Many contamination events do not start at “the product.” They start at interfaces: wrists, forearms, and glove overlaps that touch carts, bins, doors, sleeves, and pass-through surfaces. Sleeve covers exist to reduce that transfer risk, but only if the sleeve/glove interface is controlled and the donning technique is consistent across operators and shifts.

BioClean-C™ S-BCSC is a sterile sleeve cover designed for cleanroom and life-science environments, manufactured from CleanTough™ material and constructed with ultrasonically bonded seams covered with protective tape. It is packaged to help reduce cross-contamination risk and sterilized using gamma irradiation to achieve a minimum sterility assurance level (SAL) of 10^-6.

“Chemo rated” is not a generic promise. It is a test basis. S-BCSC is tested to ASTM F739 and publishes minimum breakthrough time (MBT) results for a defined set of chemotherapy drugs. Breakthrough performance can differ dramatically across drugs, concentrations, and exposure conditions.

Drug (ASTM F739 test set)	Minimum Breakthrough Time (MBT)	Selection implication
Cisplatin	> 240 minutes	Strong barrier basis for this drug under the test conditions.
Cyclophosphamide	> 240 minutes	Strong barrier basis for this drug under the test conditions.
5-Fluorouracil	> 240 minutes	Strong barrier basis for this drug under the test conditions.
Etoposide	< 6 minutes	High-risk mismatch if your workflow includes Etoposide exposure at comparable conditions; consult your safety program.
Thiotepa	55 minutes	Moderate barrier basis; confirm exposure duration and controls.

For cleanrooms, sleeve covers are evaluated as much for what they do not add as what they block. S-BCSC publishes low particle shedding (Helmke Drum) and is supplied sterile (gamma irradiated; SAL 10^-6) for programs that require sterile sleeve coverage in critical zones.

Attribute	Published value / statement	Why it matters
Particle shedding (Helmke Drum)	≥ 0.5 µm (counts/min) < 1700	Lower shedding supports cleaner forearm motion near critical work.
Sterilization / SAL	Gamma irradiated; minimum SAL 10-6	Supports sterile-area entry where sterile garments are required.
Cleanroom positioning	Class 10 / ISO 4; EU GMP Grade A	Aligns with high-criticality zones when paired with correct gowning behaviors.

ISO cleanroom classification describes air cleanliness performance, but the day-to-day outcome depends on operational control. ISO 14644-5 (Operations) places emphasis on the cleanroom operations program, which includes personnel controls and gowning discipline. In practice: garments help, but consistent donning behavior is what prevents sleeves and wrists from becoming contamination-transfer tools.

If your program aligns to EU GMP Annex 1 (sterile medicinal products), the focus on personnel and gowning becomes even more explicit: Annex 1 calls for aseptic gowning training, gowning qualification, and periodic reassessment for Grade A/B access, including monitoring of locations such as gloved fingers and forearms. Sleeve covers directly affect those forearm interfaces when used correctly.

Removal/disposal discipline matters as much as donning. Remove carefully and turn inside out to trap contamination, then dispose per your facility waste stream and regulations (especially relevant for chemotherapy-handling environments).

• Glove/sleeve gap: exposed knit cuffs or gown sleeves at the wrist become a contamination-transfer source.
• Untaped joins (when required by SOP): liquid pathways and seam exposure can defeat the intended barrier system.
• Forearm contact with carts/doors: sleeves pick up contaminants and redeposit them at benches and pass-through staging.
• Improper doffing: pulling sleeves off “outside-in” spreads contamination to hands and gown surfaces.

Compare alternatives by the published chemo permeation test set (drug list + MBT values), sterility method (and SAL), seam construction, and the cleanroom performance basis (e.g., particle shedding method). “Chemo-rated” should never be treated as an interchangeable label.