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Ansell BUPS BioClean Ultimate Sterile Neoprene Gloves Class 10 (ISO 4)

Ansell BUPS BioClean Ultimate Sterile Neoprene Gloves Class 10 (ISO 4)

$700.00
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SKU:
BUPS
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Quantity Option (Case):
200 Pairs
Inner Packaging:
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Ansell BioClean™ Ultimate BUPS Sterile Neoprene (Polychloroprene) Cleanroom Gloves — Class 10 / ISO 4, ESD Properties, and Chemotherapy-Drug Testing (ASTM D6978)
Sterile Neoprene (Polychloroprene) Class 10 / ISO 4 EU GMP Grade A/B Use Case ESD Properties Chemo Tested (ASTM D6978)

BioClean™ Ultimate BUPS is a sterile, hand-specific polychloroprene (neoprene) cleanroom glove built for precision handling in Class 10 / ISO 4 sterile spaces where hand protection must not become the dominant contamination or ESD risk. It is latex-free and powder-free, features a beaded cuff for strength and double-donning, and uses textured fingers/palm to maintain grip when work shifts from dry handling to disinfected touchpoints.

In facilities operating a contamination control strategy (CCS), BUPS is often selected when teams need a sterile glove presentation plus published chemical/chemotherapy testing references to support risk-based glove selection, change-out intervals, and task-specific compatibility reviews.

Why teams choose BioClean™ Ultimate BUPS in critical environments
  • Sterile, cleanroom-compatible glove class: listed for Class 10 / ISO Class 4 and EU GMP Grade A/B sterile cleanrooms.
  • Latex-free polychloroprene barrier: selected when natural rubber latex is not desired while retaining neoprene-like chemical resistance behavior.
  • ESD properties: supports component integrity protection where electrostatic discharge can damage sensitive devices or disrupt yields.
  • Documented testing references: includes chemotherapy-drug testing to ASTM D6978 and chemical permeation reporting summaries (see Documentation).
  • Packaging designed to reduce presentation contamination: EasyTear™ packaging format supports cleaner opening and donning flow.
Construction and usability details
  • Material: Neoprene (Polychloroprene); powder-free; latex-free (protein level N/A: contains no natural rubber latex).
  • Fit: Hand-specific shape supports dexterity and reduces excess material that can snag on fixtures or ports.
  • Grip: Textured fingers and palm for controlled handling of tools, containers, and packaged sterile components.
  • Donning and durability: Beaded cuff increases cuff strength and supports double-donning (listed recommendation: yes, as outer glove).
  • Internal surface: Polymer coated to support smoother donning and more consistent glove seating.
Sterility, packaging, and traceability characteristics
  • Sterility assurance level (SAL): 10-6.
  • Sterilization method: Gamma irradiation (minimum dose listed: 25 kGy).
  • Freedom from holes: 0.65 AQL (Performance Level 3).
  • Presentation packaging (case): 1 pair per inner PE wallet; 1 wallet per sealed EasyTear™ PE pouch; 10 pouches per sealed outer PE bag; 20 outer bags per lined carton (200 pairs).
  • Shelf life: Five (5) years from date of manufacture (storage guidance: cool, dry, <40°C, away from direct sunlight and fluorescent light).
Specifications (published)
Cleanroom class Class 10 / ISO Class 4 & EU GMP Grade A/B and other sterile cleanrooms
Color Natural
Length 300 mm / 12 in
Thickness (typical) Palm: 0.11 mm (4.33 mil)  |  Finger: 0.14 mm (5.51 mil)  |  Cuff: 0.09 mm (3.54 mil)
Surface Textured fingers and palm; polymer-coated interior
Antistatic / ESD Yes
Typical particle count <1300 counts/cm2 at ≥0.5µm (IEST-RP-CC005.4 reference on PDS)
Country of origin (PDS) Indonesia

Ordering notes: Reorder numbers by size include BUPS-60, BUPS-65, BUPS-70, BUPS-75, BUPS-80, BUPS-85, BUPS-90 (see Product Data Sheet for sizing table and palm width targets).

Chemical and chemotherapy permeation (planning snapshots)

BUPS includes published permeation summaries to support task planning. Always validate glove suitability for your specific chemical mix, concentration, temperature, dwell time, and mechanical stress. Breakthrough times are determined under laboratory conditions and may not reflect actual use.

Published chemical permeation examples (EN 16523-1 summary) Mean breakthrough time (minutes)
Sodium hydroxide (NaOH) 40% >480
Formaldehyde 37% >480
Ammonia 25% 16
Chemotherapy drug testing examples (ASTM D6978 summary) Average breakthrough detection time (minutes)
Carmustine (3.3 mg/ml) 2
Cisplatinum (1.0 mg/ml) >240
Cyclophosphamide (20.0 mg/ml) >240
Thio-Tepa (10.0 mg/ml) 47.7

Note: The full chemotherapy table includes additional drugs (e.g., doxorubicin, etoposide, 5-fluorouracil, methotrexate, paclitaxel) and should be reviewed in the Chemotherapy Permeation Report for your risk assessment.

Handling discipline aligned to EU GMP Annex 1 expectations

EU GMP Annex 1 emphasizes a risk-based contamination control strategy, documented practices, and disciplined aseptic behaviors. Sterile gloves are one component of that system. Practical practices many facilities formalize include:

  • Double-gloving logic: use BUPS as the outer glove where specified; change the outer glove whenever contacting non-sterile surfaces, after interventions, or at defined intervals in your CCS.
  • Glove sanitization: when SOPs allow, sanitize with sterile IPA and maintain wet contact time per your validated disinfection approach; avoid over-wetting cuffs to prevent wicking.
  • Damage and pinhole control: define inspection points (pre-use, post-gowning, pre-critical task) and change gloves immediately after any tear, snag, or suspected compromise.
  • Material transfer discipline: keep glove touchpoints predictable; isolate “dirty hand” vs “clean hand” roles during setups; avoid cross-contact between packaging exteriors and Grade A/B touch surfaces.
  • Documentation: retain the Product Data Sheet, declarations of conformity, and relevant permeation summaries in your controlled document set for audit readiness and training consistency.
About Ansell and why SOSCleanroom stocks it

Ansell is a global leader in hand and body protection, with dedicated cleanroom PPE lines under the BioClean™ brand. In critical environments, glove selection is not a commodity decision—it is a contamination-control and operator-safety control. SOSCleanroom prioritizes best-in-class glove options and does not compromise glove quality for cleanrooms, aseptic processing, and laboratories where process drift and particulate/chemical risk are unacceptable.

If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574. OR check out the AI ChatBot powered by SOSCleanroom data libraries - give it a try! THIS IS NEW FOR 2026! Last updated: January 10, 2026 © 2026 SOSCleanroom.com. All rights reserved.
The Technical Vault
By SOSCleanroom
Ansell BioClean™ Ultimate BUPS Sterile Neoprene (Polychloroprene) Cleanroom Gloves — Class 10 / ISO 4, ESD Properties, and ASTM D6978 Chemotherapy-Drug Testing
Class 10 / ISO 4 Sterile (SAL 10-6) Neoprene / Polychloroprene Latex-Free, Powder-Free ESD Properties Chemo Tested (ASTM D6978) 200 Pairs / Case
1. Practical solutions in a critical environment

In Class 10 / ISO 4 work, gloves are not “general PPE” — they are a primary contamination-control surface and a frequent contact interface with tools, components, and sterile transfer items. BioClean™ Ultimate BUPS is selected when programs need a sterile glove with controlled cleanliness metrics, plus documented chemical/chemotherapy testing context, without using natural rubber latex.

BUPS adds ESD properties for facilities handling electrostatic-sensitive components and assemblies, and it uses non-particulating EasyTear™ packaging to support cleaner opening and donning flow. These attributes matter most when teams are standardizing glove change-out triggers, packaging presentation discipline, and task-based compatibility reviews under the facility’s contamination control strategy.

2. What this glove is for
  • ISO 4 / Grade A/B decision sets where sterile glove presentation and low background contribution are required
  • Precision handling with a strong need for tactility (fine manipulations, fixtures, ports, and aseptic interfaces)
  • Workflows where chemical compatibility documentation is part of task planning (facility validation required)
  • ESD-sensitive handling where gloves must support a broader ESD control program
3. Selection rationale
  • ISO 4 positioning: Listed for Class 10 / ISO 4 and sterile cleanroom use cases where glove contribution must be tightly controlled.
  • Latex-free polychloroprene barrier: Chosen when latex avoidance is required while retaining neoprene-like handling and chemical resistance behavior.
  • ESD properties: Supports integrity protection for electrostatic-sensitive components when integrated into your ESD controls.
  • Documented test context: Tested for chemotherapy drugs per ASTM D6978 and supported by permeation summaries (selection still requires site validation).
  • EasyTear™ packaging: Non-particulating packaging helps reduce packaging-driven contamination risk during opening and donning.
  • Double-donning support: Beaded cuff and sterile packaging configuration support layered glove strategies and controlled change-outs.
SOSCleanroom selection philosophy
SOSCleanroom supports customers who need dependable, best-in-class cleanroom consumables. In critical environments, we do not recommend “good enough” substitutes when process risk, product integrity, and compliance expectations are on the line.
4. Materials and construction
  • Material: Neoprene (Polychloroprene)
  • Color: Natural
  • Shape: Hand-specific
  • Cuff: Beaded
  • External surface: Textured fingers and palm
  • Internal surface: Polymer coated
  • Powder content: Powder-free
5. Specifications in context

In ISO 4 programs, glove specs translate directly into operational risk: donning stability, leak control, background particle contribution, and predictable handling during sterile manipulations. The table below ties the manufacturer’s published specifications to common ISO 4 workflow outcomes (change-out discipline, transfer behavior, and controlled application of sterile alcohol).

Specification Value Operational meaning
Cleanroom class Class 10 / ISO 4 (EU GMP Grade A/B use case) Positions BUPS for critical, sterile environments where background control is a primary quality driver.
Sterility SAL 10-6 Supports sterile workflow intent when packaging presentation and donning steps are controlled.
Freedom from holes 0.65 AQL (Performance Level 3) Leak baseline; any suspected defect or touch-risk event is an immediate change-out trigger.
Length 300 mm / 12 in (typical) Supports gown-to-glove overlap and reduces exposed interface risk during reaching and rotations.
Thickness targets Palm 0.11 mm (4.33 mil) | Finger 0.14 mm (5.51 mil) | Cuff 0.09 mm (3.54 mil) Balances tactility with durability; supports stable donning and precision handling.
Tensile (before aging) See manufacturer PDS (EN 455-2 test framework) Useful for comparing platforms; in practice, change-out discipline and snag avoidance drive outcomes.
Force at break (before aging) ≥ 9 N Durability indicator; supports controlled donning and reduces tear risk in high-handling tasks.
Tested for chemotherapy drugs Yes (ASTM D6978) Supports hazardous-drug compatibility planning; validate your specific drug list, concentration, dwell time, and technique.
Anti-static Yes (ESD properties) Helps protect sensitive components when paired with facility ESD controls and grounding strategy.
Country of origin Indonesia Relevant for supplier qualification files and site documentation requirements.
Shelf life 5 years from date of manufacture Use FEFO rotation; confirm lot/expiry at point of use per SOP.
6. Cleanliness metrics

ISO 4 programs typically monitor glove background through particles and extractables because these show up as real deviations: unexpected particulate, residue films, and variability in sensitive processes. BUPS provides published particle baselines and other cleanliness indicators that support lot qualification and trending.

Metric Value Method / reference
Typical particle count ≥ 0.5 µm < 1300 counts/cm2 IEST-RP-CC005.4
Freedom from holes 0.65 AQL (Performance Level 3) EN 374-2

Cleanliness note: Avoid cuff snapping and rapid dry rubbing on packaging. In ISO 4, technique and staging discipline are often the difference between stable background and recurring excursions.

7. Packaging, sterility, and traceability
  • Case configuration: 1 pair per inner PE wallet; 1 wallet per sealed EasyTear™ PE pouch; 10 pouches per sealed outer PE bag; 20 outer bags per lined carton (200 pairs)
  • Sterilization method: Gamma irradiation (25 kGy)
  • Available sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
  • Shelf life: 5 years from date of manufacture (store <40°C, cool/dry, away from direct sunlight and fluorescent light)
8. Best-practice use
Customer SOP disclaimer
This guidance is provided as a suggested starting point for customer SOP development and operator training. Every cleanroom and process is different. Customers must evaluate risk, validate procedures, and obtain appropriate QA/ES approval before implementation. Always follow your facility gowning and aseptic technique requirements and the manufacturer’s instructions for use.
  • Stage with intent: Treat glove packaging as a controlled transfer item. Define where it is wiped, how it is introduced, and where it is opened. Open only what the sequence requires.
  • Donning without particle events: Use slow, controlled opening of EasyTear™ pouches; avoid ripping motions and excessive handling. Do not snap cuffs.
  • Sanitization (facility-defined): If glove sanitization is part of your program, use sterile alcohol, define application volume, wet-contact expectations, and drying rules in the SOP.
  • Double-donning: Define inner/outer glove roles. In ISO 4, the outer glove is commonly treated as the “work layer” with step-based change-out triggers.
  • Change-out triggers: Any tear, puncture, cuff roll-down, loss of grip, tacky residue, or contact with non-qualified surfaces is an immediate change-out event.
Suggested pairings: wipers, swabs, and solutions for sterile glove workflows
In ISO 4 work, glove performance is only part of the outcome. Consistency improves when teams standardize the “glove + wiping + detailing + solution” set so operators are not improvising at point-of-use.
Use case Recommended item Why it pairs well
ISO 4 critical wipe-downs (equipment, benches, transfer items) Texwipe TX3224 Sterile TexTra10™ 9" x 9" Polyester Cleanroom Wiper Sterile sealed-border polyester wiper supports repeatable wipe patterns with low lint and controlled extractables in critical zones.
Critical polishing / film-sensitive surfaces Texwipe TX3211 SterileWipe™ LP 9" x 9" Polyester Cleanroom Wiper Sterile continuous-filament polyester wiper used for critical cleaning and polishing where low particle generation is a priority.
Sterile gowning room wipe-downs and aseptic support areas Texwipe TX8932S Sterile TexVantage™ 12" x 12" Cellulose/Polyester Cleanroom Wiper Sterile larger-format wiper supports faster coverage on carts and staging areas while maintaining contamination-control discipline.
Detail cleaning (ports, fittings, interfaces, corners) Texwipe STX763 Sterile Gamma-Irradiated Polyester Swab Sterile swab for controlled solvent cleaning in tight geometries where wipers cannot maintain contact.
Sterile IPA delivery (routine spray application) Texwipe TX8270 Sterile 70% Isopropanol Alcohol Solution (8 oz) Sterile, ready-to-use spray format helps standardize application volume and pattern for routine glove and surface sanitization steps.
Sterile IPA bulk use (high consumption points) Texwipe TX3290 Sterile 70% Isopropanol Alcohol Solution (1 Gallon, 4/Case) Bulk sterile IPA supports high-use points; align dispensing controls to avoid over-wetting and prevent solvent-driven residue movement.
Guardrail: Confirm solution compatibility with your surfaces and your facility SOPs (wet-contact time, reapplication triggers, and glove change-out triggers).
9. Common failure modes
  • Packaging-driven contamination: Fast tearing motions, excessive handling, or opening outside defined transfer steps can create avoidable particle and touch-risk events.
  • Chemical compatibility assumptions: Published permeation data supports planning but does not replace site validation for your specific chemical mix, temperature, and mechanical stress.
  • Over-wetting during sanitization: Excess alcohol can reduce grip and move residues; define controlled application and drying expectations in the SOP.
  • Double-donning drift: When outer glove change triggers are not explicit, operators extend use beyond the intended control model.
  • ESD “checkbox” risk: ESD performance depends on the full program (grounding, surfaces, humidity targets, and training) — not gloves alone.
10. Other gloves to consider

These alternatives are commonly evaluated in sterile ISO 4–ISO 5 decision sets. Selection should be driven by allergen policy, tactile needs, and the intervention model defined in your facility procedures.

11. Program fit for regulated cleanrooms
  • ISO 4 contamination control: Strong fit when glove background and packaging presentation are treated as core controls within the contamination control strategy.
  • Chemical / HD planning: Relevant when the program needs documented test context (ASTM D6978, permeation summaries) to support task planning and change-out logic.
  • ESD-sensitive handling: Supports electronics and device environments when integrated into an established ESD program.
  • Documentation-driven qualification: Suitable where QA needs traceable packaging configuration and published cleanliness metrics for qualification files.
12. Source basis
Product documentation
Standards & guidance references
These references are included to support terminology and program alignment. Customers should confirm applicability to their processes and approved SOPs.
Technical Vault Notice
Important disclaimer: This entry is provided for general process support and reference only. It is not regulatory, legal, medical, or validation advice.
Customers must evaluate risk, confirm applicability to their processes, and follow their approved SOPs, QA requirements, and the manufacturer’s instructions for use.
Questions or documentation requests: Sales@SOSsupply.com  |  (214) 340-8574
Last reviewed: January 30, 2026
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