Ansell S-BCAS BioClean-C Sterile Chemotherapy Protective Apron with Sleeves — Class 10 (ISO 4) / EU GMP Grade A (40/Case)

The Ansell S-BCAS BioClean-C is a sterile, single-use chemotherapy protective apron with sleeves designed for critical environments where contamination control and chemical splash/permeation risk management must be handled with discipline. Manufactured from lightweight, low-linting CleanTough™ material, it features an adjustable Velcro neck fastening, rear tie tapes, and ultrasonically bonded sleeve seams with protective tape, plus elasticated cuffs to help maintain coverage at the glove interface.

Cleanroom note: Sterile garments protect only when they are donned correctly. See the Best-Practice Donning section below for cleanroom gowning technique guidance.

Specifications:

SKU (platform): S-BCAS
Cleanroom classification: Class 10 / ISO 4 & EU GMP Grade A
Sterility: Sterile; Sterility Assurance Level (SAL) 10^-6
Sterilization method: Gamma irradiation (25 kGy; minimum dose 25 kGy)
Material: CleanTough™ (polyethylene / non-woven polypropylene laminate)
Construction: Ultrasonically bonded sleeve seams with protective tape; 100% polyester elasticated cuffs
Neck seal / closure: Velcro neck fastening
Waist closure: Rear tie tapes / integral ties
Particle shedding (Helmke Drum): ≥ 0.5 µm — < 1700 counts/min
Shelf life: Three (3) years from date of manufacture
Storage: Store in a dry, cool place (40°C) away from direct sunlight and fluorescent light
Packaging (case): 1 piece per sealed inner PE bag; 1 inner bag per sealed outer PE bag; 40 outer bags per lined carton (40 pieces)
Country of origin: China
Available sizes: S, M, L, XL (see size chart link below)

About the Manufacturer:

BioClean™ garments are part of Ansell’s contamination-control and life-science PPE portfolio. For S-BCAS, Ansell positions CleanTough™ as a lightweight, low-linting laminate intended to support both product protection and operator protection in controlled environments. Manufacturer documentation includes chemical test method references, cleanroom performance statements, and sterility method/assurance information.

S-BCAS Features:

ASTM F739-12 permeation testing reference for chemotherapy drug breakthrough (see manufacturer datasheet)
Ultrasonically bonded seams with protective tape on sleeves
Adjustable Velcro neck fastening for fit control
Rear tie tapes to secure coverage
Elasticated cuffs to support glove-interface control
Sterile, gamma-irradiated with SAL 10^-6
Low particle shedding performance reference (Helmke Drum)

S-BCAS Benefits:

Reduces gowning variability: sterile, single-use, individually bagged format supports controlled entry and standardized handling.
Supports ISO 4 / Grade A workflows: designed for Class 10 (ISO 4) and EU GMP Grade A environments (program-dependent).
Improves sleeve-to-glove coverage: elasticated cuffs help reduce wrist exposure risk when paired with appropriate gloves.
Documented sterility and packaging discipline: supports QA receiving and audit expectations.
Operator and product protection intent: positioned as partial-body PPE to complement full-body systems.

Common Applications:

Cytotoxic drug handling and related compounding activities (per facility SOP and risk assessment)
Controlled and critical environments where sterile single-use partial-body PPE is required
Production/manufacturing and laboratory workflows needing low-linting protective over-garments
Work steps where sleeve contamination control and splash protection are emphasized

Best-Practice Donning (Cleanroom Gowning Discipline):

Stage first, then enter: confirm size, integrity, and expiration before you enter higher-grade areas; keep packaging closed until use.
Hand hygiene and glove strategy: follow your SOP for glove selection; many sterile programs use an inner glove while donning and an outer glove for operations.
Keep the outside clean: open the sterile packaging so the garment can be presented without touching the exterior surface.
Don in the right sequence: don base cleanroom apparel first (hood/mask/coverall/boots per SOP), then apply the apron as a final protective layer if required by your process.
Seal the interfaces: ensure cuffs are controlled at the glove line and that the apron is secured at the neck and waist without dragging the garment on the floor or benches.
Single-use means single-use: remove carefully (turn inside out to trap contamination) and dispose per regulations and facility procedure.

Chemical use reminder: Manufacturer guidance notes that garments used for protection against cytotoxic drugs must be selected specifically for the chemicals used, and that seams/closures and wear conditions can affect performance. Validate for your process and follow your site CCS/SOP requirements.

Selection Notes (Sizing):

Size to the operator: use the BioClean size chart (height and chest guidance). Oversizing can increase outer-surface contact risk; undersizing can compromise coverage at the glove line.
Confirm glove interface: if your SOP requires taped joins or specific glove layering, ensure sleeve length and cuff tension support that method.
Receiving/QA: verify sterility markings, lot traceability, and packaging condition before qualification for Grade A/B use.

Manufacturer Documentation (Recommended Reference Set):

Need help qualifying cleanroom garments? Contact SOSCleanroom for practical selection guidance based on your ISO class, EU GMP grade, and contamination-control strategy.

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

Sterile (SAL 10^-6) Gamma 25 kGy Class 10 / ISO 4 EU GMP Grade A CleanTough™ Low-Linting ASTM F739-12 (Permeation) 40/Case

Ansell BioClean-C S-BCAS Sterile Apron with Sleeves — partial-body contamination control and chemotherapy protective performance in ISO 4 / Grade A workflows

Ansell S-BCAS BioClean-C sterile apron with sleeves

SKU shown: S-BCAS (sterile BioClean-C apron with sleeves; S/M/L/XL).

Why this garment exists in cleanrooms

In high-grade cleanrooms, garments are engineered controls intended to reduce shedding, protect product-contact proximity, and (where applicable) provide barrier protection to the operator. S-BCAS is positioned as a sterile, low-linting partial-body garment intended to complement full-body systems while adding chemotherapy protective performance and sleeve coverage at critical hand/arm interfaces.

What this product is used for

Cytotoxic drug handling tasks where a documented protective apron layer is required by the facility CCS/SOP.
Critical environment workflows emphasizing low-linting behavior and controlled gowning technique.
Operations where sleeve protection and cuff control are necessary to reduce exposure and contamination transfer risk.
Production/manufacturing and laboratory work requiring sterile, single-use partial-body barrier PPE.

Why customers consider S-BCAS

Sterile and documented: gamma sterilized with SAL 10^-6, individually bagged packaging supports controlled entry and receiving expectations.
Low-linting design intent: CleanTough™ and published particle shedding results support contamination-control programs.
Sleeve seam control: ultrasonically bonded sleeve seams with protective tape reduce seam vulnerability.
Chemotherapy protective positioning: manufacturer references ASTM F739-12 permeation testing against multiple cytotoxic drugs.
Cleanroom fit statement: published as Class 10 / ISO 4 and EU GMP Grade A (always qualify to your SOP).

Materials, composition, and build

S-BCAS is manufactured from CleanTough™, a polyethylene / non-woven polypropylene laminate described as lightweight and low-linting. The garment uses an adjustable Velcro neck fastening and rear tie tapes. Sleeve seams are ultrasonically bonded and finished with protective tape; cuffs are 100% polyester elasticated.

Specifications in context

Attribute	S-BCAS
Product name	BioClean-C™ Apron with Sleeves — Sterile
Cleanroom statement	Class 10 / ISO 4 & EU GMP Grade A
Sterility assurance	Gamma irradiation; SAL 10^-6; minimum dose 25 kGy
Material	CleanTough™ (PE / non-woven PP laminate)
Seams / cuffs	Ultrasonically bonded sleeve seams with protective tape; 100% polyester elasticated cuffs
Closures	Velcro neck fastening; rear tie tapes
Particle shedding	Helmke Drum ≥0.5 µm: <1700 counts/min
Shelf life	3 years from date of manufacture
Packaging	1 per sealed inner PE bag; inner bag per sealed outer PE bag; 40 outer bags per lined carton
Country of origin	China
Primary test reference (chemo)	ASTM F739-12

Performance and cleanliness considerations

Manufacturer chemical data references ASTM F739-12 mean breakthrough time (MBT) against specific cytotoxic drugs. These results are generated under controlled laboratory conditions; real-world performance depends on wear, seams/closures, movement, contact time, and compatibility with your process chemicals.

Data point	What it implies for use	Published basis
Particle shedding	Supports contamination-control intent; still requires correct gowning and behavior controls.	Helmke Drum ≥0.5 µm: <1700 counts/min
ASTM F739-12 (MBT)	Assists chemical risk assessment; validate against your exact drug list and contact conditions.	Manufacturer table includes multiple drugs (e.g., several >240 min)
Sterility assurance	Supports sterile-area entry when paired with correct donning and controlled packaging handling.	Gamma 25 kGy; SAL 10^-6

Packaging, traceability, and controlled entry

Each apron is supplied as one piece per sealed inner PE bag, with one inner bag per sealed outer PE bag, and 40 outer bags per lined carton. This supports staged opening at gowning boundaries and reduces uncontrolled outer-surface contact during donning.

Proper gowning (donning) to minimize contamination

ISO-first: what "good gowning" looks like in operations

Treat gowning as an operational control: clothing and gowning are core contamination controls, not administrative steps.
Keep the outside sterile: open packaging so the garment can be presented without touching the exterior.
Sequence matters: don base apparel first (hood/mask/coverall/boots per SOP), then apply the apron as the final layer.
Control cuff-to-glove interfaces: ensure cuffs remain seated and the glove line is covered as intended by your SOP.
Minimize motion and contact: most contamination transfer is created by touch. Move deliberately and keep hands within controlled zones.

Annex 1 overlay (Europe): Grade A/B expectations

Aseptic gowning qualification: Annex 1 expects training, assessment, and periodic reassessment for Grade A/B access.
Double-gloving and tuck discipline: garment sleeves tucked into a second pair of sterile gloves for Grade B/A interventions.
Gowning room control: gowning should be performed in change rooms of an appropriate grade to maintain gown cleanliness.

Manufacturer donning method (IFU): don the apron (put arms into sleeves), secure at the back of the neck using the Velcro fastening, then use tie-tapes at the waist. Remove carefully and turn inside out to trap contamination; dispose per regulations.

Common failure modes

Touch contamination during donning: grabbing the outside surface, letting sleeves brush benches/carts.
Poor cuff control: cuffs migrating during work, leaving exposed wrists or creating contact points at the glove line.
Mismatch to chemical list: validate against specific drugs, concentrations, and contact times in your workflow.
Re-use behavior: single-use garments are not designed for repeated cycles.

Closest alternatives

BioClean-C non-sterile apron with sleeves (BCAS): similar build intent without sterile packaging.
BioClean sterile sleeve covers: isolate protection to the arms/cuffs when full aprons are not required.
Other sterile chemo protective aprons: validate documentation depth and permeation testing basis.

Critical environment fit

S-BCAS is typically selected by programs that require: sterile single-use protective over-garments, documented packaging discipline for controlled entry, and a manufacturer-referenced chemo permeation testing basis. Best used as part of a complete gowning system defined by your contamination control strategy and SOPs.

SOSCleanroom note about SOP's

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

Use these best-practice suggestions to strengthen your SOPs—not to replace them. Your team should review, approve, and qualify the final method for your specific surfaces, chemicals, cleanliness limits, and risk profile.

Source basis (manufacturer-first)