Exam 1 - Sterile Preparation (intro)

Question 1

Define “parenteral products”

Answer 1

products administered via injections
(typically thought of injectable formulations)

Question 2

List kinds of parenteral products

Answer 2

• solutions and suspensions ready for injection
• dry, soluble preparations ready to be combined with a solvent before use
• dry, insoluble preparations ready to be combined with a vehicle before use
• emulsions
• liquid concentrates ready for dilution prior to administration

Question 3

Describe the route of delivery for parenteral products

Answer 3

• parenteral delivery means introducing drugs into the body outside the enteral route; that is, outside the gastrointestinal tract.
• this delivery route can also be used to administer drugs directly to specific body organs and tissues to produce a desired therapeutic effect at a target site while minimizing systemic side effects

Question 4

What is important to keep in mind when manufacturing parenteral products?

Answer 4

There are VERY STRINGENT requirements !!

• sterile (ALWAYS A MUST)
• endotoxin-free (ALWAYS A MUST)
• particle-free

Question 5

Describe endotoxins (as they relate to parenteral products)

Answer 5

• pathogenic contaminants, which produces and septic shock
• remnants of microorganisms
• not removed via sterilization

Question 6

What is important to keep in mind about endotoxin contamination in parenteral products?

Answer 6

since this consists of a dead body of bacteria/bacteria membrane, it can NOT be sterilized because it’s already DEAD

Question 7

Explain why it is important to keep parenteral products particle-free

Answer 7

when injecting into bloodstream, size needs to be considered because if a particle is greater than a certain size, it could raise a safety concern

Question 8

List potential issues that can be caused by foreign particles in parenteral products

Answer 8

• trigger immune responses
• produce damage to the lungs
• produce damage to the kidneys
• has killed many people

Question 9

List dosage forms that are considered “non-sterile”

Answer 9

orals, nasals, topicals

Question 10

Which guideline(s) should be used when manufacturing non-sterile, hazardous products?

Answer 10

USP 795 and USP 800

Question 11

Which guideline(s) should be used when manufacturing non-sterile, non-hazardous products?

Answer 11

USP 795

Question 12

List dosage forms that are considered “sterile”

Answer 12

IV, eye drops

Question 13

Which guideline(s) should be used when manufacturing sterile, hazardous products?

Answer 13

USP 797 and USP 800

Question 14

Which guideline(s) should be used when manufacturing sterile, non-hazardous products?

Answer 14

USP 797

Question 15

Which USP chapters are enforceable by the FDA?

Answer 15

USP chapters <1000

Question 16

List the 6 different risks when manufacturing sterile, hazardous products

Answer 16

• microbial contamination [non-sterility]
• excessive bacterial endotoxins
• variability from the intended strength of correct ingredients
• physical/chemical incompatibilities
• chemical and physical contaminants
• use of ingredients of inappropriate quality.

Question 17

List the different options that can be used for the sterilization of products

Answer 17

• steam (autoclave)
• filtration (bacteria retentive membrane)
• dry heat (oven)
• gas (ethylene oxide)
• irradiation (gamma rays)