Sterile Product Requirements

Question 1

General sterile requirements

Answer 1

Sterile
Particulate free

Question 2

Sources of microbial contamination

Answer 2

Raw material
Water supply
Air supply
Processing operations
Equipment
Employees
Environment

Question 3

Sterility

Answer 3

Complete destruction of all living organisms and their spores or complete removal

Question 4

Sterility assurance level

Answer 4

1/10^6

Question 5

Approaches to sterility

Answer 5

Initial control
Terminal sterilization
Aseptic processing
Preservatives

Question 6

D-value

Answer 6

Time in minutes required to destroy 90% of microbes

Question 7

Biological indicator

Answer 7

Specific microorganism resistant to a particular method of sterilization

Question 8

Validation of sterility

Answer 8

At known level and known D-value survival should be less than or equal to 10^-6

Question 9

Steam sterilization

Answer 9

Moist heat causes irreversible denaturation of essential proteins
D= 1min at 121 degrees C
USP: 120 C at 15 psi for 20 min

Question 10

Steam sterilization works for

Answer 10

Equipment
Single dose in a sealed container

Question 11

Steam sterilization damages

Answer 11

Oils
Proteins
Powders

Question 12

Dry heat sterilization

Answer 12

Dehydration, denaturation, and slow burning or oxidation
D= 3 min at 160 degrees C
USP: 160-170 C for more than 2 hours

Question 13

Dry heat sterilization works for

Answer 13

Fats and oils/petroleum semi-solids
Dry items

Question 14

Radiation sterilization

Answer 14

Irradiation creates free radicals leading to cell damage and death
Gamma radiation

Question 15

Radiation sterilization orks for

Answer 15

Pharmaceuticals
Medical devices

Question 16

Radiation sterilization damages

Answer 16

Biologic drugs

Question 17

Gas sterilization

Answer 17

EO is alkylating agent—reacts with amine group on DNA
Must be allowed to dissipate after sterilization

Question 18

Gas sterilization works for

Answer 18

Heat and moisture sensitive materials
Medical devices

Question 19

Sterilization would not work on

Answer 19

Coronavirus
Pseudomonas diminutive organism

Question 20

Particulate matter tests

Answer 20

Check sterile products for particulate matter
Limit is 50 particles of 10+ micromolar per mL

Question 21

Before dispensing sterile products

Answer 21

Pharmacists should check for particulates by swirling the solution and looking at it against light and dark backgrounds

Question 22

Sources of particulate matter

Answer 22

bacteria/fungi
Incomplete dissolution of drug
Precipitate from incompatible mixtures
Glass particles from ampules
Particles from rubber stoppers
Particles from plastic

Question 23

Particulates and the IV route

Answer 23

Can be emboli leading to thromboembolism or phlebitis

Question 24

Thromboembolism

Answer 24

Embolism of thrombus

Question 25

Phlebitis

Answer 25

Inflammation of the vein Reduced when IV infusions are filtered

Question 26

Depth filter

Answer 26

Substances that trap particles in channels

Question 27

Screen Filter

Answer 27

Surface filtration

Question 28

Microbial filter

Answer 28

0.22 micromolar

Question 29

Final filter

Answer 29

Particulate or microbial; in-line filter for IV

Question 30

Issues with filtration

Answer 30

Drug loss Protein absorption especially at low C

Question 31

When is filtration preferred

Answer 31

Solutions that are unstable by thermal, chemical, or radiation sterilization

Question 32

When are preservatives required

Answer 32

In multiple-dose products

Question 33

What solutions are susceptible to microbial contamination?

Answer 33

Aqueous solutions, emulsions and suspensions

Question 34

What solutions may not need preservatives?

Answer 34

Ph<3 Ph>9 Hydroalcoholic: >15% alcohol Hypertonic solutions: 67% sucrose

Question 35

Adverse reactions

Answer 35

Death of neonates: benzoyl alcohol Intrathecal and epidural toxicity Long-term Parenteral drug treatment

Question 36

Pyrogens

Answer 36

Fever causing organic molecules from microbial contamination Primary source: water

Question 37

LPS

Answer 37

From the cell wall of bacteria