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pr3151 > sterile products > Flashcards

sterile products Flashcards

1
Q

what are the criteria that defines sterility

A

absence of viable microorganisms, endotoxins within limits, no detectable particles (perfectly clear)

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2
Q

what are the types of products that require sterility

A

parenteral, ophthalmics, preparations for irrigation

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3
Q

what are endotoxins

A

lipopolysaccharides produced by gram neg bacteria that causes the release of pro inflamm mediators IL and cytokines

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4
Q

what are pyrogens and what are the most common types of pyrogens

A

pyrogens are substances that causes fever and most common pyrogens are endotoxins

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5
Q

what is meant by sterility assurance level

A

it indicates the probability of one viable microorganism present in a certain number of drug products

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6
Q

what value indicates high sterility

A

SAL of 10^-4

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7
Q

what value indicates low sterility

A

SAL of 10^-1 to 10^-3

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8
Q

what are the types of sterility testing

A

sterility test (suitability test, growth promotion test), endotoxins test, bioburden, visible/non visible particles

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9
Q

what is meant by inactivation factor

A

degree to which the viable microorganism is reduced by the sterilisation treatment applied

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10
Q

what is the process of suitability testing (under sterility testing)

A

perform sterility test but spike the test with known quantities (<100cfu) of known microorganisms -> positive and negative controls -> incubate all tests for 3-5d -> compare levels of turbidity (if turbidity in test sample comparable to positive control -> success)

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11
Q

what is an isolator used for

A

advances aseptic processing for high potency drugs like chemo drugs, uses insulator of neg pressure

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12
Q

what is the difference between neg pressure and pos pressure insulator

A

neg pressure = air pressure inside < outside -> air enters but substance cannot exit

pos pressure = air pressure inside > outside -> air leaves and cannot reenter = protect product

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13
Q

what are examples of aerobic bacteria

A

s. aureus, bacillus, p, aeruginosa

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14
Q

what are examples of anaerobic bacteria

A

clostridium, aspergillus, candida

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15
Q

what are examples of growth medium

A

trypticase soy broth, fluid thioglucollate medium

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16
Q

what are the criteria under the growth promotion test (sterility testing)

A
  1. each lot of growth medium used in sterility test procedure will support the growth of < 100 viable microorganisms
  2. portion of each media lot must be incubated and assessed for sterility according to incubation parameters (temp and time)

if media cannot promote growth = fail, if media is non sterile = fail

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17
Q

what is a false positive result

A

think that product is not sterile as see something in final product but it came from outside and not from system

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18
Q

what is a false negative result

A

medium does not support growth so think that product is sterile

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19
Q

what is the most common endotoxins test

A

limulus amoebocyte lysate test (LAL test)

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20
Q

what is the principle of LAL test

A

reaction between lipopolysaccharide and a substance (clottable protein) contained within amoebocyte cells from the lysis of blood of the horseshoe crab

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21
Q

what is meant by endotoxin limit conc and how to calculate

A

ELC = K/M where K is max endotoxin dose in kg (usually 5EU/kg) and M is max recc dose in kg

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22
Q

what is meant by maximum valid dilution and how to calculate

A

MVD = ELC/ method sensitivity lambda

MVD refers to how much you can dilute the sample before notable to determine if number of endotoxin units is high or low enough and is dependent on lambda which varies for different methods

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23
Q

look at example for ELC and MVD calc

A
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24
Q

what is meant by safety factor

A

the range of working dilution between MVD and the first dilution fitting the specs

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25
Q

what is meant by bioburden

A

conc of microorganisms in a material (total number of organisms per ml/g)

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26
Q

what is the limit of bioburden

A

no more than 10CFU/100ml

27
Q

what are the potential process design and control strategy risk mitigation measures that can reduce the amount of bioburden

A
  1. reduce microbial load prior to and on sterile filter, remove bioburden using pre filters
  2. limit hold time and room temp storage
  3. implement aseptic handling techniques where appropriate
  4. select and validate sterile filter membranes with high microbial retention capabilities (> 10^6CFU/cm2)
  5. increase effective filter surface area by using larger single filter or multiple filters in series
  6. limit batch volume to be sterile filtered
  7. test integrity of sterilising filters pre and post use
27
Q

what are the potential process design and control strategy risk mitigation measures that can reduce the amount of bioburden

A
  1. reduce microbial load prior to and on sterile filter, remove bioburden using pre filters
  2. limit hold time and room temp storage
  3. implement aseptic handling techniques where appropriate
  4. select and validate sterile filter membranes with high microbial retention capabilities (> 10^6CFU/cm2)
  5. increase effective filter surface area by using larger single filter or multiple filters in series
  6. limit batch volume to be sterile filtered
  7. test integrity of sterilising filters pre and post use
28
Q

what is meant by D value

A

amount of time required to have at least 1 lg reduction (to reduce a microbial population by 90%)

29
Q

what are the equations to calculate bioburden

A
  1. log (N/N0) = -kt
  2. log (1/10) = -kD
  3. D = 1/K where K is death rate constant
  4. N = SAL of 10^-6 where N is number of cells surviving at time t
30
Q

what are the concerns regarding presence of sub-visible/ visible particles

A

concerns with adverse reactions like mechanical obstruction or injection site reactions (phlebitis, granuloma)

31
Q

what are the possible sources and nature of sub-visible/ visible particles

A
  1. extrinsic - environmental conditions like manufacturing equipment, primary packaging, hair, fibers, glass, rubber
  2. intrinsic - formulation related like API, proteinaceous, excipients, gas bubbles
32
Q

what are the types of tests that can test for sub-visible/ visible particles and which test is preferred

A

light obscuration particle count test, microscopic particle count test

32
Q

what are the types of tests that can test for sub-visible/ visible particles

A

light obscuration particle count test, microscopic particle count test

33
Q

which test is preferred for detecting sub-visible particles

A

light obscuration particle count test

34
Q

what is the principle of light obscuration particle count test

A

use suitable apparatus based on the principles of light blockage which allows automatic determination of size of particles and number of particles according to size

apparatus calibrated using dispersion of spherical particles of known sizes between 10-25microm

powders for parenteral use reconstituted with particle free water or with appropriate solvent without contamination of particles

35
Q

how are large and small volume parenterals tested in light obscuration particle count test

A

large volume parenterals are tested single units, small volume (<25ml) will have 10 or more units combined in a cleaned container to obtain a total volume of not less than 25ml to be tested

36
Q

what should the result be that indicates preparation complies with the light obscuration particle count test

A

number of particles present in the units tested does not exceed 6000 per container >equal 10microm and does not exceed 600 per container >equal 25microm

37
Q

what is the principle of microscopic particle count test

A

use of a suitable binocular microscope which is equipped with an ocular micrometer calibrated with an objective micrometer

sensitivity depends on kind of microscope used

38
Q

what is an ocular micrometer

A

a circular diameter graticule and consist of a large circle divided by crosshairs into quadrants, transparent and with black reference circles 10 and 25 microm in diameter

39
Q

what is the criteria that indicates preparation complies with the microscopic particle count test

A

sub-visible particles: no more than 6000 per container >equal 10microm, no more than 600 per container >equal 25microm

visible particles: essentially free of visible particles

40
Q

what are the components in ensuring a sterile preparation

A

safety - freedom from adverse toxicological concerns

sterility - freedom from microbial contamination

non pyrogenic - freedom from pyrogens, endotoxin contamination

particle free - freedom from visible particle contamination

stability - physical, chemical, microbiological

compatibility - packaging, formulation, other diluents

tonicity - isotonic with biological fluids

41
Q

what are examples of sterile products

A

sterile powders, injections, IV bags, multi dose vials, patient controlled analgesia, epidurals, irrigations, albumin, plasma protein fraction, immunoglobulins, ophthalmics

42
Q

what are sterile powders

A

drugs in powdered form are necessary if unstable in liquid form, must be reconstituted with a sterile diluent before administration

43
Q

what to look out for when dealing with sterile powders

A

expiration date, type and amount of solvent to be used in ml, stability of formulation upon reconstituation, storage

44
Q

what are the advantages of injections

A
  1. good for drugs that are poorly absorbed or inactivated in GIT
  2. good for drugs that are unpleasant
  3. immediate physiological action
  4. easy to control onset, duration and therapeutic response (circumvent intestinal absorption)
  5. easy to administer to unconscious or uncooperative patients
45
Q

what are the disadvantages of injections

A
  1. must be sterile
  2. tissue toxicity arising from local irritation
  3. frequent administration may pose difficulties and cause non compliance
  4. may require skilled personnel for administration
  5. difficulty in correcting errors
46
Q

what are the requirements for injections

A
  1. sterile and bacterial endotoxins below allowable limits
  2. standards for particulate matter
  3. limit additives use
47
Q

what are examples of additives used in injections

A

vehicles, antimicrobial agents as preservatives, tonicity adjusting agents, buffers, antioxidants, dispersing agents and surfactants

48
Q

what are examples of preservatives used in injections

A

phenols, chlorocresol, thimerosal, phenylmercuric chloride, benzalkonium chloride, benzethonium chloride, benzyl alcohol, chlorbutanol, methyl paraben, propyl paraben, butyl paraben

49
Q

what are examples of dispersing agents used in injections

A

tween 80, pluronic f68, lecithin, sodium carboxymethylcellulose, methylcellulose, acacia, gelatin

50
Q

what is meant by the term preservatives

A

inhibit bacterial growth, stable and compatible with other excipients

51
Q

what is meant by the term dispersing agents

A

prevent agglomeration and promote solubilisation, stable and compatible with other excipients

52
Q

what is the content in IV bags

A

base solution with medication dilution before administration

53
Q

what are the types of IV and the differences between them

A
  1. small volume IV (IV piggybacks)
    - administered over a short time at specific intervals
    - consist of base fluid and medication
    - 50 to 250ml
  2. continuous preparation of large volume IV
    - infused at a continuous rate
    - mostly base fluid with no additives
  3. continuous preparation of IV drips
    - infused at a very slow rate
    - usually ordered by amount of drug to be infused over given time frame
54
Q

what is the critical step for multi dose vials

A

must label date and time opened, initials of person who opened it on vial and must check expiration date when about to use

55
Q

what are patient controlled analgesia

A

IV pain medication administered via device either continuous administration or button operated, devices are calibrated to prevent overdose

56
Q

what are epidurals

A

inserted IT for pain control in surgery or obstetrics, must be preservative free as can cause paralysis, consist of anesthetic alone or with narcotic

57
Q

what are irrigation preparations

A

used in surgery to irrigate open surgical sites, usually contains abx like gentamicin, must be sterile

58
Q

what are albumin preparations

A

sterile solution for a single dose administration that contains 25% human albumin, used to treat hypovolemic shock and neonatal hyperbilirubinemia, last up to 4h once open

59
Q

what are plasma protein fraction (ppf) preparations

A

sterile solution for single dose IV administration containing 5% plasma proteins, used to treat hypovolemic shock and hypoproteinuria

60
Q

what are immunoglobulins preparations

A

sterile, lyophilised, single dose preparation of Ig, used for patients with primary defective or suppressed immune systems and at risk for infections, must be reconstituted before administration

61
Q

what are ophthalmics

A

prepared using aseptic filtration technique before being packaged into dropper, instilled onto external surface of eye (topical)/ inside eye (intraocular)/ adjacent (periocular)

pr3151 (12 decks)

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