Ansell S-BDSC-L BioClean-D Sterile Sleeve Covers — Class 10 (ISO 4) / EU GMP Grade A (90 Pairs/Case)

Ansell BioClean-D™ Sterile Sleeve Covers (S-BDSC-L) are single-use, sterile cleanroom sleeve covers designed to reduce operator-borne contamination risk at the arm-to-wrist zone. Manufactured from low-linting, antistatic CleanTough™ material with elasticated openings for a secure fit, these sleeves support consistent gowning where ISO Class 4 (Class 10) / EU GMP Grade A environments require disciplined personnel controls. Each pair is gamma irradiated (minimum dose 25 kGy) to a sterility assurance level (SAL) of 10^-6 and packaged for controlled entry (90 pairs per case).

Cleanroom use note: Sleeve covers help reduce exposed-sleeve risk and help stabilize glove-to-garment interfaces, but results depend on your gowning SOP, operator technique, and change frequency.

Specifications:

SKU / Part number: S-BDSC-L
Product type: Sterile, single-use sleeve covers
Material: CleanTough™
Fit: Elasticated openings for a firm fit
Length / size: Universal, long length (minimum 480 mm)
Construction: Bound seams with single needle stitching
Cleanroom classification positioning: Class 10 / ISO 4 & EU GMP Grade A
Sterilization method: Gamma irradiation
Sterilization minimum dose: 25 kGy
Sterility assurance level: 10^-6
ESD / antistatic note: CleanTough™ is described as static dissipative; charge half decay time 0.07 sec
Particle shedding (Helmke Drum Test): ≥ 0.5 µm (counts/min) < 260
Packaging overview: 1 pair per sealed inner PE bag; 15 inner bags per sealed outer PE bag; 6 outer bags per lined carton (90 pairs)
Shelf life: Three (3) years from date of manufacture
Country of origin: Sri Lanka (per manufacturer PDS)
Compliance context (selected): Category III PPE; EN 1149-5:2008; EN ISO 13688:2013; EN 13034:2005 + A1:2009 (see manufacturer documents)

About the Manufacturer:

BioClean-D™ garments and accessories are part of Ansell’s controlled-environment PPE portfolio. For ISO-classified cleanrooms and EU GMP sterile operations, these sleeves are positioned as a practical control for the high-shedding, high-contact arm interface—especially when your workflow requires consistent glove-to-sleeve overlap and reduced exposed garment risk.

SOSCleanroom supports contamination-control programs with dependable supply and product documentation so QA, receiving, and gowning teams can standardize how critical PPE is introduced, stored, and used.

Key Features (S-BDSC-L):

Low-linting, antistatic CleanTough™ sleeve covers designed for quick, simple donning
Elasticated openings to help maintain a stable fit during movement
Universal long length (minimum 480 mm) for extended forearm coverage
Gamma irradiated (minimum 25 kGy) for sterile use; SAL 10^-6
Packaging designed for controlled entry: 90 pairs/case with multiple bag layers

Benefits for Cleanroom Operations:

Stabilizes the wrist interface: Helps reduce exposed-sleeve risk and supports consistent glove overlap when paired with your gowning SOP.
Reduces variability across shifts: Standard sleeve format and packaging help minimize ad-hoc solutions at the gowning boundary.
Supports ESD-sensitive areas: CleanTough™ is described as static dissipative, supporting static-safe environments when grounded per site practice.
Audit-ready documentation: Sterility, packaging, and conformance documents are available from manufacturer sources.

Common Applications:

ISO-classified cleanrooms where personnel controls are required to protect the process and product
EU GMP sterile operations (Grade A) where gowning discipline and behavior reduce contamination risk
High-contact workflows (aseptic staging, handling, component prep) where sleeve-to-glove integrity matters
Static-sensitive environments where static dissipative garments are part of the control strategy

Best-Practice Donning Notes (to minimize contamination):

Don in a controlled sequence: Apply sleeve covers after your base gown/coverall is on and positioned correctly, and before final outer glove sealing (site-dependent).
Touch control: Handle sleeve covers deliberately to avoid contacting the outside surface more than necessary.
Seal the interface: Ensure the wrist opening sits flat and stable. Many aseptic SOPs require the outer glove cuff to overlap the sleeve opening to reduce gaps; tape usage is SOP-dependent.
Movement discipline: Slow, deliberate motions reduce particle generation and help maintain sleeve placement.
Single-use means single-use: Do not reuse. Remove carefully to contain contamination and dispose per your facility program.

SOP reminder: This guidance is educational. Your facility is responsible for defining and validating the final gowning method, glove interface approach, and change frequency for your specific risks and cleanroom grade.

Manufacturer Documentation:

Product Data Sheet (PDS): Click Here
EU Declaration of Conformity (DoC): Click Here
IFU (Instructions for Use — BioClean single-use Type 5/6 garment family): Click Here

Other Similar Products Available From SOSCleanroom.com

Complementary BioClean Garments & Accessories

S-BDOB-L: BioClean-D sterile longer-length overboots (Class 10 / ISO 4)
BDFC: BioClean-D non-sterile coverall with hood and integrated boots
S-BCAS: BioClean-C sterile apron with sleeves (Class 10 / ISO 4)
BCDA: BioClean-C apron

Notes: Need help selecting sterile sleeve covers vs. chemotherapy-rated sleeves, or building a complete ISO/Annex 1 gowning kit (hood, mask, coverall, overboots, gloves, sleeve interfaces)? Contact SOSCleanroom for practical selection guidance grounded in real cleanroom routines.

SOSCleanroom.com supports contamination-control programs with dependable supply, fair pricing, and responsive support.

Product page updated: Jan. 14, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault

By SOSCleanroom

Sterile Sleeve Covers CleanTough™ (Low-Linting) Universal Length ≥ 480 mm ESD Half Decay: 0.07 sec ISO 4 / Class 10 EU GMP Grade A Gamma 25 kGy • SAL 10^-6 90 Pairs/Case

Ansell BioClean-D™ S-BDSC-L: sterile sleeve covers engineered to control the arm interface and reduce operator-borne contamination variables

SKU shown: S-BDSC-L (BioClean-D™ sterile sleeve covers; universal long length).

Why sleeve covers matter in real cleanrooms

In contamination control, sleeves are a frequent failure point: forearms cross over work, cuffs shift during movement, and glove interfaces can open micro-gaps. Sleeve covers are a targeted control for that specific risk. Ansell positions BioClean-D™ S-BDSC-L as sterile, low-linting, antistatic sleeve covers with elasticated openings to help maintain a stable fit, supporting consistent technique in ISO-classified and EU GMP sterile environments.

Standards context (ISO first, then EU Annex 1)

ISO perspective

ISO 14644-1: defines cleanroom air cleanliness classification (where "ISO Class 4" sits in the ISO framework).
ISO 14644-5: addresses cleanroom operations including clothing/gowning programs, training, and behaviors that protect the environment.
In ISO 4, risk shifts toward "people contamination," making gowning interfaces (wrists, ankles, neck) disproportionately important.

EU GMP Annex 1 perspective

Annex 1 emphasizes personnel practices, training, and gowning discipline as part of contamination control in sterile manufacturing. Sleeve covers are one control in a larger system that includes aseptic technique, qualified gowning, and documented behavior expectations.

What S-BDSC-L is (per manufacturer PDS)

Material: CleanTough™ (antistatic, lightweight, low-linting).
Fit: elasticated openings for a firm fit.
Size: universal; long length minimum 480 mm.
Construction: bound seams with single needle stitching.
Sterile positioning: gamma irradiation (minimum 25 kGy) to SAL 10^-6.
Cleanroom positioning: Class 10 / ISO 4 & EU GMP Grade A.

How to don sleeve covers to minimize contamination

Prepare: Ensure base garment sleeves are positioned correctly. Perform glove sanitization if your SOP requires it before handling sterile accessories.
Open cleanly: Open inner packaging carefully to avoid generating particles.
Don deliberately: Slide the sleeve cover on slowly. Avoid snapping elastic, which can generate particles.
Seat both ends: Confirm upper and wrist elastic openings sit flat and stable (no rolling).
Seal the wrist interface: Many aseptic programs require the outer glove cuff to overlap and "capture" the sleeve opening. Tape use is site-dependent and must follow your validated method.
Final check: Inspect for tears/punctures and re-sanitize gloves if required after gowning contact steps.

In ISO 4 / Grade A thinking, your best garment is only as good as the operator technique used to put it on. Slow motions, controlled touches, and a consistently sealed glove interface are the difference between "wearing PPE" and "using PPE correctly."

Specifications in context

Attribute	S-BDSC-L
Material	CleanTough™
Size / length	Universal; long length minimum 480 mm
Construction	Bound seams with single needle stitching
Cleanroom positioning	Class 10 / ISO 4 & EU GMP Grade A
Sterilization / SAL	Gamma irradiation; minimum 25 kGy; SAL 10^-6
ESD characteristic	Static dissipative; charge half decay time 0.07 sec
Particle shedding (Helmke Drum)	≥ 0.5 µm (counts/min) < 260
Packaging	1 pair/inner bag; 15 inner/outer bag; 6 outer/carton (90 pairs)
Shelf life	Three (3) years from date of manufacture
Country of origin	Sri Lanka (confirm on label/CoC for your receiving file)

Common failure modes

Glove interface gap: ensure consistent overlap and a stable wrist seal per SOP.
Elastic "snap" donning: fast motions generate particles; don slowly and deliberately.
Cross-touching the outside surface: minimize external contact during donning; treat outer surfaces as critical.
Reuse: single-use items must not be reused; remove carefully and dispose per your contamination-control program.

ESD and safety considerations

If your environment is static-sensitive or if flammables are present, follow ESD grounding rules and safety engineering guidance. Treat ESD as a system: garment + footwear + flooring + grounding + behavior.

Documentation: what QA/receiving typically files

Product Data Sheet (PDS): technical attributes, packaging, test references, cleanroom positioning.
Declaration of Conformity (DoC): EU PPE regulation conformity and referenced harmonized standards.
IFU / Instructions: storage, disposal, warnings, and use limitations.

Manufacturer documents

SOSCleanroom note about SOPs

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.

If you adapt technique guidance from this entry, treat it as a starting template. Review, approve, and qualify the final method for your specific interfaces, acceptance criteria, and risk profile.

Source basis