GMP clean workshop maintenance management

GMP clean workshop maintenance management

Materials, tools, equipment, etc. must be purified before entering the GMP clean workshop, and must also be disinfected and sterilized before entering the aseptic production clean workshop. Air lock entry; purifying air conditioning system should keep clean workshop...

Text label: GMP clean pharmaceutical cleanroom, clean workshop management, clean workshop installation, maintenance management

GMP clean workshop maintenance management

Materials, tools, equipment, etc. must be purified before entering the GMP clean pharmaceutical cleanroom, and must also be disinfected and sterilized before entering the aseptic production clean workshop. The air lock enters; the purification air conditioning system should maintain the corresponding cleanliness level and positive pressure in the clean workshop, and take measures to prevent indoor condensation; when using a high vacuum cleaner for cleaning, the dust concentration at the exhaust port of the vacuum cleaner must be checked regularly.

Situation when the high efficiency filter should be replaced: when the air flow speed is reduced, even after replacing the primary and medium efficiency air filters, the air flow speed cannot be increased; when the resistance of the high efficiency air filter reaches 1.5-2 times the initial resistance ; When there is an irreparable leak in the HEPA filter. The maintenance and management of the clean pharmaceutical cleanroom shall include the management of the purification air conditioning system, production equipment, facilities and operators, and corresponding management systems and records shall be established; the purification air conditioning system shall be subject to a regular inspection and maintenance system, and the inspection and maintenance records shall be archived . Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and clean workshops.

The verification of the clean workshop should include the design confirmation, installation confirmation, operation confirmation and performance confirmation of the indoor systems and facilities, such as air purification, process water and other systems and facilities; The design principle and implementation plan are subject to in-depth design review; the installation confirmation of the system and facilities should include the visual inspection of each sub-project and the single-machine trial operation; the operation confirmation of the system and facilities should be carried out after the installation is confirmed to be qualified, and the content should include The combined test unit of the system with cold and heat sources should not be less than 8H.

Professional extraction machine also understand that when you're working with extraction machine product, it's important to understand that quality of CUSTOM SOLUTION SERVICES always matters.

SUZHOU PHARMA MACHINERY CO.,LTD. provides which will help you extraction machine in a durable and reliable way. To learn more, go to PHARMA MACHINERY.

The unique connections between CUSTOM SOLUTION SERVICESmanufacturing and customers happen when you find ways to relate on a more personal and engaging level that goes beyond a product.