In high-grade cleanrooms, people are a dominant contamination source: particles and fibers from skin, hair, clothing, and movement. A coverall is not just “PPE” — it is a core contamination-control barrier intended to reduce shedding, limit exposed surfaces, and stabilize day-to-day behavior in the gowning program. S-BDCHT is positioned for sterile operations where consistency, packaging discipline, and documented sterility matter as much as comfort.

• Sterile change-room gowning for EU GMP Grade A/B and ISO Class 4 cleanrooms.
• Aseptic processing, sterile manufacturing, and critical interventions where sterile garments are required by SOP/CCS.
• Controlled environments seeking a disposable, low-linting, antistatic coverall platform with published test basis.
• Programs that need double-bagged sterile packaging and a defined shelf life for receiving and audit readiness.

• Sterile and documented: gamma irradiated (25 kGy) with SAL 10^-6 and defined shelf life to support sterile gowning programs.
• Interface control features: thumb loops and elasticated hood/cuffs/ankles help reduce exposed gaps as operators move.
• Reduced leakage pathways: zip with sealable cover plus a protective flap is designed to help reduce seam/closure leakage risks.
• Low-linting + antistatic platform: CleanTough™ material and published test basis support controlled-environment use.
• Cleanroom-ready packaging: double-bag sterile presentation supports controlled entry and staged gowning workflows.

The BioClean-D™ CleanTough™ fabric is a laminate with a polyethylene film outer layer and a non-woven polypropylene inner layer, published at 60 gsm. The garment is described with bound seams with single needle stitching and a closure design that includes a zip with sealable cover plus a protective flap.

Fit and retention features include an elasticated hood, back, cuffs, and ankles plus thumb loops. In practice, these features aim to stabilize coverage and reduce sleeve ride-up at the glove interface — a common weak point in gowning discipline.

The table below consolidates manufacturer-published attributes most relevant to cleanroom receiving, gowning SOP alignment, and sterile entry discipline.

Attribute	S-BDCHT (Sterile)
Product	BioClean-D™ Coverall with Hood — Sterile
Material	CleanTough™ (PE film outer / PP non-woven inner)
Cleanroom class	Class 10 / ISO Class 4; EU GMP Grade A/B
Sterilization / sterility assurance	Gamma irradiation (25 kGy minimum dose); SAL 10-6
Packaging (sterile)	1 per sealed inner PE bag; inner bag in sealed outer PE bag; 20 per lined carton (some sizes 15/carton)
Shelf life	Three (3) years from date of manufacture
Country of origin	China
Construction	Bound seams with single needle stitching
Coverage/fit features	Elasticated hood/back/cuffs/ankles; thumb loops; zip with sealable cover; protective flap

For cleanrooms, two garment behaviors drive outcomes: (1) how much it sheds when the operator moves, and (2) how well it maintains coverage at interfaces (hood/neck, wrists/gloves, ankles/footwear, and zipper/closure). Manufacturer-published test basis for the platform includes a Helmke Drum particle shedding result of < 2000 counts/min (≥ 0.5 µm) and static-dissipative performance with a published charge half decay time of 0.07 seconds.

Sterile garments only remain “sterile” if packaging and handling discipline stay intact. For S-BDCHT, the sterile presentation is one piece per sealed inner PE bag, with that inner bag sealed inside an outer PE bag. At receiving and prior to gowning, visually confirm that packaging is intact and that the garment is within shelf life. Treat any compromised package as nonconforming per your quality system.

For sterile change-room workflows, double-bag packaging supports staged opening: remove the outer bag in a lower-grade step, then introduce the inner sterile bag to the higher-grade gowning stage per SOP.

Manufacturer handling note (always applicable): follow the published IFU for closure sealing and removal technique. IFU guidance for the platform includes fully zipping, locking the zipper, sealing the zip cover, and removing garments carefully (often turning inside-out) to trap contamination.

• Exposed zipper/closure: always seal the zip cover fully; do not enter higher-grade space with a partially covered closure.
• Sleeve ride-up at gloves: use thumb loops and verify glove overlap; apply taping only per SOP.
• Hood gaps/hair exposure: confirm hood fit before final entry; avoid adjusting hood once gloved in higher-grade areas.
• Touching exterior surfaces: don from interior contact points and avoid “patting down” the garment in the clean zone.
• Compromised sterile packaging: treat damaged bags as nonconforming; do not “use anyway.”

Comparable products are other sterile, low-linting coveralls with hood intended for ISO 4 / Grade A/B programs. When comparing, prioritize: sterility method + SAL, double-bag discipline, particle shedding basis, static performance, interface control features, size availability, and documentation sets (PDS/IFU/DoC).

S-BDCHT is best suited for sterile environments where the gowning program is treated as an operational control — with staged entry, trained operators, documented garment handling, and routine integrity checks. If your cleanroom classification, risk profile, and CCS require sterile garments with double-bag entry and published test basis, S-BDCHT aligns well with those expectations.