Microbiological Quality Control Study of “All‐In‐One” Total Parenteral Nutrition Admixtures

Abstract

A microbiological quality control study of parenteral nutrition (PN) is presented. The study was carried out in the Pharmacy and Microbiology Services of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) from April 1991 to May 1998 and represents more than 25,000 lipid-containing PN admixtures prepared during that 7-year period. A randomized sampling procedure according to the cumulative sum control charts was performed and a 0.45-microm membrane filtration method was used as the microbiological test. Validation showed that the method is sensitive for sterility tests. Bacterial growth was observed on 59 filters (4.58% of the samples). A second control was made for these positive outcomes, and bacterial growth was found in only two cases. The patients' clinical history was reviewed and no relation between the microorganisms of the nutrition and the results obtained from blood cultures was observed. The quality control study revealed a low incidence of contamination in our PN preparation process.

Physicochemical Stability and Sterility of Standard Parenteral Nutrition Solutions and Simulated Y‐Site Admixtures for Neonates

“…Sterility of ILE‐free PN solutions was assessed by means of a validated 0.45‐μm membrane filtration method . A sample of 50 mL was taken from each bag at the times stated previously.…”

“…Sterility of ILE-free PN solutions was assessed by means of a validated 0.45-μm membrane filtration method. 22 A sample of 50 mL was taken from each bag at the times stated previously. Every sample was mixed with 50 mL of a 4% wt/vol sterile solution of polysorbate 80 (Tween 80; Roig Farma, Barcelona, Spain) in water for injection.…”

Microbiologic Quality‐Control Study for the Purpose of Extending the Use of Transfer Sets on the Automix 3+3 and Micromix Automated Total Nutrient Admixture Compounding Pumps

“…Dolin et al 12 In the course of the study, 2 patients developed sepsis in which blood cultures could not be correlated with a positive culture in a TNA bag. As well, Montego et al 13 cultured 1294 TNA bags in which 59 bags were positive for S epidermidis and E cloacae. However, except for 2 bags which were confirmed to have grown E cloacae, the rest were deemed false positive because of external contamination during sampling.…”

Pasteurization of Lipid Emulsions with Supercritical CO2 and High Power Ultrasound

“…Therefore, the assurance of safe parenteral emulsions, in terms of sterility and physicochemical stability, is considered of vital importance (Montejo et al, 2000;Takagi et al, 1989). In this sense, the United States Pharmacopeia (USP) sets pharmaceutical requirements on pH, free fatty acids and droplet size (in terms of mean droplet size and population of droplets larger than 0.5 µm), among others (Driscoll, 2006;Gallegos et al, 2012;Wanten, 2015).…”

“…In this sense, the United States Pharmacopeia (USP) sets pharmaceutical requirements on pH, free fatty acids and droplet size (in terms of mean droplet size and population of droplets larger than 0.5 µm), among others (Driscoll, 2006;Gallegos et al, 2012;Wanten, 2015). As for sterility, parental emulsions are usually heat sterilized in steam autoclaves at 121ºC (Montejo et al, 2000;Riera et al, 2018). However, high temperatures are known to negatively affect heat-sensitive compounds and physicochemical properties of the emulsions (Chansiri et al, 1999).…”