Brainscape's Knowledge GenomeTM

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


See full index

Manufacturing > Sterile Products > Flashcards

Sterile Products Flashcards

1
Q

Destruction of all living organism and their spores or their complete removal from the preparation.

A

Sterilization

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

Sterilization Methods

A
  1. Steam Sterilization
  2. Dry Heat Sterilization
  3. Filtration
  4. Gas Sterilization
  5. Ionizing Radiation
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Steam Sterilization is also known as

A

Moist Heat Sterilization

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

Instrument used in Steam Sterilization

A

Autoclave
121°C,15 psi
15 - 20 minutes

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

Mechanism of Action of Steam Sterilization

A

Protein denaturation and Coagulation

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

Biological indicator in Steam Sterilization

A

Bacillus stearothermophilus

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

Instrument used in Dry Heat Sterilization

A

Oven
150 - 170°C
2-4 hours

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

Mechanism of Action of Dry Heat Sterilization

A

Oxidation

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

Biological Indicator used on Dry Heat Sterilization

A

Bacillus subtilis

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

Instrument used in Filtration

A

Membrane Filter Media

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

Mechanism of Action of Filration

A

Physical separation

For heat-labile solutions

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

Agents used in Gas Sterilization

A

Ethylene oxide
Propylene oxide
β-propiolactone

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

MOA of Gas Sterilization

A

Alkylation (Nucleic Acid, Proteins)

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

Biological Indicator in Gas Sterilization

A

Bacillus subtilis

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

Instrument in Ionizing Radiation

A

Gamma & Cathode Rays

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

Mechanism used in Ionizing Radiation

A

DNA Mutation

17
Q

Biological indicator used in Ionizing Radiation

A

Bacillus pumilus

18
Q

Depyrogenation

A

180°C for 4 hours
250°C for 45 minutes
650°C for 1 minute

19
Q

Most common pyrogen

A

Endotoxin

20
Q

Sterile Production Area

A

Clean Rooms
Air Lock

21
Q

Area with environmental control of particulate and microbial contamination, constructed, and reduce introduction, generation, and retention of contaminants; positive pressure air flow

A

Clean Rooms

22
Q

An enclosed space with two or more doors, interposed between two or ore rooms, to control the airflow between rooms

A

Air Lock

23
Q

For cleaning and wearing of PPE (class 100,000/ ISO class 8– NMT 100,000 particles [≥ 0.5 μm] per cubic foot of air)

A

Ante Room

24
Q

European Grade A

A

US Classification: 100
ISO: 5
Critical

25
Q

US Classification: 100
ISO: ISO 5
Clean

A
26
Q

European Grade C

A

US Classification: 10,000
ISO:7
Controlled

27
Q

European Grade D

A

US Classification: 100,000
ISO: 8
Pharmaceutical

28
Q

Area for staging of supplies and equipment (class 10,000)

A

Buffer Area

29
Q

5 Sections of Production Area

A
  1. Materials Support Area
  2. CompoundingArea
  3. Asepting Filling Area
  4. Quarantine Area
  5. Finishing Area
30
Q

Materials Support Area

A

Class 10,000 (ISO 7)

31
Q

Compounding Area

A

Class 100 (ISO 5)
Cabinets and counter should be stainless steel

32
Q

Aseptic Filling Area

A

Class 100 (ISO 5)
Max. microbial & particulate control

33
Q

Laminar Airflow Hood with HEPA Efficiency

A

99.97% - 0.3micron

34
Q

Test of HEPA Filter efficiency

A

Dioctylpthalate Test

35
Q

Manufacturing Procedure

A
  1. Cleaning
  2. Sterilization
  3. Compounding
  4. Filtration
  5. Filling
  6. Sealing
36
Q

Manufacturing Processes

A

Dispensing and Cleaning
Final Rinse with Water for Injection

Compounding
Sterile Solids: Spray Drying
Freeze Drying/Lyophilization

Filtration
Clarification/Polishing – 2-3µm
Cold Filtration – 0.2-0.3µm

Filling
* Gravimetric Filling
* Pressure Filling
* Volumetric Filing
* Wet Weight Filling
* Volumetric Filling – most common, for large Volume

Sealing
* Vials – siliconization or halogenization

  • Ampules
    ▪ Tip/Bead Sealing – heat tip to form a bead
    ▪ Pull Sealing – neck is heated then pulled quickly

Manufacturing (13 decks)

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