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Sterility testing of home and inpatient parenteral nutrition solutions
M H Bronson1, D J Stennett, P K Egging
1Good Samaritan Hospital, Corvallis 97330.
Abstract:
The microbial contamination rate was compared for parenteral nutrition solutions prepared by patients for home use and by pharmacy personnel for inpatient use. Phase I validated the Ivex 0.22-micron inline filter as a tool for microbiological testing by inoculating small numbers of organisms in 5% dextrose injection and testing for recovery. Phase II validated the same method for determining microbial contamination of total parenteral nutrition (TPN) solutions. Phase III compared inpatient and home TPN microbial contamination rates using the methodology validated in phase II. Test organism inocula used in phase I and II were Candida albicans, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Proteus vulgaris, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes. All contaminated solutions in phase I showed visual turbidity within 48 hr, and all test organisms were recovered and identified. All phase II-contaminated TPN solutions showed visual turbidity after 96 hr, and all test organisms were recovered and identified. One hundred postinfusion TPN samples were collected randomly during phase III from inpatient parenteral nutrition patients. Six patients and two hospitals participated in the study. None of the 44 home parenteral nutrition samples and none of the 56 inpatient TPN samples developed visible turbidity. Subcultures of each sample on blood agar were negative for microbial growth. This described methodology offers an effective means to establish contamination rates of parenteral nutrition solutions after administration.
Insights
Microbial contamination rates for home and inpatient parenteral nutrition (PN) solutions were compared. The study found no microbial growth in either home or inpatient PN samples, indicating effective preparation methods.
Area of Science:
- Microbiology
- Pharmaceutical Science
- Clinical Pharmacy
Background:
- Parenteral nutrition (PN) is crucial for patients unable to consume food orally.
- Ensuring the microbiological safety of PN solutions is paramount for patient health.
- Variations in preparation methods (home vs. inpatient) may influence contamination rates.
Purpose of the Study:
- To compare microbial contamination rates in home-prepared versus inpatient-prepared parenteral nutrition solutions.
- To validate a microbiological testing method using an inline filter for PN solutions.
- To assess the safety and efficacy of current PN preparation practices.
Main Methods:
- Validated an inline filter method for microbiological testing of dextrose injections and PN solutions.
- Inoculated solutions with various bacteria and fungi to assess test sensitivity.
- Collected and cultured post-infusion PN samples from home and inpatient settings.
Main Results:
- The inline filter method successfully recovered inoculated microorganisms, with turbidity observed within 48-96 hours.
- No microbial growth was detected in any of the 44 home PN or 56 inpatient PN samples.
- No visible turbidity or microbial growth occurred in post-infusion samples from either group.
Conclusions:
- The validated inline filter methodology is effective for assessing PN solution contamination.
- Both home-prepared and inpatient-prepared PN solutions demonstrated no microbial contamination in this study.
- Current preparation practices for both home and inpatient parenteral nutrition appear to maintain microbiological integrity.
