GMP workshop air cleanliness class

GMP workshop air cleanliness class

GMP pharmaceutical cleanroom level A: high-risk operation areas, such as filling areas, areas where rubber stopper barrels and open packaging containers for sterile preparations are in direct contact, and areas where aseptic assembly or connection operations are performed, should use one-way flow The operating station maintains the environmental status of the area; the one-way flow system must...

Text label: GMP workshop purification, air cleanliness grade, GMP pharmaceutical cleanroom engineering installation

GMP pharmaceutical cleanroom air cleanliness class

GMP workshop level A: high-risk operation areas, such as filling areas, areas where rubber stopper barrels and open packaging containers for sterile preparations are in direct contact, and areas where aseptic assembly or connection operations are performed, should use one-way flow The operating table maintains the environmental state of the area; the one-way flow system must supply air evenly in its working area, with a wind speed of 0.36-0.54m/s; in a closed isolation operator or glove box, a lower wind speed can be used. Class B: The background area where the Class A clean area for high-risk operations such as aseptic preparation and filling is located. Classes C and D: Clean areas for less critical steps in the production process. When confirming the cleanliness level, a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of suspended particles ≥5μm in the long sampling tube of the remote sampling system. In the unidirectional flow system, an isokinetic sampling head should be used; Dynamic testing can be performed during routine operations, during simulated media filling to demonstrate dynamic cleanliness levels, but simulated media filling testing requires dynamic testing under 'worst case conditions'.

The number of personnel in the clean area should be strictly controlled. Staff including maintenance and auxiliary personnel should be regularly trained and assessed on basic knowledge of hygiene, microbiology, and cleaning operations. Temporary outsiders who enter the clean area should be guided and assessed. Supervision; buffer facilities must be set up between the clean area and the non-clean area, and the direction of people and logistics is reasonable; no floor drains are allowed in the A-level GMP workshop, and operators should not operate with bare hands. When unavoidable, hands should be disinfected in time; clean The transmission equipment used in the area shall not pass through the lower level area; the clean work clothes in the area above D level shall be washed, dried and arranged in the clean area, and shall be sterilized as required if necessary; the clean area shall be free of shedding, easy to clean and easy to use. Sanitary tools for disinfection should be stored in designated places that do not cause pollution to the product, and the area of u200bu200buse should be limited; the surface of the insulation layer of the equipment in the clean area should be smooth and clean, and no particulate matter should fall off; the clean area should be under static conditions. The detected number of dust particles, planktonic bacteria or settled bacteria must meet the regulations, and the clean state under dynamic conditions should be regularly monitored; how to recycle the purified air in the clean area, effective measures should be taken to avoid contamination and cross-contamination. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and laboratories.

The air treatment measures for purifying the air conditioning system mainly include: air filter, which effectively controls the cleanliness of all the air introduced into the room from the outside, because the bacteria are attached to the suspended particles, while the particles are filtered, the bacteria It can also be filtered out; the second is to organize air flow and sewage, organize specific forms and strengths of air flow indoors, and use clean air to remove pollutants that occur in production; increase air static pressure to prevent outside polluted air from the door and various Leakage parts invade the room; take comprehensive purification measures, and take corresponding measures in process, equipment, decoration and pipelines.

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