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Microbiology > Contamination > Flashcards

Contamination Flashcards

1
Q

Why don’t we want a product to be contaminated?

A
  • because it won’t look nice
  • because it won’t be nice to apply
  • because it won’t taste good if you drink it
  • because it may cause an infection
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2
Q

What does contaminated mean?

A

Product is spoilt with microorganisms

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3
Q

What causes an infection?

A

Microorganisms, virus

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4
Q

What are the sources of microbial contamination?

A
  • Water
  • Operators (You) = the ones preparing the pharmaceutical product
  • Surfaces
  • Raw materials
  • Atmosphere
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5
Q

How do we determine spoilage of a pharmaceutical product?

A
  • bad smell

- physical degradation of cosmetics = bugs growing on the cosmetics

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6
Q

What is important in pharmacy given spoilage?

A

Prevention from contaminant is important in pharmaceutical product. Consequences of contamination can be serious, therefore we need to preserve pharmaceutical products.

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7
Q

What are preservatives?

A

Chemicals/antimicrobial contained in the formulation; they stop growth of microorganisms and therefore spoilage of product

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8
Q

Which pharmaceutical preparations contain preservatives?

A

creams, syrups , multidose injections,vaccines

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9
Q

Describe water as a source of microorganisms

A
  • The presence of water in formulations means you’ll have growth of microorganisms (water is essential for the growth of microorganisms)
  • If there is no water, there is no growth of microorganisms
  • The water we drink contains microorganisms but they are not nasty so they won’t cause an infection
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10
Q

Which formulations doesn’t get spoilt?

A

Dry tablets don’t get spoilt because there’s no water in their composition so microorganisms can’t grow. Therefore dry tablets don’t need an antimicrobial in their composition

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11
Q

Do we often see spoilage?

A

Sometimes we can see the spoilage/the physical damage but often we can’t see it ( we can’t see that the microorganism is there) Therefore we need to make sure that pharmaceutical products are not spoilt as this could harm the patient)

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12
Q

How can we reduce microbial count in water samples CHEMICALLY?

A
  • Chlorine
  • Chlorination = treatment with Chlorine
  • Sodium hypochlorite (NaCl)
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13
Q

Concentration of chlorine which is used to reduce microbial count in water

A
  • 0.5-5 ppm of free chlorine for most purposes
  • 50-100 ppm of free chlorine for storage and distribution. We need a higher concentration for the chlorine water we stock because water isn’t moving anywhere so you can have proliferation of microorganisms in water.
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14
Q

Is chlorine used to control the microbial count in the water used for pharmaceutical preparations?

A

We can’t use chlorinated water in the preparation of pharmaceutical products (Chlorine is not used in formulations), therefore we use a different type of water that will ensure there will be no microorganisms

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15
Q

Describe MEMBRANE FILTRATION

A

Used for the reduction in microbial count in water

  • There is a membrane with different pores and the pores have a defined size = 5 micrometers. Any bacteria/fungi/yeast larger than that will be stuck on the surface. Therefore the filtrate obtained will be free of microorganisms.
  • We can also use membrane filtration to check what grows in water because all bacteria will be retained on the surface of the membrane. Then you can put the membrane on a nutrient to grow colonies which will be visible.
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16
Q

Which microorganisms work for membrane filtration?

A
  • only bacteria, fungi and yeast

- Membrane filtration doesn’t work for viruses because they are smaller than the pore size

17
Q

Describe UV radiation

A
  • Used to sterilize water of a good optical quality (and also surfaces in the laminar flow cabinet)
  • The UV needs to be in close contact with the surface you want to decontaminate/irradiate
  • Water goes in front of the UV radiation –> this kills microorganisms in water
18
Q

Describe heating

A
  • Used to reduce the microbial count from water samples
  • Boiling water ( to 60-80 degrees) will decrease the number of bacteria in water; this is because bacteria can’t grow at these temperatures
  • BUT this is not sufficient for production of pharmaceutical products (because NOT ALL BACTERIA WILL DIE, only most of it)
19
Q

Describe OPERATOR (YOU) as a source of microrganisms

A
  • Contamination from the skin (S aureus); There are resident (They live in the deep layer of the skin and are difficult to get rid off) and transient ( exist on the upper layer of the skin) microorganisms
  • Contamination from the respiratory tract (coughs and sneezes spread diseases)
  • Everybody has a different ratio of resident microorganisms. Bags after you wash your hands = resident microorganisms
20
Q

How to reduce contamination from operators?

A
  • Tie hair back and wear a hair net to protect microorganisms from hair contaminating the product
  • Wear shoe cover
  • Wash hands thoroughly with antiseptic soap before and after the procedures. Wear sterile, powder free nitrile gloves throughout the procedure. BUT wearing gloves doesn’t entirely protect the product as you can touch surfaces with the glove which then contaminates the glove with microorganisms.
  • Wear sterile mask to cover the upper respiratory tract
21
Q

Describe SURFACES as a source of contamination

A

Comes from the building in which the pharmaceutical product is manufactured, the packaging of the product and the equipment with which the product is manufactured

22
Q

How can contamination arise from building?

A
  • Walls and ceiling: mould= common flora; grows in an environment with moisture+poorly ventilated building+ painted walls
  • Floors and drains
  • Windows, Doors, Fittings: there us dust outside windows which can contaminate the product
23
Q

How can we prevent contamination from building?

A
  • From Walls and Ceiling: use of disinfectant, laminated plastic, ventilation (filtration)
  • Floors and drains: easily cleaned, drains avoided in areas where products are being manufactured (drain=source of microbial contaminants)
  • Doors, windows, fittings: the windows should be permanently closed, they should only be there to provide a source of light
24
Q

How can contamination from the packaging the product be prevented?

A
  • contain the product (e.g solution and dressing)
  • use rubber cap in formulation to prevent the entry of microorganisms into the product
  • prevent the degradation of the product during storage (light, moisture)
  • withstand the appropriate sterilization process (heat and gas sterilization)
25
Q

What is the equipment used in the manufacturing of pharmaceutical products?

A
  • surgical equipment
  • critical (equipment that goes into the body), semi-critical (equipment that goes into the membrane), non critical items (skin is a good barrier against microbes)
26
Q

How to reduce contamination in equipment?

A
  • sterilization - physical (heat) + chemical (special biosites)
  • disinfection (use antimicrobials biosites on surfaces -Cl)
  • Use single use items ( these are sterile items, free of microorganisms and are discarded after one use)
27
Q

Describe raw materials as a source of microbial contamination

A
  • CONTAMINATION ARISES FROM PRODUCTS OF NATURAL ORIGIN (they contain microorganisms/viruses which are problematic)
  • Animal: gelatine,desiccated thyroid, growth hormones
  • Plant: starch, gum acacia
  • E. coli and Salmonella spp. are nasty pathogens and thus you can’t have them in a pharmaceutical product
  • depending on the type of pharmaceutical product , you are allowed to have microorganisms and thus the content of the microorganisms
28
Q

How can we reduce contamination from raw materials?

A
  • minimum water activity to prevent spoilage (because if there is no water, there will be no growth of microorganisms)
  • use packaging to prevent the entry of microorganisms
  • liquid and semi-solid raw materials should be kept at 60 degrees to prevent microorganisms from growing ( because microorganisms won’t be able to grow at those temperatures)
29
Q

Describe atmosphere as a source of microorganisms

A
  • sneezing

- pollutants

30
Q

Reduction of contamination from the atmosphere

A
  • filtration (used in the preparation of most pharmaceutical products). High efficiency particulate air (HEPA) filters are used as they can remove up to 99.997% of particles greater than 0.3 micrometers in diameter ( these particles will be stuck on the filter). Air comes from room, it is sucked in the filter and the particulates are trapped in the filter, air comes out of the filter free of microorganisms. Place air filters in the laboratory and ensure that they are regularly checked and replaced
  • chemical disinfection,where you spray chemical disinfectant in the room to neutralize it, is used in hospitals where you have a pathogen you can’t get rid off (fumigate the ward)
  • ultraviolet (UV) irradiation - 30 cm above the surface
31
Q

Describe the conditions in the rooms where pharmaceutical products are prepared

A
  • Complete room, confined to specific area (laminar air flow cabinet, isolators)
  • High pressure rooms (positive pressure):keeps atmospheric contamination out

Microbiology (11 decks)

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