Dataset Information

A non-invasive multipoint product temperature measurement for pharmaceutical lyophilization.

ABSTRACT: Monitoring product temperature during lyophilization is critical, especially during the process development stage, as the final product may be jeopardized if its process temperature exceeds a threshold value. Also, in-situ temperature monitoring of the product gives the capability of creating an optimized closed-loop lyophilization process. While conventional thermocouples can track product temperature, they are invasive, limited to a single-point measurement, and can significantly alter the freezing and drying behavior of the product in the monitored vial. This work has developed a new methodology that combines non-invasive temperature monitoring and comprehensive modeling. It allows the accurate reconstruction of the complete temperature profile of the product inside the vial during the lyophilization process. The proposed methodology is experimentally validated by combining the sensors' wirelessly collected data with the advanced multiphysics simulations. The flexible wireless multi-point temperature sensing probe is produced using micro-manufacturing techniques and attached outside the vial, allowing for accurate extraction of the product temperature.

SUBMITTER: Jiang X

PROVIDER: S-EPMC9283482 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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A non-invasive multipoint product temperature measurement for pharmaceutical lyophilization.

Jiang Xiaofan X Kazarin Petr P Sinanis Michael D MD Darwish Ahmad A Raghunathan Nithin N Alexeenko Alina A Peroulis Dimitrios D

Scientific reports 20220714 1

Monitoring product temperature during lyophilization is critical, especially during the process development stage, as the final product may be jeopardized if its process temperature exceeds a threshold value. Also, in-situ temperature monitoring of the product gives the capability of creating an optimized closed-loop lyophilization process. While conventional thermocouples can track product temperature, they are invasive, limited to a single-point measurement, and can significantly alter the fre ...[more]

PMID: 35835977

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Project description:The purpose of this study was to compare a wearable system for body core temperature measurement versus bladder and tympanic thermometers in an intensive care setting. The question was, if continuous non-invasive sensors in the intensive care unit represent an alternative to current standard methods of invasive continuous bladder temperature measurement methods?Between May and September 2023, a comparative investigation involving 112 patients was conducted in a 20-bed surgical intensive care unit to assess various temperature probes, including those placed in the tympanic tube, bladder, and skin. To achieve this, a wireless non-invasive sensor system provided by greenTEG AG, Switzerland, was affixed to different body locations (clavicular and lateral chest) of each catheterized patient (equipped with a temperature probe) admitted to the intensive care unit. Furthermore, tympanic temperatures were recorded at specified intervals. The measurement duration ranged from a minimum of six hours to a maximum of six days, resulting in the analysis of a total of 355 simultaneous temperature measurements.In this study, a wearable temperature measurement system attached to two different body sites revealed a consistent negative bias compared to bladder temperature. In addition, the measurements were particularly influenced by body constitution. The tested system in all patients showed a mean absolute error (MAE) of 0.45 °C for the lateral chest and 0.50 °C for the clavicular position. Tympanic measurements had a mean absolute error of 0.35 °C. In patients with body mass index (BMI) ≥ 25 the MAE increased to 0.5 °C for the lateral chest and 0.56 °C for the clavicular position. In contrast, the tympanic measurement had a reduced MAE of 0.32 °C, which is well below this threshold when compared to bladder measurements.In conclusion the investigated system did not meet the clinically relevant acceptance criteria and showed low precision in correctly identifying fever episodes compared to invasive temperature probes, however its main advantage lies in its continuity and non-invasiveness. This makes it a potential alternative to intermittent tympanic measurement devices. In this study we were able to show, that in at least one subset of patients, the non-invasive and continuous device demonstrated a precision comparable to tympanic measurements.The accuracy of all non-invasive methods was lower than in previous studies, suggesting that the use of bladder temperature as reference and user related variations may have introduced additional errors.

Project description:BackgroundIsolated limb perfusion (ILP) is a regional surgical treatment for localized metastatic disease. High doses of chemotherapeutic agents are administered within an extracorporeal circulated isolated extremity, treating the metastasis, while systemic toxicity is avoided. To our knowledge, indexed oxygen supply/demand relationship during ILP has not previously been described. Our aim was to measure and describe oxygen metabolism, specifically oxygen delivery, consumption, and extraction, in an isolated leg/arm during ILP. Also investigate whether invasive oxygenation measurement during ILP correlates and can be used interchangeable with the non-invasive method, near infrared spectroscopy (NIRS).MethodsData from 40 patients scheduled for ILP were included. At six time points blood samples were drawn during the procedure. DO2, VO2, and O2ER were calculated according to standard formulas. NIRS and hemodynamics were recorded every 10 min.ResultsFor all observations, the mean of DO2 was 190±59 ml/min/m2, VO2 was 35±8 ml/min/m2, and O2ER was 21±8%. VO2 was significantly higher in legs compared to arms (38±8 vs. 29±7 ml/min/m2, p=0.02). Repeated measures showed a significant decrease in DO2 in legs (209±65 to 180±66 ml/min/m2, p=<0.01) and in arms (252±72 to 150±57 ml/min/m2, p=<0.01). Significant increase in O2ER in arms was also found (p=0.03). Significant correlation was detected between NIRS and venous extremity oxygen saturation (SveO2) (rrm=0.568, p=<. 001, 95% CI 0.397-0.701). When comparing SveO2 and NIRS using a Bland-Altman analysis, the mean difference (bias) was 8.26±13.03 (p=<. 001) and the limit of agreement was - 17.28-33.09, with an error of 32.5%.ConclusionDO2 above 170 ml/min/m2 during ILP kept O2ER below 30% for all observations. NIRS correlates significant to SveO2; however, the two methods do not agree sufficiently to work interchangeable. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT04460053 and NCT03073304.

Dataset Information

A non-invasive multipoint product temperature measurement for pharmaceutical lyophilization.

Publications

A non-invasive multipoint product temperature measurement for pharmaceutical lyophilization.

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