Validation of Sanitation
   
A sound cleaning and sanitization program is needed for controlled environments used in the manufacture of Pharmacopoeial articles to prevent the microbial contamination of these articles.
This general information will discuss the selection of suitable chemical disinfectants and antiseptics; the demonstration of their bactericidal, fungicidal, and sporicidal efficacy; the application of disinfectants in the sterile pharmaceutical manufacturing area; and regulation and safety consideration. USP <1072>
 
Become in compliance with the new USP <1072> (Disinfectants and Antiseptics) and the European Committee for Normalization TC 216 Committee; Disinfectant Effectiveness requires a high level of microbiological project definition along with a sound and robust technical approach toward the Validation/Qualification of a disinfections program.
 
Some common requisites of both regulations requires the challenge of any particular disinfectant solution at the:
  1. Appropriate use dilution concentration
  2. A minimum contact time
  3. Challenge at the surface to be applied
  4. Statistical comparison after the disinfection program implementation
Disinfectant Validation Road Map

Aspects to consider for a Disinfectant Validation project

Testing Approach
  • A common requisites of both regulations requires the challenge of any particular disinfectant solution at the:
    • It is required to demonstrate that the selected neutralizer does not inactivate the microorganism
    • It is required to validate the disinfection neutralization
    • Appropriate surface representing should be selected
    • Appropriate aseptic techniques should be followed
    • Mathematical skills should be implemented for dilutions schemes and data interpretation
  • Related experience with: different types of disinfectant including:
    • Phenols
    • Quats
    • Alcohols
    • Alogenated (Chlorinated compounds)
    • Glutaraldehyde
    • Oxidants
    • Challenge of representing  microorganism
    • Challenge of representing  surfaces: Stainless Steel; Terrazzo; Pharma Wall; Kydex; Epoxic paints; Kydex
    • Stablishment of disinfections programs at 5 manufacturing sites
Synergistic Approach
The strength of each individual step is less than the sum of all the steps

Improve
  • Perform Statistical evaluation of EM
  • Use Parametric tools or non-parametric statistical tools
  • Re-evaluate your disinfectant efficacy on special events
   

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