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GOWNING CONFIGURATION FOR GRADE D CLEAN AREA

GOWNING CONFIGURATION FOR GRADE D CLEAN AREA

GOWNING CONFIGURATION FOR GRADE D CLEAN AREA

Product catalog summary
Gowning Configuration for Grade D Clean Area
Specifications:
  • Two-piece suits (Models: F-1311, F-1111) are designed for C and D grade clean areas, suitable for pharmaceutical, food processing, electronic, and cosmetic industries. They are made of 98% polyester filament and 2% conductive fiber, available in sizes XS-6XL, and comply with production standard GB12014-2019.
  • Cleanroom masks (Model: K-001) and closed-toe cleanroom shoes (Model: X-006) are also specified for these industries, with the shoes being suitable for D grade clean areas.
Procedures and Standards:
  • EU GMP guidelines for Grade D clean areas require hair, beards, and moustaches to be covered, with a general protective suit and disinfected shoes or overshoes worn to prevent contamination ingress.
  • The suits and accessories are resistant to repeated washing and sterilization at 121°C, with a maximum of 150 cycles for masks.
Performance and Features:
  • The suits offer cleanliness, isolation, anti-static performance, and comfort. They feature elastic hood rims, adjustable hoods, and hidden buckles to prevent ground contact.
  • Cleanroom masks and shoes provide anti-static properties, effectively dissipating static electricity under dry and wet conditions.
Design and Functionality:
  • The suits have special fabric in the ear area to maintain hearing when hooded, and the head-strap of masks features a pinball buckle design for a better fit.
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Catalog excerpts

GOWNING CONFIGURATION FOR GRADE D CLEAN AREA-1

GOWNING CONFIGURATION FOR GRADE D CLEAN AREA EU GMP iii. Grade D: Hair, beards and moustaches should be covered. A general protective suit and appropriately disinfected shoes or overshoes should be worn. Appropriate measures should be taken to avoid any ingress of contaminants from outside the clean area. 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, Annex 1 Manfacture of Sterile Medicinal Products Personnel GOWNING CONFIGURATION Cleanroom two-piece suits Cleanroom mask Cleanroom shoes Cleanroom two-piece suits Cleanroom mask Cleanroom shoes

 Open the catalog to page 1
GOWNING CONFIGURATION FOR GRADE D CLEAN AREA-2

TWO-PIECE SUIT WITH FRONT ZIP OPENING MODEL: F-1311 APPLICATION AREA: C, D 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. Hood can be adjusted with different sizes using a buckle designed in the back. Special...

 Open the catalog to page 2
GOWNING CONFIGURATION FOR GRADE D CLEAN AREA-3

TWO-PIECE SUIT (PULLOVER TYPE) MODEL: F-1111 APPLICATION AREA: C, D 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. Hood can be adjusted with different sizes using a buckle designed in the back. Special fabric...

 Open the catalog to page 3
GOWNING CONFIGURATION FOR GRADE D CLEAN AREA-4

CLEANROOM ACCESSORIES CLEANROOM MASK CLOSED-TOE CLEANROOM SHOES APPLICATION INDUSTRY: Pharmaceutical, food process, APPLICATION INDUSTRY: Pharmaceutical, food process, electronic and cosmetic industry. electronic and cosmetic industry. APPLICATION AREA: C grade clean area APPLICATION AREA: D grade clean area FABRIC: 100% superfine polyester fiber FABRIC: The sole and upper are made of raw materials imported from the United States PROPERTIES: Resistant to repeated washing and sterilization in 121 centi degree.(max. 150 cycles) ANTI-STATIC CLEANLINESS Repeatedly cleaning and sterilization FUNCTIONAL...

 Open the catalog to page 4

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