A Fourier-optics-based non-invasive and vibration-insensitive micron-size object analyzer for quality control assessment

Author(s):  
Sarun Sumriddetchkajorn ◽  
Kosom Chaitavon
1998 ◽  
Vol 6 (A) ◽  
pp. A211-A214 ◽  
Author(s):  
M. Ionita-Manzatu ◽  
I. Scarlat ◽  
M. Vasilescu ◽  
M. Puica ◽  
G. Blagoi ◽  
...  

The NIR reflection spectra of some purified conifer resin extracts used as a biologically active ingredient in pharmaceutical ointments were employed to reveal the possibility of applying NIR spectroscopy to quality control. The samples were analysed beforehand (by HPLC and compendial methods) in order to characterise them. The fingerprint of this raw material was achieved by using the standard methods recommended by the NSAS operating protocol (for the spectrometer delivered by NIRSystems Inc.). The poor quality samples were also tested by means of same protocol, the limits of method being pointed out.


1992 ◽  
Vol 48 (8) ◽  
pp. 1298
Author(s):  
Akira Katohno ◽  
Yosinobu Nakada ◽  
Kanae Takeuchi ◽  
Tunetosi Okuyama ◽  
Kazurou Tanabe ◽  
...  

2018 ◽  
Vol 3 (8) ◽  
Author(s):  
Nathalie Jung ◽  
Maike Windbergs

Abstract In the fast-developing fields of pharmaceutical research and industry, the implementation of Raman spectroscopy and related technologies has been very well received due to the combination of chemical selectivity and the option for non-invasive analysis of samples. This chapter explores established and potential applications of Raman spectroscopy, confocal Raman microscopy and related techniques from the early stages of drug development research up to the implementation of these techniques in process analytical technology (PAT) concepts for large-scale production in the pharmaceutical industry. Within this chapter, the implementation of Raman spectroscopy in the process of selection and optimisation of active pharmaceutical ingredients (APIs) and investigation of the interaction with excipients is described. Going beyond the scope of early drug development, the reader is introduced to the use of Raman techniques for the characterization of complex drug delivery systems, highlighting the technical requirements and describing the analysis of qualitative and quantitative composition as well as spatial component distribution within these pharmaceutical systems. Further, the reader is introduced to the application of Raman techniques for performance testing of drug delivery systems addressing drug release kinetics and interactions with biological systems ranging from single cells up to complex tissues. In the last part of this chapter, the advantages and recent developments of integrating Raman technologies into PAT processes for solid drug delivery systems and biologically derived pharmaceutics are discussed, demonstrating the impact of the technique on current quality control standards in industrial production and providing good prospects for future developments in the field of quality control at the terminal part of the supply chain and various other fields like individualized medicine. On the way from the active drug molecule (API) in the research laboratory to the marketed medicine in the pharmacy, therapeutic efficacy of the active molecule and safety of the final medicine for the patient are of utmost importance. For each step, strict regulatory requirements apply which demand for suitable analytical techniques to acquire robust data to understand and control design, manufacturing and industrial large-scale production of medicines. In this context, Raman spectroscopy has come to the fore due to the combination of chemical selectivity and the option for non-invasive analysis of samples. Following the technical advancements in Raman equipment and analysis software, Raman spectroscopy and microscopy proofed to be valuable methods with versatile applications in pharmaceutical research and industry, starting from the analysis of single drug molecules as well as complex multi-component formulations up to automatized quality control during industrial production.


2015 ◽  
Vol 4 (2) ◽  
Author(s):  
Uwe J. Netz ◽  
Lesley Hirst ◽  
Moritz Friebel

AbstractThere is currently no non-invasive measurement method available on the market for the quality control of red cell concentrates (RCCs). As the level of free hemoglobin is an indicator for hemolysis resulting from destroyed or overaged red blood cells, it is an important parameter to assess the quality and usability of RCCs before transfusion. A new optical device has been developed and tested to enable the measurement of the free hemoglobin concentration non-invasively in RCCs.


Author(s):  
Suleiman Ameir Suleiman ◽  
Salum Kombo Salum ◽  
Ebenezer Kimaro

Regular execution of quality control (QC) tests in medical diagnostic X-ray units is primarily important to provide high-quality images and proper diagnoses with least hazard. The performance criteria in diagnostic radiology in Zanzibar Islands, Tanzania were followed in accordance with the QC guidelines, and the values of the measured parameters were compared with the tolerance limits. The study was designed to perform QC tests on the diagnostic X-ray units in governmental and private hospitals. In this study six QC tests (beam alignment, beam collimation, kV reproducibility, half-value layer (HVL), mAs linearity and kV accuracy) were carried out by using beam alignment tool and Unfors non-invasive X-ray test device (Xi R/F&MAM detector). The measured parameters were conducted in two periods, from 2017 to 2018 (14 X-ray units were considered) and from 2019 to 2020 (16 X-ray units were considered). In both periods, the QC test results indicated that 100% of the X-ray units had acceptable HVL≥ 2.3 mm Al at 80 kVp. In the first period (2017−2018), the QC results showed that 78.57% and 85.71% had acceptable beam alignment (≤3% of the focus to image distance) and beam collimation (≤ ± 2 cm). Of the X-ray units evaluated, 85.71% had tolerable kV reproducibility of 5%, and 71.43% had mAs linearity within the tolerance limit of 10%, whereas 85.71% had acceptable kV accuracy within the tolerance limit of 5%. In the second period (2019−2020), the tolerance limits of X-ray units exceeded by 8.04% for kV reproducibility, 8.04% for kV accuracy, 16.07% for mAs linearity, 8.93% for beam alignment and 8.04% for beam collimation. The exceeded tolerance limits could be attributed to the new X-ray units which have full support of service agreements signed during the second period and increase of the compliances with the Tanzania Atomic Energy Act. No 7 of 2003 and its regulations. Results obtained highlight the need to regularly carry out comprehensive QC tests together with routine equipment maintenance.


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