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

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.

Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology

This study explores the use of a statistical model to build a design space for freeze-drying two formulations with ibuprofen. A 2 × 3 factorial experimental design was used to evaluate independent variables (filling volume and annealing time) and responses as residual moisture content, specific surface area and reconstitution time. A statistical model and response surface plots were generated to define the interactions among the selected variables. The models constructed for both formulations suggest that 1 mL of filled volume and no annealing should be used to achieve optimal residual moisture content, specific surface area and reconstitution time. The proposed models were validated with additional experiments, in which the responses observed were mainly in close agreement with the predicted ones. Additionally, the established models demonstrate the reliability of the evaluation procedure in predicting the selected responses.

Retention of Coagulation Factors and Storage of Freeze-Dried Plasma

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.

Design of an Innovative Moisture Separator Technology for Use in Nuclear Power Plants: Experimental Validation — Part 2

The Moisture Separator Reheater (MSR) is a key component of Nuclear Power Plants (NPP), both in terms of performance and prevention of erosion/corrosion. Wet steam is usually dried in a MSR by inertial separation of the liquid water using separator elements. Depending on the design of the MSR, the technology of the separator elements contributes significantly to its size and performance. An innovative concept of separator panels was conceived by means of aerodynamic principles as outlined in part 1 of this paper [1]. Computational Fluid Dynamics (CFD) has been used to understand the working principles of various moisture separating devices. The investigated separator panels are designed to capture the water droplets in a region of flow separation (invisible pockets) within the separator channels. To characterize the separation performance of these separator panels, a test rig has been developed and built at the University of Applied Sciences Northwestern Switzerland (FHNW). This test rig was then operated at typical MSR operating conditions. To meet the required moisture content and flow conditions, preheated water was injected into the saturated steam flow. In order to measure the residual moisture content after the separation the throttling calorimeter methodology has been adopted. The newly designed panels have shown very good separation performance. According to the measurements carried out, a residual moisture content of less than 0.1 % can be guaranteed. The innovative technology, which clearly differentiates the OEM, for who this research was carried out, from its competitors, will allow considerable size and cost reduction as well as opportunities to retrofit existing MSRs.

Environmental Durability Enhancement of Natural Fibres Using Plastination: A Feasibility Investigation on Bamboo

Natural fibers are gaining wide attention due to their much lower carbon footprint and economic factors compared to synthetic fibers. The moisture affinity of these lignocellulosic fibres, however, is still one of the main challenges when using them, e.g., for outdoor applications, leading to fast degradation rates. Plastination is a technique originally used for the preservation of human and animal body organs for many years, by replacing the water and fat present in the tissues with a polymer. This article investigates the feasibility of adapting such plastination to bamboo natural fibres using the S-10 room-temperature technique in order to hinder their moisture absorption ability. The effect of plastination on the mechanical properties and residual moisture content of the bamboo natural fibre samples was evaluated. Energy dispersive x-ray spectroscopy (EDS) and X-ray micro-computed tomography (Micro-CT) were employed to characterize the chemical composition and 3-dimensional morphology of the plastinated specimens. The results clearly show that, as plastination lessens the hydrophilic tendency of the bamboo fibres, it also decreases the residual moisture content and increases the tensile strength and stiffness of the fibers.