RESUMO
OBJECTIVES: Production of parenteral nutrition bags (PNBs) involves many nutrients: complete control of the production process decreases the risk of error. This study aimed to develop and validate two analytical methods by capillary electrophoresis (CE) for simultaneous detection of: glucose, amino acids (Primene®) and glucose-1-phosphate (Phocytan®) (anionic method, AM) on one hand; and on the other hand potassium, sodium, calcium and magnesium (cationic method, CM). METHODS: Methods were developed using capillary electrophoresis with diode array detection (CE-DAD) (CE 7100, Agilent), indirect photometric detection, 56 cm long capillary and two different buffers (pH=12.1 for AM and pH=3.2 for CM). These methods were validated according to guidelines from the Société Française des Sciences et Techniques Pharmaceutiques (SFSTP).Analytical parameters were optimised: temperature was regulated at 15°C and the current settled to - 15kV, for a 21 minute analysis time for AM. Conditions were settled to 25°C and 30kV for CM so the analysis time dropped to 7 minutes.Accuracy profiles were established and recovery rates (RR), Repeatability and Reproducibility Coefficient of Variation (respectively RaCV and RoCV) were calculated.Capability was also calculated for each nutrient and concentration range according to guidelines from the Evaluation and Research Group on Protection in a Controlled Atmosphere (GERPAC). RESULTS: Methods were successfully validated with: RR between 99.2 and 101.9%, RaCV between 1.5 and 3.1%, and RoCV between 2.4 and 4.1% for AM, and RR between 97.5 and 102.7%, RaCV between 0.5 and 2.3%, and RoCV between 0.6 and 2.8% for CM.Accuracy profiles were established with 95% ß probability, except for glucose-1-phosphate (90%). Acceptance limits were settled to ±1 0% of target value. Capabilities are defined as "good" or "very good". CONCLUSIONS: The methods developed by this research will ensure the composition of PNB is compliant to PNB formulas. These results show CE is an appropriate method for PNB quantitative control.CE utilisation for controlling other hospital preparations seems to be a relevant alternative to conventional methods such as liquid chromatography.
RESUMO
PURPOSE: Aseptic technique of pharmacy operators was assessed using simulated media-fill tests challenged with microorganisms. METHODS: Simulation of the process was done in accordance with multiple transfer steps using tryptone soya broth. All stoppers of broth medium vials were deliberately contaminated with a challenge micro-organism (Enterococcus faecalis). Each final preparation (vials, syringes, and minibags), including the culture medium, was incubated for 14 days at 32 °C. Vials, syringes, and bags were held in front of light daily for 14 days to detect any visual turbidity. At the end of the 14-day period, all clear culture media were filtered via a 0.45-µm sterile filter, which was then incubated at 32 °C on a tryptone soya agar plate. Bags and vials not subjected to manipulation were incubated simultaneously and served as controls. Visual observation by a pharmacist was conducted during the media-fill test, and finger dabs were taken at the end of the media-fill test to test for contamination. RESULTS: Ten operators previously trained in aseptic technique were assessed. The overall operator failure rate was 40%, and 2.3% of the 300 preparations were contaminated. Similarly, 10 of 60 finger dabs were found to be contaminated with E. faecalis, the challenge microorganism. There was no association between operators' years of experience and media-fill test results. CONCLUSION: Optimized media-fill tests allowed for the detection of minor deviances from standard protocol and helped to provide evidence of improper aseptic technique used by pharmacy operators.
