Ansell BDFC BioClean-D™ Non-Sterile Coverall with Hood and Integrated Boots — CleanTough™ (Class 10 / ISO 4)

Ansell BDFC BioClean-D™ is a non-sterile, single-use cleanroom coverall designed to reduce personnel-generated contamination while supporting controlled-environment workflows. Built from CleanTough™ polyethylene / polypropylene laminate, the garment is positioned by Ansell as low-linting, static dissipative (antistatic), and suited for operations targeting Class 10 / ISO 4 cleanliness. The coverall includes an elasticated hood, front zipper with protective flap, thumb loops, and integrated boots with slip-resistant soles for a head-to-toe, consistent PPE profile.

Cleanroom note: This is a non-sterile garment. If your SOP requires sterile gowning (common in EU sterile manufacturing Grade A/B programs), consider the sterile alternative: Ansell S-BDFC (Sterile).

Specifications:

Part number / SKU: BDFC
Garment type: Coverall with hood and integrated boots (single-use)
Sterility: Non-sterile
Cleanroom classification (manufacturer positioning): Class 10 / ISO 4
Fabric: CleanTough™ laminate (polyethylene film outer layer / non-woven polypropylene inner layer)
Construction: Bound seams with single needle stitching
Color: White
Closure: Front zipper with protective flap; neck seal: adhesive patch
Fit features: Elasticated hood, back, cuffs, and ankles; thumb loops
Footwear: Integrated boots with slip-resistant soles
Electrostatic behavior: Static dissipative / antistatic (CleanTough™; charge half-decay time referenced by manufacturer as 0.07 sec)
Particle shedding (Helmke Drum, manufacturer-reported): ≥ 0.5 µm — < 2000 counts/min
Available sizes: S, M, L, XL, 2XL, 3XL, 4XL
Country of origin: China
Shelf life: Five (5) years from date of manufacture
Storage: Store in a dry, cool place (< 40°C) away from direct sunlight and fluorescent light
Packaging overview (manufacturer-reported): 1 piece aseptically folded per sealed inner PE bag; 1 inner bag per sealed outer PE bag; 20 outer bags per lined carton (20 pieces). Sizes 3XL and 4XL: 15 pieces per carton.

About the Manufacturer:

Ansell markets the BioClean-D™ garment range for controlled and critical environments where personnel are a primary contamination source. BioClean-D™ garments are supported with manufacturer documentation (product data sheets, declarations of conformity, and use instructions) to help cleanroom teams align PPE selection to SOP requirements, validation expectations, and receiving/QA workflows.

In ISO-aligned operations, garments are not just “PPE” — they are part of the contamination-control system. Selecting the correct fabric, seam construction, interface control (cuff/ankle/zipper), and donning method is often the difference between stable environmental performance and routine excursions.

BDFC Features:

CleanTough™ laminate for lightweight, low-linting body coverage
Front zipper with protective flap and adhesive neck-seal patch (interface control)
Elasticated hood, back, cuffs, and ankles for a closer fit profile
Thumb loops to help stabilize sleeves under gloves
Integrated boots with slip-resistant soles (head-to-to-toe coverage in one garment)
Manufacturer-positioned as static dissipative / antistatic for static-sensitive environments

BDFC Benefits:

Reduces personnel contamination variables: Helps contain skin flakes, fibers, and clothing lint — common drivers of cleanroom particle counts.
More consistent gowning outcomes: Integrated boots and stabilized interfaces reduce “gap” risk at ankles and between footwear/garment.
Improves interface control: Zipper flap + neck seal patch + thumb loops support better glove/cuff and closure management.
Operational convenience: Single-use garment reduces laundering logistics and requalification overhead (program-dependent).

Common Applications:

Controlled-environment production and manufacturing
Pharmaceutical and biotechnology manufacturing support areas
Medical device manufacturing
Cleanroom cleaning and preparation activities
Powder handling and compounding steps (process- and risk-dependent)

Best-Practice Use (Donning / Gowning):

Start ISO-first: ISO cleanroom programs focus on controlling what people shed. Don slowly, avoid snapping fabric, and minimize talking and fast motions during gowning.
Use a clean-to-clean method: Keep the garment exterior from contacting benches, floors, or “dirty-side” surfaces during donning.
Fully close and seal interfaces: Zip fully; engage zipper lock (if present); apply/seal the zipper cover per the manufacturer IFU; confirm cuffs and ankles are seated correctly.
Control glove-to-cuff overlap: Use thumb loops, then don gloves over cuffs. Tape glove/cuff interfaces only if your SOP requires it.
Integrated boots: Don carefully to avoid floor contact on the garment exterior. Step onto approved mats and proceed into the clean zone per your gowning-room flow.
Single-use means single-use: Do not reuse. Remove carefully and turn inside out to trap contamination during disposal.

EU Annex 1 reminder: Sterile medicinal product operations typically impose stricter gowning expectations (including sterile garments, sterile gloves, and validated gowning practices). Align garment sterility and gowning sequence to your Annex 1/QA requirements when applicable.

Selection Notes (BDFC vs. Other Options):

Non-sterile vs. sterile: Choose BDFC for non-sterile programs that still require ISO 4-compatible garment performance. Choose S-BDFC (sterile) where SOP, Annex 1, or aseptic workflows require sterility documentation.
Integrated boots vs. separate boot covers: Integrated boots reduce ankle-interface variability and simplify gowning consistency.
Bound seams vs. sealed seams: For higher liquid / chemical risk, sealed-seam overgarments may be preferred. The manufacturer notes sealed-seam options (e.g., BioClean-C) can be used over a coverall for added protection in specific drug-handling scenarios.

Link to Manufacturer Documentation:

Product Data Sheet (BDFC)
BioClean-D Fabric Technical Data Sheet
Instructions For Use (Type 5/6 Single-Use Garments)
Garment Size Chart
EU Declaration of Conformity
UK Declaration of Conformity

Need help selecting the right gowning system? SOSCleanroom can help align garment choice to ISO cleanroom classification, process risk, and (when applicable) EU Annex 1 expectations.

If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.

Product page updated: Jan. 13, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault

By SOSCleanroom

BioClean-D™ CleanTough™ Non-Sterile — Single Use Coverall + Hood + Integrated Boots Class 10 / ISO 4 Helmke: <2000 @ ≥0.5µm ESD: 0.07 sec (half decay) Case: 20 (15 for 3XL/4XL)

Ansell BDFC BioClean-D™ — ISO 4 gowning control for programs that need consistent head-to-toe coverage (non-sterile)

Ansell BDFC BioClean-D Non-Sterile Coverall with Hood and Integrated Boots

SKU shown: BDFC (BioClean-D™ coverall with hood and integrated boots).

Why gowning discipline matters (ISO-first)

In most cleanrooms, people are the dominant contamination source. ISO cleanroom programs start with ISO 14644-1 for classification context and operationalize control through an operations control program (ISO 14644-5), which includes personnel management, training, entry/exit rules, and a gowning program. BDFC is designed to support those operational controls as a consistent, single-use garment system.

What this product is

Ansell BDFC BioClean-D™ is a non-sterile, single-use coverall with hood and integrated boots, positioned as low-linting, static dissipative, and suited for Class 10 / ISO 4. Key design elements include a front zipper with protective flap, elasticated hood/back/cuffs/ankles, thumb loops, and slip-resistant integrated boots.

Why customers consider BDFC

Gowning consistency: integrated boots reduce ankle-interface variability versus separate shoe/boot cover combinations.
Low-linting cleanroom positioning: manufacturer-reported Helmke Drum particle shedding supports controlled environment use.
Interface control: zipper flap + adhesive neck seal patch + elasticated boundaries help reduce leakage points.
Static-sensitive operations support: CleanTough™ is described as static dissipative (antistatic).
Documentation-ready receiving: PDS / DoC / IFU / size chart support SOP alignment and QA review workflows.

Fabric, construction, and performance context

BioClean-D™ garments use CleanTough™ fabric: polyethylene film outer layer with a non-woven polypropylene inner layer. Construction is bound seams with single needle stitching.

For chemical/repellence and penetration claims, refer to the fabric TDS and the BDFC PDS. The manufacturer cautions that seams and closures may have lower breakthrough times than fabric-only tests.

Specifications in context

Attribute	BDFC
Part number / SKU	BDFC
Sterility	Non-sterile
Cleanroom class	Class 10 / ISO 4
Fabric	CleanTough™ (PE film outer / non-woven PP inner)
Construction	Bound seams; single needle stitching
Key fit/interface controls	Zipper + protective flap; adhesive neck seal patch; elasticated hood/back/cuffs/ankles; thumb loops
Footwear	Integrated boots; slip-resistant soles
Particle shedding (Helmke)	≥ 0.5µm: < 2000 counts/min
Electrostatic behavior	Static dissipative; charge half decay time 0.07 sec
Sizes	S, M, L, XL, 2XL, 3XL, 4XL
Country of origin	China
Shelf life	Five (5) years from date of manufacture
Storage	Dry, cool (< 40°C), away from direct sunlight and fluorescent light
Packaging overview	1 per sealed inner PE bag; 1 inner per sealed outer PE bag; 20 per lined carton (3XL/4XL: 15 per carton)

Cleanroom gowning education (ISO-first, then Annex 1)

ISO operating principle: gowning is a controlled process, not a wardrobe change

Move from dirty to clean: progress through your gowning room in the correct direction; never backtrack.
Minimize shedding: slow movements, minimal talking, no snapping fabric, avoid contact between garment exterior and uncontrolled surfaces.
Control interfaces: cuffs under gloves, ankles seated properly, zipper fully closed and covered, hood fitted.
Train and standardize: documented procedures so gowning is repeatable across shifts.
Replace when compromised: if torn, poorly fitted, or contaminated during donning, discard and restart.

EU Annex 1 overlay: For sterile medicinal product manufacturing, Annex 1 drives stricter contamination-control expectations. In many Grade A/B use cases, sterile garments and sterile gloves are expected, and gowning qualification/training is scrutinized more heavily.

Donning checklist

Pre-gowning prep: remove jewelry, secure hair, perform hand hygiene. Apply hair cover/beard cover and mask as required.
Open the pack cleanly: touch only inside surfaces; keep exterior off benches/floors.
Step in carefully: insert legs without dragging the exterior on the floor.
Arms and thumb loops: insert arms and engage thumb loops to stabilize sleeves before gloving.
Zip fully and lock: zip completely; press zipper into the lock position per IFU.
Seal the zipper flap: remove backing tape and seal the cover so the zipper is fully covered.
Hood fit: seat hood properly; ensure hair is contained.
Glove-over-cuff interface: don gloves over cuffs; tape joins if required by SOP.
Final check: no exposed skin, closures sealed, ankles seated, integrated boots stable.

Common failure modes

Dragging the garment exterior: floor contact transfers contamination to the suit surface.
Unsealed zipper area: partially closed or uncovered zippers leak particles from inner clothing layers.
Poor cuff discipline: thumb loops unused and gloves not overlapping allow particle escape at the wrist.
Fast movements / snapping fabric: increases shedding and can disturb airflow patterns.
Wrong garment for the zone: using non-sterile apparel where sterile gowning is required.

Selection guidance and closest alternatives

Sterile alternative: Ansell S-BDFC
Coverall with hood (no integrated boots): Ansell BDCHT
Sterile coverall with hood (no integrated boots): Ansell S-BDCHT
Interface support (sterile sleeves): Ansell S-BDSC-L

Receiving, documentation, and training notes

Maintain current copies of the PDS, fabric TDS, IFU, and declarations inside your gowning program documentation set. Train operators to the same method every time; consistency stabilizes ISO performance and reduces excursions.

SOSCleanroom note about SOPs

The Technical Vault is written to help customers make informed contamination-control decisions and strengthen day-to-day gowning technique. It is not your facility's SOP, batch record, or validation protocol.

Use these best-practice suggestions to improve your SOPs — not to replace them. Always qualify gowning steps, interface controls, and garment selection inside your quality system.

Source basis (manufacturer-first)