Evaluation of a Process Monitoring Method for Compounding Parenteral Nutrition with the Baxter EM2400 in a Hospital Pharmacy Department

BackgroundA method for process monitoring of the Baxter ACD, Exactamix EM2400, by chemically analyzing the concentrations of the ingredients in parenteral nutrition test preparations was evaluated.MethodsIn the study, three different test preparations were developed consisting of four ingredients varying in volume and concentration, which simulated actual PN products. Each test preparation was produced in triplicate by a trained pharmacy technician using the Exactamix EM2400 from Baxter (Baxter International Inc.). The process was repeated on three consecutive days using the same conditions. The amount of each ingredient in the test preparation was measured in an external contract laboratory using European Pharmacopoeia methods. Based on USP monographies and the Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition from the ASHP the device was tested to be accurate to deliver within 5 % of the amount programmed.ResultsThe study showed that in most cases the ingredient delivery of the automated compounder deviated less than 3 % from the expected concentrations. For certain ingredients out of specification results were detected and analyzed. By resetting the flow factor, it was possible to optimize the performance of the ACD.ConclusionThe study emphasizes the need for process monitoring of the Exactamix EM2400 during the initial installation and on a regular basis for each ingredient to ensure the accurate delivery of ingredients. Further methods need to be analyzed to determine the most feasible method to regularly conduct process monitoring tests on an ACD in a hospital pharmacy setting.

Mitochondrial DNA Fragmentation to Monitor Safety and Quality in Roasted Peanuts

ABSTRACT Mitochondrial DNA (mtDNA) fragmentation has been proposed as a time-temperature integrator (TTI) for high-moisture thermal processes using low-acid, high-temperature and high-acid, low-temperature protocols. In this study, dry roasted peanuts were assayed using the same novel molecular TTI. Enterococcus faecium was evaluated as a Salmonella surrogate for process validation and compared to fragmentation of intrinsic peanut mtDNA and Hunter L color, a quality indicator, for dry roasting. Reduction curve data for E. faecium were highly repeatable as similar kinetics were observed when compared to another study which used a commercial, contract laboratory to validate this same surrogate for use with dry roasted peanuts processes (4-log reduction after 10 min at 167 C). Mitochondrial DNA fragmentation was not linear compared to time at a given temperature, but exhibited a long lag time. D and z-values were calculated using E. faecium, threshold cycle (Ct) and Hunter L color values. D values for E. faecium were 2.68, 2.06 and 1.89 min for 138, 153 and 167 C roasting temperatures, respectively. Mitochondrial DNA fragmentation as measured by Ct had a D value of 12.3 min at a roasting temperature of 167 C which was slightly higher than “wet” processes (ca. 11.5 min). Hunter L values had an inverse, linear relationship with time at a given temperature. Hunter L color, if applied to individual peanuts and empirically validated, could be used as an inexpensive visible method to troubleshoot continuous flow systems. Ct values were not linear or highly correlated to Hunter L values. Dissection of peanuts exhibited a differential heating effect depending on the part of the peanut used for DNA extraction and the type of tissue assayed. Mitochondrial DNA fragmentation as measured by Ct value was deemed too variable for thermal process or quality validation of dry, solid foods such as peanuts. However, it could be used to evaluate penetration of heat through a solid food matrix, to find the coldest spot and test the worst-case scenario.

Editors’ Note

We would like to draw our readers‘ attention to the following three joint publications in this issue:· HAHN and SCHAUB (page 100)· ROEMER et al. (page 117)· INTORP et al. (page 139)The three papers are based on an initiative of the German regulative authorities who requested and initiated a research project to get more information concerning the influence of tobacco additives on the composition of cigarette mainstream smoke. Since up to now, most of the peer reviewed publications on the effects of additives originate from scientists based in the tobacco industry, in this case an independent regulative laboratory (Chemical and Veterinary Surveillance Agency Sigmaringen) was asked to evaluate the effects of the tobacco additives sucrose, cocoa powder and glycerol on the amounts of several selected compounds in cigarette mainstream smoke. The test cigarettes for these evaluations were manufactured in the pilot plant of BAT Germany and are described and characterized by HAHN and SCHAUB. This paper also contains the results of the regulatory laboratory on the effects of the three additives on mainstream smoke composition.The influence of these additives on cigarette mainstream smoke was also evaluated by ROEMER et al. and INTORP et al. using the identical test cigarettes as studied by HAHN and SCHAUB. While INTORP et al. in their three laboratory study analyzed the same mainstream smoke component as HAHN and SCHAUB, ROEMER et al. studied the effects of these tobacco ingredients on the levels of 39 different components in mainstream smoke of the test cigarettes and also on different endpoints of some selected toxicological in vitro assays. The chemical analytical work necessary for this evaluation was done by Labstat International, an independent contract laboratory; the in vitro tests were done by the Philip Morris Research Laboratories, Cologne, Germany. The results obtained by the participating laboratories showed no overall significant effects of the tested additives on the levels of the selected smoke constituents and the biological activity.Finally, we would like to inform our readers that Nicolas Baskevitch has decided to retire from the advisory board, being a member since 2006. We would like to thank him for his collaboration in improving the manuscripts submitted to the Journal.