Intro to Sterile Pharmaceutical Production Flashcards

1
Q

What does the term sterility mean?

A

Sterility is the absence of viable micro-organisms

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2
Q

What are the three aspects of sterility in pharmaceuticals?

A

Biological –> microorganisms (infections)

Chemical –> pyrogens (pyrexia response)

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

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3
Q

What does the term bioburden mean?

A

Initial number of organisms present

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4
Q

What does the term sterilisation mean?

A

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

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5
Q

What does disinfection mean?

A

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

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6
Q

What does the term aseptic techniques mean?

A

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

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7
Q

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

A
  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)

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

> Eye ointment, irrigation solution, would cleansing

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8
Q

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

A

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)
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9
Q

What are some examples of sterile products?

A
  • Injections (small volume, large volume)
  • Implants
  • Ophthalmic preparations
  • Inserts
  • Irrigation solutions
  • Dusting powders
  • Gauze
  • Surgical equipment
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10
Q

What are the sterilization methods for thermostable drugs?

A
  • Dry Heat (sterilant = hot air)
  • Moist Heat (sterilant = saturated steam)
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11
Q

What are the sterilisation methods for thermolabile drugs?

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