Sterile Product Theory Final Exam Review
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Questions and Answers

What is the primary difference between disinfection and sterilization?

  • Disinfection destroys spores, while sterilization does not.
  • Disinfection reduces the number of harmful microorganisms, while sterilization ensures complete eradication. (correct)
  • Disinfection kills all microorganisms, while sterilization reduces them.
  • Disinfection is a chemical method, while sterilization is a physical method.

Which of the following describes a disinfectant?

  • It is more potent than antiseptics and used on living tissues.
  • It is a natural agent found in everyday household items.
  • It completely eradicates all microorganisms including spores.
  • It is used primarily on surfaces and is tolerated in higher concentrations. (correct)

What type of chemical agent is an antiseptic?

  • A gentler agent applied to skin or mucous membranes. (correct)
  • A cold sterilant used for medical equipment.
  • A chemical that can cause irritation to living tissues.
  • A potent disinfectant used for surfaces.

What does antisepsis refer to?

<p>The action of using antiseptics to kill microorganisms. (A)</p> Signup and view all the answers

A cold sterilant is best described as a:

<p>Method for achieving sterility without heat on sensitive materials. (B)</p> Signup and view all the answers

Community-acquired infections are typically contracted in which of the following places?

<p>In everyday environments like homes and schools. (A)</p> Signup and view all the answers

Which statement about disinfectants is NOT true?

<p>They can destroy spores efficiently. (D)</p> Signup and view all the answers

Which of the following is an example of antisepsis?

<p>Applying hydrogen peroxide to a wound. (D)</p> Signup and view all the answers

What term is used to describe infections acquired during a healthcare facility stay?

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

Which of the following is not an example of a nosocomial infection?

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

Which factor does not influence the incidence of endemic diseases?

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

Which of the following best defines a pandemic?

<p>A disease affecting many countries or worldwide (B)</p> Signup and view all the answers

What is a primary cause of iatrogenic infections?

<p>Contaminated medical equipment (A)</p> Signup and view all the answers

Which option does not correctly describe an epidemic?

<p>A disease that disappears completely (B)</p> Signup and view all the answers

What is a common example of an endemic disease?

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

Which of the following infections is considered preventable and a nosocomial infection?

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

What is the primary focus of applications that emphasize protecting the product more than the operator?

<p>Preventing contamination of the product (D)</p> Signup and view all the answers

How does the pre-filter operate in the airflow process?

<p>It removes large particles and contaminants from the room air (A)</p> Signup and view all the answers

In a biosafety cabinet (BSC), where is the room air primarily introduced from?

<p>From the top of the hood and the front intake vents (B)</p> Signup and view all the answers

What does the air stream pass through after being filtered by the pre-filter?

<p>A HEPA filter in a horizontal direction (D)</p> Signup and view all the answers

What defines a controlled environment under positive pressure?

<p>The air pressure inside is higher than the surrounding areas (C)</p> Signup and view all the answers

What happens to contaminated air introduced through the intake vents in a BSC?

<p>It is passed through an external venting system (B)</p> Signup and view all the answers

What is the role of the blower assembly in the airflow system described?

<p>It forces pre-filtered and contaminated air through the HEPA filter (B)</p> Signup and view all the answers

Which of the following statements about airflow in a controlled environment is correct?

<p>Horizontal airflow is typically used for contaminated air (D)</p> Signup and view all the answers

What characterizes bacteriostatic water for injection?

<p>Is sterile and contains no preservatives (A)</p> Signup and view all the answers

Which of the following is an example of mutualism?

<p>Digestive bacteria in the GI tract (D)</p> Signup and view all the answers

What is the main difference between resident and transient microflora?

<p>Resident microflora are always present, while transient microflora are temporary (C)</p> Signup and view all the answers

Which of the following correctly defines parasitism?

<p>One species is harmed while the other benefits (B)</p> Signup and view all the answers

Which microorganisms are categorized as pathogens?

<p>Approximately 3% of known micro-organisms (B)</p> Signup and view all the answers

What type of solution is Sodium Chloride 0.9% classified as?

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

Which microflora are characterized as indigenous microflora?

<p>Microorganisms that normally inhabit the human body (A)</p> Signup and view all the answers

What substances can pyrogens cause when introduced into the body?

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

What is a characteristic of isotonic vehicles?

<p>Are sterile and pyrogen-free (A)</p> Signup and view all the answers

Which of the following is NOT an opportunistic pathogen?

<p>Microorganisms that typically do not cause disease (B)</p> Signup and view all the answers

Which of these examples illustrates commensalism?

<p>Staphylococcus on human skin (C)</p> Signup and view all the answers

Which factor contributes to the classification of a microorganism as pathogenic?

<p>The potential to cause disease in a host (C)</p> Signup and view all the answers

What does the term 'mutualism' refer to in symbiotic relationships?

<p>Both species benefit (C)</p> Signup and view all the answers

Which type of water is specifically designed for irrigation, not for injection?

<p>Sterile Water for Irrigation (A)</p> Signup and view all the answers

What is the minimum duration for hand washing recommended?

<p>30 seconds (C)</p> Signup and view all the answers

Before entering the cleanroom, how should items be treated?

<p>Items should be disinfected with 70% sterile IPA wipes. (D)</p> Signup and view all the answers

What should be done if the Laminar Airflow Hood (LAFH) has been turned off?

<p>Wait 30 minutes after turning it back on before cleaning. (C)</p> Signup and view all the answers

How frequently should the Laminar Airflow Hood be cleaned?

<p>Twice daily and before each preparation (A)</p> Signup and view all the answers

What type of containers should be used to separate items for each preparation?

<p>Plastic or stainless-steel containers (D)</p> Signup and view all the answers

How should gloves be treated before entering the hood?

<p>Disinfected with sterile 70% IPA. (D)</p> Signup and view all the answers

What is the proper placement for items within the hood?

<p>Items are to be placed 6 inches inside the hood. (A)</p> Signup and view all the answers

What is one significant advantage of using pre-filled disposable syringes?

<p>Reduces medication error (C)</p> Signup and view all the answers

What should be done with non-paper items before entering the hood?

<p>Disinfect with low-shedding sterile 70% IPA wipes. (B)</p> Signup and view all the answers

What is a common disadvantage of pre-filled disposable syringes?

<p>They have a short expiry period (D)</p> Signup and view all the answers

Which IV solution is mentioned as available for use?

<p>NaCl 0.9% (D)</p> Signup and view all the answers

What is a concern associated with pharmacy prepared pre-filled syringes?

<p>Higher cost due to compounding (A)</p> Signup and view all the answers

Which statement about the manufacturing of pre-filled disposable syringes is true?

<p>They are manufactured aseptically to ensure sterility (C)</p> Signup and view all the answers

Flashcards

Sterilization

Complete eradication of harmful microorganisms.

Disinfection

Reduces or inactivates disease-causing microorganisms.

Disinfectant

Chemical that reduces microorganisms on inanimate surfaces.

Antiseptic

Chemical used on living tissue to kill microorganisms.

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Antisepsis

Process of using antiseptics to kill microorganisms on living tissue.

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Cold Sterilant

Chemical agent for sterility without heat.

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Community-Acquired Infection

Infection contracted outside of healthcare settings.

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Physical vs. Chemical Antimicrobial Methods

Two main categories of methods to control microbes.

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Mutualism

A symbiotic relationship where both organisms benefit.

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Commensalism

A symbiotic relationship where one organism benefits and the other is neither harmed nor helped.

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Parasitism

A symbiotic relationship where one organism benefits at the expense of the other.

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Symbiosis

A close association between two different species, often with one or more of the participants benefiting.

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Microorganism

A small living organism, not visible to the naked eye.

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Pathogen

A microorganism that causes disease.

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Non-pathogen

A microorganism that does not cause disease.

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Opportunistic Pathogen

A microorganism that can cause disease only when the body's defenses are weakened.

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Indigenous Microflora

Normal flora; microorganisms that live permanently on or in the body.

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Sterile Water for Injection

Water for injection, free of bacteria.

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Bacteriostatic Water for Injection

Water for injection containing bacteriostatic agents.

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Isotonic Solution

Solution with the same salt concentration as body fluids.

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0.9% Sodium Chloride Injection

Commonly known as normal saline; isotonic solution for injection.

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Pyrogens

Substances that can cause fever.

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Aqueous Vehicle

Liquid base for injecting or administering medications.

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Nosocomial Infection

An infection acquired during a stay in a healthcare facility that wasn't present upon admission.

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Iatrogenic Infection

An infection caused by medical treatment or procedures.

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Endemic Disease

A disease constantly present in a certain area or population, even if cases increase or decrease.

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Pandemic

A global outbreak affecting a large number of people, involving a specific disease.

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Epidemic

A sudden, significant increase in disease cases 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, a type of bacterial infection, resistant to some antibiotics.

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Hospital-acquired infections

Another name for nosocomial infections.

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Pre-filled Disposable Syringes

Single-use syringes containing a ready-to-administer drug solution. They come pre-filled with pre-measured doses and are typically manufactured aseptically for sterility.

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Advantages of Pre-filled Syringes

Pre-filled syringes offer benefits like ease of administration, reduced medication errors, guaranteed sterility due to aseptic manufacturing, and standardized labeling and information for stability.

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Disadvantages of Pre-filled Syringes

Pre-filled syringes are usually single-dose only, have short expiry dates, and can be costly if pharmacy prepared. Pharmacy prepared syringes also raise concerns about stability and potential contamination.

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Dead Space in Syringes

The volume of medication that remains in the syringe after administration, including the needle and hub. It can result in medication loss and affects the accuracy of dosage.

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Solution Retention in Vials

The tendency of some solutions to stick to the vial's surface during withdrawal, leading to inaccurate dosage and potential drug loss.

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Handwashing Time

Wash hands and forearms with soap and water for at least 30 seconds.

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Alcohol-Based Hand Rub (ABHR)

Apply ABHR to both palms, immerse fingertips, and cover forearms until it evaporates.

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Laminar Airflow Hood (LAFH)

A device that provides a sterile environment for compounding medications. It should run constantly (24/7).

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LAFH Cleaning Frequency

Clean the LAFH twice daily and before each medication preparation.

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Cleanroom Entry

All items must be disinfected with 70% sterile IPA wipes before entering the cleanroom.

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Cleanroom Placement

Place items in a cleanroom at least 6 inches inside the hood, open sterile items past that point, and arrange them to prevent airflow obstruction.

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Cleanroom Movement

Minimize movements inside the hood and avoid overcrowding the work area.

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Gloves Disinfection

Disinfect gloves with sterile 70% IPA wipes before entering the hood and after touching contaminated surfaces.

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Application of a Class 5 BSC

A Class 5 Biological Safety Cabinet is used when contamination protection of the product is more important than protecting the user, typically for hazardous materials or chemicals needing proper ventilation.

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Airflow Direction in Class 5

Class 5 BSCs use a horizontal airflow direction through the HEPA filter to effectively filter contaminated air, with room air introduction from the top and front sides.

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Class 5 Pre-Filter

A pre-filter in a Class 5 BSC removes large particles and contaminates from the room air before it reaches the HEPA filter.

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Class 5 HEPA Filter

The HEPA (High-Efficiency Particulate Air) filter in a Class 5 BSC removes very small particles and aerosols from the air.

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Positive Pressure Environment

A controlled environment inside a room or space that has a higher air pressure compared to the surroundings. Useful in BSC systems

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Class 5 Air Intake

In a Class 5, room air enters the cabinet via multiple locations: top and intake vents in front of the work surface.

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Contaminated Air Removal

In a Class 5 BSC, contaminated air is forced through an external venting system by the motor and blower assembly.

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Hazardous Material Protection (Class 5)

The primary focus of a Class 5 BSC is to ensure safety and protection for the product or chemicals involved in the process from contamination.

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Study Notes

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: Bacterial growth and sepsis discovered (Lister, Koch, Pasteur).
    • Late 19th century: Sterilization methods introduced.
    • 1923: Florence Seibert discovered pyrogens from water.
    • 1926: First official injection solutions.
    • 1960s: Infusion technology advancements.
    • 1971: Contaminated IV solutions, national outbreak, FDA/CDC focus on IV infection.

  • Sterile Product Standards:

    • Health Canada: Policy on compounding and manufacturing drug products. Defines compounding and manufacturing terms related to sterile and non-sterile products. Compounding of sterile products falls under section 'C' of the Food and Drugs Act, includes all drugs in Schedule C, D. Health Canada's GMP (Good Manufacturing Practices). Compounding will be regulated and include site inspections.
    • NAPRA: Models for compounding non-hazardous and hazardous sterile preparations. Adapted from USP standards and requirements. Provincial Regulatory Authorities (OCP) use these documents for sterile compounding standards.
    • CSHP: Guidelines for sterile products in pharmacies, compliance with Food and Drugs Act and Health Canada's GMP (Good Manufacturing Practices).
    • OCP: Adopted NAPRA documents, all pharmacies involved in sterile compounding now inspected by OCP.

Low, Medium, and High Risk Levels

  • Low Risk Level:

    • ISO Class 5 environment.
    • Commercially available ingredients, products, and devices.
    • Simple aseptic opening of ampoules, penetrating closures.
    • 48 hrs or less at room temp; 14 days or less refrigeration; 45 days or less in solid frozen state (if no sterility tests).

  • Medium Risk Level:

    • Includes low-risk conditions plus: Combining multiple doses for multiple patients/times.
    • Complex aseptic procedures, longer compounding times.
    • Stored up to 30 hours at room temp, 9 days refrigerated, 45 days frozen (no sterility testing).

  • High Risk Level:

    • Use of non-sterile ingredients/devices.
    • Exposure outside of ISO Class 5.
    • Inappropriate gloving/gowning, improper storage (longer than specified).

Sterility, Particulate Matter, Pyrogenicity, Stability, Viscosity, Ph, Tonicity

  • Sterility: Absence of viable microorganisms, the lower the SAL the better assurance of sterility. Includes various sources of defects (hair, lint, dust).
  • Particulate Matter: Absence of particulate matter. Includes sources like hair, lint, dust.
  • Pyrogenicity: Absence of pyrogens (fever-producing endotoxins).
  • Stability: Prevention of drug degradation (oxidation/hydrolysis/polymerization).
  • Viscosity: Plays a role in ophthalmics, solutions/suspensions - essential for contact time on the surface of the eye. Ideal pH of 3-8 for injections, close to 7.4 ideal. Maintaining pH helps ensure preparation stability.
  • Tonicity: Matching with blood/tears tonicity by way of isotonic solutions (with Sodium Chloride).

Sterile Parenteral Dosage Forms

  • Injections: Largest sterile parenteral group, aqueous/non-aqueous, IV (intravenous), IM (intramuscular), SC (subcutaneous), ID (intradermal), IT (intrathecal), IS (intraspinal).
  • Ophthalmics, Dialysates, Irrigations, Radiopharmaceuticals: Contain solutions, suspensions, or ointments; sterile and isotonic.

Virus, Pyrogens, Removal of Pyrogens

  • Viruses: Not common contaminants; can't reproduce themselves, need a host.
  • Sources of Pyrogens: Mainly water-based, chemicals, and containers/devices.
  • Elimination of Pyrogens: Primarily through aseptic technique, dry heat, autoclaving, chemical methods.

Sterilization, Disinfection

  • Sterilization: Eliminates all microbial life.
  • Disinfection: Reduces the number of harmful microorganisms.

Nosocomial Infections, Community Acquired Infections, Iatrogenic Infections

  • Nosocomial Infections: Acquired within a healthcare setting.
  • Community Acquired Infections: Contracted outside of healthcare.
  • Iatrogenic Infections: Resulting from medical treatments or procedures.

Contamination Control/Facility Engineering Control Systems

  • Requirements: Specific areas for various aspects of sterile compounding, controlled rooms (specific requirements for all aspects) -- environment is controlled & documented, NAPRA expects certain conditions to be met. Clear entry and exit points/demarcation lines. Avoid bringing in contaminants. Air handling, temperature, humidity standards.

Anteroom vs. Clean Room

  • Anteroom: Buffer zone between uncontrolled and controlled areas. Used for staging and preparing equipment, only sterile related tasks take place in this area.
  • Clean Room: Primary workspace, physically separated from pharmacy, sterile, minimized contamination, use of positive pressure. Controlled environmental factors.

ISO Classes of Clean Rooms

  • ISO Classes: Define cleanliness level by airborne particle concentration. Controlled environments based on the number and size of particles per cubic meter of air.

Laminar Airflow Hoods

  • Airflow: Constant, parallel, unidirectional flow from HEPA filter.
  • Types: Horizontal and Vertical.
  • Principle: Maintains sterile, bacteria, and particle-free environments.

Positive Pressure

  • Positive Pressure: Controlled environment where the air pressure inside the space is higher than the surrounding areas, preventing contaminants from entering.

Aseptic Techniques

  • Principles: Avoiding contamination of prepared products, personnel, and equipment.
  • Equipment: Laminar airflow hoods (LAFHs) are used for manipulating sterile products. Other equipment in compounding areas, including pumps, vials.
  • Personnel: PPE (personal protective equipment) is critical for preventing contamination. Donning/doffing processes are critical.

Vial Types

  • Single Use: Preservative-free, for single patient use.
  • Multi-Dose: Preservatives added, can be used multiple times, but must be measured and dated correctly. Critical to follow procedures on entering these vials with needles and how to preserve stability of contents.

Filters

  • Criteria: PORE SIZE, COMPATIBILITY, FLUID VOLUME, and PARTICULATE LOAD. Surface area of the filter is used to understand the volume of solution that can be filtered to minimize lost solution. Using multiple filters can ensure a complete filtration process where all materials are sterile, and the correct solution is delivered. Correct and controlled filtration processes minimize harmful biological substances entering a compounding area.

  • Filtering devices: various size depending on what needs to be filtered and to protect contents against particulate matter.

Disposables/Equipment/Supplies

  • Includes syringes, needles, filters, vials, bags, containers. Materials and devices needed to prepare sterile products.

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Sterile Product Theory Final Exam Review PDF

Description

Prepare for your Sterile Product Theory final exam with this comprehensive review covering the history and standards of sterile products. Learn about key developments in sterile products, the evolution of practices, and current regulations by Health Canada. This quiz will test your knowledge of essential concepts and important figures in the field.

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