クリーンルーム用手袋の選択ガイド — 滅菌、非滅菌、および耐薬品性のオプション

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クリーンルーム用手袋の選択ガイド — 滅菌、非滅菌、および耐薬品性のオプション

Gloves are the most frequently changed garment component and the primary contact surface between operator and environment. Selecting the right type, material, and donning protocol by cleanroom grade.

Glove Types by Application

タイプ	最高グレード	主な機能	変更頻度
Sterile Cleanroom Gloves	グレードA/B	Gamma-sterilized, individually packaged, full barrier	Per defined interval; double-glove: outer glove changed frequently
Non-Sterile Cleanroom Gloves	グレードC/D	Low particle, clean-manufactured, economical	Per shift or per SOP-defined interval
Chemical-Resistant Gloves	All grades (cleaning)	Nitrile or neoprene, thicker gauge for disinfectant handling	After each cleaning/disinfection task

Double-Gloving Protocol — Grade A/B Standard

Double-gloving is standard practice in Grade A/B aseptic areas. Two layers of gloves are worn: an inner glove and an outer glove. The outer glove is the primary contact surface and is changed at defined intervals (typically every 30-60 minutes or after any contact with non-sterile surfaces). The inner glove provides a backup barrier.

Donning: Inner glove first, pulled over the coverall sleeve cuff. Outer glove second, pulled over the inner glove. Both glove cuffs should extend over the coverall sleeve to eliminate the wrist gap.

Outer glove change: Remove outer glove, sanitize inner glove with sterile 70% IPA if required by SOP, don new outer glove. Change outer glove after any suspected contamination.

Glove integrity: Inspect gloves visually before donning. A pinhole or tear in a sterile glove compromises the aseptic barrier. Discard any glove with visible damage.

Glove Material Options

材料	Tactile Sensitivity	耐薬品性	アレルギーのリスク	最適な用途
ニトリル	良い	Good — QACs, alcohols, H2O2	Low — latex-free	General cleanroom, Grade A/B/C
ラテックス	素晴らしい	適度	High — latex allergy risk	High-dexterity tasks (less common due to allergy)
Neoprene	適度	Excellent — broad chemical resistance	低い	Chemical handling, disinfectant application

Nitrile is the default cleanroom glove material. It provides good tactile sensitivity, chemical resistance, and is latex-free. Latex offers the best tactile sensitivity but carries an allergy risk that most GMP facilities avoid. Neoprene is selected specifically for chemical-handling tasks.

Gloves FAQ

When is double-gloving required?

Double-gloving is standard for Grade A/B aseptic operations. It is not mandatory for Grade C/D but may be specified by facility SOP for certain processes. The outer glove is changed at defined intervals; the inner glove provides a backup barrier.

Nitrile vs latex for cleanroom gloves?

Nitrile is recommended for most cleanroom applications. It is latex-free (no allergy risk), provides good chemical resistance, and adequate tactile sensitivity. Latex offers better tactile feel but carries a significant allergy risk that most GMP facilities prefer to avoid.

How often should cleanroom gloves be changed?

For Grade A/B: outer glove changed every 30-60 minutes or after any suspected contamination. Inner glove changed per shift or per SOP. For Grade C/D: changed per shift, after contact with non-clean surfaces, or when visibly soiled or damaged.