application. It is not exact to generalize the hazard of contaminating microorganisms to product cathegories. Some product cathegories however are more imperilled to be contaminated with microorganisms and they are more hazardous than other ones. The most important component of the living matter is water that decides on growth, multiplication and survival of microorganisms in drugs and cosmetics. Products with a high content of available water are the most problematic ones. The consequences of survival and multiplication of microorganisms in relation to metabolic activity, pathogenicity and route of administration can be harmless or fatal. The nutritive wants of many microorganisms are very small, even simple salt solutions do not exclude microbial growth. There scarcely exist substrates not used as energy source by any microorganism and so it does not wonder that desinfectants are also used. Added preservatives may be absorbed or inactivated by suspended anorganic components, swelling agents, solubilizers etc., the containers or its closing. In the water phase of emulsions, in which under special conditions smaller amounts of the preservative are available, microorganisms sometimes can multiply. Skin care products neither belonging to pharmaceuticals nor to cosmetics present special clinical problems. Many times creams and lotions contain ingredients metabolized by microorganisms. Ointments and oils can be overgrown only by highly specialized organisms but if there is condensed water as a film at boundary surfaces much more microorganism species can grow. When using cosmetics it must be considered that parts of them will get into the eye. The eye is really endangered by Pseudomonads, which can according to the composition multiply in shampoos and whose contact to the eye can not be excluded. Syrups and solutions contain sugar concentrations, which suppress growth of most microorganisms except osmotolerant germs. Because of their low water content powders normally are protected against microbial growth but they should be free from clostridial spores for a mixture of powder and sweat is a good nutrient medium to Clostridia and fungi. Powders for surgical use must be sterile. Tablets and dragees do not allow microbial multiplication because of their low water activity. Under bad storage conditions a local increase of water content may permit microbial growth at the surface, especially in hygroscopicity. Fortunately there is seen a trend of not using multi-dose-containers for injections because of the high risk of contamination. It is to develop single-dose-containers also for other groups of preparations especially for eye-preparations. Many products microbiologically unobjectionable produced are contaminated in use, they contain the spectrum of microorganisms of the area of application...

UI MeSH Term Description Entries
D003358 Cosmetics Substances intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. (U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Office of Cosmetics Fact Sheet (web page) Feb 1995) Personal Care Products,Care Product, Personal,Care Products, Personal,Personal Care Product,Product, Personal Care,Products, Personal Care
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
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
D004356 Drug Storage The process of keeping pharmaceutical products in an appropriate location. Drug Storages,Storage, Drug,Storages, Drug
D005658 Fungi A kingdom of eukaryotic, heterotrophic organisms that live parasitically as saprobes, including MUSHROOMS; YEASTS; smuts, molds, etc. They reproduce either sexually or asexually, and have life cycles that range from simple to complex. Filamentous fungi, commonly known as molds, refer to those that grow as multicellular colonies. Fungi, Filamentous,Molds,Filamentous Fungi,Filamentous Fungus,Fungus,Fungus, Filamentous,Mold
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
D013045 Species Specificity The restriction of a characteristic behavior, anatomical structure or physical system, such as immune response; metabolic response, or gene or gene variant to the members of one species. It refers to that property which differentiates one species from another but it is also used for phylogenetic levels higher or lower than the species. Species Specificities,Specificities, Species,Specificity, Species
D013678 Technology, Pharmaceutical The application of scientific knowledge or technology to pharmacy and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures, and in the treatment of patients. Technology, Pharmacy,Pharmaceutic Technology,Pharmaceutical Technology,Pharmacy Technology,Technology, Pharmaceutic

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