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Amy Somerville > RESP - D. STERILE PRODUCTION-COVERED > Flashcards

RESP - D. STERILE PRODUCTION-COVERED Flashcards

1
Q

sterile pharmaceutical products

A
  • free of living microorganisms
  • injectable formulations must also be free of particles and pyrogens (LPS endotoxin from gram -ve bacteria)
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2
Q

what products must be sterile

A
  • those in contact within internal organs
  • eyes
  • broken skin
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3
Q

what is terminal sterilisation

A
  • 1st option as less risky
  • product is manufactured, sealed in final container and sterilised (NaCl nebuliser solution BP)
  • low risk of microbiological contamination in final product
  • not possible iF drug is thermosensitive
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4
Q

what is aseptic production

A
  • more risky
  • medium, container, closure sterilised separately then combined in a sterile environment (Na cromoglicate eye drops)
  • higher risk of microbial contamination in final product
  • sterility assurance and sterility control = crucial
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5
Q

what are 4 terminal sterilisation processes accepted by BP

A
  1. moist heat (steam)
  2. dry heat
  3. ionising radiations
  4. gaseous sterilisation

*biocidal - microorganisms killed

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6
Q

what is 1 aseptic production method accepted by BP

A
  1. filtration

*microorganisms and particles physically removed from product

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7
Q
  1. steam
A
  • sterilisation by saturated steam under pressure in autoclave
  • 121 degrees Celsius for 15 min or 134 degrees Celsius for 3 minutes (causes less damage)
  • very efficient: organisms killed by denaturation or hydrolysis of cell constituents, heat resistant bacteria spores killed
  • items packed in porous paper to allow steam penetration and post-sterilisation protection

used for:
- bottled aqueous solutions ie - for injection
- containers
- dressings: saline solution
- instruments
(anything resistant to heat)

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8
Q
  1. dry heat
A
  • sterilisation in a hot air oven
  • 160-180 degrees Celsius for 2 hours
  • paraffin is only substance that can resist this
  • less efficient than steam as killing microorganisms due to oxidation processes of lipids and proteins so slow death
  • preferred over ionising radiations
  • destruction of pyrogens (heat resistant)
  • items packed in metal boxes to allow contact with heat and post-sterilisation protection

used for:
- glass bottles
- metal surgical instruments

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9
Q
  1. ionising radiations
A
  • uses accelerated electrons or gamma rays
  • biocidal activity due to DNA damage of micro-organisms: slow process
  • used for heat sensitive products but
  • might cause accelerated degradation of some plastic containers or aqueous drug formulations (as radicals form)

used for:
- ointments
- instruments
- sutures
- UV radiations NOT suitable for sterilisation of pharmaceutical products as
less DNA DAMAGE than ionising
only used for work surfaces

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10
Q
  1. gaseous methods
A
  • ethylene oxide or formaldehyde (mutagenic and carcinogenic)
  • biocidal activity due to chemical modification or proteins and nucleic acids in microorganisms
  • not used in hospital but in specialised manufacturing plants
  • less efficient
  • sterility assurance lower than with heat processes

used for:
- powders
- instruments
in industry

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11
Q

1a. filtration of solutions

A
  • for heat sensitive injectable or ophthalmic solutions
  • pore diameter of filters: 0.22 microns (retains smallest viruses/bacteria)
  • removal of particles (not suitable for suspensions)
  • different types of filter (hydrophilic for aq formulation and hydrophobic for non-aq product)
  • work in laminar flow cabinet
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12
Q

1b. filtration of gases

A
  • sterile air in sterile production units and inside laminar airflow cabinet
  • high efficiency particulate air (HEPA) filters - in ceiling, remove up to 99.997% of particles >0.3 microns
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13
Q

laminar airflow cabinet

A
  • provides a continuous, unidirectional flow of clean sterile filtered air
  • laminar flow needs to be undisturbed: don’t place product behind another that obstructs HEPA filter at back
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14
Q

ANTT principles - aseptic non-touch technique

A
  • ‘critical site’ can’t be touched by a non-sterile item ie:hands, surface of cabinet
  • must remain sterile for final product to be sterile
    ie:eye dropper, neck of bottle, inside of bottle, lid of bottle, filter
  1. disinfect laminar airflow cabinet (back to front) and start at ceiling
  2. disinfect all items that will be placed in cabinet using wipes
  3. disinfect gloves
  4. items placed at side not in front to avoid turbulence
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15
Q

aqueous products

A

steam sterilisation but if product sensitive to heat
aseptic filtration but if product can’t be filtered (suspensions)
aseptic protection from sterile individual components

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16
Q

non-aqueous products

A

dry heat sterilisation but if product sensitive to heat
ionising radiation but if product is sensitive to radiation
aseptic filtration (hydrophobic filter) but if product can’t be filtered (suspensions)
aseptic protection from sterile individual components

17
Q
  1. sterility control
A
  • incubation of whole/portion of product with a nutrient medium under sterile conditions to verify absence of contamination (ie should be no microorganisms)
  • legally required
18
Q

limitations of sterility tests

A
  • product destroyed (can’t apply to specials product made for 1 specific patient)
  • few samples from each batch tested
  • rely on suitability of culture medium and culture conditions ie - no standard conditions
  • doesn’t detect presence of viruses
19
Q
  1. sterility assurance
A
  • clean environment
  • follow GMP/GWP rules and use correct aseptic procedure
  • use contamination free starting materials
  • validation and in-process control of sterilisation procedures ie - it occurred as planned
  • suitable packaging and storage
20
Q

regular cleaning/disinfection

A
  • floor and horizontal surfaces cleaned and disinfected every day
  • ceiling and walls cleaned and disinfected once a month
21
Q

design of premises

A
  • separation of storage and preparation areas
  • clean = grey, aseptic = white
  • different routes for staff and materials
    unidirectional flow of sterile products
  • filtered air at +ve pressure = prevents air from external environment or grey area entering aseptic area
  • smooth surfaces and rounded coving to prevent accumulation of dust/microorganisms and easy to clean and disinfect
22
Q

suitable clothing

A
  • sterile trouser suit, hat, enclosing hair, facemask, gloves, overboots
  • non-shedding materials
  • non-reusable
23
Q

strict changing procedure

A
  • passage from outside to clean area via a dividing step-over sill
  • outer garments and footwear removed in black area
  • hands washed in sink with elbow or foot operated
24
Q

in process control of procedures: biological indicators

A
  • heat sterilisation
    ampoules containing spores of a heat resistant bacteria placed autoclave then incubate
  • aseptic filtration
    filtration of culture of a non-pathogenic bacteria of 0.3microns through 0.22micron pore size filter then incubate
  • incubation to verify absense of bacterial growth in medium

*incubation time can be a few days for microorganism to grow and multiply in culture medium

25
Q

in process control of procedures: chemical/physical indicators

A

chemical
- melt when temp reached or change colour when irradiated
- don’t confirm its been completed successfully

physical (most reliable)
- heat sterilisation
temp record in autoclave (+ time temp was maintained for autoclaving )

  • aseptic filtration: integrity of filter
    bubble point pressure test for membrane filters
    retention of particles of known dimensions for HEPA filters
26
Q

water for injection BP

A

autoclaving

27
Q

eye ointment

A

ionising radiations

28
Q

NaCl nebuliser

A

autoclaving

29
Q

liquid paraffin

A

dry heat

30
Q

suspension eye drops

A

aseptic production

31
Q

powdered excipient

A

gaseous sterilisation

Amy Somerville (70 decks)

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