Intro to Sterile Pharmaceutical Production

Question 1

What does the term sterility mean?

Answer 1

Sterility is the absence of viable micro-organisms

Question 2

What are the three aspects of sterility in pharmaceuticals?

Answer 2

Biological –> microorganisms (infections)

Chemical –> pyrogens (pyrexia response)

Physical –> visible and invisble solids (blood vessels blockade)

Question 3

What does the term bioburden mean?

Answer 3

Initial number of organisms present

Question 4

What does the term sterilisation mean?

Answer 4

The subjection of products to a process whereby all viable life forms are either killed or removed

Question 5

What does disinfection mean?

Answer 5

A process which aims to reduce the number of harmful (pathogenic) MO in a particular situation

Question 6

What does the term aseptic techniques mean?

Answer 6

The preparation of pharmaceutical products from sterile ingredients by procedures that exclude the access of viable microorganisms into the products.

Question 7

When do pharmaceutical products require sterilisation? GIve 2 reasons and examples associated with those reasons.

Answer 7

1. Direct introduction into general circulation or tissues/organs

> when immediate therapeutic effect of drug is desired (IV, intrathecal injection, intravitreal injection)

> sustained release effect is desired via parenteral route (IM injection, implants insert)

2. the products will be in direct contact with membranous surface

> Eye ointment, irrigation solution, would cleansing

Question 8

What are the 3Ps that sterile compounding requires? Describe them.

Answer 8

Place

• Cleaner facilities (layout of cleanroom, use of clean bench)
• Air quality evaluation and maintenance

Personnel

• Sound knowledge of sterilisation and solution stability principles and practices
• Specific training and testing personnel in principles and practices of aseptic manipulations

Product

• Free from pathogens, particles and pyrogens
• A test for sterility (exemption for terminally sterilized products)

Question 9

What are some examples of sterile products?

Answer 9

• Injections (small volume, large volume)
• Implants
• Ophthalmic preparations
• Inserts
• Irrigation solutions
• Dusting powders
• Gauze
• Surgical equipment

Question 10

What are the sterilization methods for thermostable drugs?

Answer 10

• Dry Heat (sterilant = hot air)
• Moist Heat (sterilant = saturated steam)

Question 11

What are the sterilisation methods for thermolabile drugs?

Answer 11

• Membrane filtration (aseptic technique) –> remove MO
• Gas (sterilant = ethylene oxide gas)
• Ionising radiation (sterilant = cobalt 60 gamma rays)