Application of Statistical Quality Assurance Techniques to Continuous Process Analyzer Systems for On-Line Product Quality Certification

2009 ◽  
pp. 145-145-20
Author(s):  
ATC Lau
Radiocarbon ◽  
2010 ◽  
Vol 52 (2) ◽  
pp. 263-271 ◽  
Author(s):  
P Naysmith ◽  
G T Cook ◽  
S P H T Freeman ◽  
E M Scott ◽  
R Anderson ◽  
...  

In 2003, a National Electrostatics Corporation (NEC) 5MV tandem accelerator mass spectrometer was installed at SUERC, providing the radiocarbon laboratory with 14C measurements to 4–5‰ repeatability. In 2007, a 250kV single-stage accelerator mass spectrometer (SSAMS) was added to provide additional 14C capability and is now the preferred system for 14C analysis. Changes to the technology and to our operations are evident in our copious quality assurance data: typically, we now use the 134-position MC-SNICS source, which is filled to capacity. Measurement of standards shows that spectrometer running without the complication of on-line δ13C evaluation is a good operational compromise. Currently, 3‰ 14C/13C measurements are routinely achieved for samples up to nearly 3 half-lives old by consistent sample preparation and an automated data acquisition algorithm with sample random access for measurement repeats. Background and known-age standard data are presented for the period 2003–2008 for the 5MV system and 2007–2008 for the SSAMS, to demonstrate the improvements in data quality.


Author(s):  
Adolfo Cobo ◽  
Jesus Ma ◽  
David Solana ◽  
Alfonso Alvarez-de-Miranda ◽  
Pilar-Beatriz Garcia-Allende ◽  
...  

Transfusion ◽  
1981 ◽  
Vol 21 (3) ◽  
pp. 247-260 ◽  
Author(s):  
LC Lasky ◽  
A Lin ◽  
RA Kahn ◽  
J McCullough

POINT ◽  
2021 ◽  
Vol 3 (2) ◽  
pp. 57-70
Author(s):  
Marina Malian

This study aims to analyze partially and simultaneously the influence of product quality, brand image and consumer trust on customer satisfaction. Including quantitative research using the results of questionnaire surveys filled by respondents. The sample used is 100 consumers of on line products in Palembang. The method of data analysis uses multiple linear regression analysis. To test the hypothesis the partial effect of independent variables on the dependent variable used the t test. The F test is used to test the effect of the independent variables on the dependent variable together. The results of processing data show there is an influence of product quality on customer satisfaction. Consumer trust affects consumer satisfaction and brand image does not affect consumer satisfaction. Taken together there is the effect of independent variables on the dependent variable. Consumer trust has the most dominant influence on customer satisfaction on line products in Palembang.


Author(s):  
Arik Makovitzki ◽  
Avital Jayson ◽  
Ziv Oren ◽  
Elad Lerer ◽  
Yaron Kafri ◽  
...  

The COVID-19 pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) increases the need for rapid development of efficient vaccines. Among other vaccines in clinical trials, a recombinant VSV-∆G-spike vaccine was developed by the Israel Institute for Biological, Chemical and Environmental sciences (IIBR) and is being evaluated. Development of an efficient downstream purification process (DSP) enables advancing the vaccine to clinical trials. The DSP must eliminate impurities, either process- or product -related, to yield sufficient product with high purity, potency, and quality. To acquire critical information on process restrictions and qualities, incorporation of on-line monitoring is vital. Application of on-line monitoring should significantly impact process yield, product quality and economy of the entire process. Here, we describe an on-line monitoring technique that was applied in the DSP of the VSV-∆G-spike vaccine. The technique is based on determining concentrations of metabolites, nutrients and a host cell protein (HCP) by the automatic chemistry analyzer Cobas Integra 400 Plus. The analysis revealed critical information on process parameters and significantly impacted purification processes. The technique is rapid, easy and efficient. Adaptation of this technique during the purification process improves process yield, product quality and enhances the economy of the entire downstream process of biotechnology and bio pharmaceutical products.


2020 ◽  
Author(s):  
María Teresa García-Valverde ◽  
Verónica Sánchez de Medina ◽  
Verónica Codesido ◽  
Jesús Hidalgo-García ◽  
Carlos Ferreiro-Vera

In the last decades, cannabinoids, the active constituents of Cannabis sativa L., have been attracting a strong interest, regarding the health effects associated with the use of Cannabis and Cannabis-derived products. The progressive legalization of this species in several countries has prompted an increasing concern about the characterization and quantification of cannabinoids in diverse chemotypes of the plant, as well as the obtained final products. Therewith, Process and Product Quality Assurance (PPQA) becomes a mandatory practise to verify the Good Manufacturing Practices (GMP). Gas chromatography is one of the most used techniques in this sense due to its high attainable resolution. However, sample complexity and the thermal lability of cannabinoids hinder the analysis. In this chapter, a fully description of the recent advances in the Cannabis sativa L. analysis by gas chromatography will be presented, including different approaches that have come up to solve the obstacles encountered.


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