Effect of manufacturing process parameters on virus inactivation by solvent-detergent treatment in a high-purity factor IX concentrate

Vox Sanguinis ◽  
2003 ◽  
Vol 84 (3) ◽  
pp. 170-175 ◽  
Author(s):  
P. L. Roberts ◽  
C. Dunkerley
1991 ◽  
Vol 66 (05) ◽  
pp. 609-613 ◽  
Author(s):  
I R MacGregor ◽  
J M Ferguson ◽  
L F McLaughlin ◽  
T Burnouf ◽  
C V Prowse

SummaryA non-stasis canine model of thrombogenicity has been used to evaluate batches of high purity factor IX concentrates from 4 manufacturers and a conventional prothrombin complex concentrate (PCC). Platelets, activated partial thromboplastin time (APTT), fibrinogen, fibrin(ogen) degradation products and fibrinopeptide A (FPA) were monitored before and after infusion of concentrate. Changes in FPA were found to be the most sensitive and reproducible indicator of thrombogenicity after infusion of batches of the PCC at doses of between 60 and 180 IU/kg, with a dose related delayed increase in FPA occurring. Total FPA generated after 100-120 IU/kg of 3 batches of PCC over the 3 h time course was 9-12 times that generated after albumin infusion. In contrast the amounts of FPA generated after 200 IU/kg of the 4 high purity factor IX products were in all cases similar to albumin infusion. It was noted that some batches of high purity concentrates had short NAPTTs indicating that current in vitro tests for potential thrombogenicity may be misleading in predicting the effects of these concentrates in vivo.


GIS Business ◽  
2020 ◽  
Vol 14 (6) ◽  
pp. 1062-1069
Author(s):  
S.Ramesh ◽  
B.A.Vasu

This paper is an attempt to assess if the manufacturing process of paper machine is in statistical control thereby improving the quality of paper being produced in a paper industry at the time of process itself. Quality is the foremost criteria for achieving the business target. Therefore, emphasis was made on controlling the quality of paper at the time of manufacturing process itself, rather than checking the finished lots at a later time.  This control on quality will help the industry deduct the small shift in the process parameters and modify the operating characteristics at the time of production itself rather than receiving complaints from customers at a later stage.  This paper describes controlling quality at the time of manufacture itself and helps the industry to concentrate on quality at low cost. The researcher has collected primary data at a leading paper industry during October, 2019.  Though X-bar and Range charges were primarily used, CUSUM charts were used to sense the minor shifts in manufacturing process, to explore the possibility of adjusting process parameters during manufacture of paper.


2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Claire Dislaire ◽  
Yves Grohens ◽  
Bastien Seantier ◽  
Marion Muzy

AbstractThis study was carried out using bleached softwood Chemi-Thermo-Mechanical Pulp to evaluate the influence of Molded Pulp Products’ manufacturing process parameters on the finished products’ mechanical and hygroscopic properties. A Taguchi table was done to make 8 tests with specific process parameters such as moulds temperature, pulping time, drying time, and pressing time. The results of these tests were used to obtain an optimized manufacturing process with improved mechanical properties and a lower water uptake after sorption analysis and water immersion. The optimized process parameters allowed us to improve the Young’ Modulus after 30h immersion of 58% and a water uptake reduction of 78% with the first 8 tests done.


Haemophilia ◽  
2009 ◽  
Vol 16 (2) ◽  
pp. 240-246 ◽  
Author(s):  
T. LISSITCHKOV ◽  
M. MATYSIAK ◽  
K. ZAWILSKA ◽  
L. GERCHEVA ◽  
A. ANTONOV ◽  
...  

Procedia CIRP ◽  
2018 ◽  
Vol 72 ◽  
pp. 426-431 ◽  
Author(s):  
Julius Pfrommer ◽  
Clemens Zimmerling ◽  
Jinzhao Liu ◽  
Luise Kärger ◽  
Frank Henning ◽  
...  

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