Microbial contamination of drugs and ways to reduce it - term paper. The problem of microbial contamination of medicines The risk of contamination
The emergence of a new expression or form by combining the elements of two expressions or forms that are somewhat similar. For example, the incorrect expression "play a meaning" arose as a contamination of the two expressions "play a role" and "make a difference". In addition to compounds in one-two-way expressions or proverbs (“Do not spit in the well, you will fly out - you will not catch”), the combination of names and words (more precisely, roots) is also called contamination, for example, “F. Tolstoevsky" (Tolstoy and Dostoevsky), "tragicomic" (from tragic and comic) or “At the Academy of Poetry - in lakescastle white marble" (Igor Severyanin).
In a broad sense, the concept of contamination is based on the following provisions:
- Formally, in the neoformation, both initial words are represented by at least one letter (more precisely, a phoneme).
- In the meaning of the new formation, the meanings of both original words are intertwined in a complex way.
- Scope of operation - headings
- The nature of the selected part:
- common nouns, cf.: gay swarm of our time; I was a minister fence they; court serzhanki; beer ner is always ready; why are you bullying pace atelier? (see also Kaschenism)
- proper name, cf .: At the mine, the OGPU now work in knock anovski; Boris inca laevich on the warpath; Who was, who Alla and etc.;
- abbreviations, cf.: Most to AiF new day of the city; AiF oriya; BAM meekness; Causes a big SORM neniya and others.
- pronounced “fashion” of the topic covered in the publication, cf .: gay nially!; FROM Internet will the human race rise up as a rational?; HIV noe silence, etc.
In literature
Contamination is also called a combination of episodes from different works and the introduction of events from another literary work into the story.
Chemistry and biology
pharmaceuticals
In pharmaceuticals - mixing (resorting, leading to incorrect selection of drugs). The term is used in normative documents.
see also
Notes
Wikimedia Foundation. 2010 .
Synonyms:See what "Contamination" is in other dictionaries:
contamination- (in psychology) (from lat. contaminatio mixing) erroneous reproduction of words, which consists in combining syllables related to different words, in one word (for example, instead of the words “protein” and “turn”, it is pronounced “beltok”). Changes like this... Great Psychological Encyclopedia
- [lat. contaminatio mixing] 1) mixing, merging heterogeneous factors into a new set; 2) lingv. the emergence of a new word or expression as a result of mixing parts of two words and expressions (for example, incorrect “play meaning” as k. ... ... Dictionary of foreign words of the Russian language
Mixing, connection, pollution Dictionary of Russian synonyms. contamination see mixing Dictionary of synonyms of the Russian language. Practical guide. M.: Russian language. Z. E. Alexandrova. 2011 ... Synonym dictionary
- (from Latin contaminatio contact mixing), 1) the interaction of similar in meaning or sound of language units (most often words or phrases), leading to the emergence, not always natural, of new units or to the development of one ... ... Big Encyclopedic Dictionary
Mixing of magma with completely assimilated host or other magma. n. In the process of K., foreign material is assimilated by magma by its direct melting or by matasomatic reactions and the removal of a part ... ... Geological Encyclopedia
- (from lat. contaminatio mixing) false reproduction of information, characterized by the unification in the image or concept of parts belonging to different objects. For the manifestation of the phenomenon of contamination, it is important semantic and phonetic ... ... Psychological Dictionary
CONTAMINATION, contamination, wives. (lat. contaminatio contact) (ling.). emergence new form or expression or new meaning of the word through crossing, combining elements of two homogeneous consonant forms. Wrong expression... ... Dictionary Ushakov
CONTAMINATION, and, wives. 1. Mixing, connection (book). 2. In linguistics: the emergence of a new expression, word, form by combining elements of two expressions or forms, than n. similar (for example, the incorrect expression "play a value" from ... ... Explanatory dictionary of Ozhegov
Ingress of contaminants into a sample or culture; in microbiology. - clogging (contamination) of a pure culture with foreign microorganisms. (Source: "Microbiology: a dictionary of terms", Firsov N.N., M: Bustard, 2006) ... Dictionary of microbiology
contamination- and, well. contamination f. lat. contaminatio bringing into contact, mixing. 1. lingu. The emergence of a new word or expression through crossing, combining parts of two words or expressions; e.g., the wrong expression is to reap the inheritance ... Historical dictionary gallicisms of the Russian language
CONTAMINATION- (from Latin contaminatio desecration, infection), a little-used term for the moment of infection, that is, the introduction of an infection into the body (see Infection). In psychiatry, the term K. means the incorrect addition of words, when the beginning or end ... ... Big Medical Encyclopedia
Books
- Contamination in Modern English: A Fait Accompli, N. A. Lavrova. The monograph is devoted to the multidimensional study of the word-formation model of contamination in modern English language. The work explores the structural-semantic and ...
To date, quality control and safety medicines coming to the consumer market, becomes one of the main concerns. In the pharmaceutical industry, a quality assurance system for medicines is being introduced, from their creation to their sale and use by the consumer. One of the most important parameters characterizing the quality of dosage forms is its microbiological purity.
Many drugs serve as a medium for the development of microorganisms. Drugs contaminated (contaminated) with microorganisms pose a danger to the patient. In the process of evolution, the body of an adult with the help of various systems adapted to protection against microflora (desquamation of the epidermis, acidic environment of the stomach, lysozyme in the lacrimal fluid, etc.), but the most important organs and biological fluids (brain, heart, blood, cerebrospinal fluid) always remain sterile. The protective mechanisms of the newborn are imperfect, and in a sick person they are weakened, therefore the risk of infection increases sharply when using non-sterile external dosage forms (ointments, oils, etc.). The danger of infection of the body is also great with the introduction of injection solutions, in the treatment of injuries, burns, frostbite.
Microorganisms contained in the dosage form can cause decomposition of active and excipients. This leads to a loss of the therapeutic effect of the drug, a change appearance dosage form, sometimes to the formation of toxic products. Unlike pathogenic microorganisms, many saprophytes have a large set of enzymes and are able to decompose a wide variety of substances, proteins, lipids, etc.
The intensity of the destruction of dosage forms and substances depends on their concentration, humidity, ambient temperature, as well as the nature and degree of initial contamination. The shelf life of medicines is also important.
Sources of microbial contamination:
indoor air. We know that 1 liter of air big city contains from 1 thousand to 1 million different particles that are carriers of microflora - one microorganism accounts for 1000 suspended particles;
initial medicinal and excipients of animal, vegetable and synthetic origin (for example, heavily contaminated - pancreatin, pepsin, glucose, talc, starch, agar, etc.);
dispersion media, including purified water, microbial contamination of which occurs during transportation, storage;
auxiliary materials (filtering - cotton wool, paper, gauze; packaging - paper, bottles, cans, boxes, corks);
human. In a calm state, a person in 1 minute releases up to 200 thousand different particles (scales, epidermal cells, etc.), while moving - up to 1 million, so the presence of a significant number of visitors in the trading floor of a pharmacy, the introduction of dust and dirt from outside leads to an increase in the air of microflora penetrating into industrial premises;
pharmacy staff. Even in special clothes in cleanrooms in environment employees emit up to 2 million particles ranging in size from 0.5 microns to 5 microns, 300 thousand particles with a size of 5 microns and more than 160 particles that contain microorganisms.
The main sources of pollution are the mouth and nose. When talking, the number of particles emitted by a person increases;
technological process (equipment, devices, devices).
AT last years The problem of microbial contamination of drugs has become the subject of discussion in international symposiums, meetings of the World Federation of Pharmacists and other commissions, since numerous pharmaceutical products serve as a substrate for the reproduction of microorganisms.
Because Since a pharmacy is a health care institution, it must meet a high sanitary level. Therefore, measures aimed at reducing microbial contamination of the air in pharmacy premises, equipment, and personnel hands have great importance to reduce and in some cases completely eliminate microbial contamination of drugs.
Herbal medicinal raw materials can be contaminated with microorganisms at all stages of its preparation (collection, drying, grinding, packaging, storage). Representatives of air microflora predominate on raw materials, spore and non-spore bacilli, cocci, pigment bacteria, molds, and yeasts are often found. Being on plant medicinal raw materials, microbes not only mechanically contaminate it, but also if stored improperly (high humidity, dustiness of the room, the presence of insects, rodents, etc.) multiply on it, using it for life. At the same time, under the action of microbial enzymes, pharmacologically important active substances are destroyed, which leads to a decrease in its therapeutic value. Signs of spoilage are a change in texture, color, smell. Fresh raw materials spoil especially quickly.
Sources of contamination of finished products – non-sterile air of pharmacies, equipment, raw materials, dishes, corks, water, staff hands. The possibility of the spread of microbes, especially pathogens, through prescriptions is also becoming essential.
Microbial damage is subject to:
powders (especially talc, starch), fees
solutions, potions, infusions, decoctions, drops
ointments, pastes, balls, suppositories
sterile injectable preparations
The largest number of microbes can be in water infusions, decoctions, the smallest - in tinctures. Therefore, the storage of infusions and decoctions in the refrigerator should not exceed 2 days.
Being in finished medicinal products, microorganisms multiply in them, destroying the active components of the drug. The most common signs of damage to infusions and decoctions are the appearance of turbidity, discoloration, formation of a film, sediment, sour smell, etc. These signs of spoilage are especially pronounced when sugar syrup is added and when stored in a warm room. Microbial contamination of finished products largely depends on compliance with the sanitary and hygienic regime in pharmacies.
To prevent microbial contamination medicines, the following rules must be observed:
disinfect the air with bactericidal lamps,
follow the rules of personal hygiene,
adhere to the technology of preparation of medicines,
properly store medicinal raw materials and finished dosage forms,
apply preservatives if necessary.
3.1. Determination of microbial contamination of medicinal products
According to the requirements of the WHO and the State Pharmacopoeia of the Republic of Belarus, there are certain standards that limit the microbial contamination of drugs. Microbiological analysis methods are used to detect microorganisms in medicinal preparations. Usually determine the number of microorganisms in 1 g of dry preparation or in 1 ml of solution. Methods of microbiological analysis of a particular dosage form are individual. This is due to the bactericidal and bacteriostatic action of the drugs themselves, as well as the sensitivity or resistance of microorganisms to this drug.
The microbiological purity of medicinal products, substances and auxiliary materials for the production of medicinal products must comply with the requirements set forth in Article 5.1. State Pharmacopoeia of the Republic of Belarus "General texts on sterilization" (tables 3-4).
Table 3 - Microbiological purity of medicines
Application | ||
For parenteral administration Eye medicines For application to open wounds and burns Other medicinal products subject to the requirement of "sterility" |
Sterility |
|
For topical use, transdermally For intravaginal use For guidance in the cavity yxa, noca For introduction into the respiratory tract (with the exception of those drugs that must be sterile) |
The total number of aerobic bacteria and fungi (in total) - no more than 10 2 in 1 g or 1 ml Absence of bacteria families Enterobacteriaceae in 1 g or 1 ml Absence P. aeruginosa in 1 g or 1 ml Absence S. auraeus in l g or in 1 ml |
|
For oral or rectal administration A. Medicinesufrom substances of synthetic origin B. Medicinal funds from substances of natural origin (plant, animal, mineral), per excluding funds included in the Category 4 |
Total number aerobic bacteria not more than 10 3 per 1 g or 1 ml The total number of mushrooms is not more than 10 2 in 1 g or 1 ml Absence E. coli in 1 g or 1 ml The total number of aerobic bacteria is not more than 10 4 in 1 g or 1 ml The total number of mushrooms is not more than 10 2 in 1 g or 1 ml Absence E. coli in 1 g or in 1 ml Absence of bacteria of the genus Salmonella in 10 g or 10 ml Absence P. aeruginosa in 1 g or 1 ml Absence S. aureus 1 g or in 1 ml Enterobacteria - no more than 10 2 in 1 g or 1 ml |
|
AT. Children's medicines |
The total number of aerobic bacteria is not more than 500 in 1 g or 1 ml The total number of mushrooms - no more than 50 in 1 g or 1 ml Enterobacteriaceae in 1 g or 1 ml Absence P. aeruginosa in 1 g or 1 ml Absence S. aureus in 1 g or 1 ml |
|
Medicinal products consisting of one type of raw material (packed products) or several (fees), also herbal raw materials "angro" A. Medicinal herbal products or medicinal raw materials "angro", used in the form of infusions and decoctions, prepared using heat treatment B. Medicinal herbal products or medicinal raw materials "angro", used without heat treatment |
The total number of aerobic bacteria is not more than 10 7 in 1 g or 1 ml The total number of mushrooms is not more than 10 5 in 1 g or 1 ml E. coli- no more than 10 2 in 1 g The total number of aerobic bacteria is not more than 10 per 1 g or per 1 ml The total number of mushrooms is not more than 10 4 in 1 g or 1 ml Absence E. coli in 1 g or 1 ml Absence of bacteria of the genus Salmonella in 10 g or in 10 ml Enterobacteria - no more than 10 2 in 1 g or 1 ml |
Table 4 - Microbiological purity of substances and auxiliary materials for the production of medicines
Application | ||
Substances for production: Sterile medicines Non-sterile medicinal products belonging to the Category 2 |
Total number of aerobic bacteria and fungi (total) no more than 10 2 in 1 g or 1 ml Absence of bacteria of the family Enterobacteriaceae in 1 g or 1 ml |
|
Non-sterile medicinal products belonging to Category 3B |
Absence P. aeruginosa in 1 g or 1 ml Absence S. aureus 1 g or in 1 ml |
|
Substances synthetic origin for the production of non-sterile medicinal products |
The total number of aerobic bacteria is not more than 10 2 in 1 g or 1 ml The total number of mushrooms is not more than 10 2 1 g or in 1 ml Absence E. coli in 1 g or 1 ml |
|
Substances of natural origin (plant, animal or mineral) Auxiliary materials (wheat flour, starch, talc, etc.) |
The total number of aerobic bacteria is not more than 10 2 in 1 g or 1 ml The total number of mushrooms is not more than 10 in 1 g or 1 ml Absence E. coli in 1 g or 1 ml Absence of bacteria of the genus Salmonella in 10 g or 10 ml Absence P. aeruginosa in 1 g or 1 ml Absence S. aureus in 1 g or 1 ml Enterobacteria no more than 10 2 1 g or 1 ml |
As can be seen from the tables, sterile there should be injections, ointments, films, eye drops and all dosage forms for newborns, for the local treatment of purulent wounds, ulcers, burns.
Dosage forms for taking per os should not contain pathogenic and conditionally pathogenic microorganisms.
No more than 100 are allowed microbial cells in 1 g (ml) of the drug for dosage forms of local, intravaginal use, as well as for use in the ear and nose cavity.
Some non-sterile medicinal products contain components and preservatives that have antimicrobial activity. To avoid misjudgment of the results of the test for microbiological purity, the effect of the medicinal product is preliminarily determined in relation to the following test cultures: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, bacillus subtilis (cereus), Candida albicans. Appropriate media are used for culturing test cultures (Table 5).
Table 5. Media for culturing test cultures
The purpose of preparing articles on professional terminology is the desire of the editors of the journal to improve the terminological culture of specialists and prevent the undesirable tendency of Anglo-Americanisms in the Russian language.
Terminology in a broad sense is perceived as part of vocabulary language, covering the special vocabulary used in the field professional activity of people. Exact knowledge of this or that event or phenomenon requires the same exact knowledge of its name, the so-called "term". A term is a word or phrase deliberately selected or created to refer to special items, phenomena, professional concepts, a particular field of activity. An accurate understanding of terms helps to penetrate deeper into one or another special area of knowledge, and, accordingly, their incorrect use or a pile of unnecessary terms only removes us from understanding, blocks access to knowledge.
In an era of harmonization regulatory requirements inevitable and logical mass borrowing of terms denoting new concepts. Neologisms, which reflect new phenomena and ongoing processes, help to capture the "spirit of the times", have a serious chance of being firmly rooted in the language structure.
Borrowed from the English language, the term "contamination" is "one of the evidence of the widespread use and successful entry into the Russian language of foreign words, including special terms." How useful and correct it is, let's try to figure it out!
Without pretending to be complete and accurate, we will try to highlight at least the surface features that are most characteristic of such an ingrained and “venerable” (especially in the pharmaceutical and food industries) term “contamination”.
Majority English-Russian dictionaries when translating the word contamination» suggest the following*:
- pollution;
- contamination (radioactive, chemicals, biological agents);
- infection (Syn: infection);
- spoilage, decomposition;
- pollution, contamination;
- contamination;
- getting into a certain environment of any impurity (Syn: impurity);
- harmful impurity, undesirable impurity;
- poisoning;
- contact.
First of all, I would like to draw attention to the words "infection", "infection" - these concepts imply the microbial (viral) nature of the pollutant. Also, in many Russian-language professional texts, the term “contamination” is most often found precisely in the context of the microbial nature of pollution, although another English term “biocontamination” is widely used for this.
In many ways, the interpretation of the term "contamination" depends on the scope of its application. AT medical encyclopedias and reference publications, the term "contamination" is interpreted as a little-used term to denote the moment of infection, i.e., the introduction of a foreign object into the body (i.e., in fact, a synonym for the term "infection").
In psychiatry, the term "contamination" means the incorrect addition of words, when the beginning or end of one word is borrowed from the next word, for example, "weave" instead of "the tongue is braided", in linguistics - the formation of a new word or a new stable phrase as a result of crossing two different words or expressions , similar in sound, construction, meaning, for example, “play a value” from “play a role” + “make a difference”.
The Chemical Encyclopedia presents the term "contamination" as a borrowed term denoting the mixing of components, contamination of samples, solutions, etc., distorting the results of analysis (there is also an example of regulatory application, see GOST R 53182-2008 "... To prevent contamination, the vessel is covered with paper containing no dust"), etc.
In big Soviet Encyclopedia(TSB), the term "contamination" is considered in the context of contamination of magma by sedimentary and metamorphic rocks. And an interesting clarification regarding the fact that "in contrast to the process of assimilation, the inclusion of foreign material during contamination retains relics of the structure of primary rocks." Those. during contamination (unlike other processes), there are no significant changes in the structure of the pollutant. But the term "contamination" has found the widest use in the pharmaceutical industry and, accordingly, regulatory documents related to the circulation of medicines. Starting with the order of the Ministry of Health of the Russian Federation dated October 21, 1997 No. “Microorganism contamination is the primary contamination introduced by the air flow; secondary - as a result of non-compliance with asepsis requirements, ”and continuing in the GMP manual and related recommendations. At the same time, several categories are distinguished in GMP - cross-contamination, microbial contamination, etc.
Also, in practice, one can meet separate opinions regarding the fact that "contamination" and "pollution" are fundamentally different terms. Is it so? An analysis of all available literary sources suggests that the term "contamination" may differ from the term "contamination" in that when a medium or object is contaminated there are no structural changes, but wherein properties being learned or used are changed such environment or object. Those. it turns out that, for example, when a drug is "contaminated", its quality and quantitative composition, but the consumer properties of the drug will change - compliance with the specification, safety and therapeutic efficacy of the drug. On the one hand, it’s beautiful, but on the other hand, what exactly is the difference between the term “pollution” then?
With all the diversity and possibilities of translating the term "contamination", in the context of maintaining industrial cleanliness, in our opinion, it is most correct to use the Russian term "pollution" in possible semantic combinations, specifying, if necessary, the nature of the pollutant - microbial contamination, chemical contamination, cross contamination, etc. . (see table).
The table shows the main (frequently used) cognate terms associated with the English term "contamination".
English term |
Borrowed terms |
Existing Russian language meaning |
Contamination |
Contamination |
Pollution |
Biocontamination |
Biocontamination |
Biocontamination (special case, microbial contamination) |
Cross-contamination |
Cross-contamination |
Intersecting (associated, cross) pollution |
Contaminate |
Contaminate |
Pollute |
Contaminant |
Contaminant |
Contaminant, contaminant (e.g. microorganisms that seed objects) |
Contaminator |
Contaminator |
pollutant agent |
Decontamination |
Decontamination |
Reduced pollution |
Possible to contamination |
contamination |
contamination |
Conclusion
In the international practice of standardization, it is accepted that one standardized term is established for each concept. The use of synonymous terms for a standardized term in official standards is prohibited.
In the Russian language, there are many standardized terms that do not require replacement by "non-translatable" words. In order for specialists from different countries to understand each other, it is necessary to carry out correct translations, and for this it is not at all necessary to use "foreign" terms.
Obviously, it is not worth arguing that borrowed terms can be used in professional communication. You can use the term "contamination", and even replace the term "cleaning" with the sweet hearing "cleaning". You can discuss the acceptability of this or that term for quite some time, but that is not the point.
In practice, it is more expedient to use terminology that is understandable and perceived by the contractor (operator). For example, test colleagues for the perception of the phrase - "If a product is suspected of being contaminated with detergents used in cleaning, the assessor should conduct stratified sampling to ensure a representative sample." Most likely among professionals, similar phrase will not cause even a slight shadow of non-perception. Another question is, in what state will it “plunge” a simple worker (for example, a controller) who has little command of borrowed terminology and English? But it is precisely the misunderstanding and / or non-perception of borrowed foreign terms used in the documentation that is one of the reasons for the frequent errors of personnel.
Every industry has its own "slang" called "professional terminology". Most likely, for the pharmaceutical, chemical and food industries, it will be extremely difficult to lose the ingrained term "contamination". Already a lot of words are spent on explaining the essence of such a "venerable" term. In addition, it is in the terminology that the tastes and interests of various specialists actively manifest themselves and collide. But we must not forget that the term “contamination” is too vague and contains only a certain idea that previously did not require greater accuracy and certainty, as well as the fact that it has a clear concept in the Russian language “pollution”.
But what logic can be applied to the widely used terms "attestation", "qualification" and "validation" and how controversial such terms are, read in the next issue of our magazine.
* Listed in descending order of frequency of proposed translation
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- 08/05/2019 Compliance with the temperature regime is a stumbling block for participants in the distribution chain
The number of litigation related to thermolability of drugs is increasing. Alexander Panov, head of the Healthcare practice at the law firm Pepeliaev Group, said this during the round table "Validation of the drug transportation process" organized by the Council of Supply Chain Professionals.The event was held as part of the third meeting working group"Pharmaceutical Logistics" and brought together the heads of logistics companies, as well as representatives of pharmaceutical manufacturers and distributors.
The head of the Vialek Group of Companies, Alexander Alexandrov, drew attention to the fact that deviations in the temperature regime do not always lead to a discrepancy between the product and the proper level of quality. According to him, transportation without deviations does not happen, as evidenced, among other things, by foreign experience.
“It is impossible to ensure that the temperature regime does not go beyond the limits even for a minute,” he stressed. “Another issue is that we should not allow long-term deviations, and from a legal point of view, this still needs to be finalized, because now this issue is often equated.” Another common mistake is to measure the temperature of the air rather than the temperature of the product during transport, he added.
Continuing the theme of inaccuracies in the definitions, the expert noted that the manufacturer and the holder of the registration certificate are responsible for the quality of the products. And in this regard, there is no need to manipulate the concepts of "efficacy and safety."
“Safety and efficacy are confirmed at the stage of preclinical and clinical studies,” he recalled. - Logisticians ensure this through the application of good practices. But to say that during transportation it is necessary to ensure the safety and effectiveness of the drug is incorrect - carriers must guarantee that the transportation of the goods did not have any impact on the quality of the product.
Read the details in "FV" No. 23 (978) dated 07/23/2019 in the publication "How Lucky".