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Questions and Answers
What is the primary difference between disinfection and sterilization?
What is the primary difference between disinfection and sterilization?
Which of the following describes a disinfectant?
Which of the following describes a disinfectant?
What type of chemical agent is an antiseptic?
What type of chemical agent is an antiseptic?
What does antisepsis refer to?
What does antisepsis refer to?
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A cold sterilant is best described as a:
A cold sterilant is best described as a:
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Community-acquired infections are typically contracted in which of the following places?
Community-acquired infections are typically contracted in which of the following places?
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Which statement about disinfectants is NOT true?
Which statement about disinfectants is NOT true?
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Which of the following is an example of antisepsis?
Which of the following is an example of antisepsis?
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What term is used to describe infections acquired during a healthcare facility stay?
What term is used to describe infections acquired during a healthcare facility stay?
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Which of the following is not an example of a nosocomial infection?
Which of the following is not an example of a nosocomial infection?
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Which factor does not influence the incidence of endemic diseases?
Which factor does not influence the incidence of endemic diseases?
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Which of the following best defines a pandemic?
Which of the following best defines a pandemic?
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What is a primary cause of iatrogenic infections?
What is a primary cause of iatrogenic infections?
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Which option does not correctly describe an epidemic?
Which option does not correctly describe an epidemic?
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What is a common example of an endemic disease?
What is a common example of an endemic disease?
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Which of the following infections is considered preventable and a nosocomial infection?
Which of the following infections is considered preventable and a nosocomial infection?
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What is the primary focus of applications that emphasize protecting the product more than the operator?
What is the primary focus of applications that emphasize protecting the product more than the operator?
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How does the pre-filter operate in the airflow process?
How does the pre-filter operate in the airflow process?
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In a biosafety cabinet (BSC), where is the room air primarily introduced from?
In a biosafety cabinet (BSC), where is the room air primarily introduced from?
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What does the air stream pass through after being filtered by the pre-filter?
What does the air stream pass through after being filtered by the pre-filter?
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What defines a controlled environment under positive pressure?
What defines a controlled environment under positive pressure?
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What happens to contaminated air introduced through the intake vents in a BSC?
What happens to contaminated air introduced through the intake vents in a BSC?
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What is the role of the blower assembly in the airflow system described?
What is the role of the blower assembly in the airflow system described?
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Which of the following statements about airflow in a controlled environment is correct?
Which of the following statements about airflow in a controlled environment is correct?
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What characterizes bacteriostatic water for injection?
What characterizes bacteriostatic water for injection?
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Which of the following is an example of mutualism?
Which of the following is an example of mutualism?
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What is the main difference between resident and transient microflora?
What is the main difference between resident and transient microflora?
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Which of the following correctly defines parasitism?
Which of the following correctly defines parasitism?
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Which microorganisms are categorized as pathogens?
Which microorganisms are categorized as pathogens?
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What type of solution is Sodium Chloride 0.9% classified as?
What type of solution is Sodium Chloride 0.9% classified as?
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Which microflora are characterized as indigenous microflora?
Which microflora are characterized as indigenous microflora?
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What substances can pyrogens cause when introduced into the body?
What substances can pyrogens cause when introduced into the body?
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What is a characteristic of isotonic vehicles?
What is a characteristic of isotonic vehicles?
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Which of the following is NOT an opportunistic pathogen?
Which of the following is NOT an opportunistic pathogen?
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Which of these examples illustrates commensalism?
Which of these examples illustrates commensalism?
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Which factor contributes to the classification of a microorganism as pathogenic?
Which factor contributes to the classification of a microorganism as pathogenic?
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What does the term 'mutualism' refer to in symbiotic relationships?
What does the term 'mutualism' refer to in symbiotic relationships?
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Which type of water is specifically designed for irrigation, not for injection?
Which type of water is specifically designed for irrigation, not for injection?
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What is the minimum duration for hand washing recommended?
What is the minimum duration for hand washing recommended?
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Before entering the cleanroom, how should items be treated?
Before entering the cleanroom, how should items be treated?
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What should be done if the Laminar Airflow Hood (LAFH) has been turned off?
What should be done if the Laminar Airflow Hood (LAFH) has been turned off?
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How frequently should the Laminar Airflow Hood be cleaned?
How frequently should the Laminar Airflow Hood be cleaned?
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What type of containers should be used to separate items for each preparation?
What type of containers should be used to separate items for each preparation?
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How should gloves be treated before entering the hood?
How should gloves be treated before entering the hood?
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What is the proper placement for items within the hood?
What is the proper placement for items within the hood?
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What is one significant advantage of using pre-filled disposable syringes?
What is one significant advantage of using pre-filled disposable syringes?
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What should be done with non-paper items before entering the hood?
What should be done with non-paper items before entering the hood?
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What is a common disadvantage of pre-filled disposable syringes?
What is a common disadvantage of pre-filled disposable syringes?
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Which IV solution is mentioned as available for use?
Which IV solution is mentioned as available for use?
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What is a concern associated with pharmacy prepared pre-filled syringes?
What is a concern associated with pharmacy prepared pre-filled syringes?
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Which statement about the manufacturing of pre-filled disposable syringes is true?
Which statement about the manufacturing of pre-filled disposable syringes is true?
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Study Notes
Sterile Product Theory Final Exam Review
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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.
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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
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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).
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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).
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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
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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.
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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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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.
