This document discusses sources of contamination in sterile operations for parenteral preparations. It identifies potential sources as facilities, equipment, personnel, utilities and processes. Specific issues that can lead to contamination from each source are described, such as airborne microbes, equipment cleaning, human behavior and microbial growth factors like temperature. Methods for preventing contamination include facility design, cleaning and disinfection practices, personnel training, and process validation.
20. Materials of
Construction
Resist chipping, flacking, oxidizing,
compatible with disinfectant, durable &
easy to maintain such as stainless steel
work surfaces, epoxy floors & plastic
laminates
35. Workers may not be fluent in English
SOPs only in English … workers
language may be different
Mostly outsourced contract activity
High turnover in contractorsPotential
Troubles
36. Untrained Workers in microbial awareness
Activity often performed during night shift
Minimal supervisionPotential
Troubles
37. All staff should be trained on proper
use of disinfectants
Educational material should be available
for all employees
Esp. new hires
Potential
Troubles
38. Follow up with routine surveillance programs
For documents, users, equipment,
water quality etc.
Continually analyze
generated data
Potential
Troubles
44. Antimicrobial
Agent
Fast acting
Act against many microbes w/o harming surface
or person
Good penetrating power, compatible with
detergent
Chemically stable, environment friendly