Bioburden: 4 Facts You Need to Know
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Bioburden is the measure of living microbes on a surface that has not yet been sterilized. It is usually tested for on medical devices and other products that come in contact with patients during care at a medical facility.
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Bioburden
This document discusses bioburden testing, which quantifies the number of microorganisms present on a medical device or pharmaceutical product. It outlines the purposes of bioburden testing such as acting as a quality control measure and determining necessary sterilization doses. The key steps of bioburden testing include sampling techniques, extraction methods, enumeration procedures like plate counting, and incubation. Regulations like CFR 21 and ISO 11737 provide standards for bioburden testing to ensure product quality and safety.
Bioburden Testing 101
Bioburden Testing fulfills international standards for medical devices and pharmaceuticals by measuring the amount of living cells on a device.
Bioburden method validation
This document discusses two methods for validating the extraction efficiency of a bioburden test method: repetitive recovery and product inoculation. The repetitive recovery method involves repeatedly extracting microorganisms from a sample until no new organisms are recovered to determine the overall recovery rate. The product inoculation method involves inoculating a product with known microbes and calculating the recovery rate based on the inoculum amount and recovered amount. While product inoculation establishes a correction factor, the drying process can impact microbe viability, so repetitive recovery is generally preferred for determining bioburden extraction efficiency.
Bioburden Testing
Bioburden testing helps keep medical equipment safe for use by finding harmful microbes to eradicate during the sterilization process.
Understanding How Bioburden and Sterilization Affect Medical Devices
1) Bioburden refers to microorganisms present on medical devices and must be monitored and controlled as high levels can compromise sterilization validation.
2) Sterilization methods like gamma, e-beam, and ethylene oxide are effective when bioburden levels are properly determined and accounted for in the sterilization dose.
3) Maintaining low and consistent bioburden through environmental monitoring, personnel training, cleaning processes, and device design is essential for ensuring sterilized medical devices.
Biosafety level and biosafety cabinets
The document discusses biosafety levels and biosafety cabinets. It defines the four biosafety levels from BSL-1 to BSL-4 based on the risk group of pathogens handled. It also explains the different types of biosafety cabinets (class I to III), how they provide varying levels of protection to the user, product and environment through HEPA filtration and pressure differentials, and standards for their design and testing.
Bio burden
Bioburden refers to the number of microorganisms contaminating a material prior to sterilization. Bioburden testing measures the total microbial count on medical devices before final sterilization and use. It is important for quality control and ensuring sterilization processes are effective at eliminating microbes. Routine bioburden testing helps manufacturers monitor for changes in contamination levels, identify process improvements, and maintain sterility assurance of their medical products.
ENVIRONMENTAL MONITORING
The document provides an overview of microbial monitoring in a manufacturing area. It discusses:
1) The purpose of an environmental monitoring program is to provide crucial information on the quality of the aseptic processing environment during manufacturing and to prevent the release of contaminated batches.
2) Microbial monitoring tests for viable and non-viable particles in critical areas like cleanrooms, tank rooms, and packaging areas to demonstrate control of microorganisms.
3) Sources of contamination can come from air, personnel, equipment, cleaning agents and more. Monitoring must meet regulatory standards from agencies like FDA, ISO, and USP.
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Bioburden
This document discusses bioburden testing, which quantifies the number of microorganisms present on a medical device or pharmaceutical product. It outlines the purposes of bioburden testing such as acting as a quality control measure and determining necessary sterilization doses. The key steps of bioburden testing include sampling techniques, extraction methods, enumeration procedures like plate counting, and incubation. Regulations like CFR 21 and ISO 11737 provide standards for bioburden testing to ensure product quality and safety.
Bioburden Testing 101
Bioburden Testing fulfills international standards for medical devices and pharmaceuticals by measuring the amount of living cells on a device.
Bioburden method validation
This document discusses two methods for validating the extraction efficiency of a bioburden test method: repetitive recovery and product inoculation. The repetitive recovery method involves repeatedly extracting microorganisms from a sample until no new organisms are recovered to determine the overall recovery rate. The product inoculation method involves inoculating a product with known microbes and calculating the recovery rate based on the inoculum amount and recovered amount. While product inoculation establishes a correction factor, the drying process can impact microbe viability, so repetitive recovery is generally preferred for determining bioburden extraction efficiency.
Bioburden Testing
Bioburden testing helps keep medical equipment safe for use by finding harmful microbes to eradicate during the sterilization process.
Understanding How Bioburden and Sterilization Affect Medical Devices
1) Bioburden refers to microorganisms present on medical devices and must be monitored and controlled as high levels can compromise sterilization validation.
2) Sterilization methods like gamma, e-beam, and ethylene oxide are effective when bioburden levels are properly determined and accounted for in the sterilization dose.
3) Maintaining low and consistent bioburden through environmental monitoring, personnel training, cleaning processes, and device design is essential for ensuring sterilized medical devices.
Biosafety level and biosafety cabinets
The document discusses biosafety levels and biosafety cabinets. It defines the four biosafety levels from BSL-1 to BSL-4 based on the risk group of pathogens handled. It also explains the different types of biosafety cabinets (class I to III), how they provide varying levels of protection to the user, product and environment through HEPA filtration and pressure differentials, and standards for their design and testing.
Bio burden
Bioburden refers to the number of microorganisms contaminating a material prior to sterilization. Bioburden testing measures the total microbial count on medical devices before final sterilization and use. It is important for quality control and ensuring sterilization processes are effective at eliminating microbes. Routine bioburden testing helps manufacturers monitor for changes in contamination levels, identify process improvements, and maintain sterility assurance of their medical products.
ENVIRONMENTAL MONITORING
The document provides an overview of microbial monitoring in a manufacturing area. It discusses:
1) The purpose of an environmental monitoring program is to provide crucial information on the quality of the aseptic processing environment during manufacturing and to prevent the release of contaminated batches.
2) Microbial monitoring tests for viable and non-viable particles in critical areas like cleanrooms, tank rooms, and packaging areas to demonstrate control of microorganisms.
3) Sources of contamination can come from air, personnel, equipment, cleaning agents and more. Monitoring must meet regulatory standards from agencies like FDA, ISO, and USP.
Biosafety Levels, Biological Safety Cabinets and Biosafety Laboratory Constru...
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Microbiology Laboratory Qualifications and Microbial Testing Techniques
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The document discusses biosafety levels (BSL) which are used to classify biological agents based on risk. There are four biosafety levels, with BSL-1 posing the lowest risk (ex. E. coli bacteria) and BSL-4 posing the highest risk (ex. Ebola virus). Each level has specific containment controls for laboratory practices, safety equipment, and facility construction required to safely work with the biological agents in that risk group. The summary outlines some of the key containment controls like personal protective equipment, biological safety cabinets, and facility access restrictions that distinguish the different biosafety levels.
Updates to the Bioburden Standard ISO 11737-1; significant additional guidanc...
This document discusses updates being made to ISO 11737-1, the international standard for bioburden testing. It notes that microbiologists are less commonly employed directly by medical device companies now. This can lead to less expertise in critical areas like sterilization validation. The document advocates including knowledgeable microbiologists in product design and process validation decisions. It also provides guidance on challenges like low bioburden testing, sample pooling, atypical bioburden results, and updates being made to the standard to address these issues.
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Testing of disinfectants
This document discusses various methods for testing the efficacy of disinfectants, including carrier tests, suspension tests, and practical tests. Carrier tests involve contaminating carriers like threads with bacteria and exposing them to disinfectants. Suspension tests involve exposing a bacterial suspension directly to the disinfectant. Practical tests evaluate disinfectants under real-world conditions. The document also describes factors that can influence disinfection like temperature, pH, and the presence of organic matter or other substances. Specific tests discussed in detail include the AOAC use-dilution test, Kelsey-Sykes capacity test, and surface disinfection tests.
Sterility assurance
This document discusses microbiology activities related to sterility assurance for pharmaceutical products. It outlines the microbiological testing done on raw materials, processes, water systems, environments and finished products. This includes bioburden testing, pathogen testing, endotoxin testing, and sterility testing. It also discusses environmental monitoring programs for sterile facilities and aseptic filling areas. Key requirements outlined include pre-filtration bioburden limits, media fill qualifications, aseptic process simulations, and staff performance monitoring. Recent issues with increased out of limit environmental monitoring results are also summarized.
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Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
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This document discusses biological safety cabinets (BSCs), which are intended to protect laboratory workers from aerosols and airborne particles. It describes the three classes of BSCs - Class I, II, and III - and their varying degrees of protection. Class I BSCs protect the worker, Class II protect the worker and environment, and Class III protect the worker, environment, and product. The key features of each class are explained, including HEPA filtration and air flow patterns. Proper use and maintenance of BSCs is also covered.
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The document discusses three main methods for the bacterial endotoxin test - gel clot, turbidimetric, and chromogenic. The gel clot method is the simplest but least quantitative, while turbidimetric and chromogenic methods allow for more automation and precision using spectrophotometry. All three methods use Limulus amebocyte lysate and detect endotoxins through coagulation reactions. The choice of method depends on factors like testing volumes, sample properties, required sensitivity, and compliance needs. Photometric methods have advantages of automation and precision but higher costs, while gel clot is inexpensive but less quantitative.
Microbiological sampling of air
This document discusses microbiological air sampling methods used in quality control laboratories. It describes two primary sampling methods: active monitoring which uses air samplers to force air into collection plates, and passive monitoring which uses open collection plates exposed to ambient air. Specific active monitoring methods discussed include impactors which accelerate air onto plates, sieve samplers with stacked perforated plates, and centrifugal samplers. Gelatin membrane filtration is also covered as it can reliably capture viruses. Maintaining sample integrity and accurately measuring air volumes are challenges addressed.
Environmental monitoring
The document discusses environmental monitoring programs in clean rooms and aseptic processing areas. It describes the purpose of monitoring to control microbial and particle contamination and prevent release of contaminated products. Key aspects covered include viable and non-viable monitoring of air, surfaces, personnel and drains using methods like air sampling, surface swabbing and particle counting. It provides classification standards and action limits for contamination and validation procedures for HVAC systems. Personnel are identified as the main challenge to control in aseptic processing.
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This document discusses biofilm in endodontics. It defines biofilm as a community of microorganisms attached to a surface and embedded in a self-produced matrix. The document covers the ultrastructure of biofilm, its characteristics, development, and how it provides protection and benefits to microbes. Biofilm formation involves initial attachment, growth and maturation of microcolonies, and dispersion. Quorum sensing allows for genetic exchange between bacteria in biofilm. Due to its structure and physiology, biofilm exhibits high resistance to antimicrobial agents.
Biohazard
The document discusses biohazards and outlines procedures for ensuring environmental safety when working with biological materials. It defines biohazards as biological substances that threaten human health, such as viruses, bacteria, and toxins. Different levels of biocontainment are used depending on the risk level of the pathogens being handled, with Level 1 requiring minimal precautions and Level 4 the highest level of isolation for dangerous pathogens lacking vaccines or treatments. Proper use of warning signs, protective equipment, sterilization processes, and segregated work areas are emphasized for reducing risks of exposure or contamination.
Significance of sterility testing
Significance of sterility testingDr. Prashant L. Pingale GES's Sir Dr. M. S. Gosavi College of Pharmacy, Nashik
Sterility testing attempts to determine if viable microorganisms are present in pharmaceutical products by testing samples from a batch. It is done after sterilization but cannot guarantee sterility of the entire batch. Major factors that can affect the results are the testing environment, culture conditions, sampling procedure, and test method used. Common test methods include membrane filtration and direct inoculation into culture media like fluid thioglycollate and soya-bean casein digest media. Observation over the incubation period can indicate if the test and batch pass or fail sterility requirements. Guidelines stress the level of assurance depends on manufacturing conditions and batch homogeneity.WHO Good Practices for Microbiology Labs.
This document provides a summary of guidance from the World Health Organization (WHO) on good practices for pharmaceutical microbiology laboratories. It was compiled by Drug Regulations, a non-profit organization that provides online resources for pharmaceutical professionals. The guidance covers topics such as personnel qualifications, laboratory design, equipment calibration, test method validation, and environmental monitoring of sterility testing facilities.
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The document discusses setting alert and action levels for bioburden and endotoxin levels during biologics manufacturing. It describes using a quality risk management process like FMEA to establish risk-based alert and action levels during clinical and early commercial stages when historical data is limited. For later stages when more data is available, levels can be set statistically based on actual process capability and performance. The document provides an example of revising drug substance specifications and establishing alert and action levels for bioburden and endotoxin throughout development and commercial manufacturing.Mlt
This document provides procedures for conducting a Microbial Limit Test (MLT). The test involves several steps: sample pretreatment, total aerobic count using membrane filtration or plate count methods, and examination for specified microorganisms like E. coli, Salmonella, Pseudomonas aeruginosa, and Staphylococcus aureus. Positive and negative controls are run alongside each test. The procedures describe preparing bacterial and fungal suspensions, inoculating various media, and incubating and examining plates to identify microbial growth or absence. Safety precautions like using clean gloves and running tests under laminar airflow are also outlined.
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The document discusses biosafety levels (BSL) which are used to classify biological agents based on risk. There are four biosafety levels, with BSL-1 posing the lowest risk (ex. E. coli bacteria) and BSL-4 posing the highest risk (ex. Ebola virus). Each level has specific containment controls for laboratory practices, safety equipment, and facility construction required to safely work with the biological agents in that risk group. The summary outlines some of the key containment controls like personal protective equipment, biological safety cabinets, and facility access restrictions that distinguish the different biosafety levels.
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Good Aseptic Practices ppt
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
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A biological indicator is a standardized preparation of viable microorganisms, usually bacterial spores, that is carried either directly by some of the items to be sterilized or by carriers such as filter papers, porcelain cylinders, that serve as a challenge to the effectiveness of a given sterilization cycle
Testing of disinfectants
This document discusses various methods for testing the efficacy of disinfectants, including carrier tests, suspension tests, and practical tests. Carrier tests involve contaminating carriers like threads with bacteria and exposing them to disinfectants. Suspension tests involve exposing a bacterial suspension directly to the disinfectant. Practical tests evaluate disinfectants under real-world conditions. The document also describes factors that can influence disinfection like temperature, pH, and the presence of organic matter or other substances. Specific tests discussed in detail include the AOAC use-dilution test, Kelsey-Sykes capacity test, and surface disinfection tests.
Sterility assurance
This document discusses microbiology activities related to sterility assurance for pharmaceutical products. It outlines the microbiological testing done on raw materials, processes, water systems, environments and finished products. This includes bioburden testing, pathogen testing, endotoxin testing, and sterility testing. It also discusses environmental monitoring programs for sterile facilities and aseptic filling areas. Key requirements outlined include pre-filtration bioburden limits, media fill qualifications, aseptic process simulations, and staff performance monitoring. Recent issues with increased out of limit environmental monitoring results are also summarized.
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This document discusses biological safety cabinets (BSCs), which are intended to protect laboratory workers from aerosols and airborne particles. It describes the three classes of BSCs - Class I, II, and III - and their varying degrees of protection. Class I BSCs protect the worker, Class II protect the worker and environment, and Class III protect the worker, environment, and product. The key features of each class are explained, including HEPA filtration and air flow patterns. Proper use and maintenance of BSCs is also covered.
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Microbiological sampling of air
This document discusses microbiological air sampling methods used in quality control laboratories. It describes two primary sampling methods: active monitoring which uses air samplers to force air into collection plates, and passive monitoring which uses open collection plates exposed to ambient air. Specific active monitoring methods discussed include impactors which accelerate air onto plates, sieve samplers with stacked perforated plates, and centrifugal samplers. Gelatin membrane filtration is also covered as it can reliably capture viruses. Maintaining sample integrity and accurately measuring air volumes are challenges addressed.
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The document discusses biohazards and outlines procedures for ensuring environmental safety when working with biological materials. It defines biohazards as biological substances that threaten human health, such as viruses, bacteria, and toxins. Different levels of biocontainment are used depending on the risk level of the pathogens being handled, with Level 1 requiring minimal precautions and Level 4 the highest level of isolation for dangerous pathogens lacking vaccines or treatments. Proper use of warning signs, protective equipment, sterilization processes, and segregated work areas are emphasized for reducing risks of exposure or contamination.
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Sterility testing attempts to determine if viable microorganisms are present in pharmaceutical products by testing samples from a batch. It is done after sterilization but cannot guarantee sterility of the entire batch. Major factors that can affect the results are the testing environment, culture conditions, sampling procedure, and test method used. Common test methods include membrane filtration and direct inoculation into culture media like fluid thioglycollate and soya-bean casein digest media. Observation over the incubation period can indicate if the test and batch pass or fail sterility requirements. Guidelines stress the level of assurance depends on manufacturing conditions and batch homogeneity.WHO Good Practices for Microbiology Labs.
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Biosaftey means the needs to protect human and animal health along with the environment from the possible adverse effects of the products of modern biotechnology. Biosafety defines the containment conditions under which infectious agents can be safely manipulated. Biosafety word is used to reduce and eliminate the potential risk regulating from the modern biotechnology and its products.
Regulations for safety in biological plants
This document outlines regulations for safety in biological plants regarding biohazards and biosecurity. It defines key terms like biohazard, biosecurity, and biosafety. It discusses safety basics in biological plants including biosafety in the lab and personal biosafety. It covers national regulations in India for biological safety as well as international regulations. Guidelines are provided for risk assessment, pathogen assessment, biosafety levels, good manufacturing practices, and the roles of various containment barriers.
Microbiology | Control of Microorganisms
At the end of this session learner will be able to:
Define Common terms.
Explain the importance of microorganisms control.
Discuss the Methods of sterilization.
Categorize the broad spectrum and narrow spectrum antibiotics.
8. principles of biosafety, biocontainment & program management (nbb160)
This is an unfortunate example of how failing to follow proper biosafety procedures can put lives at risk. Some key issues:
- Margurita experienced a direct exposure to potentially infectious fluids from a non-human primate, which should have triggered an immediate medical evaluation.
- Her supervisor dismissed the incident instead of ensuring proper exposure follow up per biosafety protocols.
- The delayed onset of symptoms made the link to occupational exposure less clear, but failure to seek timely medical care likely contributed to the tragic outcome.
- All exposures, however minor they seem, must be reported and treated seriously to protect worker health and safety when handling infectious agents. Proper training and oversight can prevent such preventable accidents and protect both
Introduction to cell culture.pptx
safety data sheet, an introduction to cell culture, safety equipment, safe laboratory practices, ascetic techniques, sterile work area, good personal hygiene, sterile reagents and media, sterile handling, planning of cell culture labs.
BIOSAFETY AND INDIAN ETHICS (DRA)
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety also means safety from exposure to infectious agents.
Necessity
In order to avoid infection/biohazard to the laboratory personnel & the environment, biosafety levels are very important.
Safety considerations and guidelines veterinary microbiology laboratory
This document provides guidelines on biosafety and biosecurity for veterinary microbiology laboratories. It defines key terms like biohazard, biosafety, risk assessment, biosecurity, and the biohazard symbol. It discusses the chain of infection and approaches to reduce risk of exposure like risk assessment, personal protective equipment, immunizations, and surveillance. The document also compares and contrasts biosecurity and biosafety. It provides guidance on developing a biosecurity program and addressing breaches. It discusses challenges of preventing interference while ensuring legitimate access.
Biosafety
The document discusses biosafety concepts and practices. It begins by defining biosafety as safety from exposure to infectious agents. It then discusses biosafety issues in various disciplines like agriculture, medicine, and chemistry. The rest of the document outlines biosafety concepts, levels, and practices based on guidance from the Biosafety in Microbiological and Biomedical Laboratories (BMBL) including standard microbiological practices, safety equipment, and facility design requirements for different biosafety levels from BSL-1 to BSL-4. It also discusses risk assessment and containment practices for working with various biological hazards.
Importance of sterilization and its guidelines
Sterilization and disinfection are the basic components of hospital infection control activities. Every day, a number of hospitals are performing various surgical procedures. Even more number of invasive procedures are being performed in different health care facilities. The medical device or the surgical instrument that comes in contact with the sterile tissue or the mucus membrane of the patient during the various processes is associated with increased risk of introduction of pathogens into the patient's body. Moreover, there is chance of transmission of infection from patient to patient; from patient or to health care personnel, and vice versa; or from the environment to the patient through the improper sterilized or disinfected devices. Hence, medical personnel, laboratory people and the health care providers should have better knowledge regarding these techniques to prevent the spread of these pathogens.
Physical Methods of Sterliztaion
Physical methods of sterilization include heat, radiation, filtration, and chemical agents. Heat-based methods like autoclaving use high temperatures to kill microbes through protein denaturation. Radiation methods employ UV light or gamma rays which damage microbial DNA. Filtration removes microbes by trapping them in fine pore membranes or filters. Sterilization is important in healthcare and food production to prevent transmission of disease and control microbial growth.
Safety measures, short and accurate ppt
The document discusses safety measures for clinical microbiology laboratories. It emphasizes the importance of lab safety to prevent adverse effects from potential hazards. Good lab practices include proper personal hygiene like handwashing and avoiding eating or drinking in the lab. Labs must follow biosafety guidelines for different levels of microorganisms. Aseptic technique is also important to avoid contamination. Proper clean up and disposal of materials helps maintain safety, such as autoclaving contaminated glassware before disposal.
Sterilization in dentistry 2
This document discusses sterilization in dentistry. It defines sterilization as the process of destroying all microbial life from surfaces and instruments using physical and chemical methods. Sterilization is important in dentistry to prevent the spread of infections between patients and dental staff through contaminated instruments. Instruments are classified as critical, semi-critical, or non-critical depending on infection risk. Common sterilization methods discussed are heat (dry and moist), radiation, and chemicals. Monitoring of sterilization includes mechanical, chemical, and biological indicators to ensure the process was effective.
Clinical Biochemistry Laboratory
Biochemistry is a basic science which deals with chemical nature and chemical behaviour of living matter and with the reactions and processes they undergo.
Biochemistry involves the study of:
Chemical constituents of living matter.
Chemical changes which occur in the organism during digestion, absorption and excretion.
Chemical changes which occur during growth and multiplication of the organism.
Transformation of one form of chemical constituent to the other.
Energy changes involved in such transformation.
Note:- The term “Biochemistry” was first introduced by German chemist Carl Neuberg in 1903 from Greek word “bios” means “life”.
It is mainly deals with the biochemical aspects that are involved in several conditions.
The results of qualitative and quantitative analysis of body fluids assist the clinicians in the diagnosis, treatment and prevention of the disease and drug monitoring, tissue and organ transplantation, forensic investigations and so on.
Various biological fluids subjected to chemical tests and assays include blood, plasma, serum, urine, cerebrospinal fluid (CSF), ascetic fluid, pleural fluid, faeces, calculi and tissues.
Note:- Modern day medical practice is highly dependent on the laboratory analysis of body fluids, especially the blood. The disease manifestations are reflected in the composition of blood and other tissues.
Hence, the demarcation of abnormal from normal constituents of the body is another aim of the study of clinical biochemistry.
Sterilization in dentistry 2
This document discusses sterilization in dentistry. It defines sterilization as the process of destroying all microbial life from surfaces and instruments using physical and chemical methods. Sterilization is important in dentistry to prevent the spread of infections between patients and dental staff through contaminated instruments and surfaces. Instruments are classified as critical, semi-critical, or non-critical depending on infection risk. Common sterilization methods discussed are heat (dry and moist), radiation, and chemicals like phenols, alcohols, aldehydes, and gases. Monitoring of sterilization involves mechanical, chemical, and biological indicators to evaluate effectiveness.
Biosafety
A university researcher died from an infection caused by bacteria he was studying. The bacteria, Yersinia pestis, causes plague. An autopsy found the bacteria in his body but no obvious cause of death. More tests are planned as no other illnesses have been reported. Biosafety aims to reduce risks from exposure to infectious agents through standard practices, containment equipment, facility design and other principles outlined in publications like the Biosafety in Microbiological and Biomedical Laboratories manual. Risk assessments consider the organism, procedures, containment and other factors to determine appropriate biosafety levels and practices.
Biomedical waste management ppt
Biomedical management is one of the most important tasks in healthcare settings. An attempt has been made here to share some knowledge about this.
Biosafety Precautions and LAI.pptx
This document discusses biosafety precautions and laboratory acquired infections. It begins by introducing biosafety and biosafety levels 1 and 2. Biosafety level 1 is for well characterized agents that do not consistently cause disease, while level 2 requires specific training and procedures when working with agents that pose moderate hazards. The document then discusses principles of biosafety like containment and risk assessment. It also provides details on safety equipment, facility design, standard microbiological practices and national biosafety guidelines to prevent laboratory acquired infections.
Safety & Risk management for healthcare professionals - Dr J L Meena
MDI 2020 WEBINAR 03 On, “Safety And Risk Management For Healthcare Professionals “, September 8, 2020 , 12 Noon (India) & 9:30 am (Kenya)
Focus : Safety, Infection Control, Biomedical Waste Management, Adverse Events
Chapter 7 biological hazards
This document discusses biological and physical hazards. It defines biological hazards as organic substances that threaten health, such as bacteria, viruses, fungi and toxins. It estimates 320,000 workers die annually from work-related biological exposures. Biological hazards enter the body through inhalation, absorption, ingestion, or injection. Engineering, administrative and personal protective controls are used to limit exposure. Radiation can be ionizing (x-rays, gamma rays) or non-ionizing (visible light, radio waves) with ionizing posing health risks like cancer from tissue damage. Sources of ionizing radiation include medical equipment and nuclear reactors/materials.
Bio safety iitb 1
This document summarizes biosafety guidelines for working with biological materials in a laboratory setting. It describes the various hazards associated with bio research, including hazards from pathogens and laboratory procedures. It provides classifications for pathogens based on their risk level. It also outlines containment procedures like good microbiological techniques, personal protective equipment, and different biosafety levels that should be followed to minimize risk of exposure, depending on the pathogen risk group. The goal is to protect researchers and prevent the spread of infections.
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8. principles of biosafety, biocontainment & program management (nbb160)
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Bioburden: 4 Facts You Need to Know
- 1. Bioburden 4 FACTS YOU NEED TO KNOW
- 2. What is bioburden? Bioburden is the measure of living microbes on a surface that has not yet been sterilized. Most commonly, bioburden is referenced when being tested for on medical devices or objects used in medical care facilities.
- 3. The most common microbes tested for in bioburden are Yeast Candida albicans Bacteria Escherichia coli (E. coli) Bacteria Pseudomonas aeruginosa Bacteria Staphylococcus aureus Fungus Aspergillua niger
- 4. Candida albicans causes oral and genital infections
- 5. Escherichia coli (E. coli) is a common cause of food poisoning
- 6. Pseudomonas aeruginosa infects damaged tissue with decreased immunity
- 7. Staphylococcus aureus is the most common cause of Staph infections
- 8. Aspergillua niger causes black mold
- 9. Why test for bioburden? These microbes, though not usually much to worry about in normal life, can be extremely dangerous and life-threatening if unintentionally inserted into the body during medical procedures. By testing for bioburden, scientists can determine the most effective ways to sterilize medical equipment to make them safe for use.
- 10. Doctors don’t want to send a sick patient home with a disease that could have been prevented from a little sterilization.
- 11. Who completes bioburden testing? The FDA and International Organization for Standardization have specific guidelines that must be followed when testing for bioburden. Medical device companies are required to perform bioburden testing in house or hire a lab to perform the tests for them, such as Nelson Laboratories.
- 12. During bioburden testing, devices may be cut up and dismantled to test every surface of the product.
- 13. How is bioburden managed? Medical device companies perform bioburden testing on their first run of a product to determine the necessary sterilization techniques for all the other runs. Random routine testing is performed after that to ensure that the appropriate measures are being taken and the medical devices are truly safe.
- 14. Time lapse tests are also performed to see how often sterilization is required for certain products. Scalpels, catheters, and other frequently used medical devices are sterilized after every use. Other devices may only need to be sterilized once a week or between uses on different patients.
- 15. The are two primary sterilization methods Ethylene Oxide: devices are exposed to toxic gas, which eliminates hiding microbes. Radiation: gamma rays or X-rays that penetrate all types of materials (cloth, metal, plastic, etc.) are used to eliminate microbes on medical devices.
- 16. These sterilization techniques can be performed at medical care facilities with the right equipment, or can be sent to a secondary location to complete the same procedures. Either way, bioburden is eliminated to prevent harmful infections or diseases to patients.
- 17. Everyone is happy when patients get healthy and stay healthy.
- 18. For more information on bioburden or bioburden testing see http://www.slideshare.net/DocK etchum/bioburden-testing, or contact Nelson Laboratories