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EXAM 1 > Aseptic techniques > Flashcards

Aseptic techniques Flashcards

1
Q

What is sterility assurance level

A

The probablity of micro-organisms surviving after exposure to sterilisation

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2
Q

What is terminal sterilisation

A

Sterilisation of the fully assembled product as a last step

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3
Q

What is aseptic processing

A

Sterilisation of the raw materials separately and the subsequent assembly of the mateirals following aseptic techniques.

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4
Q

What are the two approaches to the production of sterile products

A
  • Aseptic processing
  • Terminal sterilisation
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5
Q

List the physical sterilisation methods

A
  • Filtration
  • Radiation
  • Heat sterilisation (steam/dry heat)
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6
Q

What is an autoclave

A

A machine used for steam sterilisation

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7
Q

What are the application of steam sterilisation

A
  • Porous loads (e.g. Theatre gowns & dressing packs)
  • Flexible and semi-rigid containers (e.g. Infusion solutions, bags, bottles)
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7
Q

What is a common issue with sterilisation of flexible&semi-rigid containers and how does the autoclave resolve this

A
  • Bursting of the container
  • Due to build up of pressure in the air space inside the bags/bottles.

‘Air ballasting’ which maintaints a proportion of air within the chamber to prevent package breakage

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8
Q

What are the limitations of steam sterilisation

A
  • Cannot be used on oily-base products
  • Only applicable to thermostable and moisture-stable products
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9
Q

What are the applications of dry heat sterilisation

A
  • Thermostable dry powder
  • Oily injections
  • Glassware
  • Metal instruments
  • Depyrogenation of glass (250c for 45mins)
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10
Q

What are the advantages/ disadvantages of dry heat sterilisation

A

Advantages:
* Good alternative for moisture sensetive materials
* Suitable for assembled apparatus (terminal sterilisation)
* Can be used for depyrogenation

Disadvantages:
* Not suitable for plastics and rubber
* Not suitable for surgical dressings - Natural moisture in fibres vaporises causing detoriation

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10
Q

Steam sterilisation mode of action

A
  • Protein denaturation
  • Hydrolysis of bacterial enzymes
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11
Q

Radiation sterilisation advantages

A

Advantages:
* It is a terminal technique
* Highly efficient
* Can be used for thermo-labile (sensetive) products

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12
Q

Radiation sterilisation application

A
  • Surgical instruments
  • Sutures
  • Prostheses
  • Dry powders
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13
Q

Disadvantages of radiation sterilisation

A
  • Not effetive against some viruses
  • High cost: Large installation, training, disposal
  • Dangerous
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14
Q

Filtration sterilisation application

A

Only used for liquids

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15
Q

Filtration sterilisation advantages

A
  • Good for thermo-labile products
  • Removes bacterial dead bodies
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16
Q

Filtration sterilisation disadvantages

A
  • Cannot be used for suspensions
  • Product requires equires sterility test post-sterilisation
  • Filter requires frequent monitoring and checking
  • Filtration does not remove viruses, mycoplasms
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17
Q

What are the two types of gas sterilisations

A
  • Alkylating agents (Ethylene oxide)
  • Oxidising agents (Hydrogen peroxide)
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18
Q

What are the advantages of gas sterilisation

A

Advantages:
* Good penetration in porous materials
* Effective against all micro-organisms
* Effective at relatively low humidity and temperature (less likely to damage material)

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19
Q

What are the disadvantages of gas sterilisation

A

Disadvantages:
* Can take up to 10 days
* More expesive than dry/steam
* Gas is toxic and flammable (dangerous)
* Some plastics and nylon wraps need to be left opened and then sealed aseptically after sterilisation

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20
Q

Radiation sterilisation mode of action

A

Microbial DNA damage via the formation of highly reactice radicals

21
Q

What is dry heat sterilisation mode of action

A

Mainly an oxidative process

22
Q

What is the best sterilisation technique for the depyrogenation of glass

A

Dry heat

23
Q

Good sterilisation technique for dressing packs

A

Steam sterilisation

24
Q

Good sterilisation technique for surgical tools

A

Radiation

25
Q

High level disinfectant

A

Destruction of all microorganisms but not necessarily bacterial spores

26
Q

Intermediate level disinfectant

A

Destruction of ALL vegatative bacteria but excluding some viruses and fungi

27
Q

Low level disinfectant

A

Can destroy MOST vegatative bacteria, some fungi and viruses

28
Q

What are alcohol disinfectants & their application

A
  • Bactericidal against vegatative bacteria and mycobacteria (Ethanol, isopropanol)
  • Require some water for effectiveness (Alcohol conc. 60-95%)
  • High concs. are virucidal & fungicidal (e.g. 90%)
  • Used to disinfect surfaces and skin
  • They are not sporicidal
29
Q

What are phenol disinfectants & their application

A
  • Bactericidal - Vegetative bacteria
  • Not sporicidal
  • More active at acidic pH
  • Caustic effect on skin (BAD)
  • Diluted phenols are used as preservatives and antiseptics
30
Q

Concentrations for phenols

A

Concentrations
✓0.1%-1% → Bacteriostatic.
✓1%-2% → Bactericidal and fungicidal

31
Q

Aldehydes disinfecants adn give examples

A
  • Highly effective biocides that disrupt the cell membrane
  • They are partial sporicides
  • Formalin, Glutaraldehyde
32
Q

What is Formaldehyde and what is it used for

A

An aldehyde disinfectant with maxinum activity above 20c that is used for safety cabiners and isolators.
* It is irritant to skin
* Its vapours are carcinogenic

33
Q

What is Glutaraldehyde and its application

A

An aldehyde disinfectant that is broad spectrum against bacteria, fungi, viruses and spores. Used for instruments and closed systems but not for open surfaces.

34
Q

What are pyroxygen disinfectants

A

Highly active disinfectants that can act as sporicidal at high concentration and temperature. Otherwise the act as surface disinfectants.
* Hydrogen peroxide - Open woulnds
* Peracetic acid - Used in enclosed systems.

35
Q

What is the aim of Aseptic processing

A

To maintain the sterility of a product throughout each step of its component assembly

36
Q

What are aseptic techniques

A

A set of precautions and conditions that need to be followed during manufacturing process

37
Q

Explain the differences between terminal sterilisation and aseptic techniques

A

Terminal sterilisation involves the product being sterilised in their final form and container AFTER they have been manufactured and packaged whereas aseptic manufacture involves…
* Maintaining a sterile environement for the storage of products and manufacturing processes.
* Personel training and use of PPE regulations
* Routine cleaning and monitoring of the environment and finished product via microbiological monitoring

38
Q

What are microbiological monitoring techniques

A

Processes involved in quality assurance. These assess levels of contamination and cleanliness in a sterile environment.
* Finger dabs
* Air sampling
* Surface sampling

39
Q

What does the finger dab technique achieve

A

Assesses the level of sterile manipulation and following of aseptic techniques of the individual. It is conducted in each session to assess individuals competence towards tho.

40
Q

What does air sampling achieve

A

An important way of monitoring microbiological contamination of the environment in which the aseptic techniques and manufacture process is carried out in

41
Q

What are two methods of sampling air contamination in a lab

A
  • Settle plates - Leave an agar plate exposed and opened for a few hours then incubate
  • Active air sampling - The use of a microbial air sampler which aspirates air into the machine and impacts it onto the agar plat.. incubate
42
Q

Explain surface sampling

A

An important aspect of quality insurance by measuring the level of contamination of surfaces in a room via…
* Contact plates - Surface agar is gently pressed onto the surface for 2-4 secs
* Surface swabs - Used to get samples from corners and curved surfaces

43
Q

Explain the design features of a laminar flow cabinet

A
  • Inward airflow through sash opening - Protects the user
  • HEPA filtered downflow of air onto work surface - Protects protection from unfiltered incoming air (by pushing it down)
  • Exhaust air is filtered by HEPA - Environmental protection
44
Q

What class of biosafety is a Laminar flow hood

A

Class II

45
Q

What are the application of grade A areas

A

High-risk operations such as…
* Handling sterile materials
* Aseptic connections
* Product filling

46
Q

What are the applications of grade B areas

A

A clean environment used for…
* Aseptic preparation
* Filling
* Compounding processes

47
Q

What are the applications of grade C rooms

A

A space used for less critical stages of sterile product manufacturing such as…
* Preparatiuon of solution to be sterilised
* Handling components

48
Q

What can disturb laminar flow conditions in a LFA

A
  • Sudden movements
  • Excess equipment in hood -> obstruction
  • Heat sources (e.g. bunsen burners)
49
Q

What is the purpose of testing the inside of the cabinet for Filter integrity

A

To determine if HEPA filter consists of any leaks or faulty seals

50
Q

What is the purpose of testing the inside of the cabinet for Air velocity

A

To determine if the air velocity complies with the standard and prevent ingress of dirty air

51
Q

What can Antimicrobial preservatives be used for

A
  • Oral liquid preparations
  • Creams and lotions
  • Eyedrops
  • Injectables
  • Nose & ear drops
52
Q

What is AMP not used for

A

antimicrobial preservatives are not used for…
* Dry powders
* Tablets
* Capsules
* Ointments

EXAM 1 (10 decks)

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