SKU shown: S-BDFC (sterile coverall with hood and integrated boots).
Why gowning is the control point (ISO context first)
In most cleanrooms, people are the dominant contamination source. Movement, clothing friction, exposed hair/skin, and poor gowning technique can add particles and (in aseptic operations) microbial risk to the environment.
ISO cleanroom classification (ISO 14644-1) defines cleanliness by airborne particle concentration, but maintaining that state depends on operational discipline.
ISO 14644-5 focuses on operations control: personnel practices, entry/exit behavior, cleaning, maintenance, and monitoring programs that keep the cleanroom within its specified limits.
S-BDFC is built to support those operational goals when the garment is donned correctly and handled consistently.
What S-BDFC is (manufacturer-defined)
BioClean-D™ S-BDFC is a sterile cleanroom coverall with hood and integrated boots made on CleanTough™ material, positioned for ISO Class 4 (Class 10) and EU GMP Grade A/B sterile cleanrooms.
The PDS highlights low-linting behavior, antistatic performance characteristics, and a secure-fit design: elasticated hood/back/cuffs/ankles, thumb loops, and a front zipper with protective flap.
Sterility, packaging, and traceability
- Sterilization method: gamma irradiation (minimum 25 kGy), with manufacturer stated SAL 10-6.
- Packaging configuration: 1 piece aseptically folded per sealed inner PE bag; inner bag inside sealed outer PE bag; 20 outer bags per lined carton (20 pieces). Sizes 3XL & 4XL: 15 pieces per carton.
- Shelf life: three (3) years from date of manufacture (expiry date shown on packaging).
Key performance signals (what to look at in the PDS)
For cleanroom garments, “performance” should be treated as measurable signals rather than marketing language. Below are manufacturer-published signals that commonly matter in qualification:
| Signal |
What it means in practice |
Manufacturer basis |
| Cleanroom class suitability |
Indicates intended use in ISO Class 4 operations and sterile cleanrooms (fit must still align to your SOP and risk controls). |
Class 10 / ISO Class 4 & EU GMP Grade A/B (PDS) |
| Sterility assurance |
Supports sterile-area entry controls and aseptic workflow gowning (with correct donning technique). |
Gamma (min 25 kGy) & SAL 10-6 (PDS) |
| Particle shedding |
A screening indicator for garment contribution to airborne particles (handling and movement still dominate outcomes). |
Helmke Drum: ≥0.5 µm <2000 counts/min (PDS) |
| Secure-fit interfaces |
Reduces gaps and “pumping” at cuffs/ankles/hood during movement; helps keep skin/clothing covered. |
Elasticated hood/back/cuffs/ankles; thumb loops; protective flap (PDS/Donning Guide) |
Donning (gowning) education: ISO-driven principles
Before the step-by-step, anchor on ISO-style operational logic: the gowning area is a contamination control barrier.
Your goal is to reduce particle generation and prevent transfer to the garment exterior. The most consistent programs enforce:
- Slow, controlled movement: fast motion increases shedding and turbulence.
- No talking/coughing/sneezing in gowning: reduces droplet and microbe risk (especially for aseptic areas).
- Touch only interior surfaces during donning: keep the exterior “clean side” clean.
- Control glove interfaces: disinfect gloves as required and avoid re-touching non-controlled surfaces once gowned.
Manufacturer donning sequence (S-BDFC)
Practical donning flow (summarized from Ansell S-BDFC donning guide)
- Confirm pre-gowning state per site protocol (undergarments, hair cover, and cleanroom footwear already donned before entering changing room).
- Wash hands, wrists, and fingers. Movements stay slow and controlled; avoid talking in the donning area.
- Remove coverall from packaging while maintaining aseptic handling. Garment is presented unzipped and inverted at the waist to ease aseptic donning.
- While holding the interior surface, insert each leg into the trousers one-by-one (rolling the coverall can improve grip).
- Insert arms into sleeves (shirt-style) while avoiding contact with the exterior surface; raise hands above head to fully stretch the coverall.
- Aseptically don sterile cleanroom gloves (do not touch glove exterior with bare hands) and disinfect gloves after each donning procedure, as required by your SOP.
- Don the hood using interior handling (hands inside hood; bring up and over head).
- Zip fully, then seal the zipper flap (remove backing liner and adhere flap over zippe
