scholarly journals STUDY ON THE PRODUCTION PROCESS OF SINGLE DOSE MEASLES-RUBELLA COMBINED VACCINE AT POLYVAC

2021 ◽  
Vol 62 (4) ◽  
Author(s):  
Nguyen Thuy Huong ◽  
Le Thi Hoa ◽  
Le Quoc Hung ◽  
Ngo Thu Huong ◽  
Nguyen Dang Hien
Keyword(s):  
Single Dose ◽  
Production Process ◽  
Rubella Virus ◽  
Measles Virus ◽  
Sterile Water ◽  
Residual Moisture Content ◽  
Residual Moisture ◽  
Freeze Dried ◽  
Combined Vaccine

Center for Research and Production of Vaccines and Biologicals (POLYVAC) has conducted “Study on the production process of single dose measles-rubella combined vaccine (MRVAC)” (1dose/vial) in lyophilized form to make it convenient to use for vaccination services and export. The results have determined  the formulation of MRVAC final bulk, freeze-dried process. The quality of researched products met WHO and Vietnam Pharmacopoeia V standards in both visual tests of lyophilized vaccine cake and after being reconstituted with sterile water for injection, the titer of measles virus ranges from 4.03 to 4.28 lgPFU/0.5mL and titer of rubella virus is from 3.79 to 3.98 lgPFU/0.5 mL. Results on thermal stability test when incubating the vaccine at 37oC/7days, the titer of measles virus decreased from 0.79 to 0.96 lgPFU/ 0.5mL and titer of rubella virus decreased from 0 to 0.18 lgPFU/0.5mL. Residual moisture content ranges from 0.35 to 0.72%. pH of vaccine is stable, ranges from 7.42 to 7.62.

scholarly journals Retention of Coagulation Factors and Storage of Freeze-Dried Plasma

2021 ◽  
Vol 186 (Supplement_1) ◽  
pp. 400-407
Author(s):  
Elissa J Flaumenhaft ◽  
Terry Khat ◽  
Susanne Marschner
Keyword(s):  
Moisture Content ◽  
Negative Impact ◽  
Coagulation Factor ◽  
Time Factors ◽  
Protein S ◽  
Coagulation Factors ◽  
Residual Moisture Content ◽  
Factor Activity ◽  
Residual Moisture ◽  
Freeze Dried

ABSTRACT Introduction Terumo BCT is developing a system to produce a freeze-dried plasma product, Terumo’s freeze-dried plasma (TFDP), that is stored in a rugged, light-weight plastic package suitable for field use, which retains a stable level of specific coagulation factors and proteins within clinical range, when stored for up to 2 years at room temperature and 4°C. Materials and Methods Plasma frozen within 24 hours of phlebotomy (PF24) were thawed, sampled, and individually lyophilized to produce a corresponding TFDP unit. Fresh frozen plasma (FFP) units were thawed, sampled, pooled in groups of 10 units (also sampled) and lyophilized to produce 2 lots of TFDP. Each TFDP unit was reconstituted with water for injection (WFI) and tested for pH, prothrombin time, activated partial thromboplastin time, factors V and VIII, fibrinogen, protein C, and protein S. Results were compared with PF24/FFP. Additional FFP units were thawed, sampled, pooled, divided to generate 2 TFDP units for each time point (1, 2, 3, 6, 12, 18, and 24 months, one each stored at 4°C and 25°C) and lyophilized. Postlyophilization, TFDP units were stored at 4°C or 25°C, reconstituted with WFI, and tested for the factors listed above. Residual moisture content of the lyophilized plasma was also tested. Results Coagulation factor activity of TFDP was ±20% of PF24/FFP. Pooling standardized variation in TFDP coagulation factor activities, which were within clinical ranges postlyophilization. The pH of TFDP and PF24/FFP were within required range. Residual moisture content of TFDP was <2%. Conclusions The TFDP process had no negative impact on coagulation factor activity. Input plasma and anticoagulant type did not affect TFDP quality. Pooling FFP normalized factor variability in TFDP and did not negatively impact product quality. The TFDP is stable for up to 24 months at room and refrigerated temperatures. Terumo’s freeze-dried plasma is comparable to PF24/FFP. It does not require complex logistics or time-consuming thawing. Terumo’s freeze-dried plasma may be suitable for rapid treatment of coagulopathies with logistical advantages over PF24/FFP.

Residual Moisture Content as Related to Collapse of Freeze-dried Sugar Matrices

1997 ◽  
Vol 62 (4) ◽  
pp. 693-695 ◽  
Author(s):  
PABLO BONELLI ◽  
CAROLINA SCHEBOR ◽  
ANA L. CUKIERMAN ◽  
MARIA P. BUERA ◽  
JORGE CHIRIFE
Keyword(s):  
Moisture Content ◽  
Residual Moisture Content ◽  
Residual Moisture ◽  
Freeze Dried

scholarly journals Effect of Drying Medium on Residual Moisture Content and Viability of Freeze-Dried Lactic Acid Bacteria

1985 ◽  
Vol 49 (2) ◽  
pp. 413-415 ◽  
Author(s):  
Graciela F. de Valdez ◽  
Graciela S. de Giori ◽  
Aida P. de Ruiz Holgado ◽  
Guillermo Oliver
Keyword(s):  
Lactic Acid ◽  
Lactic Acid Bacteria ◽  
Moisture Content ◽  
Residual Moisture Content ◽  
Residual Moisture ◽  
Freeze Dried

An image analysis based expert system for assessing the quality of freeze-dried protein formulations

2012 ◽  
Author(s):  
Jukka Rantanen ◽  
Hjalte Trnka ◽  
Jian Wu ◽  
Marco van de Weert ◽  
Holger Grohganz
Keyword(s):  
Image Analysis ◽  
Expert System ◽  
Protein Formulations ◽  
Freeze Dried

Statistical Management of Food Production Processes

2020 ◽  
pp. 30-35
Author(s):  
N.A. Jurk ◽  
Keyword(s):  
Production Process ◽  
Control Chart ◽  
Food Production ◽  
Time Interval ◽  
Bakery Products ◽  
Shewhart Control ◽  
Manufactured Products ◽  
Mnemonic Technique ◽  
The Stability

The article presents scientific research in the field of statistical controllability of the food production process using the example of bakery products for a certain time interval using statistical methods of quality management. During quality control of finished products, defects in bakery products were identified, while the initial data were recorded in the developed form of a checklist for registering defects. It has been established that the most common defect is packaging leakage. For the subsequent statistical assessment of the stability of the production process and further analysis of the causes of the identified defect, a Shewhart control chart (p-card by an alternative feature) was used, which allows you to control the quality of manufactured products by the number of defects detected. Analyzing the control chart, it was concluded that studied process is conditionally stable, and the emerging defects are random. At the last stage of the research, the Ishikawa causal diagram was used, developed using the 6M mnemonic technique, in order to identify the most significant causes that affect the occurrence of the considered defect in bakery products. A more detailed study will allow the enterprise to produce food products that meet the established requirements.

Typical errors and violations of biotechnics of artificial breeding of pacific salmon

2020 ◽  
pp. 13-23
Author(s):  
Ekaterina Grinberg
Keyword(s):  
Production Process ◽  
Preventive Measures ◽  
Pacific Salmon ◽  
Fish Farming ◽  
Important Condition ◽  
The Third ◽  
Fish Breeding ◽  
Artificial Breeding ◽  
Strict Compliance

In two parts of the article, more than 70 errors and violations of the Biotechnics of artificial breeding of Pacific salmon in salmon hatcheries are collected and summarized, which lead to an immediate or delayed deterioration of the quality of reared fry and a decrease in their survival rate. Deviations from the biological basis of fish farming are shown and possible consequences of such errors or violations are predicted. In the first part of the article (#7,2020) there were General errors (throughout the entire fish-breeding process), as well as violations of Biotechnics during the work with producers, collecting eggs and preparing them for incubation, in the second part-violations of Biotechnics during the incubation of eggs, holding pre-larvae, rearing and release of young. Their correction, prevention or minimization of consequences will significantly improve the quality of sexual products and offspring from producers, increase the linear and weight gain of juveniles during rearing, improve the coefficient of feed payment, reduce the time of rearing, improve the epizootic situation by developing immunity in fry and mobilizing other protective reactions of their body, significantly reduce waste at all stages of the production process, increasing survival by 10–15%. In conclusion, it is noted that the first and most important condition for an efficient salmon hatchery is the creation of optimal environmental conditions at each stage of the production process. The second condition is strict compliance with the Biotechnics of artificial salmon breeding and the complex of veterinary and sanitary, fish-breeding and meliorative and therapeutic and preventive measures. The third is the availability of competent specialists who regularly improve their skills in accredited Universities to implement, control and manage the first two conditions.

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