59 Questions
Which element is the main constituent of a cell?
Carbon
From which source do heterotrophs obtain carbon?
Organic molecules
What is the function of iron in a bacterium?
Cytochrome component and enzymatic cofactor
Which element is the electron acceptor in aerobic respiration?
Oxygen
From which source do lithotrophs obtain electrons?
Reduced inorganic compounds
What is the primary source of potassium for a bacterium?
Potassium salts
What is the primary purpose of using solid media (agar plates) for culturing microorganisms?
To form colonies with distinctive appearances for easier culture purification
What is the main difference between undefined media and defined media for microorganism culture?
Undefined media contains chemically undefined components, while defined media has all components chemically defined
Which method is used for anaerobic culture by producing CO2 and H2 from breakdown of citric acid, cobalt chloride, and sodium borohydride?
GasPak sachets
Which type of microorganism can tolerate oxygen in the air but produces energy by fermentation?
Facultative aerobe
What is the main characteristic of bacterial growth during the exponential (log) phase?
Growth and division occur at maximum possible rate given genetic potential and environmental conditions
What is the primary purpose of secondary metabolism in microbial cells?
Synthesis of natural products e.g. antibiotics
Which method aims to remove or kill all microorganisms and infectious proteins?
Gas sterilization
What type of infection is characterized by minor infections that do not spread beyond the site of injection or contact?
Local infection
Which process involves the series of operations to purify and sterilize medical products, reducing the risk of contamination and side effects?
Downstream processing
What is the most serious effect that can come from contaminated injectable products?
Systemic/bloodstream infection
Which method involves the process of separating products from production mixtures and removing unwanted components?
Purification
What is the main purpose of downstream processing?
Purification
Which method is important for minimizing microbial contamination while minimizing product damage?
Filtration
What can result from contamination of injectable products with toxic microbial metabolites?
Systemic/bloodstream infection
What is an example of a recognized sterilization method by European Pharmacopoeia(2002)?
Ionizing radiation
What is the process of separating products from production mixtures and removing unwanted components using methods such as sedimentation, precipitation, centrifugation, adsorption, and filtration?
Purification
What type of infection is often caused by ingestion of contaminated products?
GI infection
Which method involves the use of methods such as heat, filtration, and radiation to remove or kill all microorganisms and infectious proteins?
Steam sterilization
Which type of contamination is not mentioned in the text?
Radiological
What is one of the sources of biological contamination mentioned in the text?
Raw materials
Which type of area is used for clean or aseptic preparation in controlling microbial contamination?
Grade C
What is used for environmental controls in aseptic production as mentioned in the text?
High Efficiency Particulate Air (HEPA) filtration
What type of water has stricter quality guidelines than purified water as per the text?
Purified Water for injection
What is a common source of microbial contamination from personnel mentioned in the text?
Facial skin microbes
What method is used for product sampling and clinical samples as per the text?
Filtration and broth/agar methods
Which standard is mentioned in the text for regulating contamination?
QC Standards
What are the potential consequences of microbial contamination according to the text?
Spoilage and inactivation of products
What method is used for liquid sampling according to the text?
Liquid chromatography
In which area are environmental controls maintained for aseptic production?
Area with HEPA filtration and air drawn from outside aseptic area
Which method of sterilization is generally reserved for temperature sensitive items such as reusable surgical instruments and medical diagnostic equipment?
Radiation sterilization
What is the assumed mechanism of action for broad spectrum antimicrobials used in sterilization?
Alkylation of various protein functional groups
Which type of radiation used for sterilization requires the facility to be heavily shielded and can damage some materials due to radiolysis of water?
γ-rays
What is the primary target of both ionising and non-ionising radiation used for sterilization?
Microbial DNA
How can sterilization be checked to ensure its success?
Using chemical indicators based on visible alteration of chemical characteristics
What is the purpose of using biological indicators during sterilization?
To assess the sterilization process by placing non-pathogenic bacterial spore preparations around the sterilizer
According to sterility assurance, what does 'sterile' mean?
No surviving organism after exposure to the sterilization process
What is the microbial safety index aiming for in terms of probability?
1 in 1 million (10-6)
What method is used as the primary choice for assessing whether a sterilized product is free from microbial contamination by incubating a sample in nutrient medium?
Membrane filtration
What can happen when sterility testing indicates that a sterilized product is not free from microbial contamination?
Product recall and litigation
What does achieving true sterility entail based on microbial safety index probability?
Achieving a probability no more than 1 in 1 million (10-6)
What will have a direct impact on the success of sterilization, according to the text?
The nature of the contaminant involved
Which type of culture allows for controlled growth with constant nutrient supply?
Continuous culture
What are the three growth modes for bulk culturing?
Batch, fed batch, continuous
What is an important criterion for scaling up production?
Maintaining adequate mixing
What does viral replication rely on?
Host cell machinery
What can bacterial evolution result from?
Mutation or DNA acquisition
What results from bacterial evolution and selective pressure from antibiotics?
Antimicrobial resistance
What is strain improvement aimed at achieving?
Improving product production
What is the process of producing human-identical insulin through cloning and gene modification in E. coli called?
Heterologous gene expression
What mechanism does bacterial evolution include?
Transformation, transduction, and conjugation
What can contamination of pharmaceutical products lead to?
Increased resistance in bacteria
What does lab-scale culture optimize steps for?
Product production only
What can some viruses do during replication?
Destroy host cells
Study Notes
- Pyocyanin: produced in batch and continuous laboratory-scale cultures
- Batch culture: limited nutrient availability and product production due to closed systems
- Continuous culture: open systems, allows for controlled growth with constant nutrient supply
- Scaling up production: bulk culturing, three growth modes: batch, fed batch, and continuous
- Important criteria: maintain adequate mixing, high oxygen levels, control pH, temperature, and foam
- Viral replication: relies on host cell machinery, can lead to cell destruction or budding
- Bacterial evolution: changes in population over time due to mutation or DNA acquisition
- Antimicrobial resistance: results from bacterial evolution, selective pressure from antibiotics
- Strain improvement: increase production through spontaneous or targeted mutations, genetic modification
- Heterologous gene expression: production of human-identical insulin through cloning and gene modification in E. coli
Additional bullet points:
- Lab-scale culture: optimizes steps for product production, limited in industrial applications
- Viral replication: can lead to human disease, some viruses integrate into host genome
- Bacterial evolution: mechanisms include transformation, transduction, and conjugation
- Antimicrobial resistance: can lead to increased resistance in bacteria, decreased effectiveness of treatments
- Contamination of pharmaceutical products: understanding origins, reducing risks, testing and results.
Test your knowledge of the types of contamination in pharmaceuticals, including chemical, biological, bacterial, fungal, viral, and physical contamination. Explore the sources of biological contamination and the control measures to reduce the risk of microbial contamination. Learn about environmental controls, clean room practices, personnel controls, and more.
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