GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2)
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GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) - 1

GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) EU GMP Grade B (including access / interventions into grade A): appropriate garments that are dedicated for use under a sterilised suit should be worn before gowning. Appropriately sterilised, non-powdered, rubber or plastic gloves should be worn while donning the sterilised garments. Sterile headgear should enclose all hair (including facial hair) and where separate from the rest of the gown, it should be tucked into the neck of the sterile suit. A sterile facemask and sterile eye coverings (e.g. goggles) should be worn to cover and enclose all facial skin and prevent the shedding of droplets and particles. Appropriate sterilised footwear (e.g. over-boots) should be worn. Cleanroom gowning should be performed in change rooms of an appropriate cleanliness grade to ensure gown cleanliness is maintained. Outdoor clothing including socks (other than personal underwear) should not be brought into changing rooms leading directly to grade B and C areas. Single or two-piece facility trouser suits covering the full length of the arms and the legs, and facility socks covering the feet, should be worn before entry to change rooms for grades B and C. Facility suits and socks should not present a risk of containation to the gowning area or processes. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use,Brussels,22.8.2022 C(2022) 5938 final, 7.13, 7.14 Annex 1 Manfacture of Sterile Medicinal Products Personnel GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) Cleanroom shoes Medical isolation goggles

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GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) - 2

UPGRADED 2-IN-1 CLEANROOM COVERALL MODEL: L-2111X APPLICATION AREA: A/B, C grade clean area FABRIC: 98% Polyester filament+ 2% conductive fiber PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree APPLICATION INDUSTRY: Pharmaceutical, food process, electronic and cosmetic industry. PERFORMANCE: Cleanliness, isolation, anti-static performance, duality. Comfort and soft to wear. It achieves an impressive point-to-point 5 resistance of 1.0×10~1.0×10Ω. Whole piece resistance<0.6uc/piece. M-005 Hood can be adjusted with different sizes using a buckle designed in the...

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GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) - 3

UPGRADED CLEANROOM UNDERGARMENT MODEL: N-1101WX APPLICATION AREA: A/B, C grade clean area FABRIC: 98% Polyester filament+ 2% conductive fiber PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree. APPLICATION INDUSTRY: Pharmaceutical, food process, electronic and cosmetic industry. PERFORMANCE: Superfine polyester fiber, comfort and soft, sweat-absorbing, non-fibber shedding. Dressing and folding training video are provided for customers. Face tightness adjustment for different head size. Special fabric in the ear area to make the hearing is not affected when...

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GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) - 4

CLEANROOM ACCESSORIES(1) STERILIZABLE BOOTS MEDICAL ISOLATION GOGGLES PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree. PROPERTIES: Resistant to repeated sterilization in 121 centi degree condition APPLICATION AREA: A/B, C grade clean area APPLICATION AREA: A/B, C grade clean area FABRIC: Imported TPV+clean canvas+polyester filament with conductive fiber FABRIC: Imported polymer material (lens)+ medical grade silicone (frame and strap) CLEANLINESS Repeatedly cleaning and sterilization ANTI-STATIC The anti-static function of the clean shoes can effectively...

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GOWNING CONFIGURATION FOR GRADE B CLEAN AREA(2) - 5

CLEANROOM ACCESSORIES(2) CLEANROOM MASK PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree. PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree. APPLICATION AREA: A/B, C grade clean area APPLICATION AREA: A/B, C grade clean area Fabric: 98% superfine polyester fiber+ 2% conductive fiber Fabric: 98% superfine polyester fiber+ 2% conductive fiber PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree. PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree. APPLICATION SUGGEST: Use for...

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