Shown: sterile hood with ties (manufacturer code 25797). Hood does NOT include a mask.
Why head/neck containment matters in contamination control
In most cleanrooms, the operator is the largest contamination source. Hair, skin flakes, and clothing fibers can become airborne and migrate with airflow. A sterile hood helps manage this risk by containing hair and reducing exposed skin around the head/neck interface—an area frequently challenged during movement, line-of-sight adjustments, and repeated entry/exit.
What this product is (manufacturer-defined)
Kimtech™ PURE* A5 sterile cleanroom hoods with ties are disposable sterile hoods made from 100% polypropylene breathable SMS fabric. The manufacturer describes them as triple-bagged and vacuum packaged with a sterility indicator, and folded inside-out (or cuffed) to support aseptic donning technique. Suitable for ISO Class 5 or higher cleanrooms.
Specifications
| Attribute |
25797 |
| Type | Sterile hood with ties (disposable PPE) |
| Material | 100% polypropylene breathable SMS fabric |
| Cleanroom suitability | ISO Class 5 or higher |
| Packaging | Triple-bagged, vacuum packaged; sterility indicator included |
| Aseptic donning support | Folded inside-out (or cuffed) |
| Sterilization / SAL | Gamma irradiated; SAL 10-6 (ANSI/AAMI/ISO 11137) |
| BFE (3.0 µm) | 97% (ASTM F2100) |
| PFE (0.5 µm) | 94% (ASTM F2299) |
| Particle shedding | Helmke Drum Category 1 (IEST-RP-CC003.3) |
| Case pack | 100 hoods / case (universal size) |
| Material restrictions | No silicone, no latex, no BHT preservative |
| Shelf life | 5 years from manufacture |
ISO-first guidance: what "good gowning" means operationally
ISO cleanroom control is an operational system. Gowning must be standardized, taught, observed, and periodically requalified—because uncontrolled variations in donning technique reliably become contamination excursions over time.
Donning technique: hood-with-ties best practice
- Pre-gown readiness: remove jewelry if required, secure hair/beard containment per SOP, complete hand hygiene.
- Open the sterile pack correctly: use aseptic opening technique; avoid contacting the outside garment surface.
- Use the inside-out/cuffed fold as intended: reduces handling of the outside surface during donning.
- Don smoothly (no snapping): insert head without abrupt movements; keep the hood away from floors, benches, and unclassified surfaces.
- Tie without cross-contamination: keep tie ends controlled; do not allow ties to drag across sleeves, carts, or door handles.
- Final coverage check: confirm hair containment and minimize exposed skin at forehead/cheek areas per your risk assessment.
This hood configuration does not include a mask. Validate your sequence, touch-points, and inspection criteria during gowning qualification and periodic reassessment.
EU GMP Annex 1 context
Annex 1 reinforces that personnel are a critical contamination source and places strong emphasis on personnel training, aseptic gowning, and periodic reassessment for Grade A/B access. Treat gowning as a qualified process step with documented competency—not as a "dress code."
Common failure modes
- Touching the outside surface during donning: retrain to use the inside-out/cuffed fold as the primary handling surface.
- Tie ends contacting dirty surfaces: control tie ends and secure without dragging.
- Exposed hair/skin near the face opening: add a defined "coverage check" step before entering higher-grade areas.
- Re-use or adjusting after entry: treat adjustments as a contamination event; re-gown when required by SOP.
Closest alternatives
- Sterile Tyvek-style cleanroom hoods: confirm documentation depth and gowning method before substituting.
- Other sterile SMS hood systems: validate particle shedding data, packaging, and training fit for your entry sequence.
SOSCleanroom note about SOP's
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 gowning rooms, behaviors, monitoring limits, and contamination control strategy.
Source basis
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: May 1, 2026
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