Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Drug Delivery Systems > Sterile Dosage Forms & Biologics > Flashcards

Sterile Dosage Forms & Biologics Flashcards

1
Q

Means the destruction of all living organisms and their spores or their complete removal from any preparation

A

sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Steam under pressure in an autoclave

A

Steam/Moist Heat Sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

MOA of Steam/Moist Heat Sterilization

A

Denaturation and coagulation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

p, time, and temp required for Steam/Moist Heat Sterilization

A

10 lb pressure for 30 mins → 115.5 C
15 lb pressure for 20 mins →121.5 C
20 lb pressure for 15 mins →126.5 C

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

commonly used for moist heat sterilization

A

Autoclave

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

heat-stable materials used for Moist heat Sterilization

A

Bulk solutions
Glassware
Medical devices
Surgical dressings
Not for oils, fats, oleaginous preparations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Dehydration followed by slow oxidation

A

Dry Heat Sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

temperature and time required for Dry Heat Sterilization

A

160°C for 120 minutes
150-170°C for not less than 2 hours

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

heat-stable materials which cannot be sterilized by moist heat

A

Fixed oils, glycerin, various petroleum products,
Glassware
Medical devices, instruments

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Non-thermal method based on the removal of microorganisms by adsorption on filter medium

A

Sterilization by Filtration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Millipore filter

A

14 to 0.025 um

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

RBC Millipore filter

A

6.5 um

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

smallest bacteria Millipore filter

A

0.2 um

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

poliovirus Millipore filter

A

0.025 um

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

usually consist of fritted glass or unglazed porcelain-substances that trap particles in channels.

A

Depth filter

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Particulate filter remove particles of glass, plastic, rubber, and other contaminants

A

Screen filter

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

which may be either particulate or microbial, are in-line filters used to remove particulates or microorganisms from an intravenous solution before infusion

A

Final Filter

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

filter for Cellulosic materials (acetate, nitrates, fluorocarbonate, acrylic polymers, polyester, PVC, vinyl, nylon, polytef)

A

Membrane filter

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

examples of cellulosic materials

A

acetate, nitrates, fluorocarbonate, acrylic polymers, polyester, PVC, vinyl, nylon, polytef

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

In this method, ethylene oxide is generally used in combination with heat and moisture

A

Gas Sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

used to sterilize surfaces and porous materials (e.g., surgical dressings) that other sterilization methods may damage.

A

Gas Sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Gas Sterilization is Affected by

A

time, temperature, gas concentration, humidity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

is suitable for the industrial sterilization of contents in sealed packages that cannot be exposed to heat (e.g., prepackaged surgical components and some ophthalmic ointments).

A

Radioactive sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

This technique involves irradiation causing cellular destruction

A

Radioactive sterilization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

Radioactive sterilization sometimes results

A

Accelerated drug decomposition

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Media fills is that the growth medium will support the growth of the contaminating microbe, and this growth can be detected.

A

Validation of sterility

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

bacteria used for steam and gas sterilization

A

B. stearothermophilus

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

bacteria used for dry heat

A

B. subtilis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

bacteria used for membrane filtration

A

P. diminuta

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Time required to kill a particular organism under specified conditions

A

Thermal death time

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

e lipid substances associated with a carrier molecule, which is usually a polysaccharide but maybe a protein.

A

Pyrogen

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

are fever-producing organic metabolic products arising from microbial contamination and responsible for many of the febrile reactions in patients following injection

A

Pyrogen

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

Pyrogen is aka

A

bacterial endotoxins

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

This is a test for estimating the concentration of bacterial endotoxins

A

Bacterial Endotoxin Test

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

Endotoxins react with enzyme __forming gel-clot formation

A

Limulus Amebocyte Lysate (LAL)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

LAL are obtained from aqueous extracts of the circulating amebocytes of the

A

horseshoe crab, Limulus polyphemus

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

General Process of parenteral production

A

procurement and selection of the components
production facilities and procedure
quality control
packaging handling

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

is used to remove particles from solutions.

A

Filtration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

sealed glass containers with an elongated neck that must be broken off.

A

Ampules

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

Types of Ampule

A

Pull seal
Tip seal

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

are made of glass or plastic and are sealed with a rubber stopper.

A

Vials

42
Q

A cartridge-type package

A

Prefilled syringes

43
Q

Ready-to-mix systems

A

Mix – O – Vial (Pharmacia)
Example: Solu-Medrol
ADD Vantage System (Abbott)

44
Q

can be defined as the sum total of methods and manipulations required to minimize the contamination of sterile compounded formulations.

A

Aseptic technique

45
Q

The USP provides two basic methods of Sterility Test

A

direct introduction method
membrane filtration method.

46
Q

is a quantitative fever response test in rabbits.

A

Pyrogen testing

47
Q

is a tube that is open at one end and tapers into a hollow tip at the other end.

A

barrel

48
Q

is a piston-type rod with a slightly cone-shaped top that passes inside the barrel of the syringe.

A

plunger

49
Q

provides the point of attachment for a needle

A

tip

50
Q

secure screw type connection

A

luer lok tip

51
Q

slip or push-on connection

A

slip tip

52
Q

off center tip used for surface veins or artery injections

A

eccentric tip

53
Q

longer and tapered slip tip used for irrigation or with tubing

A

catheter tip

54
Q

The set contains a spiked plastic device to pierce a port on the IV container

A

IV Infusion Pumps

55
Q

This connects to a sight or drip chamber that may be used to set the flow rate

A

IV Infusion Pumps

56
Q

is a short piece of tubing attached to a needle or intravenous catheter

A

Heparin lock

57
Q

separation of substances from one another in solution by taking advantage of their differing diffusibility through membrane

A

Dialysis

58
Q

It is now known that prolonged exposure to these agents may lead to the development of cancers.

A

Cytotoxic Agents

59
Q

These agents also represent an environmental hazard and must be handled carefully.

A

Radiopharmaceuticals

60
Q

These agents should be prepared in a shielded vertical flow hood, so that materials are not blown into the operators face

A

Cytotoxic Agents

61
Q

it is desirable to work with them in a shielded vertical flow hood to avoid environmental contamination.

A

Antibiotics

62
Q

are substance derived from a living organism and used for the prevention or treatment of disease

A

Biologicals

63
Q

include antitoxins, bacterial and viral vaccines, blood products and hormone extracts.

A

Biologicals

64
Q

any virus, therapeutic serum, toxin, antitoxin, or analogous product employed for prevention, treatment, or cure of diseases in humans (Code of Federal Regulations)

A

Biologicals

65
Q

State of relative resistance to a disease that develops after exposure to the specific diseasecausing agent

A

Immunity

66
Q

Also known as innate or native immunity

A

Natural Immunity

67
Q

is the process by which an individual is exposed to an agent that is designed to fortify his or her immune system against that agent.

A

Immunization

68
Q

originated vaccination procedure

A

Edward Jenner

69
Q

defined a chemical nutrient medium in which cells can grow and replicate

A

Dr. Raymond Parker

70
Q

developed polio vaccine

A

Jonas Salk

71
Q

vaccine that was developed few years later

A

Sabin polio vaccine

72
Q

Substance used to produced immunization

A

Vaccines

73
Q

it refers to the use of a biologic product (a vaccine) to develop active immunity in the patient.

A

Vaccination

74
Q

is where the actual microbe is taken in by a person. Antibodies are created by the recipient and are stored permanently

A

Active immunization

75
Q

when an untreated microbe is received by a person who has not yet come into contact with the microbe and has no pre-made antibodies for defense.

A

Natural active immunization

76
Q

where the treated microbe is injected into the person before they are able to take it in naturally

A

Artificial active immunizationv

77
Q

is where pre-made antibodies are given to a person.

A

Passive immunization

78
Q

when antibodies are being transferred from mother to fetus during pregnancy, to help protect the fetus before and shortly after birth

A

Natural passive immunization

79
Q

given by injection and is used if there has been a recent outbreak of a particular disease or as an emergency treatment to poisons.

A

Artificial passive immunization

80
Q

contain bacteria or viruses that have been altered so they can’t cause disease

A

Live attenuated vaccines

81
Q

contain killed bacteria or inactivated viruses.

A

Killed vaccines

82
Q

contain toxins (or poisons) produced by the germ that have been made harmless.

A

Toxoid vaccines

83
Q

contain parts of the whole bacteria or viruses.

A

Component vaccines

84
Q

usually are created from the naturally occurring germ itself.

A

Live attenuated vaccines

85
Q

Viruses are weakened by growing them over and over again in a laboratory under nourishing conditions called cell culture.

A

Live attenuated vaccines

86
Q

Examples of live attenuated vaccines include:

A

Measles vaccine (as found in the MMR vaccine)
Mumps vaccine (MMR vaccine)
Rubella (German measles) vaccine ( MMR vaccine)
Oral polio vaccine (OPV)
Varicella (chickenpox) vaccine

87
Q

cannot cause an infection, but they still can stimulate a protective immune response.

A

Inactivated (killed) vaccines

88
Q

Viruses are inactivated with chemicals such as

A

formaldehyde

89
Q

Examples of Inactivated (killed) vaccines

A

Inactivated polio vaccine (IPV), which is the shot form of the polio vaccine
Inactivated influenza vaccine

90
Q

shot form of the polio vaccine

A

Inactivated polio vaccine (IPV)

91
Q

made by treating toxins produced by germs with heat or chemicals, such as formalin, to destroy their ability to cause illness.

A

Toxoid vaccines

92
Q

toxoids vaccines are made by treating toxins produced by germs with heat or chemicals, such as

A

formalin

93
Q

do not cause disease but they stimulate the body to produce protective immunity just like the germs’ natural toxins.

A

Toxoid vaccines

94
Q

examples of Toxoid vaccines

A

Diphtheria toxoid vaccine
Tetanus toxoid vaccine

95
Q

made by using only parts of the viruses or bacteria

A

Component vaccines

96
Q

Examples of component vaccines:

A

Haemophilus influenzae type B (Hib) vaccine
Hepatitis B (Hep B) vaccine
Hepatitis A (Hep A) vaccine
Pneumoccocal conjugate vaccine

97
Q

Production consists of

A

Extraction
Chemical synthesis
GENETIC ENGINEERING

98
Q

is the artificial alteration of the genetic composition of cells or organisms.

A

Genetic engineering

99
Q

is fundamental to genetic engineering.

A

Gene cloning

100
Q

is the common preservative

A

Thimerosal (49.6%)

Drug Delivery Systems (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions