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Pharmaceutics Year 2 > Section 11 - Microbial Control > Flashcards

Section 11 - Microbial Control Flashcards

1
Q

When does microbiological contamination become a problem?

A

When it results in unwanted effects to product or user

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2
Q

What determines the severity of the effects of microbiological contamination?

A

Nature and number of contaminating organisms

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3
Q

W/ respect to microbiologicals, what are the 2 types of pharmaceutical products available?

A

1) Sterile products that contain no viable microorganisms

2) Non-sterile products that may contain viable microorganisms, but these should not damage patient or product

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4
Q

Which dosage forms allow for limited microbiological contamination?

A
  • Inhalations
  • Tablets
  • Oral liquids
  • Creams and ointments
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5
Q

What does it mean when a product is allowed limited microbiological contamination?

A
  • May require numbers of microbiological contaminants per unit of volume or weight be limited
  • May require specified microbes not be present at all
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6
Q

What causes spoilage of formulation?

A
  • Microorganisms use the product as a growth medium

- Viable cells can produce enzymes to degrade complex macromolecules into easily assimilated nutrients

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7
Q

How are non-sterile pharmaceutical products generally formulated?

A

To prevent any microorganisms from increasing during shelf life

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8
Q

How do non-sterile aqueous dosage forms and syrups prevent the number of microorganisms from increasing during shelf life?

A
  • Non-sterile aqueous dosage forms usually include antimicrobial preservatives
  • Syrups contain high concentrations of sugar (~85%) to resist growth b/c of lack of free water
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9
Q

Which products are self-preserving?

A

Products containing more than 15% alcohol

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10
Q

What are some possible physical changes caused by microbial contaminants?

A
  • Breakdown of emulsions
  • Visible surface growth on solids
  • Formulation of slimes, pellicles, or sediments in liquids
  • Production of gas, odours, or unwanted flavours
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11
Q

What is an example of a microorganism that won’t product visible signs of spoilage?

A

Salmonella, presents a serious health hazard but will cause little or no visible spoilage

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12
Q

What is an example of a microorganism that will produce disease w/o producing spoilage of the product?

A

Corynebacterium diphtheriae

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13
Q

What factors determine risk of infection?

A
  • Species and quantity of microorganisms
  • Route of administration
  • Susceptibility of px receiving the medication
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14
Q

What are the USP indicator organisms which must not be present? Why were they chosen?

A
  • Staph aureus
  • Pseudomonas aeruginosa
  • E coli
  • Salmonella species
  • Chosen b/c they are typical types that could cause infection
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15
Q

What was the contaminating organism in the albuterol event?

A

P. fluorescens

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16
Q

Which fungi were found in tablets of micronase?

A
  • Penicillium
  • Aspergillus
  • Paecilomyces
  • Botryotrichum
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17
Q

What are the majority of contaminants?

A

Bacteria, yeasts, and filamentous fungi (molds)

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18
Q

What are the 4 main sources of contamination?

A

1) Raw materials
2) Personnel
3) Equipment
4) Environment

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19
Q

What should be done to each lot of raw materials?

A
  • Should be evaluated for microbiological suitability

- Those deemed liable to microbiological contamination should be subjected to microbiological tests before use

20
Q

When is raw material considered high contamination level?

A
  • Unprocessed raw materials of animal, plant or mineral origin
  • May contain high bioburden, gram neg, gram pos, mold, microbial pathogens, or objectionable microorganisms w/ an ability to proliferate in or biodegrade the materials
  • High risk of microbial contamination
21
Q

When is raw material considered moderate contamination level?

A
  • Moderately processed natural material or chemicals and their bioburden levels depend on extent and type of manufacturing process
  • Predominant organisms are mold and spore forming bacteria
22
Q

When is raw material considered low contamination level?

A
  • Synthetic materials, or chemically purified natural extract
  • Manufacturing processes are too extreme for survival of most microorganisms
  • Generally provide poor growth conditions for microorganisms due to antimicrobial properties (bacteriostatic or fungistatic) or low water activity levels
23
Q

Which organisms are the ones usually found in water?

A
  • Pseudomonas
  • Achromobacter
  • Alcaligenes
24
Q

Which type of bacteria will grow rapidly in water under ambient conditions?

A

Gram negative rods

25
Q

How is purified water made?

A

Distillation combined w/ ion exchange or reverse osmosis

26
Q

How is water for injection made?

A

Purified water that is also sterilized

27
Q

What are sources of contamination for water?

A
  • Ion-exchange columns

- Inappropriate storage

28
Q

Which forms of matter are most susceptible to microbial contamination?

A

Liquid > semi-solid > solid

29
Q

What is water activity?

A
  • Measure of degree w/ which water is bound and its availability to support growth
  • Ratio of vapor pressure of H2O in product to vapor pressure of pure H2O at the same temp
30
Q

What is the range of water activity and what is the minimum water activity required for microbial growth?

A
  • Range is 0.1 to 1.0

- Water activity of 0.6 is considered minimum

31
Q

Which raw materials are known to possess antimicrobial properties?

A

Acids, alkalis, organic solvents, antibiotics, and fungicides

32
Q

Which nutrients provide a source for microbial growth?

A

Proteins, carbs, lipids, vitamins, minerals, and polyalcohols

33
Q

Which processes are used to treat raw materials to reduce or eliminate microbial contamination?

A
  • Ionizing radiation
  • Ethylene oxide
  • Thermal methods (autoclaving, dry heat)
  • *Important that material not be damaged or altered by the process
34
Q

What should be done to equipment w/ respect to antimicrobial properties?

A
  • Equipment should be smooth and crevice free, as well as clean and dry
  • Need to monitor quality of cleaning and rinsing fluids as well as air quality
35
Q

What type of environment are sterile products made in?

A

Environment w/ highly controlled factors

36
Q

What can be done to decrease bioburden?

A
  • Use of solvent environments that are hostile to microorganisms
  • Processes involving heat (distillation, heat sterilization, evaporation, crystallization, drying)
  • Some manufacturing processes (manufacture of tablets including mixing, granulation) drying, tableting; drying process)
  • Formulation type
37
Q

Can temperatures of 80-100 C destroy microbes?

A

No

38
Q

Can tablet compression destroy bacterial spores?

A

No, the shearing forces and heat generated during compression may not be sufficient

39
Q

What should the raw material for sterile products be?

A

Sterile, or a low bioburden raw material w/ sterility and endotoxin criteria

40
Q

Which organisms are tested for in USP tests to prove microbial purity of raw materials?

A
  • E. coli
  • Salmonella species
  • P. aeruginosa
  • Staph aurues
  • Also includes total aerobic microbial counts (TAMC) for ingredients
41
Q

What should be done for raw materials w/o compendial microbiological requirements?

A
  • If raw materials for oral dosage form, recommendation is to default to TAMC of no more than 1000 cfu/g or mL, and absence of E coli and Salmonella species
  • For raw materials in parenteral proucts, default to TAMC of no more than 100 cfu/g or mL and bacterial endotoxin requirement
42
Q

What are objectionable organisms for products for immunocompromised px?

A
  • Pseudomonas species
  • Staph aureus
  • Candida albicans
  • Mycotoxin producing fungi
  • B cepacia
43
Q

What should raw material for ophthalmic dosage forms be evaluated for?

A
  • P aeruginosa
  • Pseudomonas species
  • Staph aureus
  • Serratia marcescens
  • Serratia liquifaciens
44
Q

What should raw material for topical dosage forms be evaluated for?

A
  • P aeruginosa
  • Klebsiella species
  • Staph aureus
  • Ser. marescens
  • Ser. liquifaciens
  • Pseudomonas species
  • Clostridium species
  • C. albicans
  • B. cepacia
45
Q

What should raw material for genitourinary dosage forms be evaluated for?

A
  • E coli
  • Proteus species
  • Ser. marcescens
  • P aeruginosa
  • P multivorans
  • C albicans
  • Klebsiella species
  • Acinetobacter species
  • B cepacia
  • Molds

Pharmaceutics Year 2 (17 decks)

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