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 not “just clothing” — they are engineered controls intended to reduce shedding,
protect product-contact proximity, and (where applicable) provide barrier protection to the operator.
S-BCAS is positioned by the manufacturer 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 are designed to 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 (program-dependent; 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 (for QA, receiving, and SOP alignment)
| Attribute |
S-BCAS (Manufacturer / Listing Basis) |
| 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 (manufacturer-referenced permeation method) |
Performance and cleanliness considerations (what the data means)
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.
The manufacturer explicitly cautions that garments must be selected specifically for the chemicals used.
| 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 and layer strategy; validate against your exact drug list and contact conditions. |
Manufacturer table includes multiple drugs (e.g., several >240 min; one noted as <6 min) |
| Sterility assurance |
Supports sterile-area entry expectations when paired with correct donning and controlled packaging handling. |
Gamma 25 kGy; SAL 10-6 |
Packaging, traceability, and controlled entry
Packaging is structured to support clean introduction: 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.
In practice, this supports staged opening at gowning boundaries and reduces the chance of 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: ISO cleanroom operations standards emphasize control of personnel entry/exit, behavior, and contamination pathways — clothing and gowning are core controls, not administrative steps.
- Keep the outside sterile: open packaging so the garment can be presented without touching the exterior; once the outside is touched, assume you transferred contamination.
- Sequence matters: don base apparel first (hood/mask/coverall/boots per SOP), then apply the apron as the final layer if required for the process step.
- Control cuff-to-glove interfaces: ensure cuffs remain seated and sleeves are managed so the glove line is covered as intended by your SOP (often double-gloving or taped joins in higher-risk work).
- Minimize motion and contact: most contamination transfer is created by touch (self-contact, bench contact, cart contact). Move deliberately and keep hands within controlled zones.
Annex 1 overlay (Europe): what changes in Grade A/B expectations
- Aseptic gowning qualification: Annex 1 expects training, assessment, and periodic reassessment of aseptic gowning and behaviors for personnel accessing Grade A/B.
- Double-gloving and tuck discipline: Annex 1 describes Grade B (with interventions into Grade A) practices including sterile headgear enclosing all hair, facemask/eye coverings, and garment sleeves tucked into a second pair of sterile gloves.
- Gowning room control: Annex 1 states gowning should be performed in change rooms of an appropriate grade to maintain gown cleanliness.
Manufacturer donning method for aprons (IFU): don the apron (put arms into sleeves if applicable), secure at the back of the neck using the Velcro fastening,
then use tie-tapes at the waist and tie securely at the rear. Remove carefully and turn inside out to trap contamination; dispose per regulations.
Common failure modes (what defeats even good garments)
- Touch contamination during donning: grabbing the outside surface, letting sleeves brush benches/carts, or dragging ties across non-controlled surfaces.
- Poor cuff control: cuffs migrating during work, leaving exposed wrists or creating contact points at the glove line.
- Mismatch to chemical list: assuming “chemo rated” equals universal protection; validate against the specific drugs, concentrations, and contact times in your workflow.
- Re-use behavior: single-use garments are not designed for repeated cycles; re-use changes risk and violates many qualification assumptions.
Closest alternatives (same family / comparable use intent)
Closest alternatives are typically sterile partial-body chemotherapy protective garments with comparable cleanroom claims, packaging discipline, and documented permeation methods.
Compare cleanroom class/grade statement, sterility method, packaging format, and chemical test basis — not just price.
- BioClean-C non-sterile apron with sleeves (BCAS): similar build intent, but without sterile packaging/sterility documentation.
- BioClean sleeve covers (sterile) when aprons are not required: isolate the protection need to the arms/cuffs based on the CCS.
- Comparable sterile chemo protective aprons from other life-science PPE suppliers: validate documentation depth and permeation testing basis.
Critical environment fit (who should use this)
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. It is best used as part of a complete gowning system (hood, coverall, gloves, mask/eye protection, footwear)
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 and improve day-to-day handling technique.
It is not your facility’s Standard Operating Procedure (SOP), batch record, or validation protocol.
Customers are responsible for establishing, training, and enforcing SOPs that fit their specific risks, products, equipment, cleanroom classification, and regulatory obligations.
Always confirm material compatibility, cleanliness suitability, sterility requirements, and acceptance criteria using your internal quality system and documented methods.
If you adapt any technique guidance from this entry, treat it as a starting template. Your team should review and approve the final method, then qualify it for your specific surfaces,
chemicals, cleanliness limits, inspection methods, and risk profile. Use these best-practice suggestions to strengthen your SOPs—not to replace them.
Source basis (manufacturer-first)
- SOSCleanroom product page (S-BCAS): https://www.soscleanroom.com/product/brands/ansell-s-bcas-bioclean-c-sterile-apron-with-sleeves-class-10-iso-4/
- Manufacturer Product Data Sheet (S-BCAS): https://www.soscleanroom.com/content/Ansell_PDF/bioclean-c-apron-with-sleeves-sterile-s-bcas_pds_us.pdf
- BioClean-C Fabric Technical Data Sheet: https://www.soscleanroom.com/content/Ansell_PDF/BioClean%20C_Fabric_TDS.pdf
- IFU (Type PB[6] partial-body garments): https://www.soscleanroom.com/content/Ansell_PDF/PB6Part%20Body%20Garment%20IFU.pdf
- EU Declaration of Conformity: https://www.soscleanroom.com/content/Ansell_PDF/bioclean-c-apron-with-sleeves-sterile-s-bcas_bioclean-c%E2%84%A2-s-bcas_eu_20230512_declaration%20of%20conformity.pdf
- BioClean Garment Size Chart: https://www.soscleanroom.com/content/Ansell_PDF/BioClean%20C%20Garment%20Size%20Chart.pdf
- ISO cleanroom operations context (ISO 14644 series): https://www.iso.org/standard/88530.html
- EU GMP Annex 1 (sterile manufacturing gowning expectations): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: Jan. 13, 2026
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