Ansell BNAL BioClean Nerva Cleanroom Nitrile Gloves Class 10 (ISO 4)

Ansell BioClean™ Nerva (BNAL) is a cleanroom nitrile glove positioned for Class 10 / ISO 4 environments, where the margin for error is narrow and where hand contact control can directly determine particle counts, visual defects, rework frequency, and yield. At ISO 4, glove selection is not simply “PPE selection”—it is a defined contamination control measure that supports the entire operations system.

In ISO 4 work, many defects do not come from “big events” but from repeated small touches: glove-to-surface contact, glove-to-gown contact, repeated handling of packaging, and glove loading over time. This is why ISO 4 glove programs are commonly tied to defined donning discipline, controlled staging, restricted movements, and SOP-defined glove change triggers.

ISO 14644 operations guidance recognizes personnel as a primary contamination source and emphasizes the role of gowning, behavior, and materials controls. As you move toward ISO 4, the tolerance for small, repeated contamination contributions decreases. A glove that is acceptable in ISO 7 can become a root cause in ISO 4 simply because the operating envelope is tighter. This makes glove selection, glove cleanliness, and glove behavior part of the facility’s contamination control strategy.

USP-influenced programs apply similar logic for critical work zones: define touch points, define change frequency, and enforce method discipline so results remain repeatable across operators and shifts. Even in non-sterile ISO 4 workflows, residue transfer and glove loading can drive defects in inspection-sensitive processes.

Best practice begins with gowning sequence and controlled donning. Gloves should be donned according to your ISO 4 SOP, minimizing contact between glove exteriors and non-controlled surfaces. Avoid snapping gloves on, which can generate particles. Once donned, treat the glove exterior as a controlled surface and keep hands within the defined work zone. Hand travel is often the hidden failure mode in ISO 4 programs—operators touch a cart handle, adjust eyewear, brush a sleeve, or reposition packaging and then return to critical contact.

Establish clear glove change triggers and enforce them. Common triggers include: leaving the ISO 4 zone, touching non-controlled surfaces, after defined time intervals (risk-based), after handling packaging that is not within the same control state, and after any event that compromises technique. In many programs, glove change discipline becomes the single most effective lever for reducing micro-defects and shift-to-shift variability.

For precision cleaning and inspection-sensitive processes, control how gloves interact with solvents. Over-wetting gloves or allowing solvent to sit on glove surfaces can move contamination and create residue transfer. Define solvent contact limits and glove replacement intervals when solvents are used frequently.

ISO 4 glove programs are most effective when paired with controlled cleaning tools and defined solvent/wetness practices. The intent is to reduce variables: the glove controls the touch interface, while swabs and wipers control geometry and pickup behavior.

• Suggested swab (keep hands away from critical surfaces): Texwipe TX761 Alpha® Polyester Cleanroom Swab (Long Handle) — supports precision cleaning and reduces the chance of glove/sleeve intrusion into product-critical areas.
• Suggested wiper (controlled follow-up pickup): Texwipe TX1010 Vectra® Alpha® 10 Polyester Cleanroom Wiper — sealed-edge control for wipe-down steps where fiber control and consistent pickup behavior matter.
• Suggested solution (wetness control / surface prep): Texwipe TX167 Non-Sterile 70% IPA (16 oz) — commonly used for controlled damp-film technique in non-sterile workflows; if your ISO 4 process requires sterile chemistry or specific disinfectant controls, follow SOP and select approved sterile-presented chemistries.

This Technical Vault content is provided as supplemental operational guidance only and does not replace manufacturer instructions, facility SOPs, validation protocols, quality risk assessments, or regulatory requirements. Always follow applicable ISO standards, USP chapters, and site-specific procedures. Refer to current manufacturer documentation for sterility status, performance data, and chemical compatibility. For ISO 4 programs, control substitutions and document receiving/lot traceability.