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How is a vaccine stored and stored? What kind of procedures and conditions do you need to meet? The reporter visited the vaccine manufacturers and hospitals in Beijing.
Medical refrigerator vaccine
At 9:00 on March 19, in the vaccination room of Chaoyang Maternal and Child Health Hospital, the doctor took out a vaccine in the refrigerator, torn a disposable needle, and the needle was inserted into the bottle to take out the vaccine. The needle just touched the child's arm, and a crisp cry was heard. It was reported that the entire injection process took less than two minutes.
There are four refrigerators in the injection room, and a red number flashes on the top of the refrigerator, indicating that the temperature of the refrigerator is 4.9 °C. The refrigerator is divided into four layers, with different types of vaccines placed. The paper near the glass door of the refrigerator is labeled with the type of vaccine, hepatitis B, chickenpox... placed neatly behind the paper.
"If there is a power outage, put the vaccine into the refrigerated bag, first put the ice on the bottom of the bag to ensure that the temperature is around 6 ° C. If the power outage is long, then look for the refrigerator in the big hospital," the doctor said.
According to reports, the CDC has established a “cold chain†mechanism for the distribution of vaccines. Vaccine transport vehicles transport the vaccines to various inoculation sites. The vaccines are then quickly transferred to medical refrigerators for storage and the vaccines are recorded. The whereabouts of the vaccine will be closely tracked. "As long as the vaccine comes in from the regular way of the country, it is guaranteed to be cold chain transport, and there is no problem in the middle of storage and inoculation techniques. It is rare that there will be adverse reactions."
Cold chain? What kind of process is this? This has to be traced back to the birth of the vaccine.
After two physical examinations, wearing three special coats
In the closed operation room of Beijing Kexing Biological Products Co., Ltd. located in Haidian District, after three repeated injections of water for injection and high pressure steam and high temperature drying at 350 °C, the small bottles lined up into the filling workshop, one white. The staff of the isolation suit sit motionless in front of the assembly line and inject the vaccine into the bottle through the protective glasses. The filling process must be carried out in a clean workshop where they move very lightly and move very little to avoid dusting. With the rubber stopper and cap, the vaccine is isolated from the outside world.
The assembly line sends the filled vaccine to the packaging workshop. The seven cameras compare the vaccines at different angles and different backgrounds to ensure that the vaccine in the vial is not contaminated with impurities and the accuracy of loading the drug, and the bottle The cover is mounted flat. The vial was affixed with a label bearing the date of manufacture and the batch number of the production, and 10 bottles of vaccine were placed in a box along with a detailed instruction manual. “Each box also has an electronic supervision code printed on it. This is the ID number of the vaccine. When was the vaccine in the box produced, and then it was sent to where it can be traced very quickly? ."
Liu Peicheng, Corporate Development Department of Beijing Kexing Biological Products Co., Ltd. introduced that in the next two or three weeks, the vaccine will undergo two assessments: the manufacturer and the China National Institute for the Control of Pharmaceutical and Biological Products will randomly select a part of the packaging. The vaccine is then subjected to a rigorous “physical examinationâ€. After reaching the nationally approved standards, the China National Institute for the Control of Pharmaceutical and Biological Products will issue a certificate of conformity to each batch of vaccines, and the vaccine will be allowed to be used at this time.
Dispensing is no longer a closed space, the staff began to put a "coat" on the vaccine, they quickly put 5 boxes into the refrigerated bag, a group of 4 refrigerated bags into a dark silver foil box, Zui The rear silver foil box is then placed in a high density foam box.
Before the sealing, four blue plastic boxes with large palms were stuffed into the foam box, two on the top and bottom. “The refrigerated bag plays the role of heat insulation, the silver foil box will be protected from light, and the foam box will play a role in moisture protection.†Liu Peicheng said that the small blue box is called the ice platoon, which contains a special liquid. When the refrigeration equipment stops working during transportation or storage, the ice platoon will self-cool in the box. "At normal temperature, the ice platoon can cool itself for about 24 hours."
After the packaged foam box is pushed into the cold storage, the vaccine enters the dispensing line until it is pushed into the cold storage and stays at room temperature for about 10 minutes.
Sealed warehouse refrigerated can automatically alarm
Pushing a door about 10 cm thick, the box is neatly placed in a 60-square-meter cold storage, and a high-powered compressor is constantly pouring out air. The staff pushed 4 boxes of vaccine and immediately closed the cold storage door.
“The storage temperature of all vaccines is strictly controlled between 2°C and 8°C. Monitoring equipment is also installed here. Although the storage area is some distance from the office area, the alarm equipment will be used when the temperature abnormality may endanger the vaccine. The signal is transmitted to the network and passed to the 24-hour staff to ensure that the drug is stored without fail.†Liu Peicheng pointed to the monitoring device hanging on the cold storage door. This is a “microcomputer multi-channel thermometerâ€, 4.8, 4.5...temperature The table can monitor the temperature changes of the 8 cold storages, and the numbers on the display are constantly changing as the different cold storages are monitored. The staff launched an empty car and wrote it on the register outside the cold storage: "At 1600 on March 18, the temperature was 4.6 °C".
"The vaccines have a very different storage time at room temperature. Some vaccines can be stored at 37 ° C for one month. Some vaccines are unstable and sensitive to temperature. Although there are no problems in transportation and storage, In the storage vaccine, the space temperature exceeds 2 ° C to 8 ° C, and the vaccine is destroyed." Liu Peicheng believes that the special nature of the vaccine makes it highly demanding storage conditions, and the distribution and storage must be carried out at a suitable temperature. The "cold chain" cannot be interrupted. High temperatures can cause the vaccine to become degraded and the vaccine will fail. It may take a month or two for the vaccine to go from production to market. The so-called vaccine validity period also refers to the effective time in the prescribed refrigeration state. "Influenza flu vaccines that are sensitive to temperature have not yet been produced. The northern hemisphere countries wait for the flu strains recommended by the World Health Organization every year in February and March, and they can only produce them if they get the strains until the high-influence period of influenza in August and September. â€
GPS tracking cold chain transportation
The white car transporter parked outside the warehouse door, with a compressor hanging from the car, half embedded in the car and half exposed. The driver Zhang Shi dialed the switch, the temperature control device in the cab started, and the compressor made a sound. After 10 minutes, the instrument showed the temperature as “5°Câ€. "The refrigerated truck with the vaccine is different from the ordinary car. The door is sealed. The general door is a thin plate. The door has three layers of insulation film. The temperature inside the car is kept between 2 °C and 8 °C. â€
The staff along the ramp, quickly push the vaccinated trolley to the side of the car, and then lift the box into the compartment, the bottom of the compartment is not flat, there is a channel groove, "This is the diversion channel, through them It can let the gas inside and outside the car circulate." Master Zhang said while loading the car, the temperature control device in the car monitors the temperature of the cabin. When the temperature is between 2 °C and 8 °C, the cooling is stopped, and when it is higher than 8 °C, it starts automatically.
After 5 minutes, 8 boxes of vaccine were loaded into the refrigerated truck. Master Zhang lightly stepped on the gas pedal, and the refrigerated truck will send the vaccine to the cold storage designated by the CDC. “To prevent bumps, the speed is slower than the average car.â€
When the refrigerated truck leaves the factory, every minute the staff in the monitoring room records the temperature change inside the car. “Each refrigerated truck has a GPS positioning device. After the vehicle is shipped from the factory, the time and direction used along the way are as follows. The temperature inside the cabin will be transmitted back to the monitoring room in real time. If an abnormality occurs, the GPS will prompt an abnormality at * time." Liu Peicheng said that when the refrigerated truck arrives at the cold storage, the CDC also has a professional cold storage and has a special person to take care of it. The CDC also follows the same storage method and then distributes the vaccine to each vaccination clinic via a refrigerated truck.
Secret: a "cold chain" process
Shanxi's vaccination has caused children's illness and disability to be of concern to all walks of life. On the afternoon of the 22nd, the Shanxi Provincial Government informed that the vaccine company had not undergone a strict bidding process. Some media also pointed out that the company was completely at room temperature during the labeling process, so this high-temperature exposure vaccine was produced.