Sterile Product Theory - Exam Review
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Questions and Answers

What best describes sporadic infections?

  • They always lead to an epidemic.
  • They are isolated cases that occur infrequently and irregularly. (correct)
  • They have a large number of cases in a specific region.
  • They occur predictably in every population.
  • Which of the following is an example of a disease that can cause nosocomial infections?

  • Ebola
  • West Nile virus
  • Urinary tract infections (correct)
  • Measles
  • What distinguishes sterilization from disinfection?

  • Sterilization ensures complete eradication of all microbial life. (correct)
  • Sterilization reduces the number of harmful microorganisms.
  • Disinfection eliminates all forms of microbial life.
  • Disinfection is more effective than sterilization.
  • Which of the following pathogens is not a common cause of nosocomial infections?

    <p>Norovirus (A)</p> Signup and view all the answers

    What method can help control sporadic infections in a population?

    <p>Vaccinations and good public health practices. (D)</p> Signup and view all the answers

    Which type of infection is defined as being acquired during a stay in a healthcare facility?

    <p>Nosocomial infections (A)</p> Signup and view all the answers

    What is an example of an iatrogenic infection?

    <p>Infections from contaminated equipment (D)</p> Signup and view all the answers

    Which of the following infections is considered endemic?

    <p>Malaria (D)</p> Signup and view all the answers

    What distinguishes a pandemic from an epidemic?

    <p>A pandemic involves multiple countries. (D)</p> Signup and view all the answers

    How many people in the USA are affected annually by nosocomial infections?

    <p>2 million (A)</p> Signup and view all the answers

    Which factor does NOT affect the incidence of endemic diseases?

    <p>Global travel patterns (A)</p> Signup and view all the answers

    Which of the following infections is caused by a resistant bacterium?

    <p>Tuberculosis (D)</p> Signup and view all the answers

    What percentage of nosocomial infections are considered preventable?

    <p>33% (D)</p> Signup and view all the answers

    What is the primary purpose of sterilization compared to disinfection?

    <p>It ensures complete eradication of all microorganisms. (B)</p> Signup and view all the answers

    Which of the following statements about disinfectants is true?

    <p>They are used on inanimate surfaces where higher concentrations are tolerable. (B)</p> Signup and view all the answers

    What defines an antiseptic?

    <p>A chemical agent used on living skin or mucous membranes. (D)</p> Signup and view all the answers

    Which of the following correctly describes the use of cold sterilants?

    <p>They achieve sterility without using heat. (C)</p> Signup and view all the answers

    What is the main characteristic of community-acquired infections?

    <p>They typically occur in everyday environments. (B)</p> Signup and view all the answers

    Which type of disinfectant is typically used for cleaning hospital floors?

    <p>Bleach (D)</p> Signup and view all the answers

    What is the primary function of antisepsis?

    <p>To kill microorganisms on living skin or mucous membranes. (D)</p> Signup and view all the answers

    Why are antiseptics typically gentler than disinfectants?

    <p>They are meant for direct application on skin or wounds. (A)</p> Signup and view all the answers

    What are the factors contributing to the increase of drug-resistant pathogens?

    <p>Poor hygiene procedures and aseptic techniques (D)</p> Signup and view all the answers

    Which method utilizes hot air for sterilization?

    <p>Dry heat (C)</p> Signup and view all the answers

    What is a major disadvantage of using dry heat for sterilization?

    <p>It is time-consuming. (B)</p> Signup and view all the answers

    Which physical anti-microbial method is suitable for materials that cannot be exposed to moisture?

    <p>Dry heat (D)</p> Signup and view all the answers

    What is the primary application of cold methods in microbial growth control?

    <p>To inhibit microbial growth (C)</p> Signup and view all the answers

    What temperature range is generally used for sterilization in a dry heat oven?

    <p>160-180°C (B)</p> Signup and view all the answers

    Which of the following is NOT a characteristic of moist heat sterilization?

    <p>Uses high pressure (B)</p> Signup and view all the answers

    What is a potential consequence of thawing previously frozen items in terms of microbial growth?

    <p>Can allow bacteria to resume growth (B)</p> Signup and view all the answers

    Which of the following statements reflects a pro of using dry heat sterilization?

    <p>It is non-toxic. (A)</p> Signup and view all the answers

    What is the main use of filtration in physical anti-microbial methods?

    <p>To remove particles and bacteria from liquids (C)</p> Signup and view all the answers

    What is the primary function of hydrophobic filters?

    <p>To filter gases and solvents while repelling water (B)</p> Signup and view all the answers

    Which of the following is a disadvantage of using low-level anti-microbial agents like phenols?

    <p>They can be absorbed through skin or stoppers of vials. (B)</p> Signup and view all the answers

    Which concentration range defines intermediate level chemical anti-microbial agents?

    <p>50-80% (B)</p> Signup and view all the answers

    What is a key characteristic of alcohol as an intermediate level anti-microbial agent?

    <p>It provides effective skin antisepsis. (A)</p> Signup and view all the answers

    What is a limitation of using phenols for disinfection?

    <p>They can be corrosive and used minimally. (B)</p> Signup and view all the answers

    What is one of the benefits of using low-level anti-microbial agents?

    <p>They maintain contact with surfaces to extend their effect. (A)</p> Signup and view all the answers

    In what scenario should low-level anti-microbial agents not be employed?

    <p>Use in neonatal units. (A)</p> Signup and view all the answers

    What type of solutions are hydrophilic filters designed for?

    <p>Aqueous solutions. (B)</p> Signup and view all the answers

    What is a primary route through which sexually transmitted infections (STIs) can be transmitted?

    <p>Direct mucous-to-mucous membrane contact (D)</p> Signup and view all the answers

    Which of the following diseases can be transmitted through airborne droplets?

    <p>Tuberculosis (B)</p> Signup and view all the answers

    What is the main concern regarding surfaces contaminated with fecal matter?

    <p>Gastrointestinal infections (C)</p> Signup and view all the answers

    What are fomites?

    <p>Inanimate objects that can transmit pathogens (B)</p> Signup and view all the answers

    What is a requirement for controlled rooms according to NAPRA?

    <p>Areas must maintain positive pressure (A)</p> Signup and view all the answers

    Which of the following is NOT a function of an anteroom?

    <p>Monitoring of air quality (B)</p> Signup and view all the answers

    What type of environment is a clean room designed to be?

    <p>Ultra-clean with strict control measures (D)</p> Signup and view all the answers

    Which of the following is not a guideline for constructing controlled environments?

    <p>Ceilings must be absorbent to reduce contaminants (B)</p> Signup and view all the answers

    What can be a consequence of improper sterilization of medical instruments?

    <p>Increased likelihood of infection transmission (A)</p> Signup and view all the answers

    Which activity is expected to take place in a controlled room?

    <p>Compounding of sterile preparations (C)</p> Signup and view all the answers

    Flashcards

    Sterilization

    The complete eradication of harmful microorganisms.

    Disinfection

    Process using a disinfectant to reduce or inactivate disease-causing microorganisms.

    Disinfectant

    A chemical agent that reduces the number of microorganisms on non-living surfaces.

    Antiseptic

    A chemical agent used on living skin to kill microorganisms.

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    Antisepsis

    The process of using antiseptics on living surfaces to kill germs.

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    Cold Sterilant

    A chemical agent used to sterilize equipment without heat.

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    Community-Acquired Infection

    An infection caught outside a healthcare setting.

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    Physical Anti-Microbial Method

    Methods that reduce/kill microorganisms without chemicals.

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    Nosocomial Infections

    Infections acquired during a hospital stay, not present on admission.

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    Iatrogenic Infections

    Infections caused by medical treatment or procedures.

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    Endemic Disease

    A disease regularly found in a specific area or group without disappearing.

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    Pandemic

    A widespread disease affecting many countries globally.

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    Epidemic

    A sudden increase in disease cases above the normal level in a specific area.

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    MRSA

    Methicillin-resistant Staphylococcus aureus, a type of bacterial infection.

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    VRE

    Vancomycin-resistant Enterococci, another type of antibiotic-resistant bacterial infection.

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    Hospital-acquired infections

    Infections obtained during a stay in a healthcare facility; another name for nosocomial infections.

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    Sporadic Disease

    A disease that occurs infrequently and irregularly in a population, with cases scattered and unpredictable.

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    Urinary Tract Infection

    A common nosocomial infection affecting the urinary system, typically caused by bacteria.

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    Gram + Positive Cocci

    A type of bacteria commonly found as a cause of nosocomial infections, characterized by its spherical shape and ability to retain stain.

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    Coli

    A type of bacteria that can cause infections in the intestines, urinary tract, and other parts of the body.

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    Enterococcus species

    A group of bacteria that can cause infections in the urinary tract, bloodstream, and wounds. Some strains are resistant to multiple antibiotics.

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    Klebsiella species

    A group of bacteria that can cause pneumonia, urinary tract infections, and other infections. Some strains are resistant to multiple antibiotics.

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    Dry Heat Sterilization

    A method of sterilizing materials using hot air at high temperatures in an oven. It's suitable for heat-resistant materials like medical instruments.

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    Moist Heat Sterilization

    A method of sterilization using steam or boiling water. It's effective and suitable for many medical instruments and materials.

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    Autoclaving

    A method of sterilization using pressurized steam at high temperatures. It's the most common method for sterilizing medical instruments and materials.

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    Freeze-Drying

    A method of preserving microorganisms and other biological materials by freezing them and then removing the water by vacuum.

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    Filtration

    A method of sterilizing liquids or gases by passing them through a filter with pores small enough to trap microorganisms.

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    Cold Sterilization

    A method of sterilizing materials using low temperatures like refrigeration or freezing. It's primarily used to inhibit microbial growth and not kill all microorganisms.

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    What are the factors contributing to the increasing number of infections?

    Factors contributing to the rise in infections are: the emergence of drug-resistant pathogens, failure to follow infection control guidelines, poor hygiene practices, overcrowding, lack of training, economic constraints, and increased use of immunosuppressant agents.

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    Membrane Filters

    Filters used in aseptic compounding and administration of heat-sensitive drugs. They separate particles and contaminants from solutions. There are two main types: hydrophobic filters for non-aqueous solutions and hydrophilic filters for aqueous solutions.

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    Phenols in Disinfection

    Phenols are a class of chemicals used for low-level disinfection of inanimate objects like surfaces. They have strong anti-microbial activity but are corrosive and not suitable for use near food or in neonatal units.

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    How do phenols work?

    Phenols disrupt the cell membranes of microorganisms, leading to their death. This makes them effective against a range of bacteria and fungi, but not against spores (dormant bacterial forms).

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    Alcohol for Disinfection

    Alcohols are used as intermediate-level disinfectants for both inanimate objects and skin. They are effective against bacteria, fungi, and some viruses.

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    Alcohol Concentration

    Alcohol is effective as a disinfectant at concentrations between 50-80%. Higher concentrations might be less effective as they evaporate quicker, reducing contact time.

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    Advantages of Phenols

    Phenols have the advantage of leaving a residual film on surfaces, which prolongs their anti-microbial action. When combined with detergents, they offer one-step cleaning and disinfection.

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    Disadvantages of Phenols

    Phenols have several disadvantages: they are corrosive, cannot be used in neonatal units or near food, and can be absorbed through skin or vial stoppers.

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    Types of Membrane Filters

    Membrane filters are categorized based on their interaction with water. Hydrophobic filters repel water and are used for non-aqueous solutions, while hydrophilic filters allow water to pass through and are used for aqueous solutions.

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    Direct Contact Transmission

    Spread of infection through direct physical contact with an infected person or their bodily fluids, such as skin-to-skin, mucous membrane contact, or kissing.

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    Airborne Droplet Transmission

    Spread of infection through tiny droplets of respiratory secretions released when an infected person coughs, sneezes, talks, or breathes.

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    Fecal-Oral Transmission

    Spread of infection through ingesting contaminated food, water, or surfaces with fecal matter, often due to poor sanitation or hygiene practices.

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    Fomite Transmission

    Spread of infection through contact with inanimate objects or surfaces contaminated with pathogens, such as stethoscopes, bedding, or surgical equipment.

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    What is the difference between a clean room and an anteroom?

    A clean room is the primary workspace for sterile compounding, with ultra-clean conditions, while an anteroom acts as a buffer zone between uncontrolled areas and the clean room, ensuring personnel are properly prepared and reducing contamination.

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    What are the requirements for a controlled room?

    Controlled rooms used for sterile compounding should be designed to prevent contamination, with features like positive pressure, smooth surfaces, and controlled access for specifically trained personnel.

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    What are some examples of controlled rooms in sterile compounding?

    Controlled rooms specifically designed for sterile compounding might include areas for personnel preparation, product compounding, product labeling, quality control, and documentation.

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    What are the requirements for surfaces in a controlled room?

    Surfaces in a controlled room must be smooth, impervious to water, free from cracks and crevices, non-porous, and resistant to damage caused by cleaning agents.

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    Why is positive pressure important in controlled room environments?

    Positive pressure within a controlled room helps prevent contaminants from entering by pushing air out of the room, creating a barrier against external airborne particles.

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    What are some examples of particle shedding items that should be avoided in controlled areas?

    Particle shedding items like cardboard and paper can release contaminants into the cleanroom environment, increasing the risk of contamination. These materials should be avoided.

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    Study Notes

    Sterile Product Theory - Exam Review

    • Sterile Product History:

      • 1616: Dr. William Harvey described blood circulation.
      • 1665: Sir Christopher Wren successfully injected opium.
      • 18th-19th century: Bacterial growth and sepsis discovered by scientists (Robert Koch, Joseph Lister, Louis Pasteur).
      • Late 19th century: Sterilization considered to prevent infection.
      • 1923: Florence Seibert discovered pyrogens.
      • 1926: First injection solutions added to the National Formulary.
      • 1960s: Developments in infusion technology (laminar airflow).
      • 1971: Contaminated IV solutions caused a nationwide outbreak.
    • Standards and Guidelines:

      • Health Canada: Policy on manufacturing and compounding drug products; defines compounding and manufacturing sterile/non-sterile products.
      • NAPRA: Model standards for pharmacy compounding (hazardous and non-hazardous sterile preparations) - minimum practice and quality standards.
      • CSHP : Guidelines for Preparation of Sterile Products. - compliance with Food and Drugs Act and GMP.
      • OCP: Adopted NAPRA documents as guidelines, inspection of pharmacies involved in sterile compounding.

    Low, Medium, and High Risk Levels

    • Low Risk:
      • Compounding under ISO Class 5 environment using commercially available ingredients, products, components, and devices.
      • Simple aseptic opening of ampoules, penetrating disinfected closures/stoppers of vials using sterile needles and syringes.
      • Transferring/measuring and mixing with no more than 3 sterile commercial products and no more than 2 entries.
      • Storage of finished product for 48 hours or less at room temperature or 14 days or less refrigeration or 45 days or less frozen, with no sterility test needed.
    • Medium Risk:
      • Combining or pooling multiple doses of commercial products for multiple patients. Complex aseptic manipulations. Longer duration of compounding time.
      • Storage: 30 hours or less at room temperature, 9 days or less refrigerated, or 45 days or less frozen (no sterility testing). Combining multi-component admixtures.
    • High Risk:
      • Use of non-sterile ingredients and/or devices. Exposure outside of an ISO Class 5 environment for more than 1 hour. Inappropriate gloving and gowning.
      • Storage: 24 hours or less at room temperature, 3 days or less refrigerated, or 45 days or less frozen (no sterility testing).Using non-sterile components to prepare solutions to be sterilized, sterile ingredients measured/mixed in non-sterile devices before sterilization.

    Sterility

    • Sterility: Absence of viable microorganisms, Sterile Assurance Level (SAL): Lower value equals greater assurance of sterility.
    • Particulate Matter: Absence of particulate matter (hair, lint, dust).
    • Pyrogenicity: Absence of pyrogens (fever-producing endotoxins).
    • Stability: Prevention of drug degradation (oxidation, hydrolysis, polymerization).
    • Viscosity: Essential characteristic of ophthalmic preparations.
    • pH: Commonly 3-8 for injections, close to 7.4 for ideal stability.
    • Tonicity: Adjusted with sodium chloride to match the patient's tears.
    • Sterile Parenteral Dosage Forms: Injections, ophthalmics, dialyzates, irrigations, radiopharmaceuticals.

    Sterile Product Types

    • Solutions: Medication in a solvent (water, NaCl, dextrose).
    • Powders/Solids: Freeze-dried and reconstituted at time of use.
    • Suspensions: Drug suspended in a suitable vehicle.
    • Emulsions: Insoluble drugs, emulsified for administration.
    • Vehicles: No therapeutic/toxic activity; solvents and carriers; aqueous and non-aqueous types. Water for injection (most common).
    • Isotonic Vehicles: Sodium Chloride for Injection (Normal Saline), Dextrose 5%, Lactated Ringers.

    Virus & Pyrogens

    • Pyrogens: Soluble or insoluble in organic solvents. Common sources of pyrogens include water, containers, chemicals.
    • Prevention of pyrogensis: Use of sterile ingredients, proper aseptic technique, using pyrogen-free water.
    • Sterilization methods: Use of dry heat, autoclaving, and chemical methods.

    Sterile Products Engineering Requirements

    • Controlled Rooms: Specific areas with the following: personnel preparation, product compounding, labeling, final product release, documentation, and environmental controls. Need for air handling/temperature/humidity control, staff and material entry/exit control.
    • Clean Room Classes: (ISO Standards) to determine the allowable amount and size of particles.
    • Anterooms: Buffer zones between uncontrolled and controlled areas, controls the entrance of contaminants. Necessary for preparation, donning of PPE, control and storage of supplies. Demarcation line for clean/dirty sides.
    • Positive Pressure: Air pressure kept higher inside the room than outside to prevent outside contaminants from entering. Essential for the sterile environment.
    • Laminar Airflow Hoods:
    • Horizontal and vertical types: Airflows from the back toward the front or top toward the work surface, respectively, to ensure a unidirectional flow of air directed away from the operator and to the product.
    • HEPA Filters: Remove contaminants from the incoming air.
    • Advantages and disadvantages: Specific consideration is given to the different types of laminar airflow hoods and their best applications for various sterile products and materials, depending on the level of contamination and materials.

    Chemical Anti-microbial Agents

    • Low Level: Phenols (e.g., lysol, carbolic acid) maintain contact; used with detergents, but not for all situations or individuals).
    • Intermediate Level: Alcohols (e.g., ethanol, isopropanol) acting fast; quick residual effect.
    • High Level: Aldehydes (e.g., formaldehyde, glutaraldehyde) effective, but corrosive, irritating fumes, ventilation required. Hydrogen peroxide-oxidizing agent, rapidly acting, but not for all materials. Peracetic acid (cold sterilant)- rapid action.

    Types of Infections

    • Direct contact: Skin-to-skin, mucous membrane-to-mucous membrane.

    • Airborne droplets: Coughing, sneezing, talking.

    • Fecal material contamination: Ingestion of contaminated food and water.

    • Fomites: Touching inanimate objects contaminated with pathogens (e.g., contaminated surgical and medical equipment).

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    Prepare for your exam on Sterile Product Theory with this comprehensive review. Covering key historical milestones and important standards and guidelines in sterile product preparation, this quiz will enhance your understanding of sterile and non-sterile manufacturing practices. Test your knowledge and get ready for success in your examination.

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