Oral liquid GMP workshop requirements for equipment? -common problem

Oral liquid GMP workshop requirements for equipment?

Requirements for equipment in oral liquid GMP pharmaceutical cleanroom In addition to the design of the equipment should meet the requirements of the production process, the equipment should be able to prevent cross-contamination, does not affect the product quality itself, and is easy to clean and maintain. The design and layout of the equipment can cause errors. risks are minimized;...

Text label: Oral liquid GMP workshop requirements, GMP plant equipment requirements

Oral liquid GMP workshop requirements for equipment?

Requirements for equipment in oral liquid GMP pharmaceutical cleanroom In addition to the design of the equipment should meet the requirements of the production process, the equipment should be able to prevent cross-contamination, does not affect the product quality itself, and is easy to clean and maintain. The design and layout of the equipment can cause errors. The risk of the equipment is reduced to a minimum; the performance and technical indicators of the equipment meet the design standards, and the new equipment should be tested and verified after installation; the equipment should be placed in the GMP workshop with enough space and not crowded, and the equipment should not be placed unreasonably. Causes errors and is not conducive to cleaning and maintenance; dust disposal and cross-contamination in the production process, in addition to using closed operating systems as much as possible, such as crushing, weighing, mixing, sieving, drying, granulation and other production processes There should be a reasonable dust filtration system that can overcome cross-contamination and minimize investment and operating costs.

The equipment should not be polluted by the leakage of the sealing sleeve and the leakage of lubricating oil; equipment cleaning is one of the important provisions of GMP. The equipment should be easy to clean, and some parts should be able to be disassembled. Cleaning procedures for cleaning agents, inspections after cleaning, cleaning cycles, etc. For containers used in production, they should be cleaned immediately after use, and cleaning procedures should also be formulated, and records should be recorded for the cleaning of equipment; cleaned equipment should be placed in In a clean and dry environment, check whether it meets the requirements of cleanliness before use; the adaptability and precision of instruments, meters, measuring instruments, weighing tools, etc. used for production and inspection should be specified, regularly calibrated and recorded; Equipment that is not in use shall not be placed in the production area; all equipment shall have labels of use and cleanliness; equipment shall have equipment files and maintenance records, and verification records shall be provided if equipment is verified. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and GMP workshops.

According to the requirements of the production process, determine the position of all equipment in the plane and space, and determine the structural form of the workshop or frame accordingly. The workshop layout is also designed for civil engineering, heating, ventilation, electrical, automatic control, water supply and drainage, etc. To provide a basis, in order to ensure the safety of the produced items, each designer must deeply understand and master the content and specific requirements of GMP, so that the designed pharmaceutical cleanroom can meet the safety requirements, and the selected equipment should also be considered. , materials, the selected process, whether the determined layout meets GMP requirements, meets the space required for operation and production, meets the energy requirements for production and equipment, and meets the post cleanliness level, temperature and humidity, heat dissipation, moisture dissipation, dust removal According to the geometric size and installation requirements of the selected equipment, the building and structure of the workshop, such as floor height, span, column spacing, ventilation and lighting, are clearly required.

extraction machine CUSTOM SOLUTION SERVICES is generally used to extraction machine.

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