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Manufacturing > C2-Sterile dosage forms > Flashcards

C2-Sterile dosage forms Flashcards

1
Q

what are the qualifications for parenteral preparations?

A

Stability of the API during storage and administration
API content and identity accurrency
no microorganisms
limits of pyrogens and ednotoxins

free of visible particles
adequte tonicity, ph

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2
Q

Container size classifications

A 
SVP= small volume parenteral ( < =100 ml)
LVÜs= larger voulme parenteral (>=100 ml)
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3
Q

glass types?

A

type 1 (2-100 ml), have highest quality and high resistance of hydrolytic attack

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4
Q

Antimicrobial, when should it be used?

A

in all multiple-dose
single dose without a terminal sterilization (may be added)
injections (> 15 ml) no preservatives)

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5
Q

Antioxidants?

A

ascorbic acid and sodium bisulfits

prevention of oxidative degradation

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6
Q

why are parenteral applications important

A

due to fast onset of and length of the drug action

action can be control with injectables

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7
Q

what does sterility means?

A

the absence of viable and actively multiplying microorganisms

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8
Q

on what does the release of the batch depends?

A

on the validated process

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9
Q

what is a SAL

A

Sterility assurance level, used to express the probability of a mO to survuve in the product

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10
Q

meaning of a paramerically release

A

the release is based on the process parameter of the sterilization proces, which are already validated

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11
Q

sterilization processes

A

steam, dry heat, radiation

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12
Q

steam sterilization process

A

end product is treated using water vapour as energy conductor

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13
Q

why do we have a shorter sterilization time in steam processing

A

due to better conduction of water vapor than dry air, (7-fold higher).

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14
Q

temperature in steam and dry heat sterilization

A

steam temperatur is lower, due to higher energy conductor

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15
Q

what is the case, if sterilization is possible?

A

sterile filtration and aseptic manufacuring

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16
Q

when is sterilie filtration used?

A

when steam and dry heat sterilization is not possible

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17
Q

why can’t we used ionizing radiation

A

due to instabilities of drug susbstance and excipients

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18
Q

On which products can raidation sterilization used?

A

non-aqueous liquif

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19
Q

when do we used aspetic conditions?

A

if steam or sterile filtrated is not possible

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20
Q

when do we used dry sterilization process

A

STANDRAD 160 °c; 2h
METAL AND GLASSS EQUIPMENT
OIL PREPARATION

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21
Q

SAl, on what does the probability of surving of MO depends?

A

enviroment, the count, type and the resistance of MO

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22
Q

what can be done to ensure high sterility level?

A

filtration beofre sterilization can be conducted

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23
Q

what can influence the resistance of the MO

A

pH and antimicrobial compound

number of MO in the prodcut can be affect by the water content

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24
Q

what is the SAL required by Ph.Eur.

A

10-6

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25
Q

What’s the D-value

A

decimal reduction value, define as the rate at which the MO are killed during sterilization

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26
Q

what does the D-value meanse?

A

the number of germs can be reduced at the giving rate by one log

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27
Q

on what does the d-value depends?

A

on the germs type and procedure

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28
Q

D-value of 15 mins is asign to which baterial?

A

for geobacillus stearothermophilus or bacillus atrohaeus

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29
Q

what does spore means?

A

there are heat reistance

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30
Q

Equation for D-value?

A

D121°C * 10 ^ (121-T/Z)

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31
Q

Z-value?

A

the temperature coefficient, temerature different at which the D-value is change to the tenfold

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32
Q

F-value?

A

the time to achive an effective sterilization procedure

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33
Q

Equation for the F-value, when the bioburden is giving

A

F=n*D–>F=[log(N0)-log (N)] *D

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34
Q

which filter are used for the filter integrity tests?

A

cartidge and flat filer membranes

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35
Q

on what does the filtration process based?

A

on the filterion medium, type of filter, pore size, amerial and applied pressure

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36
Q

how can the filter be differentiated?

A

sepration mechanism
pore structure
property of the filter

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37
Q

PES filter?

A

Polyether sulfone, asymmetrical structure, hydrophilic

suitbale for aqueous media

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38
Q

classification of the filter integrity test?

A

destructive and non-destructive

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39
Q

name a destructive test and explained

A

bacterial challenge test, carried out as a full flow analysis

filter is exposed to > 10^7 CFU/cm of a specific test organism

WFI mixed with the test O-pumped towards the filter to be tested
solution flows through a second filter, transfering it to a agar plat

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40
Q

Non-destrutive test can be divided in ?

A

convection and diffusion

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41
Q

Bubble point?

A

convection test
the sterile filter membrane is wetted with the medium, the filter is pressurized with air at the non-sterile side. the diffusion rate highly increses at the bubble point

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42
Q

diffusion tests?

A

forward flow test, where the gas diffusion needs to stay below the bubble point pressure

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43
Q

pressure hold test?

A

a pressure is set on the unsterile side

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44
Q

the requirement for the pressure hold test?

A

intact filter, the pressure stays the same, the bubble point est can follo

otherwiese,there will be a decrease of the pressure over time

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45
Q

what does a redudeant filtration mean?

A

a two sterile filtration steps
Bublle point test (before and ) after the filteration of the product while the transfer (zone B) from production in zone C, filling in zone A

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46
Q

what are the requirment inorder to start the validation process

A

germ count of the raw material

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47
Q

on what should the validation based on?

A

on worst-scenario, to reduce the probability of an error

48
Q

was have to be tested after setting the CP

A

efficiency of the sterilization process and the controllability of the parameter

49
Q

where are the clean rooms zones mesntioned?

A

Annex 1, GMP

50
Q

Grade A

A

high risk operations (aseptic preparation and filling of products

51
Q

what is require in G A

A

the laminar air flow

52
Q

Grade B

A

aseptic preparation and filling, background enviroment for the grade A

53
Q

Grade C and D

A

less critical stages

54
Q

Ventilation type

A

GA: LAF, HEPA-filter
GB/GC: turbulent dilution flow HEPA filter
GD: turbulent dilution flow

55
Q

Laminar air flow

A

air comes from the high efficiency particulate (HEPA) filter , filter size of 0.3 µm

56
Q

Process of the LAF?

A

it carries off emitted particles within seconds and prevent their entrance from outside

57
Q

what does the LAF provides

A

horizontal and vertical, provides only product protection

58
Q

cabinet/banche provides?

A

the product against contamination from the ambient air, also from working peronnel from aerosols

59
Q

air flow in the cabinets

A

the air flow passes into the work zone and enter into the exhaust slits at the front and back egde of the working area

60
Q

How is the safety cabine arranged?

Was the results of this arrangment?

A

it is arrange in a way that the exhaust capacity is higher than the supply rate of the filter air

the stucking of the air from the internal space and that of the ambient air, which prevent both the entrace and the exist of the suspended particles

61
Q

Pyrogen testing

A

trigger hyperthermia due to release of interleukins

62
Q

What is major group of pyrogens?

A

endotoxins

63
Q

what are endotoxins?

A

cell wall constituents of Gram-negative bateria

64
Q

what are other pyrogenic substnaces

A

living organism (viruses, fungi and bacteria) and non-living, rubber, metal ions, plans

65
Q

what is the important pyrogenic moiety of the endotoxin?

A

phosphorylated polysaccaride tighly connected to the lipid component

66
Q

test of pyrogens

A

rabbit test and limulus-amoebocyte-lysate-test (LAL

monocyte activation test

67
Q

used of mannitol in medecine?

A

infusion solution indicted for osmotic diuretic

it is a hypertonic solution introducing new solute in the plasma, which increase the tonicity of the plasma

68
Q

which method can be used to monitor the clean room?

A

Glove print, settle plate and volumetric air sample method and surface sampling (swabs and contact plates)

69
Q

CFU stands for?

A

colony forming unit

70
Q

which tool is used to determine the airbone particle concentration?

A

Light scattering and airbone particle counter

71
Q

test for sterility of the product is?

A

used of membrance filtration and by direct incoculation

72
Q

membrane filter test for which product?

A

aqueous preparation, alcoholic or oily preparations

73
Q

pore size of the membrane filter

A

50 mm

74
Q

direct inoculation?

A

the test sample is diretly inoculated into the culter medium

75
Q

particle contamination

A

visible and nonvisible particles

76
Q

method for visible particles

A

used of a simplex device, light diffraction

77
Q

nonvisible particles

A

based on counting the number of particles, using a light absorption method or microscopy

78
Q

tes for Euhydrie in the Ph.Eur.

A

no test mentioned in the Ph. Eur.

79
Q

ph for infusion, injections and opthalmic

A

infusion: 3.5-9.5
injections: extreme acidic or alkalic range
opthalmic: 5.5-11

80
Q

Hypotonic

A

solution has lower tonicity, resulting in the influx of water in the blood cells, increasing of the pressure inside the cells

81
Q

plasmolysis

A

occur by hypertonic solution influx of water into the plasma

82
Q

osmotic pressure?

A

the pressure required to stop osmosis

83
Q

osmosis?

A

influx of water through a semipermeable membrane to equalize the solute concentration on boh sides of the membrane

84
Q

what does colligative property means?

A

property of the solution depends on the number of sollute particle in solution and not on their physical nature

85
Q

example of colligative property

A

osmotic pressure,
boiling point
freezing point depression

86
Q

on what is the osmotic pressure related to?

A

to the molar concentration of solute M

R, gas constant and T absoulte temperature

87
Q

what is added to th equation of the OP when we have an electrolytes?

A

the van’t hoff factor

88
Q

what is used to determine the osmotic pressure of a solution

A

by measuring the freezing point depression, an indirect method

89
Q

freezing point os proportional to what?

A

it is directly propertional to the molality of the solut (Raoult’s law)

90
Q

step Determination of FPD?

A
  1. first determine the freezing temperatures of the pure solvent and that of the solution
91
Q

what is used to determine FPD?

A

electronic osmometer

92
Q
  1. process in the osmometer
A
  1. the solution is cooled down to its freezing point by mesnd of a cooling block in the device
93
Q

what happend during the cooling process?

A

the solution is not rigidfied

94
Q

what happend after the cooling process?

A

the solution is uncooled to a certain temperature, where cystallization occure due to mechanical trigger

95
Q

what is the regidification point?

A

it is a point where the temp increase due to the occurrence of crystallization

96
Q

how is the fluid called at the regidification point

A

regidifying fluid

97
Q

till which point do the temperature rise?

A

till ine mmelting point.

98
Q

what happend after the meltinng point is reached?

A

the solution solidified

99
Q

when does the solidification takes places?

A

in cases where one has a pure solvent

100
Q

which maximum temepertaure is reach, if we don’t have a pure solvent?

A

the freezing point temp. of the solution is reached and not the melting point temp.

101
Q

why does the freezing point decreases

A

because only the crystals of the our solvent will seperate and thus making the solution more concentrated

102
Q

Apart from the Raoult Law method, which other method is used to calculate the freedzing point depression?

A

DAC-method,
NaCL equivalent method
White-Vincent-Method
nonogram

103
Q

Osmolality for infusion, injections and ophthalmic

A

infusion: 900 mOsmol/kg
injections: 600 mOsmol/kg
Ophthalmic: 275-300 mOsmol/kg

104
Q

when do we used membrane filtration and filter integrity?

A

when sterilization by other methods is not possible

105
Q

what has to be done with filters

A

it has to be sterilzed by a validated produre

106
Q

how can you test the integrity?

A

forward flow, bubble point and water intrusion test

107
Q

what is a filter integrity tests

A

it is used to investigate the compliance to the respective filter specifications of the manufacturer

108
Q

in which law is the bubble point test beaded on?

know the eqaution

A

on the laplace law

109
Q

when is the bubble point reached, when using a syringe?

A

when a continous bubble hain is coming out of the filtrate side

110
Q

importnat guidelines and cocuments regarding asecotic processing

A

EU GMP Annex 1, 17

111
Q

What is a parenteral drug association technical report?

A

it provide informtion regarding vaidation of sterilization processes and bioburden recovery, steilizing filteration of liquid, package integrity.

112
Q

whar are media fills?

A

it is define as a limiation of the contatmination risk to 10-03, it is relavent during the validation of aseptic manufacturing

113
Q

how are contaminations tried to be avoided?

A

using validated porcesses and room concepts

114
Q

when are suspension preparation suitable?

A

where the API has a low solubility in water

115
Q

what is a nonogram,

A

it is used to calculte the amount oFNacl, by creation a calibration.

116
Q

what is the blow fill technology?

A

used to formed plastic containers, which are the filled with sterile filter poduct ans asepticall sealed
forming filling and sealing are conducted under aseptic conditions without interrupting the operations sequence.

Manufacturing (7 decks)

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