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DDS III Big Quiz 3 > PDD Process Lecture > Flashcards

PDD Process Lecture Flashcards

1
Q

Lyophilization

A

Refers to a dehydration process for a perishable material

  • Injections are unstable
  • Extracts the water from drugs and other products = remain stable
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2
Q

Process of Lyophilization

A

Sublimation
- Freezing the product so that the water in the product becomes ice
- Sublimating the ice directly into water vapor by applying vacuum
Drawing off the water vapor
Freeze-die products and removed from the machine

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3
Q

Lyophilization Advantages

A 
Stored in dry state
Dried without elevated temperature
Sterile
Rapid reconstitution
Good for air-sensitive drugs
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4
Q

Lyophilization Disadvantages

A

Not suitable for volatile
Expensive
Instability

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5
Q

Spray Dry

A

Solution of a drug is placed into the drying chamber where it passes through an atomizer that creates an aerosol of small droplets
Aerosol come sin contact with a hot sterile gas usually air
Solvent evaporates quickly

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6
Q

Sterilization

A

Purpose is to destroy or eliminate microorganisms that are present in a preparation
Methods depend on nature of preparation

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7
Q

Steam Sterilization

A

An autoclave and employs steam under pressure
- Destroy via denaturation and coagulation
121 C for 20 minutes
Not suitable for oil based formulation

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8
Q

Steam Air Mixture

A

Good for prefilled syringes
Inefficient
Batch process

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9
Q

Dy Heat Sterilization

A

Ovens are heated either by gas or electricity and are generally thermostatically controlled
160-170 for 2+ hours
Effective for depyrogenation
Sterilized by moist heat

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10
Q

Sterilization by Filtration

A

Physically removed by absorption on a filter medium or by a sieving mechanism but are not destroyed
Pores are .2 micrometers
Heat sensitive materials nad lyophilized sterile powders

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11
Q

Gas Sterilization

A

Exposure to ethylene oxide or propylene oxide gas
Kills by interference with the metabolism of bacterial cells (alkylating agent)
Effectiveness depends on humidity, concentration and temp
Employed to sterilize heat sensitive and moisture sensitive material

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12
Q

Gas Sterilization

A 
Hydrogen peroxide (vapor phase hydrogen peroxide VPHP)
- Facility sterilization
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13
Q

Sterilization by Ionizing Radiation

A

Destroy cellular structure DNA
Effective for ointments
Bandages, baby bottle nipples
Change polymer/API characteristics

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14
Q

Manufacture of Parenterals

A

Special floor plans: Filtered air supply, use of UV light, sterile, access)

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15
Q

HEPA Filter

A

Filters air

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16
Q

Facility design

A 
Low traffic area
Wire shelved
Cool
A positive airflow
Ceiling should be non-porous and non-shedding
Eliminate cracks
Change disinfectants
17
Q

Clean Room and IV room Personnel

A

People: contamination
Restricted access
No talking except via phone or intercom

18
Q

Sterility Testing

A

Determine the probable sterility of a specific batch

- Direct introduction to culture medium or filtering test samples

19
Q

Pyrogen Testing

A

Cause fever, chills, pain, malaise

Quantitative biological test based on fever response in rabbits

20
Q

Limulus Amebocyte Lysate Test (LAL Test)

A

In vitro detection of pyrogen
– Horseshoe craps
Reacts with LPS

21
Q

Leaker Testing and Sealing Verification

A

1% methylene blue and applying vacuum (25 in for 25 min)

Ampoules are then washed and checked if there is any blue solution

22
Q

Clarity and Particulate Analysis

A

State or quality being clear and transparent to the eye

23
Q

Physical Complications

A 
Infection 
Central Catheter Misplacement
Hypothermia
Neurotoxicity
Phlebitis
Extravasion
Thrombosis
Hemolysis
Pain
Air Embolism
Allergic Reactions
24
Q

Infection

A

Central IV Lines

Contaminated tuing or catheter

25
Q

Central Catheter Misplacement

A

Embolism or pneumothorax

Verified radiologically

26
Q

Hypothermia

A

Use of a cold IV solution

27
Q

Neurotoxicity

A

A complication of intrathecal or intraspinal admin with preservatives

28
Q

Phlebitis

A

Inflammation of veins due to irritation or injury

- Proper IV insertion techniques prevent this

29
Q

Extravasation

A

Accidental admin of IV infusion drug into surrounding tissue (leakage)

30
Q

Thrombosis

A

Formation of a clot

31
Q

Hemolysis

A

Breakdown of RBC with release of hemoglobins

32
Q

Pain

A

Peripheral IV

Switch type

33
Q

Air embolism

A

Entry of air into the IV tubing

34
Q

Allergic Reactions

A

Hypersensitivity to IV solution

35
Q

Mechanical Complications

A 
Infusion pump or controller failure
IV tubing
Particulate matter
Glass container
Rubber vial closure

DDS III Big Quiz 3 (6 decks)

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