52 Questions
What was the year of the Breckenbridge Report that led to changes in Aseptic Services?
1974
What is one of the benefits of making products aseptically in a pharmacy aseptics unit?
Reducing or eliminating medication dosing errors
What is the purpose of risk assessment tools developed by NPSA?
To identify risks in aseptic production
What is the main reason for making unlicensed products in an aseptics unit?
When licensed products are not commercially available
What is one of the complexities around stability in Parenteral Nutrition?
Unstable pH levels
What is the benefit of ready-to-use injectables in clinical areas?
Saves nurses time for better patient care
What is the primary importance of taking finger dabs before sanitizing the gloves?
To prevent glove contamination
What type of agar medium is used in the finger dab plates?
Tryptic Soy Agar (TSA)
How should the plates be incubated to reduce the risk of condensation?
In an inverted position
What is the purpose of operator broth validation?
To validate the operator's aseptic technique
How many consecutive validation tests must an operator pass?
3
What is the purpose of process simulation in validation?
To simulate the product preparation process
What is the focus of product validation?
Product consistency and shelf life
What is the purpose of validation of training?
To ensure staff have the required knowledge and competency
How often must operators repeat the validation process?
Every 6 months
What is the definition of validation?
The accumulation of documented evidence to show that a system will consistently perform as expected
What is the primary purpose of producing high risk drug lists by Aseptic Organisations PASG and UKMI?
To categorize injectable medicines according to their risk level
What is the significance of finding Streptococcus in environmental monitoring samples?
It may have clinically significant consequences if introduced into the bloodstream
Where should additions to Parenteral nutrition (PN) be made?
In the aseptics unit
What is the consequence of contamination in injectables given to patients?
Serious and possibly fatal infections
What property of Bacillus cereus makes it resistant to physical removal?
Adhesive-like substances
Why are Staphylococcus species often found in environmental monitoring samples?
Because they are commensals found on human skin and in sputum
What is the primary purpose of an isolator's hatch?
To allow access of materials into and out of the isolator
Why are Pseudomonas aeruginosa found in warm wet conditions?
Because they are saprophytes in warm wet conditions
What is the primary method of controlling Staphylococcus contamination?
Using 70% alcohol solution
What is the purpose of finger dabs in environmental monitoring?
To check for contamination of the gloved hand
What is the consequence of finding glove holes during manufacture?
Manufacturing is stopped and a deviation is raised
What is the primary goal of a Contamination Control Strategy (CCS)?
To protect the product from contamination
What is the purpose of reviewing errors or incidents in relation to injectables across the organisation?
To learn from errors and put risk reduction and control measures in place
What is the significance of finding Micrococcus in environmental monitoring samples?
It indicates poor cleaning or transfer technique
What is the benefit of automation in aseptic manufacturing?
Improving efficiency and meeting the increasing demand for injectables
Why are biofilms formed by Pseudomonas species?
To survive attack by disinfectants
What is the consequence of system failures in aseptics units?
Serious harm or catastrophic harm to patients
Who should prepare intrathecal chemotherapy and Parenteral nutrition (PN)?
Pharmacy aseptics unit
What is the purpose of microbial monitoring in aseptic units?
To ensure robust processes and safe product manufacturing
What is the purpose of a pressure decay test in isolator operation?
To verify the integrity of the isolator
What is the expected outcome of implementing a Contamination Control Strategy (CCS)?
Layers of protection for the product
What is the significance of Bacillus species in environmental monitoring samples?
It may indicate inadequate cleaning or disinfection
Why is effective communication necessary in relation to injectables prepared in clinical areas?
To cover contingency plans and define responsibilities
Why are Pseudomonas species opportunistic pathogens?
Because they can cause disease in immunocompromised patients
What is the purpose of the risk register in relation to injectable medicines?
To record and review risks that have not been appropriately controlled
What is used to remove Bacillus species from surfaces?
Sporicidal agents such as hypochlorite
What is the primary purpose of validating cleaning processes in parenteral nutrition manufacturing?
To ensure the removal of chemical contaminants
Why is it essential to maintain physical stability in parenteral nutrition formulations?
To prevent precipitation of ingredients
What happens when lipid globules come into contact with cationic electrolytes in large quantities?
The lipid globules separate out
Why is it essential to protect parenteral nutrition formulations from light?
To prevent lipid peroxidation
What is the purpose of a multilayer bag in parenteral nutrition manufacturing?
To prevent the introduction of air bubbles
What is the maximum number of particles (0.5 μm) permitted per cubic meter of air in a Grade B cleanroom at rest?
3,520
What is the primary purpose of using a laminar airflow cabinet in parenteral nutrition manufacturing?
To reduce the risk of contamination
What is the primary purpose of wearing clean room clothing in parenteral nutrition manufacturing?
To reduce the risk of contamination
What is the significance of maintaining staff hygiene in parenteral nutrition manufacturing?
To reduce the risk of contamination
What is the primary purpose of using HEPA filters in parenteral nutrition manufacturing?
To reduce the risk of contamination
Assess your knowledge on aseptic services, sterile products, and microbiology. Learn about the importance of contamination control, microbiological monitoring, and the impact of contamination on patients.
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