Verification and steps of biological clean room
1. Definition of biological clean room
Clean Room (Clean Room), also known as clean room or clean room. A clean room is a room where the concentration of airborne particles is controlled. It is constructed and used in such a way as to minimize the particles that enter, generate, and stay in the room. The temperature, humidity, pressure and other related parameters in the room are controlled as required (ISO14644-6). The main function of the clean room is to control the cleanliness, temperature and humidity of the atmosphere that the products (such as silicon chips) are exposed to, so that the products can be produced and manufactured in a good environmental space. This space is called a clean room. The clean room empty pipe items include: can remove the floating dust particles in the air, prevent the generation of fine dust particles, control of humidity and temperature, pressure regulation, the removal of harmful gases, the airtightness of structures and compartments, static electricity Prevention, electromagnetic interference, safety factor, energy saving parameters are considered.
Second, the significance of biological clean room verification
According to China's GMP, there are specific requirements for the implementation verification of equipment. An important principle in GMP is not only the inspection effect on the final product, but also to ensure that the same product has the same production conditions at every step of the production process and at any time. Therefore, the harsh conditions of this clean room occupy Important location. An important part of the pharmaceutical production management specification during verification, it ensures that the verification system, equipment process and testing process are under the control of GMP, thereby ensuring the quality of each product. The definition of verification is that a formal document process is required to prove that a specific product can be reliably produced through a pre-established production process. Validation is used for analytical testing, equipment, auxiliary systems such as air, water, steam, and production equipment.
The verification process should be carried out under the worst conditions in the production process to prove that the equipment and facilities can always meet the requirements. When the verification is completed, if the process changes, a fault occurs, or the equipment is updated or moved, it must be re-verified. It can be seen from the above definition that verification is a document process, and some domestic manufacturers pay more attention to the update of equipment and facilities, and pay less attention to the establishment of documents, which will cause certain difficulties in future acceptance. The process is fully verified. The document includes important basic information, a method to explain the research object, a detailed process to be established to establish measurement parameters, and how to analyze the results to provide the acceptance criteria established in advance.
3. Steps of verification of biological clean room
The verification process of biological clean room is mainly divided into three parts: installation verification, operation verification and performance verification. The verification documents need to provide the original verification records, acceptance standards, materials and the list of documents required for verification, and follow the verification steps in an orderly manner.
1) First of all, it is necessary to formulate a relevant verification plan. It is necessary to list the equipment, systems, methods, processes and schedules to be verified in detail. For new processes and systems, design verification must also be performed.
2) Installation verification includes various inspection information and locations, as well as the required safety performance of auxiliary facilities and equipment. The name included in the installation verification file needs to be more detailed. General standard installation verification documents mainly include: name, system description, model and number, installation location, auxiliary facilities required for installation, required connections and equipment, and safety performance requirements of facilities. In addition, the installation file should provide a comparison of the equipment purchased, a copy of all drawings and manuals, and the contract number and related accessories that were purchased.
3) Operation verification is to give inspection and certification of the operation process, including certification of all alarm points, all switch displays, operations and functions of the equipment. Operation verification requires a manual for implementation during the operation, maintenance, and verification process. It also needs to record the operator's training plan, static and dynamic tests, and proof of equipment-related operational performance. Operation verification requires acceptance of all operations. Standard operation verification documents should include equipment and system verification, pre-operation preparations, and correct operating procedures and related acceptance criteria.
4) Performance verification is carried out after installation verification and operation verification are completed and confirmation work is carried out. The performance verification document describes the system and equipment that can work stably under normal working conditions and even in harsh environments. Performance verification should include a description of the pre-established process, detailed related performance tests, and acceptance criteria for each test of the equipment.
4. Verification of medical clean room
The verification of the medical clean room should include the verification of indoor systems and facilities, such as the purification of air, process water and installation confirmation, operation confirmation and performance confirmation of the facility. The installation and confirmation of systems and facilities shall include the visual inspection and stand-alone trial operation of each branch project; the confirmation operation of systems and facilities shall be carried out after the installation is qualified, and shall include the joint trial operation with cooling and heating systems, which shall not be less than 8h ; The comprehensive performance verification of the medical clean room should include the system and indoor air supply, fresh air, return air and exhaust air volume, static pressure value, average wind speed of the interface, air cleanliness, bacteria detection, indoor temperature and humidity, noise and other indicators Detection.
The verification of the medical clean room needs to include the following documents:
1) Main design documents and completion drawings of the medical clean room;
2) Factory certificate and inspection documents of main equipment;
3) All equipment unpacking inspection records, pipeline pressure test records, pipeline system blowing and degreasing records, air duct leakage records, and completed acceptance records;
4) Stand-alone operation, system joint operation and performance test record of medical clean room.
The verification of the medical clean room needs to follow the following regulations:
1) The current national standard "Code for Construction and Acceptance of Clean Rooms"
2) The current national standard "Testing methods for plankton in the pharmaceutical industry"
3) The current national standard "Testing methods for floating sedimentary bacteria in the pharmaceutical industry"
4) The current national standard "Testing methods for suspended particles in the pharmaceutical industry"
5) The current national standard "Code for Quality Management of Pharmaceutical Production"
6) The current national standard "Pharmacopoeia of the Republic of China"
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