Aseptic Services and Sterile Products
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Questions and Answers

What was the year of the Breckenbridge Report that led to changes in Aseptic Services?

  • 1974 (correct)
  • 1972
  • 1994
  • 1984

What is one of the benefits of making products aseptically in a pharmacy aseptics unit?

  • Reducing the cost of production
  • Improving product shelf life
  • Reducing or eliminating medication dosing errors (correct)
  • Increasing the production capacity

What is the purpose of risk assessment tools developed by NPSA?

  • To control medication dosing errors
  • To monitor microbiological contamination
  • To improve patient care
  • To identify risks in aseptic production (correct)

What is the main reason for making unlicensed products in an aseptics unit?

<p>When licensed products are not commercially available (B)</p> Signup and view all the answers

What is one of the complexities around stability in Parenteral Nutrition?

<p>Unstable pH levels (D)</p> Signup and view all the answers

What is the benefit of ready-to-use injectables in clinical areas?

<p>Saves nurses time for better patient care (B)</p> Signup and view all the answers

What is the primary importance of taking finger dabs before sanitizing the gloves?

<p>To prevent glove contamination (B)</p> Signup and view all the answers

What type of agar medium is used in the finger dab plates?

<p>Tryptic Soy Agar (TSA) (C)</p> Signup and view all the answers

How should the plates be incubated to reduce the risk of condensation?

<p>In an inverted position (B)</p> Signup and view all the answers

What is the purpose of operator broth validation?

<p>To validate the operator's aseptic technique (A)</p> Signup and view all the answers

How many consecutive validation tests must an operator pass?

<p>3 (A)</p> Signup and view all the answers

What is the purpose of process simulation in validation?

<p>To simulate the product preparation process (D)</p> Signup and view all the answers

What is the focus of product validation?

<p>Product consistency and shelf life (C)</p> Signup and view all the answers

What is the purpose of validation of training?

<p>To ensure staff have the required knowledge and competency (D)</p> Signup and view all the answers

How often must operators repeat the validation process?

<p>Every 6 months (B)</p> Signup and view all the answers

What is the definition of validation?

<p>The accumulation of documented evidence to show that a system will consistently perform as expected (D)</p> Signup and view all the answers

What is the primary purpose of producing high risk drug lists by Aseptic Organisations PASG and UKMI?

<p>To categorize injectable medicines according to their risk level (C)</p> Signup and view all the answers

What is the significance of finding Streptococcus in environmental monitoring samples?

<p>It may have clinically significant consequences if introduced into the bloodstream (D)</p> Signup and view all the answers

Where should additions to Parenteral nutrition (PN) be made?

<p>In the aseptics unit (A)</p> Signup and view all the answers

What is the consequence of contamination in injectables given to patients?

<p>Serious and possibly fatal infections (D)</p> Signup and view all the answers

What property of Bacillus cereus makes it resistant to physical removal?

<p>Adhesive-like substances (B)</p> Signup and view all the answers

Why are Staphylococcus species often found in environmental monitoring samples?

<p>Because they are commensals found on human skin and in sputum (C)</p> Signup and view all the answers

What is the primary purpose of an isolator's hatch?

<p>To allow access of materials into and out of the isolator (D)</p> Signup and view all the answers

Why are Pseudomonas aeruginosa found in warm wet conditions?

<p>Because they are saprophytes in warm wet conditions (C)</p> Signup and view all the answers

What is the primary method of controlling Staphylococcus contamination?

<p>Using 70% alcohol solution (B)</p> Signup and view all the answers

What is the purpose of finger dabs in environmental monitoring?

<p>To check for contamination of the gloved hand (A)</p> Signup and view all the answers

What is the consequence of finding glove holes during manufacture?

<p>Manufacturing is stopped and a deviation is raised (A)</p> Signup and view all the answers

What is the primary goal of a Contamination Control Strategy (CCS)?

<p>To protect the product from contamination (B)</p> Signup and view all the answers

What is the purpose of reviewing errors or incidents in relation to injectables across the organisation?

<p>To learn from errors and put risk reduction and control measures in place (C)</p> Signup and view all the answers

What is the significance of finding Micrococcus in environmental monitoring samples?

<p>It indicates poor cleaning or transfer technique (A)</p> Signup and view all the answers

What is the benefit of automation in aseptic manufacturing?

<p>Improving efficiency and meeting the increasing demand for injectables (B)</p> Signup and view all the answers

Why are biofilms formed by Pseudomonas species?

<p>To survive attack by disinfectants (B)</p> Signup and view all the answers

What is the consequence of system failures in aseptics units?

<p>Serious harm or catastrophic harm to patients (D)</p> Signup and view all the answers

Who should prepare intrathecal chemotherapy and Parenteral nutrition (PN)?

<p>Pharmacy aseptics unit (A)</p> Signup and view all the answers

What is the purpose of microbial monitoring in aseptic units?

<p>To ensure robust processes and safe product manufacturing (D)</p> Signup and view all the answers

What is the purpose of a pressure decay test in isolator operation?

<p>To verify the integrity of the isolator (C)</p> Signup and view all the answers

What is the expected outcome of implementing a Contamination Control Strategy (CCS)?

<p>Layers of protection for the product (C)</p> Signup and view all the answers

What is the significance of Bacillus species in environmental monitoring samples?

<p>It may indicate inadequate cleaning or disinfection (A)</p> Signup and view all the answers

Why is effective communication necessary in relation to injectables prepared in clinical areas?

<p>To cover contingency plans and define responsibilities (A)</p> Signup and view all the answers

Why are Pseudomonas species opportunistic pathogens?

<p>Because they can cause disease in immunocompromised patients (D)</p> Signup and view all the answers

What is the purpose of the risk register in relation to injectable medicines?

<p>To record and review risks that have not been appropriately controlled (D)</p> Signup and view all the answers

What is used to remove Bacillus species from surfaces?

<p>Sporicidal agents such as hypochlorite (A)</p> Signup and view all the answers

What is the primary purpose of validating cleaning processes in parenteral nutrition manufacturing?

<p>To ensure the removal of chemical contaminants (B)</p> Signup and view all the answers

Why is it essential to maintain physical stability in parenteral nutrition formulations?

<p>To prevent precipitation of ingredients (C)</p> Signup and view all the answers

What happens when lipid globules come into contact with cationic electrolytes in large quantities?

<p>The lipid globules separate out (D)</p> Signup and view all the answers

Why is it essential to protect parenteral nutrition formulations from light?

<p>To prevent lipid peroxidation (D)</p> Signup and view all the answers

What is the purpose of a multilayer bag in parenteral nutrition manufacturing?

<p>To prevent the introduction of air bubbles (C)</p> Signup and view all the answers

What is the maximum number of particles (0.5 μm) permitted per cubic meter of air in a Grade B cleanroom at rest?

<p>3,520 (D)</p> Signup and view all the answers

What is the primary purpose of using a laminar airflow cabinet in parenteral nutrition manufacturing?

<p>To reduce the risk of contamination (D)</p> Signup and view all the answers

What is the primary purpose of wearing clean room clothing in parenteral nutrition manufacturing?

<p>To reduce the risk of contamination (D)</p> Signup and view all the answers

What is the significance of maintaining staff hygiene in parenteral nutrition manufacturing?

<p>To reduce the risk of contamination (B)</p> Signup and view all the answers

What is the primary purpose of using HEPA filters in parenteral nutrition manufacturing?

<p>To reduce the risk of contamination (B)</p> Signup and view all the answers

Flashcards

What year was the Breckenbridge Report published?

The year the Breckenbridge Report, which led to important changes in aseptic service practices, was published.

How does aseptic manufacturing benefit patients?

One way aseptic manufacturing in pharmacies benefits patients is by reducing the chance of incorrect medication doses, leading to better outcomes.

What's the purpose of NPSA's risk assessment tools?

These tools, developed by NPSA, help identify potential risks in aseptic production processes.

Why are unlicensed products made in aseptic units?

When a specific medication isn't commercially available, unlicensed versions can be made in aseptic units to meet patients' needs.

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What's a stability challenge in Parenteral Nutrition?

Parenteral Nutrition (PN) can be challenging to ensure stability due to variations in pH, which can affect the effectiveness and safety of the solution.

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How do ready-to-use injectables benefit clinical areas?

Ready-to-use injectables streamline the workflow in clinical areas, allowing nurses to spend more time on patient care.

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Why are finger dabs essential before sanitizing?

Finger dabs are crucial before sanitizing gloves because they help prevent contamination by detecting any microbes present.

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What type of agar medium is used in finger dab plates?

Tryptic Soy Agar (TSA) is the standard medium used in finger dab plates to grow a wide range of bacteria.

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How should finger dab plates be incubated?

Incubating plates upside down helps prevent condensation from dripping onto the agar surface, which could interfere with bacterial growth.

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What's the purpose of operator broth validation?

This test is crucial to ensure that the operator's aseptic technique consistently produces sterile solutions.

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How many consecutive validation tests are needed?

The operator must successfully complete 3 consecutive validation tests to demonstrate consistent aseptic technique.

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What's the purpose of process simulation in validation?

This simulation involves mimicking the entire product preparation process to assess aseptic technique and identify potential weak points.

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What's the focus of product validation?

Product validation focuses on ensuring the consistency of the product, its stability over time, and verifying that the shelf life claims are accurate.

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What's the purpose of validation of training?

Staff training validation ensures that all employees have the necessary knowledge and skills to perform their aseptic roles safely and effectively.

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How often does validation need to be repeated?

Operators must repeat the validation process every 6 months to stay up-to-date on aseptic technique and ensure ongoing competence.

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Define validation.

Validation is the process of gathering proof that a system consistently performs as expected, providing confidence in its reliability.

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Why do aseptic organizations create high-risk drug lists?

These lists, developed by aseptic organizations, categorize injectable medicines based on their potential risks to patients.

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Why is finding Streptococcus in an environment important?

Finding Streptococcus in environmental samples is significant because it suggests a potential contamination risk that could lead to blood infections in patients.

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Where should PN additions be made?

Additions to Parenteral Nutrition (PN) should ideally be made in a controlled aseptic environment to protect the solution from contamination.

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What are the consequences of contamination in injectables?

Contamination in injectables can lead to severe and potentially life-threatening infections in patients, highlighting the critical need for sterility.

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What makes Bacillus cereus hard to remove?

Bacillus cereus has adhesive-like substances on its surface, making it hard to remove through simple cleaning methods.

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Why are Staphylococcus species often found in environmental samples?

Staphylococcus species are often found in environmental samples because they are common bacteria on human skin and in respiratory secretions.

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What's the purpose of an isolator's hatch?

The hatch is an opening in the isolator that allows controlled access for materials, ensuring sterility is maintained.

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Where are Pseudomonas aeruginosa usually found?

Pseudomonas aeruginosa thrives in warm, moist conditions as a decomposer, which is why it's often found in aseptic environments.

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How is Staphylococcus contamination controlled?

Using 70% alcohol is a key method for controlling Staphylococcus contamination, effectively killing these bacteria.

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What's the purpose of finger dabs in environmental monitoring?

Finger dabs are part of environmental monitoring to ensure that the gloved hands of personnel are clean and not a source of contamination.

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What happens when a glove hole is found?

Finding glove holes during manufacturing is serious because it compromises sterility, requiring immediate action to stop production and investigate.

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What's the primary goal of a Contamination Control Strategy (CCS)?

The goal is to create a multi-layered strategy that protects the product from contamination at every stage of the manufacturing process.

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Why review errors in injectables?

Reviewing errors in relation to injectables helps learn from mistakes and implement changes to reduce risks and improve control measures.

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What does finding Micrococcus in a sample indicate?

Finding Micrococcus in environmental samples suggests poor cleaning or transfer technique, indicating a potential contamination risk.

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What's the benefit of automation in aseptic manufacturing?

Automation in aseptic manufacturing improves efficiency, helping meet the growing demand for injectable medications while maintaining quality.

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Why do Pseudomonas form biofilms?

Pseudomonas species form biofilms to protect themselves from disinfectants and other hostile environmental conditions.

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What happens when systems fail in aseptic units?

System failures in aseptic units can have serious consequences for patients, ranging from harm to potentially fatal infections.

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Who prepares intrathecal chemotherapy and PN?

Pharmacy aseptic units specialize in preparing high-risk medications such as intrathecal chemotherapy and Parenteral Nutrition (PN), ensuring safety and accuracy.

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What's the purpose of microbial monitoring in aseptic units?

Microbial monitoring aims to ensure that aseptic processes are robust and that the manufactured products are free from contamination, protecting patients.

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What's the purpose of a pressure decay test?

This test verifies the integrity of the isolator's seal, ensuring the internal sterile environment remains undisturbed.

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What's the expected outcome of a CCS?

The goal of a CCS is to create multiple layers of protection for the product, making contamination highly unlikely at every stage.

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What does finding Bacillus in a sample indicate?

Bacillus species in environmental samples suggest inadequate cleaning or disinfection, indicating a potential risk for contamination.

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Why is communication important with injectables in clinical areas?

Effective communication is crucial for ensuring everyone involved in preparing injectables in clinical areas understands responsibilities and can manage potential problems.

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Why are Pseudomonas opportunistic pathogens?

Pseudomonas species are opportunistic pathogens, meaning they can cause infections in people with weakened immune systems who are susceptible to disease.

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What's the purpose of the risk register?

The risk register records and reviews risks related to injectable medicines that have not been sufficiently controlled, aiding in ongoing risk management.

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How are Bacillus species removed from surfaces?

Sporicidal agents such as hypochlorite are used to remove Bacillus species from surfaces because they effectively kill even spore-forming bacteria.

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Why is it essential to validate cleaning processes?

Validating cleaning processes ensures that chemical contaminants are removed effectively, minimizing the risk of toxic residues in parenteral nutrition formulations.

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Why is physical stability essential in PN?

Physical stability in parenteral nutrition formulations is crucial to prevent ingredients from separating or settling out, affecting their effectiveness and safety.

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What happens when lipid globules meet too many cationic electrolytes?

When lipid globules come into contact with high concentrations of cationic electrolytes, they can separate, leading to an unstable and potentially ineffective PN formulation.

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Why must PN formulations be protected from light?

Light exposure can damage lipids in parenteral nutrition, leading to peroxidation, which can affect the quality and safety of the solution.

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What's the purpose of a multilayer bag?

Multilayer bags in parenteral nutrition manufacturing act as a barrier against air bubbles, ensuring the solution remains stable and safe for patients.

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What's the maximum particle count in a Grade B cleanroom?

In a Grade B cleanroom at rest, the maximum number of particles larger than 0.5 μm allowed per cubic meter of air is 3,520.

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What's the purpose of a laminar airflow cabinet?

Laminar airflow cabinets generate a controlled stream of air to reduce the risk of airborne contamination during the preparation of parenteral nutrition.

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Why is wearing clean room clothing essential?

Clean room clothing, like gowns and gloves, act as a barrier, preventing shedding of skin cells and other contaminants from staff, ensuring sterility.

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