Sterile Products

Question 1

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

Answer 1

Sterilization

Question 2

Sterilization Methods

Answer 2

1. Steam Sterilization
2. Dry Heat Sterilization
3. Filtration
4. Gas Sterilization
5. Ionizing Radiation

Question 3

Steam Sterilization is also known as

Answer 3

Moist Heat Sterilization

Question 4

Instrument used in Steam Sterilization

Answer 4

Autoclave
121°C,15 psi
15 - 20 minutes

Question 5

Mechanism of Action of Steam Sterilization

Answer 5

Protein denaturation and Coagulation

Question 6

Biological indicator in Steam Sterilization

Answer 6

Bacillus stearothermophilus

Question 7

Instrument used in Dry Heat Sterilization

Answer 7

Oven
150 - 170°C
2-4 hours

Question 8

Mechanism of Action of Dry Heat Sterilization

Answer 8

Oxidation

Question 9

Biological Indicator used on Dry Heat Sterilization

Answer 9

Bacillus subtilis

Question 10

Instrument used in Filtration

Answer 10

Membrane Filter Media

Question 11

Mechanism of Action of Filration

Answer 11

Physical separation

For heat-labile solutions

Question 12

Agents used in Gas Sterilization

Answer 12

Ethylene oxide
Propylene oxide
β-propiolactone

Question 13

MOA of Gas Sterilization

Answer 13

Alkylation (Nucleic Acid, Proteins)

Question 14

Biological Indicator in Gas Sterilization

Answer 14

Bacillus subtilis

Question 15

Instrument in Ionizing Radiation

Answer 15

Gamma & Cathode Rays

Question 16

Mechanism used in Ionizing Radiation

Answer 16

DNA Mutation

Question 17

Biological indicator used in Ionizing Radiation

Answer 17

Bacillus pumilus

Question 18

Depyrogenation

Answer 18

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

Question 19

Most common pyrogen

Answer 19

Endotoxin

Question 20

Sterile Production Area

Answer 20

Clean Rooms
Air Lock

Question 21

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

Answer 21

Clean Rooms

Question 22

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

Answer 22

Air Lock

Question 23

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

Answer 23

Ante Room

Question 24

European Grade A

Answer 24

US Classification: 100
ISO: 5
Critical

Question 25

US Classification: 100 ISO: ISO 5 Clean

Question 26

European Grade C

Answer 26

US Classification: 10,000 ISO:7 Controlled

Question 27

European Grade D

Answer 27

US Classification: 100,000 ISO: 8 Pharmaceutical

Question 28

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

Answer 28

Buffer Area

Question 29

5 Sections of Production Area

Answer 29

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

Question 30

Materials Support Area

Answer 30

Class 10,000 (ISO 7)

Question 31

Compounding Area

Answer 31

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

Question 32

Aseptic Filling Area

Answer 32

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

Question 33

Laminar Airflow Hood with HEPA Efficiency

Answer 33

99.97% - 0.3micron

Question 34

Test of HEPA Filter efficiency

Answer 34

Dioctylpthalate Test

Question 35

Manufacturing Procedure

Answer 35

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

Question 36

Manufacturing Processes

Answer 36

**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