Chapter 3: Microbiological Considerations in Parenteral Compounding

bloodstream infections may results from what?

contaminated parenteral preparations from humans

define sterility

free from viable microorganisms.

sterility is influenced by…

• operator - GREATEST SOURCE OF CONTAMINATION is TOUCH

  • handwasing, PPE, aseptic technique

• equipment/supplies- BIGGEST RISK (IV contamination) 

• environment - air. that’s why we use PEC (laminar flow)

Talk about sterility and appearance 

• You cannot visually confirm sterility.

  • Example: bottles look “clear” even with 10³–10⁵ bacteria/mL.

  • Only when ~10⁷ bacteria/mL does solution appear cloudy.

• Exam tip: Don’t trust appearance for sterility.

define endotoxins

• toxic, Heat-stable lipopolysaccharides found in outer membrane Gram-negative bacteria.

• Released when bacteria die.

• form Chemical contamination, not living organisms.

endotoxins are a form WHAT?

• form Chemical contamination, not living organisms.

why endotoxins matter?

• Immunogenic → trigger severe immune response.

• Professor’s note: Patient may look sicker after first antibiotic dose due to endotoxin release.

define Pyrogens

Any foreign substance that causes fever.

What’s most potent pyrogen?

endotoxin.

Talk relation between sterilization/sterile and pyrogens

• Sterilization does NOT eliminate pyrogens.

• a product can be sterile but still contain pyrogens

What require pyrogen/endotoxin testing?

Some CSPs

What’s most common source of microbial contamination?

touch

Contaminated preparations can result in what?

• Bloodstream infections

• Sepsis → death

Touching WHAT leads to contamination of the entire IV?

touching critical sites

What can the presence of physical matter lead to?

• Occlusion of vessels

• Thrombus → organ damage

• Phlebitis (vein inflammation)

• Possible death

What’s our greatest Asset & Liability

Operator

Even with controlled environment, what can happen…

• operator introduces most contamination

  • Bacteria (antibiotic-resistant).

  • Shedding particles (skin cells, particles on clothing).

What does ISO do?

• Measures particles ≥ 0.5 microns (µm)/m³ (IN SIZE) 

• air quality rate is based on ISO classification

Tell us about ISO number and clean air pattern

• Smaller ISO number → cleaner air.

What are the Typical compounding areas:

• ISO 5: Primary hood (3,500 particles/m³ allowed).

• ISO 7: Buffer room.

• ISO 8: Ante room.

difference between Alcohol gel and IPA

• Alcohol gel = hand sanitizer for SKIN (bare hands).

• IPA (sterile 70% isopropyl alcohol) = disinfectant for GLOVES + SURFACES in the hood.

Where are disinfectants used?

on surfaces.

What’s our preferred disinfectant?

 sterile 70% isopropyl alcohol (IPA).

What matters in disinfectants?

• Contact time matters!

  • Surfaces: ≥ 30 sec.

  • Vials/ampules: 10 sec wet + allow to dry before use.

What is not killed by IPA?

• Spores: not killed by IPA → require physical removal/sporicidal agents (ex: C. difficile).

Where are antiseptics used?

• Used to destroy microorganisms on living tissue (e.g., hands).

What is the purpose of antiseptic? 

reduce bacterial load after handwashing.

What to do if hands are visibly dirty?

• wash with soap & water first.

• Then → use antiseptic alcohol-gel/scrubs to reduce bacterial load before putting on sterile gloves.

sterility is a responsibility of…

• all personnel involved in compounding 

Best practices of preventing contamination 

• Consistent aseptic technique.

• Proper PPE: gloves, gown, hair cover, mask.

• Disinfect ampule closures & vial stoppers with alcohol every access.

• Proper storage & discard protocols.

What should you NEVER do when compound?

• Reuse single-dose vials.

• Pool leftover solutions from multiple vials.

What has reduce preservatives & high risk?

 single-dose vials/prefilled syringes