The cold chain safety of vaccines is a global issue. The electronic vaccine vial monitor (eVVM) label can monitor the temperature of vaccines in real time and provide "early warning" prompts. In order to comprehensively evaluate the monitoring efficiency of eVVM, this study selected 75 eVVM labels and distributed them with a total of 600 vaccine vial monitor (VVM) labels of four different types in different experimental environment (2-8℃, -20℃ and 40℃), and used a temperature recorder as "gold standard". The results showed that the accuracy of the eVVM labels and VVM labels in high temperature environment was as same as that of the temperature recorder (
Drug Storage ; Electronics ; Refrigeration ; Temperature ; Vaccines

PURPOSE: This study was conducted to investigate the epidemic pyrogenic reactions that occurred hospital-widely in 51 patients on 30-31 Mar. 1995 at a tertiary, educational, and acute care hospital. METHODS: The remained intravenous (IV) drugs and IV fluids that were infused to patients (N=51) who developed pyrogenic reactions were cultured and tested pyrogenic matter. Pyrogenic test was done by Limulus Amebocyte Lysate (PyrotellRMA,USA). RESULTS: IV normal saline 50 cc bottles (AAXSAT and AAX5AV) those were collected being used from case patients, and new bottles stocked in the drug storage were positive to pyrogenic test. Used normal saline collected from case patients were cultured coagulase-negative Staphylococus. Moreover the company, manufacturer of these fluids reported the positive pyrogenic test on these IV fluids (AAXSAT and AAX5AV). CONCLUSION: This epidemic was a pyrogenic reaction for infused the intrinsic contaminated fluid with pyrogen. We could prevent not the additional pyrogenic reactions in study hospital but national wide epidemics to apply the rapid and well-designed epidemic investigation and infection control.
Bacteremia ; Cross Infection ; Drug Storage ; Horseshoe Crabs ; Humans ; Infection Control

OBJECTIVETo develop a set of low temperature medical shipping refrigerated box for storage and shipping for biologicals in field environment.

METHODSSemiconductor cooling device (SCD) and phase change energy storage materials (PCESM) were adopted as the means for refrigeration and coolness storage, coolness was produced by SCD and stored by PCESM while power source present, and low temperature state for biologicals was keep by PCESM.

RESULTSThe problem for biologicals storage and shipping in low temperature state for medical experiment and clinic was resolved.

CONCLUSIONMedical shipping refrigerated box can be used not only in medical, but also in other field such as food storage and shipping, etc.

Cryopreservation ; instrumentation ; Drug Storage ; Equipment Design ; Incubators ; Transportation ; instrumentation

This paper introduces an automatic control system for the cylindrical rotating medicine-storage which is composed of a microcontroller, a motion control chip, a motor driver, the memory, the watch dog, etc. This system is able to restore a larger amount of medicine, and the user can take the medicine more quickly, more accurately and more easily.
Automation ; instrumentation ; Drug Storage ; Equipment Design ; Pharmacies ; Software Design

Storage of Chinese medicinal materials was an important part in the circulation process. During storage, medicinal herbs, the factors in the outside world and their own physical and chemical properties of the interaction, gradually occurring physical, chemical and biological changes. Phenomenon such as mold, moth-eaten, color change, taste change and "Fan You" would be seen. The intrinsic quality changes related to the mechanism: oxidation, polymerization or decomposition reaction, Maillard reaction, enzymatic reaction and transformation reactions. It resulted to increasing or decreasing of the active ingredient content in medicinal materials, losing of volatile components, forming of biological metabolites and transformation products of damage insects.
Drug Contamination ; Drug Stability ; Drug Storage ; Drugs, Chinese Herbal ; chemistry ; Plants, Medicinal ; chemistry

OBJECTIVETo detect the stability of PEGylated puerarin (PEG-PUE), in order to provide experimental basis for storage conditions of PEGylated puerarin.

METHODFirst, a method for determining the content of PEG-PUE was established. Next, a system study was conducted for the stability of PEG-PUE affected by different factors such as temperature, humidity, light and light avoidance.

RESULTPEG-PUE was severely degraded under the conditions of high temperature, high humidity and light. It was also seriously degraded under high temperature.

CONCLUSIONPEG-PUE shall be stored under low temperature and in a dark and dry environment.

Drug Stability ; Drug Storage ; Isoflavones ; chemistry ; Light ; Polyethylene Glycols ; chemistry ; Temperature

OBJECTIVETo predict the shelf life of Chinese Angelica by investigating the stability of its active components.

METHODThe classic homeothermia method was used for forecast the shelf life, and HPLC was applied for quantitative determination of chemical compounds in Chinese Angelica.

RESULTThe correlation equations, thermal constant at ambient temperature (k(25 degrees C)) and shelf life (t(0.9)) for coniferyl ferulate and Z-Ligustilide were lgk = -5152. 1/T + 13.8 (r = 0.9985), 3. 33 x 10(-4), 13 d and lgk = -4064.6/T + 10.4 (r = 0.9997), 5.91 x 10(-4), 7 d, respectively.

CONCLUSIONThe shelf life of Chinese Angelica has been established, which suggests that it is very important for ensuring the safety and efficacy of Chinese crude drug.

Angelica sinensis ; chemistry ; Drug Stability ; Drug Storage ; Drugs, Chinese Herbal ; chemistry

Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.
China ; Data Collection ; standards ; Drug Evaluation ; standards ; Information Storage and Retrieval ; standards ; Internet

OBJECTIVETo investigate the effect of temperature on the stability of intermediate and final products of inactivated enterovirus 71 vaccine, which was prepared in human diploid cells.

METHODSThe different batches of harvest viral cultures, the vaccine stock solutions and the final productions of inactivated enterovirus 71 vaccine were stored at different temperatures. The samples of viral culture stored at -20°C or 4°C were harvested at 0, 6, 12 and 24 months later. The samples of vaccine stock solutions stored at -20°C were harvested at 0, 6, 12 and 24 months later, and that stored at 4°C were harvested at 0, 1, 3, 6 and 12 months later. The samples of finial products were harvested at different time points (0, 6, 12 and 24 months for storing at 4°C; 0, 7, 14, 28, 42 and 60 d for storing at 25°C; 0, 3, 7, 14 and 21 d for storing at 37°C). The viral titer, antigen content, antigen purity, endotoxin content, effectiveness, pH and appearance of samples were determined, respectively. A total of 1 800 BLAB/c mice were immunized by vaccine and 150 control mice were injected by diluents without antigen via intraperitoneal. The tail vein blood (500 µl per mouse) from 1 950 mice were harvested after 4 weeks post injected. The neutralization antibody titers of the serum were tested to calculate the half effective dose (ED50) of final products. All results were analyzed using analysis of variance to compare the differences of the above indexes.

RESULTSThe viral titers of harvest viral culture of inactivated EV71 vaccine were (6.67 ± 0.13), (6.56 ± 0.09), (6.52 ± 0.04), (6.39 ± 0.16) lgCCID50/ml (CCID50, the half cell culture infective dose) after 0, 6, 12 and 24 months storage at -20°C; and (6.67 ± 0.13), (6.41 ± 0.13), (6.19 ± 0.18), (5.97 ± 0.09) lgCCID50/ml at 4°C. The viral titers reduced with time (F = 9.81 or 44.16, P < 0.05). The antigen contents of the vaccine stock solution were maintained at (3 626.67 ± 1 382.56) EU/ml within 3 months at 4°C, but were (2 080.00 ± 876.36), (951.17 ± 346.35) EU/ml at 6 and 12 months, respectively. The ED50 of the final production were (31.00 ± 2.71), (32.93 ± 3.22), (39.37 ± 3.44) and (46.04 ± 3.25) EU/ml after 0, 6, 12 and 24 months storage at 4 °C, but were (31.00 ± 2.71), (32.23 ± 2.66), (34.70 ± 1.77), (40.04 ± 2.10), (47.78 ± 1.93) and (56.97 ± 0.50) EU/ml at 0, 7, 14, 28, 42 and 60 days at 25°C, and were (31.00 ± 0.00), (36.20 ± 0.00), (41.87 ± 0.50), (53.25 ± 0.50) and (64.84 ± 0.58) EU/ml at 0, 3, 7, 14 and 21 days at 37°C, respectively. The ED50 had increased with the time by and had significantly differences compared with the beginning level (F = 28.49, 215.15 or 156.12, P < 0.05).

CONCLUSIONThere is a good stability of the intermediate and final productions of inactivated enterovirus 71 (EV71) vaccines, within 24 months at -20°C or 6 months at 4°C storage for viral culture, 24 months at -20°C or 3 months at 4°C storage for stock solution and 24 months at 4°C or 28 d at 25°C or 7 d at 37°C storage for finial vaccine.

Animals ; Drug Storage ; methods ; Enterovirus A, Human ; Humans ; Immunization ; Mice ; Vaccination ; Vaccine Potency ; Vaccines, Inactivated

Because of the compact structure of the field low temperature box for storage and transportation, which is due to the same small space where the compressor, the condenser, the control circuit, the battery and the power supply device are all placed in, the design for heat dissipation and ventilation is of critical importance for the stability and reliability of the box. Several design schemes of the heat dissipation design of the box were simulated using the FLOEFD hot fluid analysis software in this study. Different distributions of the temperature field in every design scheme were constructed intimately in the present study. It is well concluded that according to the result of the simulation analysis, the optimal heat dissipation design is decent for the field low temperature box for storage and transportation, and the box can operate smoothly for a long time using the results of the design.
Cryopreservation ; instrumentation ; Drug Storage ; Equipment Design ; Specimen Handling ; instrumentation ; Thermal Conductivity ; Transportation