Exactitude, précision et rapidité de fabrication des poches de mélanges nutritifs parentéraux : comparaison de techniques automatisée et manuelle

Zegbeh, H.; Pirot, Fabrice; Quessada, T.; Durand, Thomas; Vételé, F.; Rose, Aldo Franco De; Bréant, V.; Aulagner, G.

doi:10.1016/j.pharma.2010.09.003

Cited by 8 publications

(6 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Overall, the volumetric accuracy results obtained for each ACD are improved for large sampled volumes compared with small volumes. In addition, we have observed that the viscosity of the ingredients (water for injection and 50% glucose) can influence the volumetric accuracy as it has already been demonstrated in a number of publications 2–4 24…”

Section: Discussionmentioning

confidence: 64%

“…The volumetric accuracy specifications of the ACD were established by the suppliers taking into account the maximal relative biases and not the mean relative bias. On the different volumes evaluated in volumetric tests (test 1), we therefore decided to select the maximum bias on the 10 test measurements, while in previously published papers, accuracy was often evaluated using the mean relative bias 7 12 24 25. ASHP recommends that the ACD should be accurate to within 5% for the amount programmed 5.…”

Section: Discussionmentioning

confidence: 99%

“…For the paediatric Industrial configuration, the discrepancies observed in the sodium values could probably be due to the low volume of Phocytan added in the bag. This test is also needed for the performance qualification of ACD and for this reason we find it in many publications relative to this topic 24–27. Concerning the parameters evaluated, we must underline that the measurement of the weight makes it possible to avoid the possible analytical bias linked to the dosage of ions and osmolarity measurement due to the pretreatment of the samples.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Comparison of three automated compounding devices for parenteral nutrition according to four key technical tests

et al. 2021

View full text Add to dashboard Cite

ObjectivesAutomation of parenteral nutrition (PN) preparation is nowadays a recommended practice in order to reduce human errors and thus improve the safety and accuracy of the finished product. Other benefits of automation may include full documentation of preparation and a reduction in personnel requirements or staff injuries. The market of automation compounding presents different automated compounding devices (ACDs). The aim of this study is to compare the technical characteristics of ACDs by carrying out four specific challenges.MethodsThree ACDs: Two piston pumps with ACD 1: MediMix Multi 4120R (Impromediform) and ACD 2: Mibmix Compounder C12 (Hemedis), and one peristaltic pump ACD 3: ExactaMix Compounder EM2400 (Baxter) were assessed in a pharmaceutical manufacturing unit within a controlled atmosphere area, under horizontal laminar flow hood (LFH) according to four tests: volumetric accuracy, flush volume, smoke test, and a production test with three configurations of PN bags. For this test, a PN bag was considered accepted when all quality controls (weight, molar concentration of sodium, potassium and calcium) were fulfilled.ResultsThe maximum relative biases found for the different ACDs were heterogeneous. ACD 1 had the best volumetric accuracy with respect to supplier specifications and for extreme volumes (0.2 mL). Evaluation of the flushing volume allowed the validation of 50 mL volumes for ACD 1 and ACD 3. The smoke test was only conclusive for ACD 1 under a horizontal LFH. The percentage of PN bags accepted were 98.8% for ACD 1, 70% for ACD 2%, and 95.5% for ACD 3.ConclusionThis study compared three ACDs according to four relevant and specific tests. Based on the data acquired, we conclude that ACD 1 is the most accurate, has the lowest flushing volume, is suitable for use in a LFH, and achieves the best results in the production test.

show abstract

Section: Discussionmentioning

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of three automated compounding devices for parenteral nutrition according to four key technical tests

et al. 2021

View full text Add to dashboard Cite

show abstract

“…But, there is not the case for all of device and moreover, there don't measure the quantity of ingredients. On the other hand, the assay of electrolytes such as sodium and potassium is accepted as an end-product quality assurance marker [4][5][6][7] with which to estimate compounding errors and moreover, the errors on them are potentially serious clinical consequences [8].…”

Section: Introductionmentioning

confidence: 99%

“…There are some widely used analytical techniques for sodium and potassium quantification that are based on atomic emission spectrometry (flame photometry), inductively coupled plasma atomic emission spectrometry (ICP-AES) or quadrupole mass spectrometry (ICP-MS), capillary electrophoresis coupled with indirect UV detector or with capacitively coupled contactless conductivity detection, ion chromatography and electrochemical methods with ion sensitive (selective) electrodes [9][10][11][12][13][14][15][16]. Some of them were developed for the analysis of inorganic cations in pharmaceutical solutions and TPN such as flame photometry, selective electrode and capillary electrophoresis [5][6][7]17,18] but not always with successful results [6,17,18]. These results would be reliable to the fact that TPN have a high ionic force which product seriously distorted results for methods function activity and not concentration such as ion sensitive electrode.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Sodium and Potassium in Total Parenteral Nutrition Bags by ICP-MS and ICP-AES:Critical Influence of the Ingredients

Marie¹,

Verdier²,

Bot³

et al. 2011

AJAC

View full text Add to dashboard Cite

The compounding of total parenteral nutrition solutions (TPN) in the hospital pharmacy is a high-risk activity for which a quality assurance programme is necessary. The complexity of parenteral nutrition solutions containing almost 50 ingredients makes it difficult to measure each of them. On the other hand, the assay of electrolytes such as sodium and potassium is accepted as a quality marker for estimating compounding errors. Thus, the aim of this study was to estimate the influence of ingredients on the accuracy of assays of electrolytes. Experiments were performed with aqueous working simulated solutions of sodium and potassium prepared by the addition of each nutrient step by step, (dextrose, amino acids, lipids, vitamins and trace elements). Sodium and potassium levels were measured by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) and Atomic Emission Spectroscopy (ICP-AES). The performance of these methods was compared using statistical evaluations (t-test and Mann-Whitney test).The study highlights the interference of amino acids, vitamins and trace elements when measuring sodium, but no interference was noted during the measurement of potassium. To reduce the risk and to improve the quality of compounding, we used an automated compounding device but, even in this case, the acceptance criterion for sodium and potassium determination was not <10%.

show abstract

A quality by design approach for the qualification of automating compounding device for parenteral nutrition

Perrier

Piquemal

Leenhardt

et al. 2022

European Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

Exactitude, précision et rapidité de fabrication des poches de mélanges nutritifs parentéraux : comparaison de techniques automatisée et manuelle

Cited by 8 publications

References 3 publications

Comparison of three automated compounding devices for parenteral nutrition according to four key technical tests

Comparison of three automated compounding devices for parenteral nutrition according to four key technical tests

Analysis of Sodium and Potassium in Total Parenteral Nutrition Bags by ICP-MS and ICP-AES:Critical Influence of the Ingredients

A quality by design approach for the qualification of automating compounding device for parenteral nutrition

Contact Info

Product

Resources

About