Qaulity-control plan for intravenous admixture programs. II: Validation of operator technique

Area of Science:

• Pharmaceutical Sciences
• Microbiology
• Quality Control

Background:

• Aseptic technique is critical in sterile parenteral medication preparation.
• Ensuring operator competency is essential for patient safety in intravenous admixture programs.

Purpose of the Study:

• To propose a validation plan for aseptic-operator technique in intravenous admixture programs.
• To introduce and evaluate two methods for testing this validation plan.

Main Methods:

• The plan involves operator qualification via statistically valid sample preparation, followed by random in-process monitoring.
• Two testing methods were employed: trypticase soy broth transfers and Addi-Chek filtrations.
• Trained operators prepared initial validation samples and ongoing monitoring samples.

Main Results:

• All initial validation samples (40 per operator) showed no microbial growth.
• All randomly selected in-process monitoring samples (1 per 25 admixtures) were also negative for microbial growth.
• These results indicate sustained aseptic technique by the operators.

Conclusions:

• The proposed validation plan is effective and statistically sound for ensuring aseptic technique.
• The plan can be integrated into quality control programs to qualify intravenous admixture program operators.
• This approach provides assurance of operator qualification for preparing sterile parenteral medications.