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Bioburden
Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized. The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products proves that these requirements have been met. Bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737. The aim of bioburden testing is to measure the total number of viable micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use. 21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written proce ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biofouling
Biofouling or biological fouling is the accumulation of microorganisms, plants, algae, or small animals where it is not wanted on surfaces such as ship and submarine hulls, devices such as water inlets, pipework, grates, ponds, and rivers that cause degradation to the primary purpose of that item. Such accumulation is referred to as '' epibiosis'' when the host surface is another organism and the relationship is not parasitic. Since biofouling can occur almost anywhere water is present, biofouling poses risks to a wide variety of objects such as boat hulls and equipment, medical devices and membranes, as well as to entire industries, such as paper manufacturing, food processing, underwater construction, and desalination plants. Anti-fouling is the ability of specifically designed materials (such as toxic biocide paints, or non-toxic paints) to remove or prevent biofouling. The buildup of biofouling on marine vessels poses a significant problem. In some instances, the hull str ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medication
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmacotherapy) is an important part of the medicine, medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are Drug class, classified in many ways. One of the key divisions is by level of controlled substance, control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the medical prescription) from over-the-counter drugs (those that consumers can order for themselves). Medicines may be classified by mode of action, route of administration, biological system affected, or therapeutic effects. The World Health Organization keeps a list of essential medicines. Drug discovery and drug development are complex and expensive endeavors undertake ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introductio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Microbe
A microorganism, or microbe, is an organism of microscopic size, which may exist in its single-celled form or as a colony of cells. The possible existence of unseen microbial life was suspected from antiquity, with an early attestation in Jain literature authored in 6th-century BC India. The scientific study of microorganisms began with their observation under the microscope in the 1670s by Anton van Leeuwenhoek. In the 1850s, Louis Pasteur found that microorganisms caused food spoilage, debunking the theory of spontaneous generation. In the 1880s, Robert Koch discovered that microorganisms caused the diseases tuberculosis, cholera, diphtheria, and anthrax. Microorganisms are extremely diverse, representing most unicellular organisms in all three domains of life: two of the three domains, Archaea and Bacteria, only contain microorganisms. The third domain, Eukaryota, includes all multicellular organisms as well as many unicellular protists and protozoans that are ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Title 21 Of The Code Of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requireme ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Organization For Standardization
The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and () it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by the International Electrotechnical Commission.Editors of Encyclopedia Britannica. 3 June 2021.Inte ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Most Probable Number
Most or Möst may refer to: Places * Most, Kardzhali Province, a village in Bulgaria * Most (city), a city in the Czech Republic ** Most District, a district surrounding the city ** Most Basin, a lowland named after the city ** Autodrom Most, motorsport race track near Most * Möst, Khovd, a district in Khovd, Mongolia * Most, Mokronog-Trebelno, a settlement in Slovenia * Most, Istria County, a settlement in Croatia Other uses * Most (surname), including a list of people with the surname * Franz Welser-Möst (born 1960), Austrian conductor * ''Most'' (1969 film), a film about WWII Yugoslavian partisans * ''Most'' (2003 film), a Czech film * ''Most!'', 2018 Czech TV series * Most (grape) or Chasselas * most (Unix), a terminal pager on Unix and Unix-like systems * Most (wine) or Apfelwein * ''most'', an English degree determiner * Monolithic System Technology (MoST), a defunct American fabless semiconductor company * Most (Croatian political party), a party founded in 201 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Colony Forming Unit
In microbiology, a colony-forming unit (CFU, cfu or Cfu) is a unit which estimates the number of microbial cells (bacteria, fungi, viruses etc.) in a sample that are viable, able to multiply via binary fission under the controlled conditions. Counting with colony-forming units requires culturing the microbes and counts only viable cells, in contrast with microscopic examination which counts all cells, living or dead. The visual appearance of a colony in a cell culture requires significant growth, and when counting colonies, it is uncertain if the colony arose from a single cell or a group of cells. Expressing results as colony-forming units reflects this uncertainty. Theory The purpose of plate counting is to estimate the number of cells present based on their ability to give rise to colonies under specific conditions of temperature, time, and nutrient medium. Theoretically, one viable cell can give rise to a colony through replication. However, solitary cells are the exception i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
USP Controlled Room Temperature
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; the relevant omnibus standard is USP 797. Although 100% compliance remains challenging for any given facility, the larger protocol may be regarded as constituting a form of clean room which is included in a suite of best practice A best practice is a method or technique that has been generally accepted as superior to alternatives because it tends to produce superior results. Best practices are used to achieve quality as an alternative to mandatory standards. Best practice ...s. References Drug safety {{pharmacy-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Healthcare-associated Infections
A hospital-acquired infection, also known as a nosocomial infection (from the Greek , meaning "hospital"), is an infection that is acquired in a hospital or other healthcare facility. To emphasize both hospital and nonhospital settings, it is sometimes instead called a healthcare-associated infection. Such an infection can be acquired in a hospital, nursing home, rehabilitation facility, outpatient clinic, diagnostic laboratory or other clinical settings. A number of dynamic processes can bring contamination into operating rooms and other areas within nosocomial settings. Infection is spread to the susceptible patient in the clinical setting by various means. Healthcare staff also spread infection, in addition to contaminated equipment, bed linens, or air droplets. The infection can originate from the outside environment, another infected patient, staff that may be infected, or in some cases, the source of the infection cannot be determined. In some cases the microorganism origi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Hospital-acquired Infection
A hospital-acquired infection, also known as a nosocomial infection (from the Greek , meaning "hospital"), is an infection that is acquired in a hospital or other health care, healthcare facility. To emphasize both hospital and nonhospital settings, it is sometimes instead called a healthcare-associated infection. Such an infection can be acquired in a hospital, nursing home care, nursing home, physical medicine and rehabilitation, rehabilitation facility, outpatient clinic, diagnostic laboratory or other clinical settings. A number of dynamic processes can bring contamination into operating rooms and other areas within nosocomial settings. Infection is spread to the susceptible patient in the clinical setting by various means. Healthcare staff also spread infection, in addition to contaminated equipment, bed linens, or air droplets. The infection can originate from the outside environment, another infected patient, staff that may be infected, or in some cases, the source of the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
HEPA
HEPA (, high efficiency particulate air) filter, also known as a high efficiency particulate arresting filter, is an efficiency standard of air filters. Filters meeting the HEPA standard must satisfy certain levels of efficiency. Common standards require that a HEPA air filter must remove—from the air that passes through—at least 99.95% (ISO, European Standard) or 99.97% (ASME, U.S. DOE) of particles whose diameter is equal to 0.3 μm, with the filtration efficiency increasing for particle diameters both less than and greater than 0.3 μm. HEPA filters capture pollen, dirt, dust, moisture, bacteria (0.2–2.0 μm), viruses (0.02–0.3 μm), and submicron liquid aerosol (0.02–0.5 μm). Some microorganisms, for example, ''Aspergillus niger'', '' Penicillium citrinum'', ''Staphylococcus epidermidis'', and ''Bacillus subtilis'' are captured by HEPA filters with photocatalytic oxidation (PCO). A HEPA filter is also able to capture some viruses and ba ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
