[Accuracy, precision and speed of parenteral nutrition admixture bags manufacturing: comparison between automated and manual methods]

Introduction: The parenteral nutrition admixture (PNA) manufacturing in hospital pharmacy is realized by aseptic transfer (AT) or sterilizing filtration (SF). The development of filling systems for PNA manufacturing requires, without standard, an evaluation comparing to traditional methods of SF.

Materials and methods: The filling accuracy of automated AT and SF was evaluated by mass and physical-chemistry tests in repeatability conditions (identical composition of PNA; n=five bags) and reproducibility conditions (different composition of PNA; n=57 bags). For each manufacturing method, the filling precision and the average time for PNA bags manufacturing were evaluated starting from an identical composition and volume PNA (n=five trials).

Results: Both manufacturing methods did not show significant difference of accuracy. Precision of both methods was lower than limits generally admitted for acceptability of mass and physical-chemistry tests. However, the manufacturing time for SF was superior (five different binary admixtures in five bags) or inferior (one identical binary admixture in five bags) to time recorded for automated AT.

Discussion and conclusions: We show that serial manufacturing of PNA bags by SF with identical composition is faster than automated AT. Nevertheless, automated AT is faster than SF in variable composition of PNA. The manufacturing method choice will be motivate by the nature (i. e., variable composition or not) of the manufactured bags.