30 Questions
What are the different types of contamination commonly found in pharmaceutical products?
Biological, Bacterial, Fungal, Viral
Which of the following is NOT a source of biological contamination in pharmaceuticals?
Chemicals
How can the risk of contamination be reduced in pharmaceutical manufacturing processes?
Regular hand hygiene practices
Which of the following is NOT a control measure used to reduce microbial contamination in pharmaceutical production?
Reuse of disposable gloves
What is one way to reduce the risk of long-term contamination and spoilage in pharmaceutical products?
Sterilisation of contaminated products before release
What is a common method used to reduce the risk of personnel contamination in pharmaceutical manufacturing?
Wearing Personal Protective Equipment (PPE)
What is the purpose of using High efficiency particulate air (HEPA) filtration in pharmaceutical manufacturing?
To remove at least 99.97% of 0.3 µm diameter airborne particles
Which of the following environmental controls is specifically designed to provide a local zone for high-risk operations in pharmaceutical manufacturing?
Micro.Glovebox/isolator
What distinguishes Grade A areas in aseptic production from other grades when manufacturing sterile medicinal products?
They are the local zones for high-risk operations
Which of the following statements about water used in pharmaceutical manufacturing is true?
Purified water has stricter quality guidelines than water for injection
Why is controlling microbial contamination from personnel important in pharmaceutical manufacturing?
To maintain sterility and prevent contamination of medicinal products
What common source of biological contamination is highlighted in the text as being present on people's hands and worksurfaces?
~100 million microbes/cm3 from facial skin
What is a common method to reduce the risk of transmission of contaminants between hands and products?
Using alcohol hand gels
Which equipment is typically used for non-sterile manufacturing to reduce contamination?
Hairnets
What does flow cytometry utilize to count microbes?
Fluorescence
Which method can show only viable cells and colony forming units (CFU)?
Direct inoculation
What is the purpose of calculating the Total Viable Count in microbiology?
Calculating CFU/mL of the original inoculum
Which method is believed to be suitable for getting organisms that are difficult to grow?
Total viable count
What is the most serious health hazard associated with contamination of injectable products?
General bacteraemic shock
In the context of pharmaceutical contamination, what can lead to death in patients?
Systemic/bloodstream infection
Which type of patients are most vulnerable to serious infections from contaminated products?
Immunocompromised patients
What is the most significant effect of contamination with toxic microbial metabolites in pharmaceuticals?
Death
Which measure is particularly important to reduce the risk of contamination in pharmaceuticals?
Implementing aseptic techniques
Which regulatory aspect is aimed at controlling microbial contamination in pharmaceutical products?
Microbial limit testing requirements
What is the acceptable limit for E.coli in oral non-aqueous pharmaceutical products according to the British Pharmacopoeia standards?
100 CFU/mL
Sterile pharmaceutical products must meet which criteria in terms of microbial contamination?
Contain no microbial contaminants and adhere to additional criteria
What is one of the factors that can influence the rate of breakdown of a pharmaceutical product by microbial contamination?
Type and number of microbial contaminant
What is an example of inactivation of a pharmaceutical product due to microbial contamination mentioned in the text?
Breakdown of thickening agents by amylases
Which type of packing material is mentioned as being more resistant to microbial contamination in the text?
Nylon
Why is it important to understand where and how a pharmaceutical product will be used?
To manipulate the formulation for resistance to spoilage
This quiz covers the origins and sources of microbial contamination in pharmaceutical products, methods to reduce risks of contamination, testing procedures, and interpreting contamination results. Ideal for students studying pharmacy. Reference material includes 'Hugo & Russell’s Pharmaceutical Microbiology'.
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