micro 6

Study Flashcards Play Quiz

Questions and Answers

Which method of downstream processing is based on the principle of chromatography?

Adsorption

In downstream processing, what does the ion exchange method bind proteins based on?

Protein charge

Which method uses antigenic regions to bind unwanted components?

Immuno-affinity

What does the sterilization process primarily remove or kill?

Viruses Signup and view all the answers

In which situation would sterilization be essential for a medical product?

Products for IV administration Signup and view all the answers

Which downstream processing method is NOT specifically related to purifying proteins?

Sterilization Signup and view all the answers

What is the purpose of downstream processing in biotechnology?

To remove contaminants from the product Signup and view all the answers

Which factor does NOT affect the sedimentation speed during downstream processing?

Temperature Signup and view all the answers

How does precipitation contribute to downstream processing?

It removes products from the solution Signup and view all the answers

What is required for centrifugation during downstream processing to effectively separate products?

Components with a higher density than the medium Signup and view all the answers

Why is it important for denser particles to move to the outside first during centrifugation?

To ensure efficient separation Signup and view all the answers

Which method of downstream processing is commonly used in the production of recombinant DNA polymerases?

Centrifugation Signup and view all the answers

What is the primary purpose of sterility testing in downstream processing?

To eliminate unwanted contaminants Signup and view all the answers

Why is sterilisation important in pharmaceutical production?

To reduce the risk of contamination and ensure product safety Signup and view all the answers

Which method is commonly used to ensure sterility assurance during downstream processing?

Membrane filtration with specified molecular weight cut-off Signup and view all the answers

How do contaminants impact the success of sterilisation processes in pharmaceutical production?

Contaminants can interfere with the effectiveness of sterilisation methods Signup and view all the answers

In what way does membrane filtration contribute to downstream processing?

It removes unwanted components based on molecular weight cut-off Signup and view all the answers

What is the key benefit of reducing risk of side effects while maintaining yield in pharmaceutical purification processes?

Minimized adverse reactions in patients Signup and view all the answers

What is the purpose of sterility testing?

To check if a sterilized product is free from microbial contamination Signup and view all the answers

What does the purple to yellow color change in steam indicate?

Non-sterile condition Signup and view all the answers

Why does achieving true sterility take a long time?

Because spores are very resistant to heat Signup and view all the answers

What is the purpose of membrane filtration in sterilization processes?

To collect microorganisms from liquid products for testing Signup and view all the answers

How does the nature of contaminants impact the success of sterilization?

It directly influences the effectiveness of the sterilization process Signup and view all the answers

What is the microbial safety index aiming for in sterilization processes?

$10^{-6}$ chance of a single surviving organism Signup and view all the answers

What is the major use of MWCO filters in sterilization?

Removing contaminants based on atomic mass Signup and view all the answers

Which type of radiation requires heavy shielding due to its damaging effects on materials?

γ-rays Signup and view all the answers

What is the mechanism of action assumed for ethylene oxide gas in sterilization?

Alkylation of various protein functional groups Signup and view all the answers

Why is ethylene oxide gas sterilization generally reserved for temperature-sensitive items?

It can penetrate packaging materials Signup and view all the answers

How are membrane filters different from depth filters in sterilization?

Membrane filters retain particles on the filter surface, while depth filters trap particles within the filter. Signup and view all the answers

What is a key consideration when assessing the efficacy of filtration in sterilization?

The reduction in bacterial count achieved Signup and view all the answers

Study Notes

Purification and Sterilization in MPharm Programme

Downstream processing involves purification and sterilization of products to remove unwanted components and contaminants
Purification involves separation of products from production mixtures using various methods such as sedimentation, precipitation, centrifugation, adsorption, and micro-filtration

Purification Methods

Sedimentation: separates products based on cell size, density, and mixing speed
Precipitation: lowers solute solubility and causes product to fall out of solution through chemical, temperature, or pH changes
Centrifugation: applies centrifugal force to separate products based on different densities
Adsorption: uses chromatography principle to capture proteins based on charge or antigenic regions
Micro-filtration: uses filters with specified molecular weight cut-off (MWCO) to separate products

Why Purify?

Increases yield and reduces risk of side effects
Yield depends on the number of steps involved in the purification process
Each step can result in loss of product, affecting the overall yield

Sterilization

Sterilization involves the removal or destruction of all microorganisms, including bacteria, fungi, and viruses
Sterility is achieved when there are no surviving microorganisms
Sterilization methods include heat-based methods, gas-based methods, filtration, and radiation

Sterilization Methods

Heat-based methods: moist heat (steam) and dry heat (oven) methods
Gas-based methods: uses chemically reactive gases like ethylene oxide and formaldehyde
Filtration: removes microorganisms using filters with varying pore sizes and compositions
Radiation: uses ionizing and non-ionizing radiation to destroy microorganisms

Sterility Testing and Assurance

Sterility testing involves incubating a sample in nutrient medium to check for microbial contamination
Sterility assurance involves ensuring that the sterilization process is effective in reducing microbial populations
Microbial safety index is used to ensure that the probability of a non-sterile unit is no more than 1 in 1 million (10-6)

Importance of Sterilization

Sterilization is critical in pharmaceutical products, especially those that come into contact with mucosal surfaces or internal organs
The nature of the contaminant affects the success of sterilization
Sterilization methods must be selected based on the type of product and the level of microbial reduction required

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.