I have shared with you some basic knowledge about clean workshops for medical device production before, and this article will focus on the relevant knowledge of building clean workshops.
First of all, we simply popularize science how to establish a clean workshop for the production of medical devices
The clean workshop for the production of medical devices is not built by a construction team casually, but he has a lot of requirements.
First, let's consider the layout requirements. The layout of the clean room should be set in accordance with the level of cleanliness in accordance with the sterile medical equipment production management practice. Put simply, the process should be designed as short as possible so that the risk of contamination is reduced.
Next is the design requirements. Clean rooms are designed not only to meet today's production needs, but also to take into account future developments. Don't forget to take into account personnel purification, material purification, process water, etc.
Then there are the construction requirements. We can refer to some standards and working documents, such as the Good Manufacturing Practice for Sterile Medical Devices and the aseptic processing of medical products. These specifications will give you detailed guidance so that you don't have to get lost. There is also the monitoring and control aspect. Air purification should follow general regulations, including the purification air conditioning system, airflow pattern and supply air volume, air ducts and accessories, etc. Of course, we also need to monitor and control the clean workshop to ensure the stability and cleanliness of the production environment.
Finally, site selection and general layout. Choosing the right factory site and making a reasonable general layout are also important links in the establishment of a clean workshop. In general, the establishment of a clean plant for medical device production is a complex project involving many aspects. We need to comprehensively consider multiple factors such as production process, personnel purification, material purification, equipment selection, architectural design, air purification, etc. During the implementation process, it is also necessary to pay close attention to the update of relevant regulations and standards to ensure the compliance and effectiveness of plant construction.
Does the clean workshop for medical device production need to be accepted by the regulatory department after it is established?
According to the Regulations on the Supervision and Administration of Medical Devices and related regulations (Design Standards for Clean Workshops in the Pharmaceutical Industry (GB 50457-2019)), clean workshops for medical device production need to be accepted by the regulatory authorities after they are established. Specifically, the guidelines for setting the cleanliness level of the production environment of sterile medical devices specify the layout requirements of the clean room (area). In addition, the Ministry of Housing and Urban-Rural Development has also issued a mandatory national specification "General Specifications for Industrial Cleanrooms (Draft for Comments)", which makes mandatory requirements for the design, construction, acceptance, performance and maintenance of industrial cleanrooms including the pharmaceutical industry, medical devices, and electronics industries.
In terms of acceptance, it is necessary to provide an environmental test report from a qualified third-party testing agency within one year, and the test report must be accompanied by a floor plan indicating the area of each room. There are six items to be tested: temperature, humidity, pressure difference, number of air exchanges, dust number, and sedimentation bacteria. The parts of the test include the production workshop: the personnel clean room;Material clean room;Buffer;The room required by the product process;Workstation appliance cleaning room, sanitary ware room, laundry room, temporary storage room, etc., as well as sterility testing room.
The above knowledge will give you a basic understanding of how to build your own clean workshop, and if you want to know more about medical device registration, medical device production and other related knowledge, you can***.