[Study of physicochemical and bacteriological impact of a weekly assembly of automated compounding BAXA(®) Exacta-Mix 2400 on parenteral nutrition admixture manufacturing]. / Étude de l'impact physicochimique et bactériologique d'un montage hebdomadaire de l'automate BAXA(®) Exacta-Mix 2400 sur la fabrication des poches de nutrition parentérale.

INTRODUCTION: The parenteral nutrition admixtures are manufactured with an automated compounding BAXA(®) Exacta-Mix 2400. A 48-hour assembly has been validated. To optimize time and cost, a weekly assembly was tested. MATERIALS AND METHODS: Assembly was made on the first day. Ten identical parenteral nutrition admixtures (different volumes and compositions) were produced each day. A macroscopic examination was done at D0, D7 and D14. Physicochemical controls (electrolytes determinations by atomic absorption spectrophotometry, osmolalities measurements) were performed. Microbiological tests included a filtration membrane sterility test (Steritest(®)) and a plate count agar environmental monitoring. RESULTS: All mixtures were considered stable. The 12 Steritest(®) (H24, H48, D7 and D14) did not show any bacterial or fungal contamination. No microorganism has been detected on the plate count agar at D4 and D7. Concerning the physicochemical parameters of each parental nutrition admixture, no significant difference (Wilcoxon test) with the first day was found. DISCUSSION AND CONCLUSIONS: The automated filling system BAXA(®) Exacta-Mix 2400 improves the quality and safety of production. According to these results, the weekly assembly is validated and permit to save time (80hours/year) and cost (40 000 euros on consumable/year).

[Stability and sterility of parenteral nutrition admixture for patients home care manufactured by the automated compounding BAXA® EM 2400]. / Étude de stabilité et de stérilité des poches de nutrition parentérale pour patients à domicile fabriquées à l'aide de l'automate BAXA® EM 2400.

INTRODUCTION: Initially, parenteral nutrition admixtures are produced by sterile filtration with a stability of 14 days This study was conducted to check the stability (physicochemical and microbiological) when automated compounding BAXA(®) EM 2400 is used. MATERIALS AND METHODS: Forty pockets corresponding to 10 patients have been manufactured in according to Good Manufacturing Practice. Macroscopic and physicochemical tests (determination of electrolytes by atomic absorption spectroscopy, osmolality and pH measurements) were performed at different times (D0, D7, D14). To complete these checks, the emulsions were analyzed (size, stability, optical microscopy) at D0 and D14. Finally, microbiological research (Bact-Alert(®), filtration membrane sterility tests Steritest(®) and plate count agar) was performed. RESULTS: No lipid cluster was observed with an optical microscope. Comparison of data observed for all controls showed no significant difference in the production of D0 by the Wilcoxon test. Microbiology (Bact-Alert filtration membrane sterility tests Steritest(®) and plate count agar) was negative for all samples. Consequently, all mixtures were considered stable. DISCUSSION AND CONCLUSIONS: The automated compounding BAXA(®) EM 2400 ensures quality and safety of production. The results of this study have shown stability and sterility of parenteral nutrition admixtures for 14 days.

[Accuracy, precision and speed of parenteral nutrition admixture bags manufacturing: comparison between automated and manual methods]. / Exactitude, précision et rapidité de fabrication des poches de mélanges nutritifs parentéraux: comparaison de techniques automatisée et manuelle.

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.

Prevalence of Borrelia burgdorferi species and identification of Borrelia valaisiana in questing Ixodes ricinus in the Lyon region of France as determined by polymerase chain reaction-restriction fragment length polymorphism.

Many cases of Lyme borreliosis have been reported over the years in the region of Lyon, France. The identification and prevalence of Borrelia burgdorferi sensu lato in Ixodes ricinus were investigated by polymerase chain reaction (PCR) of the flagellin gene and restriction fragment length polymorphism (RFLP) analysis. Questing Ixodes ricinus larvae, nymphs and adults were collected by the flagging method from deciduous forests in four areas in the Lyon region of France between October 1994 and September 1995 and in June 1998. The overall prevalence of Borrelia burgdorferi sensu lato was 13.2% (91/688). No significant differences in prevalence were observed between the different stages and sex of the ixodids or between collection areas. The majority of infections were simple infections (82.4%; 75/91), most of which were due to Borrelia afzelii (41.4%), while coinfections (12.1%) were predominantly (54.5%) a combination of Borrelia valaisiana and Borrelia garinii. No tick was infected with more than two borrelial species, nor was Borrelia lusitaniae identified. The Borrelia valaisiana species was detected for the first time in France, confirming its widespread presence in Europe. This study confirms that the surroundings of Lyon are risk areas for contracting Lyme disease and that no particular clinical manifestations predominate due to the heterogeneous distribution of Borrelia genospecies. Moreover, the polymerase chain reaction restriction fragment length polymorphism analysis is a rapid and easy method for genotyping of Borrelia species.