Contamination of medicinal products

• What are spores resistant to?

  Spores are resistant to heat, radiation, and chemical agents.
• How are organic acids limited in their effectiveness?

  They are limited by pH dependence and work at specific pH values.
• What advantage do parabens have over organic acids?

  Parabens overcome the pH dependence of organic acids.
• Why are parabens used in combination with other substances?

  They are not very soluble, provide slow release, and are stable.
• What is the purpose of a challenge test?

  To assess the purity of a product in its supply container.
• How many colony-forming units (cfu) should be inoculated in a challenge test?

  ≤10-100 cfu per ml/g of product.
• What factors affect the choice of preventive measures in medicinal product design?

  Intended application, type of microorganism, safety/toxicity, cost, and microenvironment.
• What is a characteristic of bakery waters in relation to contamination?

  They are readily used in manufacturing pasta and are non-toxic to the route of administration.
• What factors can affect the stability of a medicinal product?

  Microenvironment interaction with form or container, pH phase, and moisture.
• What is the effect of pH on the potency of acids?

  pH affects the ionization and potency of acids.
• What is the significance of dilution in the context of medicinal products?

  Dilution affects the provenance, quantity, and appropriateness of the product.