Sterile Product Theory - Exam Review
49 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

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</p> Signup and view all the answers

    What method can help control sporadic infections in a population?

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

    What is an example of an iatrogenic infection?

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

    Which of the following infections is considered endemic?

    <p>Malaria</p> Signup and view all the answers

    What distinguishes a pandemic from an epidemic?

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

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

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

    Which factor does NOT affect the incidence of endemic diseases?

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

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

    <p>Tuberculosis</p> Signup and view all the answers

    What percentage of nosocomial infections are considered preventable?

    <p>33%</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.</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.</p> Signup and view all the answers

    What defines an antiseptic?

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

    What is the main characteristic of community-acquired infections?

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

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

    <p>Bleach</p> Signup and view all the answers

    What is the primary function of antisepsis?

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

    Which method utilizes hot air for sterilization?

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

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

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

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

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

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

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

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

    <p>Uses high pressure</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</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.</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</p> Signup and view all the answers

    What is the primary function of hydrophobic filters?

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

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

    <p>50-80%</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.</p> Signup and view all the answers

    What is a limitation of using phenols for disinfection?

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

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

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

    What type of solutions are hydrophilic filters designed for?

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

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

    <p>Tuberculosis</p> Signup and view all the answers

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

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

    What are fomites?

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

    What is a requirement for controlled rooms according to NAPRA?

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

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

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

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

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

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

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

    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).

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Related Documents

    Sterile Product Theory Final Exam Review PDF

    Description

    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.

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser