Sterility testing using a closed system transfer device in oncology medication compounding: a novel method for testing partially used vials
Bibliographic record
Abstract
The National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for non-hazardous sterile preparations and the model standards for pharmacy compounding of hazardous sterile preparations, calls for partially used single dose vials to be used or discarded within six hours of first access. This may lead to significant wastage, particularly with less utilized and expensive medications like oncology treatments. If demonstrated that sterility of these partially used vials can be maintained through a compounding procedure, there may be an opportunity to consider their re-uses. The primary objective is to determine the ability of a compounding procedure, including a closed system transfer device (CSTD), to maintain sterility for partially used vials at two compounding centres at Trillium Health Partners. A secondary objective was to evaluate a novel method for verifying sterility. A CSTD was incorporated into the standard compounding methods at two hazardous compounding centres. Using growth media to detect any bacterial or fungal contamination that might have occurred during compounding, storage, and repeated access, the vials were tested in various growth conditions. There was no growth noted in all compounded samples. The CSTD, when used in our environment with certified personnel, maintained sterility for 14 days, even with repeated access. This study demonstrates that under our local compounding procedure using CSTD we were able to maintain vial sterility when stored under typical conditions and accessed several times for up to 14 days. This method may be considered to assess a facility’s local compounding procedures and provide valuable information regarding storage and utilization of partial vials, which may result in reduced waste and cost avoidance for the health care system.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".