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Sterile Products Flashcards

1
Q

Sterility

A

Absence of microorganisms

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2
Q

Why give a drug by injection?

A

Rapid action
Localised action
Prolonged activity
Drug not active by other routes
Drugs degrading by oral route
Metabolised by oral route = low bioavailability

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3
Q

Characteristics of the vehicle in injections

A

Pharmacologically inert
Non toxic
Non irritant liquid
Usually water for injection

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4
Q

Pyrogens

A

Substances when administered to humans result in an increase in temperature

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5
Q

Isotonic

A

Solutions with same osmolarity

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6
Q

What happens when IV administration of hypotonic solutions (lower osmolarity than blood)?

A

RBC swelling and irreversible haemolysis

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7
Q

Clean room

A

Concentration of airborne particles is controlled
Temperature, humidity and pressure are controlled

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8
Q

Active monitoring

A

Air sampling
Contact plates
Finger dabs
Swabs

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9
Q

Grade B clean rooms temp and humidity

A

Temp of 18 +- 3
Humidity 45+- 15%

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10
Q

Why is Clean room clothing needed

A

Outermost layer of skin sheds
Approx 1% carries bacteria

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11
Q

Separation device

A

Some form of barrier between the device and surrounding clean rooms

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12
Q

Isolators

A

Used for sterility testing, aseptic filing…
Arrangement of physical barriers that are integrated

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13
Q

Restricted access Barriers (RABs)

A

Open passive RABs utilise existing clean room overhead air supply systems to deliver filtered air
Closed RABs is a positive pressure system with on board fan/filtration units to supply filtered air over the critical process before being recirculated

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14
Q

Terminally sterilised

A

Sterilised in the final container

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15
Q

Non terminally sterilised

A

Not sterilised in final container, but prepared under aseptic conditiond

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16
Q

Methods of sterilisation : heat

A

Microorganisms lose their viability

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17
Q

What is the heat resistance of different microorganisms

A

Vegetative bacteria, viruses and fungi= hot water at 60-100
Spores= >100

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18
Q

Autoclave

A

Sterilisation by saturated steam under pressure

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19
Q

Saturated steam

A

Water vapour in equilibrium with water
Temp of steam corresponds to the boiling point of the water producing it
Releases latent heat of vaporisation on condensing

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20
Q

What indicators can you use in an autoclave

A

Chemical and biological indicators

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21
Q

Biological indicators

A

Must come with a certificate of conformity
Should indicate the population, D value and purity of the microorganisms

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22
Q

Chemical indicators: Bowie and dick test

A

A test of the effectiveness of the air removal scheme
Indicator turns dark if it was properly sterilised ( all air was removed)
If the indicator changes colour, it wasn’t subjected to the required time/ temp (121C for 15 mins)

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23
Q

Advantages of autoclaving

A

Terminal sterilisation
Any dose volume
Good safety margin
Viruses killed
Relatively short progress
Suitable for dressings, rubber, some plastics
Suitable for solutions and suspensions

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24
Q

Disadvantage of autoclaving

A

Unsuitable for heat unstable materials
Unsuitable for anhydrous materials (oil and powders)
Organisms killed but not removed
Skilled operators required
May damage glass and metal
Batch process

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25
Dry heat
Water absent from the heating environment
26
Hot air oven
Electrically heated Insulated chamber and doors Fan to ensure air circulation Heat transfer by convection and radiation Temp variation should not exceed 5
27
Applications of dry heat
Heat stable items, either sensitive to moisture or impermeable to steam High temps to sterilise and depyrogenate glassware Anhydrous materials (oils, fats, non aq) Glass and metal-waders Some rubbers
28
Advantages of dry heat
Terminal sterilisation Any dose volume Viruses killed For anhydrous materials Suitable for solutions and suspensions Less damage to glass and metal than moist heat Suitable for some assembled equipment
29
Disadvantages of dry heat
Drastic heat treatment Organisms killed but not removed Unsuitable for dressings, rubber and plastics Suspensions may give a different crystal form on cooling
30
D value (decimal reduction value)
Time required to produce a tenfold reduction in no. Of viable organisms
31
Bioburden
Number of organisms present on a surface or in a sample before sterilisation Must achieve 10^-6
32
filtration
means of sterilising fluids through the removal of microorganisms
33
filtration sterilisation
filter through a sterile bacteria proof filtration aseptically distribute into sterile filled containers aseptically seal ensure medicament is not adsorbed onto filter perform sterility test
34
factors affecting filtration
product properties (ionic strength, ph, viscosity) bioburden (microorganism, size, shape, cell wall/deformability) process of filtration (time, temperature, pressure, flow dynamic) filter properties (structure, pore size, surface chemistry)
35
membrane filters
thin uniform pore sheets which acts as sieves that trap particles larger in size than the pores used for injections
36
types of filters
disk filters cartridge filters
37
disc filters
direction of fluid flow is from above the filter to below the filter membrane is placed between the metal inlet and outlet plates sealed by elastomeric O rings difficult to sterilise
38
cartridge filters
filters are located within the cylindrical stainless steel housings compact presentation provides a large surface area
39
what is a challenge of using cellulose as a material in filters
cellulose found in plant cell wall different types in summer, spring, winter high amount of microorganisms on the cellulose
40
ideal properties in a filter
non toxic integrity test sterilisable must not absorb formula compounds must not add extractables to process must remove the bioburden associated with the product
41
bubble point pressure
test to determine individual pore size by using pressure
42
pore size formula
d= 30y/P D= max pore size y= surface tension of liquid in dynes per cm P= pressure in mm Hg
43
testing of filters
1) use of micro organisms after 7 days sterile= no growth destructive test because sample used is lost 2) Pre use, post sterilisation integrity test (PUPSIT) pressure max pore size is calculated from the pressure required to force the first air bubble through a filter first bubble forms at the pore of the largest diameter
44
limitations of filtration sterilosations
solutions can be readily oxidised suspensions/ emulsions are difficult to filter medicants are highly adsorbed by filters products unstable in solution
45
advantages of filtrations
no thermal effects, no heat used removed dead and viable organisms clarifies filtrate
46
disadvantages of filtrations
cannot remove viruses non terminal sterilisation requires sterility testing= delay defects in filters not visible possibility of adsorption of medicament, liberation of particles, or alteration of pH unsuitable for suspensions
47
filters failing sterilisation
ignored filter manufacturer's technical specifications improper end use training improper sterilisation process design (temp or pressure) defective cartridges membrane failures grow through of microorganisms- bacteria trapped in filter continue to grow
48
what are the types of radiation for sterilisation
electromagnetic- gamma rays and uv light particulate- accelerated electrons
49
microbial resistance to radiation
vegetative bacteria= growing= most sensitive bacterial spores and viruses can be dormant= most resistant
50
what does resistance of organism depend on
extent of dna damage required to produce cell death ability to carry out effective repair
51
which radiation is more effective
gamma rays and accelerated electrons due to ionisation and free radical formation
52
terminal sterilisation
sterilisation in final container
53
when can you not use gamma rays
in aq solutions (creams) where radiolysis of water produces free radicals
54
when can you use radiation sterilisation
surgical instruments sutures unit does ointments heat sensitive materials clean room garments
55
sterilising dose for radiation
time or dose of radiation to kill microorganism by 90%
56
measures to prevent radiation exposure
2m thick concrete wall securely locked chamber continuously check for leaks
57
what affects the dose delivereed
density of material being irradiated distance between load and source exposure period source strength = half life
58
direct effect of radiation on dna
radiation induces bonds between strands of dna or the intra-strand cross links disrupts normal structure prevents replication and transcription dna can break, making it impossible for the cell to repair its genetic material effectively
59
indirect effect of radiation on dna
indirect effects due to radiolysis of water to get radicals active species that can directly target the proteins in dna
60
importance of oxygen in radiation
makes micro organism more sensitive to radiation enhances the formation of radicals makes radiation more effective in killing bacteria anaerobic conditions= reduce the indirect effects of radiation, makes sone microorganisms more resistant
61
factors affecting radiation
species difference= vegetative or spores stage of cell growth= actively dividing cells (vegetative) are more sensitive than stationary phase cells presence of oxygen= increases sensitivity moisture= complex interaction with oxygen - microbial resistance decreases temp= below 0c, decreased activity, immobilised free radicals penetrating power= gamma rays are better than beta rays
62
uv light
lower energy and causes less damage to microbial dna does not penetrate metal used for sterilisation of air and aseptic work areas
63
gaseous sterilisation
temp sensitive items used for surgical instruments ethylene oxide and formaldehyde
64
ethylene oxide
highly explosive so used with other gases boiling point 10.7= liquid temp >10.7 is used= low temp to form gases for sterilisation miscible with water= reduces the resistance, increases sensitivity
65
properties of ethylene oxide
good penetrating powers minimum level of moisture is required 30-60% highly diffusible toxic by inhalation and contact alkylating agent
66
disadvantages of ethylene oxide
absorption during the process treated articles must go through desorption stage to remove toxic residues can take many days or left in a ventilated cupboard
67
formaldehyde
temp of 70-75 similar toxicity to ethylene oxide low penetrating power= limits packaging materials
68
desorption of gas
usually quarantined for 7-10 days in controlled conditions of temp and air flow
69
factors affecting gases bactericidal activity
concentration= increasing conc increases activity exposure time= 3-6 hours pressure= increasing pressure increases gas penetration and increases activity humidity temp
70
advantages of using gases for sterilisation
effective at low temp few materials damaged good penetration terminal sterilisation
71
disadvantages of using gases for sterilisation
special apparatus/ trained staff toxic expensive explosion hazard slow removal of gas from some materials
72
Difference between quality control and in process control
Quality control= check the product before it is released, once batch is done In process control= during manufacturing process
73
Sterility testing
Confirm that product is sterile
74
Two types of sterility testing
Membrane filtration test- wash filter to remove preservatives Direct inoculation
75
Membrane filtration
Clear liquids and large volumes Larger sample size Product may need neutralisation or dilution Requires filtration and rinsing steps Requires membrane filtration setup
76
Direct inoculation
Suitable for viscous, oily or solid products Smaller sample size Product may inhibit microbial growth Direct addition No specialised equipment
77
Limitation of sterility testing
A universal culture medium capable of supporting the growth of all possible contaminants does not exist Destructive testing Statistical sampling- only tests a batch
78
Pyrogens
Substances that cause a ride in body temp/ fever
79
Endotoxins
Common type of pyrogens
80
Tests for pyrogens
Rabbit testing= monitor body temp change after injection Bacterial endotoxin test= use lyses amoebocytes from horseshoe crab blood Monocytes activation Factor c
81
Incubation conditions
20-25C for min 7 days the re incubate at 30-35C for min 7 days

Phay0004 (17 decks)

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