Microbiology_6_Sterilization

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Questions and Answers

What is the primary principle on which ion exchange chromatography operates?

Separation based on solubility

Separation based on protein charge (correct)

Separation based on protein conformation

Separation based on molecular size

Which method is commonly used for the industrial removal of bacterial endotoxins?

Size exclusion chromatography

Reversed-phase chromatography

Centrifugation

Immuno-affinity chromatography (correct)

In what instances is sterilization particularly necessary for medical products?

Only for products that are exposed to open air

For all injectable medications regardless of exposure

Only for products intended for long-term storage

For parenteral administration and contacting broken skin (correct)

What specific type of infectious proteins may modern sterilization processes target for removal?

Prions Signup and view all the answers

What is a crucial aspect of the process of sterilization?

Killing or removing all forms of microbial life Signup and view all the answers

What is the primary purpose of purification in downstream processing?

To separate products from unwanted components Signup and view all the answers

Which method relies on the application of centrifugal force?

Centrifugation Signup and view all the answers

In the context of purification, what does the term 'MWCO' refer to?

Molecular Weight Cut-Off Signup and view all the answers

Which factor does NOT affect the yield during purification?

The type of contaminant present Signup and view all the answers

What is a common application of precipitation in downstream processing?

Isolating recombinant DNA polymerases Signup and view all the answers

What does sedimentation speed primarily depend on?

Cell size, density, and mixing speed Signup and view all the answers

What is the role of sterility checking in downstream processing?

To verify the absence of viable microorganisms Signup and view all the answers

Which of the following processes is NOT used in purification?

Gene cloning Signup and view all the answers

Which type of microorganism is known to exhibit exceptional resistance to sterilization methods?

Prions Signup and view all the answers

Which sterilization method primarily uses hydrolytic action?

Moist heat sterilization Signup and view all the answers

What is the minimum pore size recommended for filtration to effectively remove microorganisms?

0.22µm Signup and view all the answers

Which of the following sterilization methods is generally not reliable compared to heat-based methods?

Gas sterilization Signup and view all the answers

What is a major disadvantage of using ethylene oxide for sterilization?

It is flammable and toxic Signup and view all the answers

Which sterilization method is primarily used for heat-sensitive items?

Gas sterilization Signup and view all the answers

In filtration, depth filters function to trap particles within the filter. What is the primary mechanism used?

Absorption Signup and view all the answers

What type of radiation is considered ionizing and requires heavy shielding in facilities?

X rays Signup and view all the answers

Which of the following statements about sterilization methods is false?

Steam sterilization is suitable for all types of materials. Signup and view all the answers

What is a key factor in selecting a sterilization method?

Therapeutic efficiency and product stability Signup and view all the answers

Which method is primarily used to assess the success of sterilization by checking for microbial contamination?

Biological indicators Signup and view all the answers

Which of the following organisms is commonly used as a biological indicator due to its thermal resistance?

Geobacillus stearothermophilus Signup and view all the answers

What is the minimum acceptable microbial safety index indicating a sterilization process?

10^-6 Signup and view all the answers

What type of sterilization indicator visually changes during the heating process?

Color-changing chemical indicators Signup and view all the answers

What does the term 'sterile' refer to in the context of microbial populations?

A guaranteed absence of survivors Signup and view all the answers

Which of the following statements about sterilization is true?

Contaminant nature influences sterilization success. Signup and view all the answers

Which physical method is utilized for the optimal testing of pharmaceutical products in terms of sterility?

Membrane filtration Signup and view all the answers

What contributes significantly to failures in achieving successful sterilization?

Poor equipment maintenance Signup and view all the answers

Study Notes

MPharm Purification & Sterilization

The presentation covers purification and sterilization within the MPharm program.
The lecture notes provide a useful reference for purification and sterilization in the MPharm program, as well as Micro courses.
Learning objectives include introduction to downstream processing, purification, sterilization, different sterilization processes, sterility checking, and sterility testing.
A diagram outlines the mAb upstream process, from cell bank storage to production/seed bioreactor and primary recovery.
Purification separates products from production mixtures by removing unwanted components, using methods like sedimentation, precipitation, centrifugation, adsorption, and microfiltration (specified MWCO).
Purification reduces risks of side effects while maintaining yield, which depends on the number of steps and product loss at each.
Different yield percentages are shown at various stages of product recovery.
Downstream processing involves techniques like sedimentation and precipitation, which rely on cell size, density, and mixing speed.
Sedimentation and precipitation methods lower the solubility of the solute in the media and causes the product to fall out of solution.
This is useful in production of recombinant DNA polymerases via chemical, temperature, or pH changes.
Centrifugation uses centrifugal force to separate products, with denser particles moving outwards.
Adsorption chromatography is used for protein separation. Ion exchange binds proteins to the charge, while immuno-affinity uses antigenic regions to bind unwanted components.
Sterilization removes all microorganisms, including bacteria, fungi, and viruses (including those in biologically derived therapeutics such as monoclonal antibodies and plasma components). It can also include disabling/destruction/removal of infectious proteins (e.g., Prions, or Transmissible Spongiform Encephalopathies).
Microbial resistance to various sterilization methods is evaluated; prions show exceptional resistance to most sterilization agents.
Sterilization methods include steam (autoclave), gas sterilization, filtration, dry heat (oven), and ionizing radiation.
Filtration removes microorganisms rather than destroying them by size using varying filter grades, pore size, and membrane composition.
Heat-based sterilization methods use either moist heat (hydrolytic action at >120°C and >1 atm pressure) or dry heat (oxidative action at >150°C) for a wide spectrum of antimicrobial use in inactivating biohazard waste.
Gas-based sterilization uses ethylene oxide or formaldehyde, often for more temperature-sensitive items like reusable surgical instruments or medical devices.
Sterilization using radiation includes methods such as ionizing or non-ionizing radiation. Ionizing forms like Gamma or X-rays are common in industrial sterilizing while non-ionizing ultraviolet light has uses in surface disinfection and other forms of sterilization.
Sterilization success is verified using a combination of physical, chemical, and biological indicators. Physical indicators provide temperature & pressure records. Chemical indicators, such as autoclave tape, visually react to process conditions, and biological indicators demonstrate sterilization success by growing bacteria after the sterilization process if living microorganisms remain.
Sterility testing verifies that the sterilized product is free from contamination by incubating it in a nutrient medium. Membrane filtration is a common technique.

Sterility Assurance

Sterility testing involves assessing if a sterilized product is free from microbial contamination by incubation in an appropriate sterile nutrient medium.
Sterility assurance relies on the understanding that microbial populations decrease exponentially with exposure to the sterilization process, regardless of the initial contamination level.
Achieving true sterility is theoretically possible but practically takes an infinite time to ensure zero survivors. Testing can minimize microbial contamination but doesn't guarantee 100% sterility.
The presence of different microbial contaminants will affect the sterilization efficiency.

Additional Information

Useful references for the study material include the textbook Principles and Practice of Disinfection, Preservation and Sterilization by Russell, Hugo & Ayliffe and the other reading materials from the pharmaceutical microbiology text.

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Description

This quiz on MPharm Purification and Sterilization covers essential concepts in the field of pharmaceutical sciences. It includes downstream processing, different sterilization methods, and various techniques involved in purification and sterility testing. Assess your understanding of these critical processes in the drug manufacturing industry.