The Technical Vault
By SOSCleanroom
RABS / isolator gloves
Class 10 / ISO 4 environments
Non-sterile
100% water leak tested
ASTM D6978 (chemo handling)
Managing port fit, VHP exposure, and glove integrity in RABS with Ansell BioClean CGL (Class 10 / ISO 4)
Product shown: long-cuff ambidextrous nitrile RABS/isolator glove (port-mounted format).
1) Practical solutions in a critical environment
In isolators and RABS (Restricted Access Barrier Systems), the “glove + port + decontamination cycle” becomes a single risk item inside your Contamination Control Strategy (CCS). The wrong glove spec (port mismatch, chemical incompatibility, or weak integrity testing) can create repeated interventions, micro-tears at the ring, and avoidable downtime.
Ansell BioClean CGL is designed for non-sterile product-contact work inside barrier systems where you need a long gauntlet, dependable water-leak integrity testing, and materials intended to tolerate common disinfectants plus VHP (vaporized hydrogen peroxide) and IPA (isopropyl alcohol) exposures used in isolator programs.
2) What it’s for
- RABS and isolator operations in life sciences and electronics environments where Class 10 / ISO 4 contamination control is specified.
- Barrier-system manipulations involving frequent disinfectant contact and planned VHP/IPA exposure during decontamination cycles.
- Processes where glove integrity is managed as a routine control point (incoming inspection, in-use checks, and change-out criteria).
- Chemo-drug handling use cases where ASTM D6978 testing is required as part of a handling risk assessment (note: the product page states “not listed in the US FDA 510k”).
Important operational note (non-sterile)
This CGL listing is non-sterile. In sterile product operations, non-sterile gloves may still be used in specific designs only when your validated barrier/decontamination approach (e.g., VHP cycle development, contact-time verification, glove-surface compatibility, and documented change-out rules) supports it. Do not assume sterility; treat glove disinfection as a controlled, documented step.
3) Why should customers consider this swab
- Integrity-first handling: 100% water leak tested on the product page, which supports barrier-system risk controls tied to glove failure modes.
- Barrier-system chemical exposure intent: positioned as resistant to VHP, IPA, and common disinfectants used in isolator programs.
- Long reach for ports and sleeves: published length of 840 mm / 33 in supports deep isolator work without exposing the arm at the port transition.
- Clear ordering logic: port size is selectable on the SOSCleanroom page; packaging and case configuration is explicitly stated for receiving control.
- Documentation set: SOSCleanroom provides a Product Data Sheet, Declaration of Conformity, GMP declaration, and IFU link for qualification packages.
4) Materials and construction
Material: Nitrile, white, ambidextrous shape, smooth external surface, beaded cuff. The long gauntlet format is built for port-mounted work where the highest stress often occurs at the glove ring interface and at repeated flex points inside the isolator.
Thickness targets (single-wall): Palm 0.50 mm (20 mil), finger 0.60 mm (24 mil), cuff 0.50 mm (20 mil). Thicker fingers can be beneficial in repetitive pinch-and-rotate manipulations (stopper bowls, line set-ups, component transfers) where localized abrasion and flex fatigue drive early failures.
5) Specifications in context
ISO class labels and glove specs are only useful when mapped to how you actually run the isolator: your VHP cycle design, disinfectant rotation, glove leak-testing cadence, and the mechanical loads you apply at the port and in the work zone. For Annex 1-aligned programs, treat the glove as part of the CCS: define what “acceptable integrity” means, how you detect drift (pinholes, tackiness, loss of elasticity), and what triggers a controlled change-out.
| Published specification |
Value / note |
| SOSCleanroom SKU |
CGL |
| Cleanroom class |
Class 10 / ISO 4 |
| Sterile |
No (non-sterile) |
| Material / color |
Nitrile / white |
| Shape / surface |
Ambidextrous / smooth external surface |
| Cuff style |
Beaded |
| Length |
840 mm / 33 in |
| Port size options on SOSCleanroom page |
203 mm / 8 in and 304 mm / 12 in (other port sizes: “please call to inquire”) |
| Thickness targets (single-wall) |
Palm 0.50 mm (20 mil) / Finger 0.60 mm (24 mil) / Cuff 0.50 mm (20 mil) |
| Freedom from holes |
Inspection Level I; product page states 100% leak tested |
| Chemo drug handling testing |
Yes, in accordance with ASTM D6978 (product page notes: “Not listed in the US FDA 510k”) |
| Shelf life (from SOS-hosted PDS) |
Three (3) years from date of manufacture |
| Operating temperature range (from SOS-hosted PDS) |
-10°C to 120°C |
| Country of origin (from SOS-hosted PDS) |
Malaysia |
| Packaging configuration (case) |
1 piece per sealed inner PE bag; 1 inner bag per sealed second inner PE bag; 1 second inner bag per sealed outer PE bag; 20 outer bags per lined inner white Correx polyethylene box (20 pieces) |
Document fit check: The SOS-hosted Product Data Sheet provided on the product page is for CGL36NIT59 (12-inch port). If you select the 8-inch port option, request the matching port-specific documentation set for your qualification file.
6) Cleanliness metrics
For this CGL listing, the product page emphasizes ISO cleanroom processing and low particle levels, but does not publish numeric particle, ionic, or NVR values in the on-page “Product Details” block. When numeric limits matter (e.g., Grade A/B practices, critical aseptic interventions, or sensitive electronics), ask SOSCleanroom for the lot documentation package and any available extractables/particles data associated with your exact port configuration.
| Metric |
Published value |
How customers typically use this |
| Typical particle release |
Not published on the SOS product page / SOS-hosted PDS provided |
Select glove + disinfection method to minimize particle contribution at the work zone; verify with environmental monitoring trend review. |
| Typical ionic extractables |
Not published |
Electronics customers may require supplier data for ion-sensitive processes; request documentation if this is a gating spec. |
| Typical NVR (non-volatile residue) |
Not published |
Used to assess residue risk after glove contact with product-contact surfaces and tools; request data if residue is a critical-to-quality attribute. |
7) Packaging, sterility, and traceability
- Packaging: triple-bag progression (inner PE bag → second inner PE bag → outer PE bag), with 20 outer bags per lined Correx polyethylene box (20 gloves). This supports staged wipe-down and controlled introduction practices.
- Non-sterile: control of bioburden/sterility is not implied; align glove-surface disinfection and/or VHP exposure to your validated barrier approach.
- Documentation set: Product Data Sheet, Declaration of Conformity, GMP declaration, and IFU link are provided on the SOSCleanroom page for audit support.
- Receiving control tip: treat port size as a receiving-critical attribute (check ring/port dimension, glove labeling, and PDS match before release to production).
8) Best-practice use (operator-level)
Below is a practical, technician-focused module used by many facilities to reduce glove-related deviations. Adapt it to your site procedures and validation requirements.
- Port fit verification (before install): confirm the ordered port size (8 in or 12 in) matches the isolator ring. A small mismatch often shows up later as repeated leaks at the clamp line.
- Visual inspection under bright light: check the gauntlet for creases, thin spots, or shipping damage at the cuff and palm. Long gloves can pick up stress whitening at fold points if mishandled.
- Install without torsion: while mounting, keep the glove oriented so the gauntlet is not twisted; torsion accelerates fatigue at the ring and creates “memory folds” that crack early.
- Decontamination compatibility check: for VHP, confirm your cycle parameters and gloves’ change-out interval are defined. For IPA/disinfectants, respect contact times and avoid mixing chemistries unless your program documents compatibility.
- In-use handling discipline: avoid dragging fingertips across sharp ferrules, tri-clamp edges, or un-deburred fixtures. Inside RABS, glove damage is most often mechanical, not chemical.
- Integrity monitoring: use a documented cadence (e.g., shift start, after interventions, after heavy manipulations) aligned to your CCS risk assessment. If you use an isolator glove leak tester, ensure the alarm limits and pass/fail logic are documented.
- Change-out triggers: define objective triggers (failed leak test, tackiness, stiffness, visible abrasion, discoloration after VHP, recurring EM excursions linked to glove interventions) and treat them as controlled events, not ad hoc decisions.
Matching the glove with the right low-linting wipers and swabs
In Class 10 / ISO 4 environments, glove performance and surface cleaning performance must match. No wiper is truly lint-free; select
low-linting wipers with sealed edges and controlled extractables to reduce variability across shifts.
Suggested Texwipe pairings (same ISO class range for accuracy):
- Texwipe TX8659 Vectra Alpha 10 LT (sealed-border polyester): the SOSCleanroom listing explicitly includes ISO Class 4 (Class 10) among the supported ISO class ranges. Great for dry wipe-down of isolator exterior surfaces, cart tops, and controlled staging areas.
- Texwipe Sterile AlphaSat 10 with WFI (example datasheet reference TX3280 family): the datasheet describes extremely low releasable visible fibers consistent with requirements for sterile ISO Class 4 (Class 10) and higher environments—useful when your CCS requires pre-wetted, validated wiping around aseptic interfaces.
- Texwipe sterile sealed-edge polyester options (Vectra Alpha 10 family): for over 35 years, SOS and Texwipe have been close partners, and SOSCleanroom is the authorized Master Distributor of ITW Texwipe for the United States market—helping customers standardize documentation, lot traceability, and continuity of supply.
9) Common failure modes
- Clamp-line fatigue at the port: micro-tears initiated by torsion during mounting or by repeated stress at a sharp ring edge.
- Pinholes after high-repetition work: most common at fingertip flex points and pinch zones (filling-line adjustments, stopper handling, manipulating rigid tools).
- Chemical “softening” or tackiness: can occur when disinfectant rotation is not aligned to compatibility and contact-time controls; treat surface feel changes as a documented change-out trigger if they correlate to integrity drift.
- VHP cycle stress: repeated VHP exposure can change elastomer behavior over time; manage by defining validated exposure count or time-in-service limits.
- Packaging introduction errors: skipping staged wipe-down or opening the wrong layer in the wrong zone defeats the purpose of multi-layer packaging and can increase bioburden risk.
10) Closest competitors
Competitor selection is most meaningful when it is “mechanism-based” (port system compatibility, sterilization/decon compatibility, integrity testing approach, and mechanical durability), not just material type.
- Ansell BioClean GGL (sterile nitrile RABS/isolator option): use when sterility is required at receipt and the glove is introduced as a sterile component of the system.
- PIERCAN isolator/RABS gloves (materials vary by model): common in isolator markets with broad material offerings; validate port fit, decontamination compatibility, and integrity testing equivalency before substitution.
11) Program fit
- Pharma / biotech RABS: strong fit where your CCS treats gloves as a controlled barrier component with defined leak testing and change-out criteria.
- Annex 1 alignment: supports a risk-based approach to contamination control when paired with validated disinfection/VHP steps, documented glove integrity checks, and intervention reduction.
- Electronics: strong fit when long-cuff isolation and cleanliness control matter; confirm whether your process requires numeric extractables/particle metrics and request documentation if needed.
Why SOSCleanroom emphasizes Ansell
SOSCleanroom supports critical environments with best-in-class glove lines and does not recommend “inferior substitutes” just to save cost—because the environment cannot be compromised. Cleanroom Technology also reported that SOS Cleanroom Supply became an Ansell authorized distributor (June 20, 2023), reinforcing supply chain legitimacy and documentation discipline for customers who operate under audit pressure.
12) Customer SOP disclaimer (recommended template language)
SOSCleanroom can provide suggested SOP language and best-practice templates to help customers improve consistency, training, and documentation. However, each facility is responsible for validating and approving its own procedures based on its processes, products, regulatory requirements, and risk assessments. Always align glove selection, disinfection methods, VHP parameters, integrity testing frequency, and change-out criteria to your site’s Contamination Control Strategy (CCS), quality system, and validated state.
13) Source basis
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: Jan. 11, 2026
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