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Questions and Answers
What is the primary method for classifying bacteria based on their staining characteristics?
What is the primary method for classifying bacteria based on their staining characteristics?
How do anaerobic bacteria differ from aerobic bacteria?
How do anaerobic bacteria differ from aerobic bacteria?
Which temperature range is preferred by thermophiles for optimal growth?
Which temperature range is preferred by thermophiles for optimal growth?
What characteristic is shared by both Neisseria gonorrhoeae and Neisseria meningitis?
What characteristic is shared by both Neisseria gonorrhoeae and Neisseria meningitis?
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Which pH range is preferred by acidophiles for growth?
Which pH range is preferred by acidophiles for growth?
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What color do gram-positive bacteria typically stain after a gram stain procedure?
What color do gram-positive bacteria typically stain after a gram stain procedure?
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What is a common characteristic of psychrophiles?
What is a common characteristic of psychrophiles?
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Which of the following describes mesophiles in terms of preferred growth temperatures?
Which of the following describes mesophiles in terms of preferred growth temperatures?
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What is a significant consequence of poor hygiene procedures and aseptic techniques?
What is a significant consequence of poor hygiene procedures and aseptic techniques?
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Which method utilizes steam or boiling water for sterilization?
Which method utilizes steam or boiling water for sterilization?
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What is the primary application of the dry heat method?
What is the primary application of the dry heat method?
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Which of the following is a disadvantage of using dry heat sterilization?
Which of the following is a disadvantage of using dry heat sterilization?
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What is the main limitation of freezing as a cold method of sterilization?
What is the main limitation of freezing as a cold method of sterilization?
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Which of the following pathogens is associated with the increased prevalence of drug-resistant infections?
Which of the following pathogens is associated with the increased prevalence of drug-resistant infections?
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What is a key advantage of using moist heat for sterilization?
What is a key advantage of using moist heat for sterilization?
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What contributes to the increasing presence of immuno-compromised patients?
What contributes to the increasing presence of immuno-compromised patients?
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What is a method used for medical devices that cannot withstand high temperatures?
What is a method used for medical devices that cannot withstand high temperatures?
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Why may overcrowding and staff shortages contribute to the spread of pathogens?
Why may overcrowding and staff shortages contribute to the spread of pathogens?
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What type of vehicle is Sterile Water for Injection classified as?
What type of vehicle is Sterile Water for Injection classified as?
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Which of the following is a characteristic of commensalism?
Which of the following is a characteristic of commensalism?
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What defines an opportunistic pathogen?
What defines an opportunistic pathogen?
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Which solution is considered isotonic and commonly used for injection?
Which solution is considered isotonic and commonly used for injection?
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What is one example of a parasitic relationship?
What is one example of a parasitic relationship?
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Which type of microorganism is classified as pathogenic?
Which type of microorganism is classified as pathogenic?
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What percentage of known microorganisms are considered pathogenic?
What percentage of known microorganisms are considered pathogenic?
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Which of these is NOT a common bacteriostatic agent?
Which of these is NOT a common bacteriostatic agent?
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What is the main function of indigenous microflora?
What is the main function of indigenous microflora?
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What does pyrogen refer to?
What does pyrogen refer to?
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Which of the following statements about Lactated Ringer’s Injection is correct?
Which of the following statements about Lactated Ringer’s Injection is correct?
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Which type of organism benefits in a mutualistic relationship?
Which type of organism benefits in a mutualistic relationship?
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What does the term 'resident microflora' refer to?
What does the term 'resident microflora' refer to?
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What is a common use for 0.9% Sodium Chloride Solution?
What is a common use for 0.9% Sodium Chloride Solution?
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What is the primary purpose of an anteroom in sterile compounding?
What is the primary purpose of an anteroom in sterile compounding?
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What are the environmental control requirements documented daily for a cleanroom?
What are the environmental control requirements documented daily for a cleanroom?
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Which ISO class of cleanroom is typically used in sterile compounding procedures?
Which ISO class of cleanroom is typically used in sterile compounding procedures?
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In the anteroom, what must personnel do with shoe covers?
In the anteroom, what must personnel do with shoe covers?
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What is a characteristic of the cleanroom's design regarding airflow?
What is a characteristic of the cleanroom's design regarding airflow?
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Which of the following is NOT a restriction for personnel in the cleanroom?
Which of the following is NOT a restriction for personnel in the cleanroom?
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What feature distinguishes the dirty side of the anteroom?
What feature distinguishes the dirty side of the anteroom?
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What is the significance of using HEPA filters in a cleanroom?
What is the significance of using HEPA filters in a cleanroom?
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What does the term 'pass-through windows' refer to in a cleanroom?
What does the term 'pass-through windows' refer to in a cleanroom?
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What is a key difference between custom and modular cleanrooms?
What is a key difference between custom and modular cleanrooms?
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What is the primary purpose of aseptic technique?
What is the primary purpose of aseptic technique?
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Which item of personal protective equipment is specifically designed to prevent contamination from mouth secretions?
Which item of personal protective equipment is specifically designed to prevent contamination from mouth secretions?
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What is the minimum duration for performing an aseptic handwash?
What is the minimum duration for performing an aseptic handwash?
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What characteristic is NOT required for a gown used in aseptic technique?
What characteristic is NOT required for a gown used in aseptic technique?
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Which of the following is a recommended practice for handling gloves?
Which of the following is a recommended practice for handling gloves?
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Why is eye protection recommended during cytotoxic spill clean-up?
Why is eye protection recommended during cytotoxic spill clean-up?
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Which of the following should be done before donning sterile gloves?
Which of the following should be done before donning sterile gloves?
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What type of material should gloves be made of when handling hazardous materials?
What type of material should gloves be made of when handling hazardous materials?
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Which practice is critical to prevent touch contamination?
Which practice is critical to prevent touch contamination?
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What is the significance of having a line of demarcation in a cleanroom environment?
What is the significance of having a line of demarcation in a cleanroom environment?
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What is the primary use of a Volume Control Set or Buretrol?
What is the primary use of a Volume Control Set or Buretrol?
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Which of the following is NOT an advantage of gravity flow for IV infusion?
Which of the following is NOT an advantage of gravity flow for IV infusion?
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What is a major disadvantage associated with gravity flow IV infusions?
What is a major disadvantage associated with gravity flow IV infusions?
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Which factor can affect the accuracy of flow rate in IV infusions?
Which factor can affect the accuracy of flow rate in IV infusions?
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How do electronic infusion devices improve IV fluid administration?
How do electronic infusion devices improve IV fluid administration?
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Which type of electronic infusion device uses positive pressure to administer fluids?
Which type of electronic infusion device uses positive pressure to administer fluids?
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What factor increases flow resistance and could potentially reduce the flow rate?
What factor increases flow resistance and could potentially reduce the flow rate?
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What is a characteristic of peristaltic pumps?
What is a characteristic of peristaltic pumps?
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Which of the following factors does NOT affect flow rate accuracy in gravity flow IV infusions?
Which of the following factors does NOT affect flow rate accuracy in gravity flow IV infusions?
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What happens to the flow of IV fluid if the height of the container is lowered?
What happens to the flow of IV fluid if the height of the container is lowered?
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Study Notes
Happy Finals Week Meme
- A humorous image depicting a character from the movie "The Hunger Games"
- Expresses good wishes for success in final exams
- Encourages positive outcomes for grades
Sterile Product Theory Final Exam Review
-
History of Sterile Products:
- 1616: Dr. William Harvey described blood circulation
- 1665: Sir Christopher Wren successfully injected opium
- 18th-19th centuries: discoveries about bacterial growth and sepsis by Robert Koch, Joseph Lister, and Louis Pasteur.
- Late 19th century: Sterilization methods introduced
- 1923: Florence Seibert discovered fevers from pyrogens
- 1926: First official injection solutions in National Formulary.
- 1960s: Infusion technology advances including laminar air flow technique
- 1971: Nationwide outbreak due to contaminated IV solutions.
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Standards and Guidelines:
- Health Canada: Created a policy on compounding and manufacturing. Defines compounding and manufacturing drug products. Sterile compounding falls under section C of the Food and Drugs Act. includes all drugs scheduled in C and D. Includes site inspections by each provincial regulatory authority
- NAPRA: Developed standards for pharmacy compounding of both hazardous and non-hazardous sterile preparations.
- CSHP: Developed guidelines for preparing sterile products in pharmacies.
- OCP (Provincial Regulatory Authorities): Adopted NAPRA documents as guidelines. All pharmacies involved in sterile compounding follow these guidelines.
Sterile Products - Low, Medium, High Risk
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LOW RISK:
- ISO Class 5 environment
- Commercially available ingredients
- Simple aseptic opening of ampoules/vials
- No more than 3 sterile commercial products. No more than 2 entries into one sterile container.
- Storage of finished product : 48 hours or less at room temp/ 14 days or less refrigeration max and 45 days or less in solid frozen state- if no sterility test
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MEDIUM RISK:
- Combining multiple doses of commercial products
- Complex aseptic manipulations
- Longer duration of compounding time
- Storage: max 30 hours or less at room temp / 9 days or less under refrigeration / 45 days or less in a frozen state- no sterility test
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HIGH RISK:
- Use of non-sterile ingredients and/or non-sterile devices
- Exposure outside ISO 5 environment for more than 1 hour.
- Inappropriate gloving and gowning
- Storage: 24 hours or less at room temp/ 3 days or less refrigeration / 45 days or less in a frozen state- no sterility test
Sterile Product Characteristics
- Sterility: Absence of viable microorganisms
- Particulate Matter: Absence of particulate matter (dust, lint)
- Pyrogenicity: Absence of pyrogens (fever-producing substances)
- Stability: Prevention of drug degradation
- Viscosity: Essential characteristic of ophthalmic preparations
- pH: Typically 3-8 for injections, close to 7.4 is Ideal
- Tonicity: Must simulate blood / isotonic/hypertonic/hypotonic
Sterile Parenteral Dosage Forms
- Injection: Aqueous or non-aqueous sterile products
- Ophthalmics: Solutions, suspensions, and ointments
- Dialysates: Sterile and isotonic solutions
- Irrigations: Similar packaging/solutions
- Radiopharmaceuticals: Radioactive chemicals used clinically for diagnostics
Solutions, Powders, Solids
- Solutions: Medication in solution of a suitable vehicle (water, saline, dextrose) for injection.
- Powders/solids: Drug less stable, freeze-dried, reconstituted at time of use.
Vehicles
- Aqueous Vehicles/Water: Water for injection (sterile), bacteriostatic water for injection, sterile water for irrigations.
Vehicles (cont.)
- Isotonic Vehicles: NaCl 0.9% injection, 0.9% for irrigation, dextrose 5% , Lactated Ringers.
Infectious Disease transmission
- Direct: Skin-to-skin contact, mucous membranes
- Respiratory droplets: From infected people coughing, sneezing, talking or breathing
- Fecal material: Contaminated food, water, or surfaces
Contamination Control and Facility Design
- Separate areas: For sterile compounding from other areas
- Air Handling: Temperature/humidity control
- Personnel flow: Controlled access
- Personnel preparation: PPE and handwashing
- Cleaning/sterilization: Frequent cleaning and sterilization
Anteroom vs. Cleanroom
- Anteroom: Buffer zone to prevent contaminants entering cleanroom.
- Cleanroom: Main area for sterile compounding, under positive pressure
Types of Physical Anti-microbial Methods:
- DRY HEAT: Use hot-air oven, for items that cannot endure moist heat.
- MOIST HEAT: Use an autoclave (pressure cooking).
- FREEZE DRYING: A dehydration process; removes moisture; useful for heat-sensitive products.
- FILTRATION: Use sterile membrane filters to remove microorganisms from solutions.
Types of Chemical Anti-microbial Agents:
- Low-level: Phenols (ex. Lysol).
- Intermediate-level: Alcohol (ex. 70% isopropyl).
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High-level:
- Aldehydes (ex. Formaldehyde, glutaraldehyde)
- Hydrogen Peroxide
- Peracetic acid
Total Parenteral Nutrition (TPN)
- Definition: IV infusion of amino acids, glucose, lipids, vitamins, and minerals as nutritional support.
- Indications: Malnutrition, severe illnesses.
- Components: Carbohydrates (dextrose), proteins (amino acids), lipids, electrolytes, vitamins, and minerals
Hazardous Drugs
- Definition: Exhibit carcinogenicity, teratogenicity, reproductive toxicity or toxicity at low doses.
- Exposure risks: Healthcare professionals, delivery personnel.
- Exposure scenarios: Receiving drugs, preparation, administration, waste disposal.
- Key principles: Proper PPE, safety procedures, spill management, and disposal.
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Description
Test your knowledge on the classification of bacteria and their growth preferences with this engaging quiz. Explore topics such as staining characteristics, temperature ranges, and sterilization methods used in microbiology. Challenge yourself and enhance your understanding of bacterial behavior in various environments.