Ansell BioClean-C S-BCSC Sterile Chemotherapy Protective Sleeve Covers - Class 10 / ISO 4 - 90 Pairs/Case
Ansell BioClean-C™ S-BCSC sterile sleeve covers provide additional arm and forearm protection for critical cleanroom operations and selected chemotherapy drug-handling applications. Manufactured from lightweight, low-linting CleanTough™ polyethylene and nonwoven polypropylene laminate, these protective sleeves are designed to be worn over appropriate cleanroom garments as part of a complete contamination-control and personal protective equipment program.
Each sleeve cover features ultrasonically bonded seams covered with protective tape for added barrier integrity and elasticated cuffs that support controlled positioning at the wrist and upper arm. The universal-size design accommodates a range of operators and can be integrated with facility-approved sterile glove and cleanroom garment configurations.
BioClean-C S-BCSC sleeve covers are suitable for Class 10 / ISO Class 4 and EU GMP Grade A controlled environments. They are gamma sterilized at a minimum dose of 25 kGy to a Sterility Assurance Level (SAL) of 10-6 and supplied as individually sealed sterile pairs. Each manufacturer case contains 90 pairs, equivalent to 180 individual sleeve covers.
Sterile Arm Protection Advantage: BioClean-C S-BCSC combines sterile CleanTough™ material, low particle shedding, protective taped seams, and published chemotherapy-drug permeation results. Its purpose-built design helps facilities add protection to exposed gown sleeves and forearms while maintaining controlled interfaces with sterile gloves and underlying cleanroom apparel.
Specifications:
- Manufacturer: Ansell
- Brand: BioClean-C™
- Manufacturer Part Number: S-BCSC
- Product Type: Sterile Chemotherapy Protective Sleeve Covers
- Protective Garment Format: Partial-body arm and forearm protection
- Material: CleanTough™ polyethylene / nonwoven polypropylene laminate
- Color: Blue
- Material Characteristics: Lightweight and low-linting
- Cleanroom Classification: Class 10 / ISO Class 4
- EU GMP Application: Grade A, subject to facility qualification
- Sterility: Sterile
- Sterilization Method: Gamma irradiation
- Minimum Sterilization Dose: 25 kGy
- Sterility Assurance Level: 10-6
- Seam Construction: Ultrasonically bonded seams covered with protective tape
- Cuff Style: Elasticated
- Available Size: Universal
- Particle Shedding: Less than 1,700 counts/min for particles ≥0.5 µm
- Particle Test Method: Helmke Drum Test
- Chemotherapy-Drug Permeation Testing: ASTM F739-12
- Permeation Test Threshold: 0.1 µg/cm²/min
- European PPE Classification: Category III
- Protective Clothing Standards: EN 14605:2005 + A1:2009, EN 13034:2005 + A1:2009, EN ISO 14325 and applicable protective-clothing standards within the manufacturer certification
- Seam Strength: 74 N under the manufacturer-referenced test method
- Puncture Resistance: 10 N under the manufacturer-referenced test method
- Country of Origin: China
- Inner Packaging: One pair per sealed polyethylene inner bag
- Outer Packaging: 15 inner bags per sealed polyethylene outer bag
- Case Packaging: Six sealed outer bags per lined carton
- Case Quantity: 90 pairs
- Individual Sleeve Covers per Case: 180
- Published Shelf Life: Three years from date of manufacture
- Storage: Dry conditions in original packaging, away from direct sunlight and ozone sources
- Use: Disposable protective garment
- Ordering Configuration: Universal size; case of 90 sterile pairs
About the Manufacturer:
Ansell manufactures protective gloves and garments for pharmaceutical manufacturing, biotechnology, healthcare, laboratory research, medical device production, and other critical environments. Its BioClean™ portfolio includes sterile and non-sterile cleanroom apparel, protective gloves, sleeve covers, and specialized products for contamination-sensitive manufacturing.
The BioClean-C™ protective apparel family uses CleanTough™ laminate and specialized seam construction to support controlled-environment use and protection against selected chemical hazards. BioClean-C sleeve covers are designed to supplement approved cleanroom garments where additional forearm coverage is needed.
SOSCleanroom supports customers with Ansell sterile apparel selection, protective garment documentation, chemotherapy permeation information, packaging configurations, and procurement assistance for critical manufacturing environments.
BioClean-C S-BCSC Features:
- Sterile protective sleeve covers supplied in matched pairs
- Class 10 / ISO Class 4 cleanroom compatibility
- EU GMP Grade A application suitability
- Gamma sterilized to SAL 10-6
- Minimum 25 kGy sterilization dose
- Lightweight CleanTough™ polyethylene / polypropylene laminate
- Low-linting material construction
- Ultrasonically bonded seams
- Protective tape over seams
- Elasticated cuffs for controlled arm positioning
- Universal-size configuration
- Published Helmke Drum particle-shedding results
- ASTM F739-12 chemotherapy permeation testing
- Published mechanical and liquid-resistance testing
- Designed for additional arm and forearm protection
- Individually bagged sterile pairs
- Multilayer polyethylene protective packaging
- Three-year manufacturer shelf life
- 90 pairs per case, totaling 180 sleeve covers
BioClean-C S-BCSC Benefits:
- Additional Arm Protection: Provides an outer protective layer over appropriate cleanroom sleeves during selected chemical handling and contamination-sensitive tasks.
- Sterile Presentation: Gamma sterilization and individually packaged pairs support approved sterile gowning procedures.
- Critical Cleanroom Compatibility: Developed for Class 10 / ISO 4 and EU GMP Grade A controlled environments.
- Documented Material Performance: ASTM F739-12 results help evaluate protection against the specific chemotherapy drugs tested.
- Reinforced Seams: Ultrasonically bonded, taped construction supports sleeve integrity during qualified handling activities.
- Low Particle Contribution: CleanTough™ construction and published particle testing support contamination-control programs.
- Controlled Glove Interface: Elasticated cuffs help operators position protective sleeves within the approved glove-overlap arrangement.
- Universal Fit: One-size design supports standardized material selection where fit is suitable.
- Ease of Donning: Manufacturer-designed sleeve construction and an official donning guide support repeatable gowning procedures.
- Protective Packaging: Individual sterile pairs and additional outer bags support staged transfer into controlled areas.
- Inventory Clarity: Packaging in pairs supports issuance of complete left- and right-arm protection for individual operators.
Common Applications:
- Additional sleeve protection during selected cytotoxic drug-handling procedures
- Aseptic pharmaceutical manufacturing
- Class 10 / ISO Class 4 cleanroom operations
- EU GMP Grade A controlled manufacturing activities
- Biotechnology manufacturing and laboratory processing
- Controlled material preparation and handling
- Work requiring added forearm coverage over cleanroom garments
- Approved pharmaceutical cleaning and decontamination procedures
- Activities involving compatible chemical splash exposure
- Controlled transfer and manipulation of process materials
- Cleanroom gowning systems requiring sterile sleeve supplementation
- Medical device production in contamination-sensitive environments
- Additional arm protection in qualified hazardous-drug PPE systems
Best-Practice Use:
- Confirm Protection Requirements: Review the chemical hazard assessment and facility gowning procedure before selecting sleeve covers.
- Inspect Sterile Packaging: Check both packaging layers for damage, open seals, or evidence of moisture intrusion.
- Check Product Expiration: Verify the date on the supplied manufacturer packaging.
- Transfer Appropriately: Follow the facility's controlled material-transfer procedure for removing outer packaging.
- Don Base Garments: Put on approved cleanroom clothing and other required PPE according to the gowning sequence.
- Handle the Inner Surface: During donning, avoid touching the outside of the sleeve cover.
- Position the Wrist Cuff: Establish the correct glove-to-sleeve overlap required by the facility SOP.
- Extend Over the Arm: Pull the sleeve cover upward with controlled movements until it is properly positioned.
- Check Upper-Arm Coverage: Ensure the sleeve remains secure without excessive tension or rolling.
- Repeat for the Other Arm: Maintain aseptic technique when donning the second sleeve.
- Inspect Seams: Confirm that the ultrasonically bonded seams and protective tape are intact.
- Verify Range of Motion: Move the arms through normal work positions to confirm coverage and sleeve stability.
- Avoid Uncontrolled Contact: Do not touch nonqualified work surfaces, clothing, or equipment after sterile donning.
- Change When Required: Replace sleeves after damage, contamination, or an exposure event requiring protective garment removal.
- Remove Carefully: Follow controlled doffing procedures to keep potentially contaminated exterior surfaces away from skin and clean garments.
- Dispose Properly: Follow the facility's applicable hazardous-drug and contaminated-PPE waste requirements.
Official Ansell Sleeve Cover Donning Procedure:
Ansell provides a dedicated donning guide for BioClean-C BCSC/S-BCSC sleeve covers. It emphasizes slow, controlled movements and avoiding contact with the external protective surface.
- Prepare the Gowning Area: Complete required undergarment and cleanroom attire steps before handling the sleeve covers.
- Open the Protective Packaging: Remove the sleeve covers using the approved aseptic opening method.
- Insert the Hand: Slide the hand into the half-folded sleeve until the elastic cuff reaches the fingers.
- Grip the Inner Cuff: Hold the inner surface of the elastic cuff while avoiding contact with the exterior.
- Extend the Sleeve: Unfold and pull the sleeve cover upward over the arm until fully extended.
- Repeat: Don the second sleeve using the same controlled procedure.
- Complete Glove Integration: Position compatible gloves over or with the sleeve cuffs according to the facility's approved protective configuration.
- Inspect the Final Fit: Verify that both sleeves remain correctly positioned and protective interfaces are maintained during movement.
Donning Technique: Ansell directs operators to handle the sleeve from the inner cuff surface and avoid touching the exterior while extending it over the arm. Use slow, controlled movements and follow the facility's validated gowning sequence. View the Official Ansell Sleeve Cover Donning Guide (PDF).
ASTM F739-12 Chemotherapy Permeation Performance:
Ansell's BioClean-C S-BCSC U.S. technical data sheet provides laboratory permeation results for nine chemotherapy drugs under ASTM F739-12. The published results describe the mean breakthrough time for the tested material at the specified permeation rate.
Permeation Breakthrough Criterion: 0.1 µg/cm²/min.
| Tested Chemotherapy Drug |
Mean Breakthrough Time |
| Cisplatin |
>240 minutes |
| Carmustine |
>240 minutes |
| Cyclophosphamide |
>240 minutes |
| Doxorubicin hydrochloride |
>240 minutes |
| 5-Fluorouracil |
>240 minutes |
| Methotrexate |
>240 minutes |
| Etoposide |
<6 minutes |
| Paclitaxel |
>240 minutes |
| Thiotepa |
55 minutes |
The results are from laboratory testing under defined conditions. Actual barrier performance can vary with drug formulation, chemical concentration, contact time, temperature, material condition, mechanical stress, and exposure at seams or garment interfaces.
Drug-Specific Protection Guidance: The manufacturer-reported breakthrough time is less than 6 minutes for etoposide and 55 minutes for thiotepa under the referenced ASTM F739-12 test conditions. These results require particular consideration when selecting protective sleeves for those drugs. Laboratory breakthrough times are not approved garment-wear durations, and performance against one chemotherapy drug does not establish protection against other drugs or formulations. Select PPE using the actual hazardous-drug list and documented facility risk assessment.
Sleeve-to-Glove Interface and Overlap:
The wrist and forearm interface between gloves, sleeve covers, and the underlying cleanroom garment is a critical part of protective clothing performance. S-BCSC sleeve covers provide an additional layer of material, but the complete barrier depends on how the sleeve is integrated with the gloves and base garments.
- Appropriate Gloves: Select sterile cleanroom gloves with chemical and chemotherapy-drug test documentation appropriate for the task.
- Wrist Coverage: Maintain sufficient glove overlap at the elasticated sleeve cuff.
- Upper-Arm Coverage: Ensure the opposite end of the sleeve remains positioned over the approved underlying garment.
- Double-Gloving: Follow the facility's inner- and outer-glove procedures where required for hazardous-drug work.
- Approved Gowning Tape: Use an approved sealing method where the site SOP requires taped glove-to-sleeve interfaces.
- Movement: Verify that reaching, bending, lifting, and turning do not create exposed gaps.
- Elastic Tension: Confirm the sleeve is secure without uncomfortable constriction or excessive material stretching.
- Seam Position: Avoid unnecessary pulling or abrasion against the taped sleeve seam.
- Glove Changes: Replace gloves in a way that preserves the approved sleeve interface and avoids contaminating the sleeve exterior.
- Contamination Checks: Inspect exposed interfaces after splashes, chemical handling, and other events requiring PPE assessment.
- Replacement: Remove and replace protective sleeves whenever the required barrier cannot be maintained.
Glove Interface Guidance: Protective sleeve performance depends on continuous coverage at the glove-to-sleeve and sleeve-to-coverall interfaces. Establish a consistent overlap and sealing procedure where required. Inspect the interface during normal working movements and change compromised protective items immediately.
Partial-Body Protection and PPE Selection:
S-BCSC sleeve covers are Category III partial-body protective apparel. They provide additional coverage to the arms but do not independently protect the torso, neck, head, legs, or other exposed body areas.
- Arm and Forearm Protection: S-BCSC supplements the underlying garments over the covered arm areas.
- Torso Protection: Use an appropriate apron, coverall, or other protective garment when front-body chemical exposure is possible.
- Full-Body Hazards: Select a complete protective clothing system if the hazard assessment requires full-body coverage.
- Face and Eye Protection: Add suitable eye or face protection wherever splashes could affect the face.
- Respiratory Protection: Follow the facility's respiratory protection requirements for applicable inhalation hazards.
- Hand Protection: Use gloves qualified for the chemical or hazardous-drug exposures involved.
- Material Selection: Compare the actual drug and chemical permeation results before substituting protective garment materials.
- Uncovered Interfaces: Consider contamination transfer or chemical entry at any unsealed garment junction.
- Facility Qualification: Confirm that the complete PPE combination satisfies the cleanroom and occupational protection requirements.
Protective Clothing Principle: BioClean-C S-BCSC is an arm-protection supplement, not a substitute for a chemotherapy-protective apron or full-body coverall where torso or whole-body exposure is possible. Match the complete protective clothing configuration to the tasks, drugs, exposure pathways, and applicable facility procedures.
BioClean-C Sleeve Covers vs. Sterile Apron with Sleeves:
Ansell offers BioClean-C protective sleeve covers and a separate sterile apron with integrated sleeves. Although both use protective CleanTough™ material, they provide different areas of coverage and should be selected according to the anticipated chemical exposure.
- S-BCSC Sleeve Covers: Provide supplemental arm and forearm protection over suitable underlying garments.
- S-BCAS Apron with Sleeves: Provides additional front-body and arm coverage in one integrated partial-body garment.
- Coverage Selection: Choose sleeve covers when added arm protection is the primary need and other protective garments adequately cover the remaining exposure areas.
- Front-Body Exposure: Consider the sterile apron with sleeves when the work procedure requires additional protection across the front torso.
- Drug-Specific Testing: Review the product-specific chemotherapy permeation data for the exact garment being selected.
- Seam Construction: Assess garment seams, taped joints, closures, and overlaps as part of the complete protective clothing system.
- Sterile Transfer: Follow the packaging and material-transfer procedure appropriate to the selected product.
- Layering: Confirm the selected garment fits appropriately over existing sterile coveralls, gloves, and other PPE.
- Change Procedures: Establish clear replacement criteria for contaminated sleeves, aprons, gloves, and underlying protective clothing.
Selection Guidance: Choose S-BCSC when the procedure calls for supplemental arm coverage and the rest of the PPE system provides the necessary protection. Choose S-BCAS when additional front-body and arm coverage is needed. Both products require evaluation against the actual chemical hazards, documented permeation performance, and facility protective clothing procedures.
Material and Seam Performance:
CleanTough™ is a lightweight polyethylene and nonwoven polypropylene laminate used in Ansell's protective cleanroom apparel. S-BCSC incorporates ultrasonically bonded seams with protective tape to support barrier continuity.
- Material Construction: Polyethylene / nonwoven polypropylene laminate
- Ultrasonic Seam Bonding: Supports construction without conventional stitched sleeve seams.
- Protective Seam Tape: Adds protection over the bonded seam area.
- Seam Strength: 74 N under the manufacturer-referenced test method.
- Puncture Resistance: 10 N under the reported test conditions.
- Trapezoidal Tear Resistance: 32.3 N cross direction and 50.6 N machine direction.
- Tensile Strength: 47 N cross direction and 94 N machine direction.
- Liquid Repellence: Manufacturer data include testing with sulfuric acid, sodium hydroxide, o-xylene, and butan-1-ol.
- Liquid Penetration: Manufacturer testing documents material performance against selected liquid chemicals under defined conditions.
- Material Abrasion: Avoid repeated rubbing against rough surfaces that may damage protective material.
- Seam Inspection: Replace sleeve covers if protective tape separates or the underlying material becomes damaged.
- Chemical Qualification: Evaluate the actual chemical formulation, concentration, temperature, and contact conditions.
Sterility and Cleanroom Particle Control:
BioClean-C S-BCSC provides manufacturer-documented sterilization and particulate performance characteristics for critical cleanroom applications.
- Sterilization Method: Gamma irradiation at a minimum of 25 kGy.
- Sterility Assurance Level: SAL 10-6 under the validated manufacturing sterilization process.
- Cleanroom Suitability: Class 10 / ISO 4 and EU GMP Grade A.
- Particle Shedding: Less than 1,700 counts/min for particles ≥0.5 µm.
- Testing: Manufacturer-published Helmke Drum particle-shedding test.
- Low-Linting Material: CleanTough™ construction supports contamination-controlled apparel use.
- Package Integrity: Sterile presentation requires sealed, undamaged packaging and proper handling.
- Controlled Donning: Exterior contamination can occur if the sleeve contacts unqualified surfaces during gowning.
- Operator Movement: Abrasion, repeated contact, and other work practices may affect particulate contribution.
- Single-Use Procedures: Follow the facility's approved replacement and disposal requirements.
- Process Qualification: Verify compatibility with site gowning practices and contamination-control expectations.
Cleanroom Performance Guidance: Manufacturer sterility and particle-shedding data support product qualification but do not replace controlled transfer, aseptic gowning, and ongoing contamination-control procedures. Proper sleeve positioning, glove overlap, and inspection remain necessary throughout use.
Sterile Packaging and Material Transfer:
S-BCSC sleeve covers are supplied as complete sterile pairs in multilayer polyethylene packaging. The manufacturer configuration supports controlled issuance and staged introduction into critical environments.
- Sealed Inner Bag: One sterile pair of sleeve covers.
- Sealed Outer Bag: 15 individually packaged sterile pairs.
- Case: Six outer bags per lined carton.
- Total Case Quantity: 90 sterile pairs.
- Individual Sleeve Covers: 180 per case.
- Receiving: Confirm the correct S-BCSC manufacturer code, quantity, lot identification, and expiration date.
- Outer Packaging Removal: Remove shipping packaging at the facility-approved material preparation stage.
- Controlled Transfer: Follow site procedures for handling outer polyethylene bags before introduction into higher-grade areas.
- Individual Pair Issuance: Use the sealed inner bag to issue one complete pair for an operator.
- Aseptic Opening: Avoid touching the exterior sleeve material with unqualified hands or equipment.
- Package Integrity: Reject torn, opened, wet, or otherwise compromised sterile packaging.
- Lot Traceability: Retain manufacturer identification and supporting processing documentation where required.
- Exposure After Opening: Follow the approved procedure for use or disposal of opened sterile items.
Packaging Quantity Guidance: S-BCSC is packaged and sold by the pair. One case contains 90 pairs of sleeve covers, not 90 individual sleeves. The manufacturer packaging consists of one pair per inner bag, 15 inner bags per outer bag, and six outer bags per lined case.
Hazardous-Drug Handling and Sleeve Replacement:
Chemotherapy-protective sleeve covers should be incorporated into a documented hazardous-drug PPE program. Garment selection and replacement depend on the drug, potential exposure, chemical test results, and approved work practices.
- Drug-Specific Selection: Check the reported permeation results for the actual chemotherapy substances handled.
- Etoposide Exposure: The U.S. technical data sheet reports breakthrough below 6 minutes under the stated ASTM F739-12 conditions.
- Thiotepa Exposure: The U.S. technical data sheet reports breakthrough at 55 minutes under the stated test conditions.
- Untested Drugs: Do not assume the sleeve has equivalent protection against drugs absent from the manufacturer report.
- Formulation Differences: Drug concentration, carriers, solvents, and mixtures may affect barrier performance.
- Glove Protection: Use appropriately qualified chemotherapy gloves when required by the task.
- Routine Change Procedures: Follow site-defined sleeve replacement intervals rather than laboratory breakthrough times.
- After Chemical Contact: Remove contaminated or compromised sleeves in accordance with the facility hazardous-drug SOP.
- After Damage: Replace any sleeve with tears, punctures, damaged tape, or impaired cuff retention.
- Safe Doffing: Avoid touching contaminated exterior material or spreading contamination to clean PPE.
- Waste Classification: Dispose of potentially contaminated sleeves in the designated hazardous-drug waste stream when required.
- Training: Ensure personnel understand the correct gowning sequence, glove overlap, removal technique, and replacement triggers.
Size and Fit Guidance:
Ansell manufactures S-BCSC in a universal-size configuration. Correct placement and glove integration are essential to maintaining coverage despite the single-size design.
- Manufacturer Size: Universal
- Manufacturer Part Number: S-BCSC
- Coverage: Designed to provide additional arm and forearm protection
- Elasticated Cuffs: Help position the sleeve at the wrist and upper arm
- Wrist Interface: Confirm appropriate overlap with the selected protective gloves
- Upper-Arm Interface: Confirm secure positioning over the underlying garment
- Movement Assessment: Check the fit while extending, bending, and rotating the arms
- Material Tension: Avoid excessive stretching of the protective sleeve and seams
- Fit Qualification: Ensure the universal-size configuration provides suitable coverage for the individual operator and assigned work
Packaging and Storage Recommendations:
- Inner Packaging: One sterile pair per sealed polyethylene bag
- Outer Packaging: 15 sealed inner bags per sealed polyethylene outer bag
- Shipping Carton: Six outer bags per lined case
- Case Quantity: 90 pairs
- Total Individual Sleeves: 180
- Sterility: Gamma irradiated to SAL 10-6
- Shelf Life: Three years from date of manufacture
- Expiration Control: Follow the labeled expiration date on the supplied product
- Storage Conditions: Keep dry and in original protective packaging
- Direct Sunlight: Protect from direct sunlight
- Ozone: Keep away from ozone-generating equipment and sources
- Package Inspection: Check sterile package seals before use
- Handling: Follow the appropriate gowning and material-transfer process
- Single Use: Do not reuse protective sleeves after the designated operation
- Contaminated Garments: Remove and dispose of according to the facility PPE and hazardous-drug procedures
- Packaging Waste: Segregate uncontaminated packaging from chemically contaminated waste where appropriate
Manufacturer Technical Documents:
Ansell BioClean-C S-BCSC Manufacturer Product Information: Click Here
Ansell BioClean-C S-BCSC U.S. Technical Data Sheet - Product Specifications and ASTM F739-12 Chemotherapy Results (PDF): Click Here
Ansell BioClean-C S-BCSC Manufacturer Product Data Sheet: Click Here
Official Ansell BioClean-C BCSC / S-BCSC Sleeve Donning Guide (PDF): Click Here
Ansell Instructions for Use and Regulatory Documentation: View Manufacturer Downloads
SOSCleanroom BioClean-C S-BCSC Product Information: Click Here
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Notes: Need assistance selecting sterile chemotherapy protective sleeve covers, reviewing manufacturer permeation results, or establishing the correct glove-to-sleeve interface? Open the SOSCleanroom Technical Vault tab above for additional guidance on sterile gowning, contamination-control practices, chemical protection, protective garment selection, and complete PPE systems.
SOSCleanroom.com supports pharmaceutical, biotechnology, medical device, laboratory, and other critical environments with sterile cleanroom apparel, chemotherapy protective garments, cleanroom gloves, wipers, and specialized contamination-control supplies. Our team provides manufacturer documentation, product-selection assistance, packaging information, and procurement support.
Product description updated: October 23, 2026 (SOS Technical Staff)
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