Discussion on quality technology in the production of freeze-dried powder injection

First, the freeze-drying powder injection workshop design has a decisive impact on product quality. Due to the continuous improvement of GMP awareness and implementation, enterprises should take the control of production risk from the source as the starting point in determining the design target and positioning of freeze-dried powder injection. They should not adopt GMP as the standard, and should not consider the hardware in the early stage of design. Insufficient, software supplement."

Before designing, enterprises must first have a clear design concept and accurate positioning, fully consider and evaluate the risk points of production links, and establish corresponding project plans. Foreign companies usually establish a single plan for important projects, not only to propose the implementation requirements of the project, but also to specify the specific requirements of their production links.

If the design needs to be changed after completion of the design, the pharmaceutical manufacturer shall fully evaluate the risk of change and obtain confirmation from the designer, and shall not arbitrarily change or modify it. If the room where the original two production lines are arranged is simply divided into two, the airflow direction, the pressure difference and the number of air changes in the room will be greatly changed, which may damage the original design and bring potential risks.

Second, the exchanges between the two sides are the basis for the design of a good freeze-dried powder injection. In the design process of the plant, especially the foreign party to carry out the concept design project, the enterprise and the design unit should participate as soon as possible, strengthen the exchange, repeatedly demonstrate, promptly put forward the demand and confirm the information, and avoid the disconnection between the conceptual design and the drawing design. Pharmaceutical manufacturers should provide detailed production information and production risk control points to make the design more in line with actual production needs. The information to be provided at least includes the product (prospective production variety, batch, batch production time and production process), material and equipment transfer method. The equipment and parameters to be used (cleaning, disinfection/sterilization methods, parts to be disassembled before and after production), each aseptic operation process involves the number of people, time, movements, etc.

Example 1. When transferring materials and appliances, the actual production operations should be fully considered, such as packaging/unpacking method, sterilization/sterilization method, stop location, residence time, protection of arrival location, number of operators required, and actions.

For example 2, when designing the technical interlayer, the layer height and load-bearing requirements should be fully considered to meet the requirements of maintenance and replacement during actual production.

Third, freeze-dried powder injection production design should be based on the sterility guarantee. In order to improve the sterility assurance of freeze-dried powder injections, the internationally accepted design method is: when production, people and things are separated as much as possible, giving priority to isolation systems and automatic feeding technology.

When dynamically monitoring suspended particles and microorganisms in the production environment, it is necessary to set the monitoring points reasonably from the control risk to achieve the purpose of assessing the aseptic production status, instead of monitoring the sites through GMP and speculation.

Fourth, equipment selection and risk assessment will directly affect the production design of freeze-dried powder injection. Separation of people and objects, isolation system or glove box; intermediate product transfer, automatic boxing technology or semi-automatic transportation, these are directly related to freeze-dried powder injection plant design. In the initial stage of design, the company should clearly define the key production equipment, operation methods, operation methods, etc., and evaluate the risk points of equipment and methods. Different equipments, methods, and the required air supply volume and number of air changes are different. For key production process design, the design unit should also focus on possible risks such as equipment and operation.

For example, the pressure difference between the sterilization section of the tunnel of the vial, the cooling section and the amount of steam exhausted, the air intake mode, the pressure difference between the oven room and the adjacent room environment, the air supply, the number of air changes, and the oven are extinguished. There is a certain correlation between the gradient of the bacterial section and the cooling section, and the direction of the airflow, and it has an impact on the sterility assurance of the vials after sterilization. During the actual production, when the personnel enters or exits the room, the opening/closing action will affect the direction of the airflow, and whether the protection of the cooling section of the tunnel oven is damaged. The actual situation should be fully considered during the design to avoid risks or hidden dangers.

5. A good equipment supplier will enhance the equipment's equipment validation and production verification purpose and effectiveness. When the company conducts equipment risk assessment, installation confirmation and production verification, a good equipment supplier can not only provide detailed equipment construction, parameters and possible failures, treatment methods, etc., but also provide certain technical support or assistance.

Sixth, aseptic and dressing is an important part of the production design of freeze-dried powder injection. The personnel is the only non-killing/sterilizing process in the production process of freeze-dried powder injection into the aseptic operation area. Therefore, the aseptic dressing of personnel is an important link that affects the quality of the product. When designing aseptic dressing, not only should reasonable people enter and exit the passage, the number of air changes in the dressing room, but also the dressing procedures should be reasonably set, such as the design and folding method of sterile clothes, the standard dressing action, and the regular evaluation of personnel changing. , sterilization methods and storage time.

Seven, disinfectant selection, not only should pay attention to the disinfection effect, but also should pay attention to its residues, equipment and environmental damage and other issues. Different disinfectants have different requirements for production design and equipment, so the use of disinfectants should be fully considered in the design. When using H2O2 disinfection, it should be vaporized as much as possible to prevent liquid H2O2 from directly spraying equipment or surface damage.

Temperature Device

The Temperature Device includes the Temperature Device(Infrared Temperature Device) for the industry and the Temperature Device for human beings. Sanan Technology mainly runs the Temperature Device for human beings and we hope our Temperature Device could help in front of the COVID-19, the disaster humans all over the world are facing this year.

So what types do the Temperature Devices mainly include?
The Temperature Devices(Heat Detector Temperature) mainly can be divided into the Manual Temperature Device and the Electrical Temperature Device. The Manual Temperature mainly refers to the Mercury Thermometer, one of the most accurate thermometers in the world, which are widely used in all kinds of hospitals and medical institutions. As for the Electrical Temperature Devices(Human Temperature Detection), there are all many types and the most popular ones are the Infrared Thermometer and the Thermal Camera.

What is the Infrared Thermometer?
The Infrared Thermometer(Temperature Device for Home) measures the body temperature via the infrared rays, and it can be divided into the contact Infrared Thermometer and the non-contact Infrared Thermometer; which is relatively safe and accurate when we are doing the body temperature measuring, and it is very suitable for the elderly, children, hospitals and families.

What about the Thermal Camera?
The Thermal Camera measures the body temperature via the infrared rays, too. Except that, the Thermal Camera can show the images of the detected faces(with the temperature marked). Besides, the Thermal Camera can automatically alarm in time once the abnormal body temperture is found. So convenient!

In conclusion, compared with the Manual Temperature Device(COVID-19 Temperature Monitor), the Electrical Temperature Device is faster, safer, and more convenient. As time goes by, the Electrical Temperature Device is getting more and more widely accepted and used.

Thermal Camera

Infrared Thermometer

Temperature Device, Infrared Temperature Device, Heat Detector Temperature, Human Temperature Detection, Temperature Device for Home, COVID-19 Temperature Monitor

SHENZHEN SANAN TECHNOLOGY CO.,LTD , https://www.sanan-cctv.com