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 that is 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.
The program listing states suitability for ISO Class 5 or higher cleanrooms.
Specifications that drive receiving, SOP alignment, and gowning consistency
| Attribute |
Kimtech™ PURE* A5 Hood w/ Ties (25797) |
| Type |
Sterile hood with ties (disposable PPE) |
| Material |
100% polypropylene breathable SMS fabric |
| Cleanroom suitability |
Suitable for ISO Class 5 or higher cleanrooms (program listing) |
| Packaging |
Triple-bagged, vacuum packaged; sterility indicator included |
| Aseptic donning support |
Folded inside-out (or cuffed) to support aseptic donning |
| 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 (program listing) |
| Expiration / shelf life |
5 years from manufacture (program listing) |
ISO-first guidance: what “good gowning” means operationally
ISO cleanroom control is not just a room classification; it is an operational system. ISO cleanroom operations guidance emphasizes an operations control program that includes
personnel management, entry/exit control, training, cleaning, monitoring, and a defined gowning program. In practical terms: gowning must be standardized, taught, observed,
and periodically requalified—because uncontrolled variations in donning technique reliably become contamination excursions over time.
Donning (gowning) technique: hood-with-ties best practice
Step-by-step (adapt to your SOP)
- Pre-gown readiness: remove jewelry if required, secure hair/beard containment per SOP, and complete hand hygiene.
- Open the sterile pack correctly: use your gowning room’s aseptic opening technique; avoid contacting the outside garment surface.
- Use the inside-out/cuffed fold as intended: the manufacturer’s fold is designed to reduce 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. Secure per SOP.
- Final coverage check: confirm hair containment and minimize exposed skin at forehead/cheek areas as required by your classification and risk assessment.
Remember: if your process requires a mask/respirator, it is typically donned per SOP in the proper sequence relative to the hood (site-dependent). This hood configuration does not include a mask.
Validate your sequence, touch-points, and inspection criteria during gowning qualification and periodic reassessment.
European Annex 1 context (sterile manufacture programs)
For EU sterile medicinal product manufacture, Annex 1 reinforces that personnel are a critical contamination source and places strong emphasis on personnel training,
aseptic gowning, and periodic reassessment (including visual and microbial assessment) for personnel accessing Grade A/B environments. If you operate under Annex 1,
treat gowning as a qualified process step with documented competency—not as a “dress code.”
Common failure modes (and what to change)
- 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 across sleeves/carts/door hardware.
- 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 (compare like-for-like)
Closest alternatives are other sterile hood programs designed for ISO-controlled environments. Compare: material system (SMS vs. Tyvek-style), packaging discipline (triple-bag/vacuum),
published cleanliness data (shedding category), and how the garment supports aseptic donning.
- Sterile Tyvek-style cleanroom hoods: often selected for different chemical/particle tradeoffs; confirm documentation depth and gowning method.
- 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 and improve day-to-day gowning technique.
It is not your facility’s SOP, batch record, or validation protocol.
Customers are responsible for establishing, training, and enforcing SOPs that fit their specific risks, cleanroom classification, product type, and regulatory obligations.
Always confirm suitability, sterility requirements, acceptance criteria, and gowning sequence using your internal quality system.
If you adapt any technique guidance from this entry, treat it as a starting template. Your team should review and approve the final method, then qualify it for your specific
gowning rooms, behaviors, monitoring limits, and contamination control strategy.
Source basis (manufacturer-first)
- SOSCleanroom product page (this SKU): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-a5-sterile-cleanroom-hood-with-ties/
- Manufacturer technical data sheet (Kimtech™ PURE* A5 Sterile Cleanroom Apparel; includes 25797 listing): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/88807%20hood/KIMTECH%20PURE%20A5%20Sterile%20Cleanroom%20Apparel.pdf
- ISO cleanroom classification context (ISO 14644-1): https://www.iso.org/standard/53394.html
- ISO operations context (ISO 14644-5): https://www.iso.org/standard/88599.html
- EU GMP Annex 1 (sterile manufacture gowning/training emphasis): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
If you have any questions please email us at Sales@SOSsupply.com
Last reviewed: Jan. 14, 2026
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