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Evaluation of glutaraldehyde and hydrogen peroxide for sanitizing packaging materials of medical devices in sterility
Abstract:
External surfaces of packaging materials used for sterile medical devices may introduce contaminants into working areas used for sterility testing. Light wiping with tissues moistened with alkaline 2% glutaraldehyde (Cidex) or 3% hydrogen peroxide effectively reduced counts on 5 X 8 cm strips of packaging material (Tyvek) inoculated with 10(7) spores of Bacillus subtilis. The ability of antimicrobial agents to penetrate packaging material and kill contaminants on the medical device was tested by inoculating filter membranes with ca 100 cells of Pseudomonas aeruginosa or Staphylococcus aureus or ca 100 spores of Bacillus subtilis. A sterile square of test packaging material placed over the inoculated membrane (direct method) or 0.5 cm above the membrane (indirect method) was wiped with the antimicrobial agent. Except for polyethylene film (3 mil), all materials tested, including glassine and several types of coated and uncoated Tyvek, were penetrated by the agents, killing cells on the inoculated membranes. Death rates varied, depending on the organism, packaging material, and testing method. It is suggested that penetration tests be performed before using antimicrobial agents for sanitizing packaging materials during sterility tests.
Insights
Wiping sterile medical device packaging with glutaraldehyde or hydrogen peroxide effectively reduced bacterial contamination. Most packaging materials allowed antimicrobial penetration, killing microbes on underlying membranes, but testing is advised.
Area of Science:
- Microbiology
- Sterilization and Disinfection
- Medical Device Packaging
Background:
- Contamination of sterile medical device packaging can compromise sterility testing.
- Antimicrobial agents are used for surface disinfection, but their penetration through packaging is critical.
Purpose of the Study:
- To evaluate the efficacy of antimicrobial agents in reducing microbial contamination on medical device packaging materials.
- To assess the penetration capability of antimicrobial agents through various packaging materials to kill underlying microorganisms.
Main Methods:
- Bacterial spores (Bacillus subtilis) and vegetative cells (Pseudomonas aeruginosa, Staphylococcus aureus) were inoculated onto filter membranes.
- Packaging materials (Tyvek, glassine, polyethylene film) were placed directly or indirectly above inoculated membranes.
- Surfaces were wiped with 2% glutaraldehyde or 3% hydrogen peroxide, and microbial kill rates were assessed.
Main Results:
- Light wiping with 2% glutaraldehyde or 3% hydrogen peroxide significantly reduced Bacillus subtilis spore counts on Tyvek.
- Antimicrobial agents penetrated most tested packaging materials (except 3 mil polyethylene film), killing inoculated bacteria and spores.
- Penetration and kill rates varied based on the antimicrobial agent, packaging material type, and testing method (direct vs. indirect).
Conclusions:
- Antimicrobial agents can effectively reduce surface contamination on medical device packaging.
- Penetration through packaging materials is crucial for antimicrobial efficacy against underlying contaminants.
- Penetration tests should be conducted before implementing antimicrobial agents for sanitizing packaging during sterility testing.