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Method for testing aseptic technique of intravenous admixture personnel
Abstract:
A method of checking the aseptic technique of personnel that prepare i.v. admixtures is described. The following sterile dosage forms of trypticase soy broth (TSB) were prepared: (1) single-strength ampuls 5 ml, (2) six-times (6X) concentrated broth ampuls 10 ml, (3) lyophilized broth sufficient to make 5 ml single-strength broth in 10-ml vials, and lyophilized broth sufficient to make 10.6 ml 6X concentrated broth in 20-ml vials. Admixture personnel were told these were investigational products, and they were given simulated orders to prepare syringes and 50-ml piggyback admixtures of the products. The specimens containing the broth were intercepted by an investigator, incubated for seven days at 37 degree C, and observed for turbidity on days 2 and 7. To verify that the broth supported the growth of bacteria, two common contaminants were inoculated into the broth in the syringes and admixtures to serve as positive controls. At least 100 samples from each of four procedures were processed during the three-month study period. A total of 405 samples prepared by 13 individuals were tested. None of the samples became turbid; hence, the bacterial contamination rate was 0%. Among the positive controls, 98% inoculated with one species and 100% inoculated with the other became turbid. This method is now used for monitoring the aseptic technique of new admixture personnel. This unique method of checking the aseptic technique of personnel is accurate and cost effective, and it avoids the risk of adventitious contamination.
Insights
This study introduces a novel, cost-effective method for assessing aseptic technique in intravenous admixture preparation. The validated method demonstrated a 0% contamination rate, ensuring personnel safety and product integrity.
Area of Science:
- Pharmaceutical Sciences
- Microbiology
- Healthcare Quality Assurance
Background:
- Aseptic technique is critical in preparing sterile intravenous (IV) admixtures to prevent patient infections.
- Current methods for monitoring aseptic technique may be resource-intensive or carry risks of adventitious contamination.
Purpose of the Study:
- To describe and validate a novel, cost-effective method for assessing the aseptic technique of personnel preparing IV admixtures.
- To establish a reliable monitoring system for aseptic technique in admixture preparation.
Main Methods:
- Sterile trypticase soy broth (TSB) in various forms (single-strength, 6X concentrated, lyophilized) was prepared.
- Admixture personnel prepared simulated IV admixtures (syringes, 50-ml piggyback) using these products.
- Prepared specimens were incubated and monitored for turbidity over seven days.
- Positive controls with common bacterial contaminants were used to validate broth growth support.
Main Results:
- A total of 405 samples prepared by 13 individuals were tested over a three-month period.
- No turbidity was observed in any of the prepared samples, indicating a 0% bacterial contamination rate.
- Positive controls demonstrated high turbidity rates (98% and 100%), confirming the broth's ability to support bacterial growth.
Conclusions:
- The described method accurately and cost-effectively assesses aseptic technique in IV admixture preparation.
- This validated method is now implemented for monitoring new admixture personnel.
- The technique avoids the risk of adventitious contamination, enhancing safety and reliability.