Shown: Kimtech PURE A5 sterile boots (boots w/ ties). Size and code vary by option.
Practical solutions at the cleanroom floor interface
Footwear is one of the highest-frequency contamination transfer points in a cleanroom because it crosses boundaries, contacts floors, and moves continuously.
Sterile boot covers help reduce that transfer risk when used with a disciplined gowning sequence and proper change-room controls.
Kimtech PURE A5 Sterile Boots with Ties are positioned for ISO Class 5 (and cleaner) programs that want packaging discipline (triple-bagging and vacuum packaging),
sterility assurance (gamma, SAL 10-6), and repeatable donning that minimizes outer-surface contact.
What this product is used for
- Footwear barrier control for ISO Class 5+ cleanrooms and associated gowning transitions.
- Aseptic support environments where sterile footwear/overboots are required by SOP (facility- and industry-dependent).
- Change rooms/airlocks where “dirty-to-clean” movement is enforced and footwear is donned before entering higher-grade areas.
- Situations where slip/trip risk and “tie control” are important (boots with ties allow closure tension control).
Why customers consider this product
- Sterility assurance: gamma irradiated with SAL 10-6 (documentation-supported sterile program).
- Packaging discipline: triple-bagged and vacuum packaged; individually packed pairs support cleaner handling.
- ISO Class 5+ suitability: manufacturer positions the A5 sterile apparel line for ISO Class 5 or higher cleanrooms.
- Low-lint control: fabric cleanliness basis includes Helmke Drum Category 1 (IEST method basis).
- Fit control: ties help stabilize the boot cover and reduce slippage that can create both contamination and safety risks.
Materials and build (manufacturer basis)
Kimtech A5 sterile boots use breathable SMS (100% polypropylene) as the base garment material and are described with a vinyl sole and serged seams in the A5 sterile apparel technical data sheet.
For tie versions, closure stability is achieved using long ties that must be controlled during donning to avoid floor contact.
In cleanroom terms, the “build” objective is not ruggedization for outdoor wear—it is reducing particle shedding and preventing cross-boundary transfer while maintaining worker comfort and movement.
The garment must be donned without contacting the outside surfaces, and it must remain stable during walking to minimize pumping and rubbing that can liberate particles.
Specifications in context (receiving, SOP alignment, and stocking)
| Attribute |
Kimtech PURE A5 Sterile Boots w/ Ties |
| Codes / sizes |
12922 (SM/MD) | 12920 (XL/2XL) | 88808 (Universal)
|
| Case pack |
100 pairs per case |
| Material |
100% polypropylene breathable SMS (manufacturer attribute) |
| Sterility method |
Gamma irradiated; SAL 10-6 |
| Packaging |
Triple-bagged and vacuum packaged; sterility indicator (manufacturer attribute) |
| Cleanroom suitability |
Suited for ISO Class 5 or higher cleanrooms (manufacturer attribute) |
| Expiration dating |
5 years (manufacturer attribute) |
Performance and cleanliness considerations
For cleanroom footwear covers, “performance” is mostly about contamination control and stability:
controlling shedding, preventing floor transfer, and maintaining a closed interface with coveralls or lower-leg garments.
The biggest performance variable is almost always donning technique, not the catalog spec.
If tie ends contact the floor, or if the outer surface is touched during donning, the footwear barrier can become the contamination source.
A structured gowning sequence and a properly designed change room (dirty-to-clean progression) are what convert a sterile boot cover into real process protection.
Packaging, sterility, traceability (what QA cares about)
Kimtech positions the A5 sterile apparel program with triple-bagging and vacuum packaging, including a sterility indicator.
For sterile programs, receiving typically verifies packaging integrity, confirms expiry, and confirms the correct code/size is stocked for the gowning area.
If your quality system requires certificates (e.g., Certificate of Conformance and Certificate of Irradiation), Kimtech references certificate availability online for the A5 sterile program.
Treat certificates as receiving requirements and qualify them before initial use in critical areas.
Best-practice donning (ISO context first, then EU GMP Annex 1)
ISO cleanroom context (baseline)
- ISO Class matters: ISO 14644 cleanroom classes define allowable airborne particle concentrations; ISO Class 5 is a high-cleanliness environment where personnel controls strongly affect performance.
- Gowning is a contamination-control system: footwear covers work only when paired with controlled entry, correct donning, and boundary discipline (dirty-to-clean flow).
- Technique focus: avoid outer-surface contact, keep ties off the floor, and move donned footwear onto the clean-side surface immediately.
EU GMP Annex 1 (more prescriptive aseptic expectations)
- Sterile areas (Grade A/B support): Annex 1 expects aseptic gowning qualification and describes sterilized footwear such as over-boots as part of typical Grade B clothing (supporting Grade A operations).
- Interface control: trouser legs are typically tucked inside the footwear, and garments should be packed/folded to allow donning without contacting the outside or touching the floor.
- Behavioral control: gowning compliance is confirmed via assessment and periodic reassessment (visual and microbial in Annex 1 programs).
Practical donning sequence (boots with ties)
- Inspect the pack: confirm integrity and vacuum seal (where used). Open at the notches; avoid tearing into the product.
- Extract by the cuff: handle only the inside presentation areas during donning. Avoid touching the outside surface.
- Control the ties: keep tie ends elevated so they never contact the floor. If a tie touches the floor, treat as contaminated per SOP.
- Don one boot, then step to clean side: place the donned foot onto the clean-side bench/mat surface before donning the second boot.
- Tie for stability: secure at the ankle/calf so the boot does not slip and does not pump against the leg during walking.
- Close the interface: align coverall legs/garments per your SOP (often legs tucked into the boot/overboot in aseptic programs).
These steps are technique guidance intended to reduce contamination risk. Your facility’s SOP governs the official sequence, acceptance criteria, and qualification.
Common failure modes (what to watch for)
- Tie ends hit the floor: frequent root cause of “sterile item becomes contaminated during donning.”
- Outer surface touched: handling the outside of the boot transfers skin/glove contamination onto the barrier.
- Slip/trip due to loose tying: safety event + increased contamination from rubbing/pumping.
- Boundary discipline gaps: donned footwear placed back onto dirty-side surfaces or walked backward across boundaries.
Closest alternatives
Alternatives are typically other sterile cleanroom overboots/boot covers positioned for ISO Class 5+ programs.
Compare sterility method, packaging discipline (triple-bag/vacuum), sizing/fit stability, and certificate availability—not just price.
- Kimtech PURE A5 Boots with Grasp Ties: selection preference when grasp-tie handling reduces tie-floor contact risk in your gowning flow.
- Sterile overboots from other cleanroom brands (e.g., BioClean/Ansell lines): compare documentation sets and interface requirements with your SOP.
- Non-sterile boot covers: appropriate only when your program does not require sterile packaging/sterility documentation for the area and process.
Critical environment fit
Kimtech PURE A5 sterile boots are typically selected when a site wants a standardized sterile footwear barrier for ISO Class 5+ cleanrooms and where packaging discipline and expiry dating support controlled entry.
They are most effective when the change room is designed for dirty-to-clean progression and when operators are trained to don without contacting outside surfaces or allowing ties to touch the floor.
SOSCleanroom note about SOPs
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 appropriate to their cleanroom classification, products, equipment, and regulatory obligations.
Always confirm garment compatibility, sterility needs, certificate requirements, and acceptance criteria using your internal quality system.
If you adapt 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 facility’s risks and controls.
Source basis (manufacturer-first)
- SOSCleanroom product page (this SKU family): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-pure-a5-sterile-cleanroom-boots-w-ties/
- Kimtech Scientific Products Catalog (PDF): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/Kimtech_scientific_products_2022_catalog.pdf
- Kimtech A5 Sterile Accessories Brochure (PDF): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/A5%20Sterile%20Accessories%20Brochure.pdf
- Kimtech A5 Sterile Cleanroom Apparel TDS (boots w/ ties codes, packaging attributes) (PDF): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/A5%20Cleanroom%20Sterile%20Apparel%20TDS.pdf
- Kimtech A5 Sterile Boot Covers Sell Sheet (PDF): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Boot%20Covers/A5%20Sterile%20Boot%20Covers%20sell%20sheet.pdf
- Kimtech Boot Cover Donning Poster (PDF): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Boot%20Covers/A5%20Boot%20Cover%20Donning%20Poster.pdf
- ISO cleanroom classification context (ISO 14644-1): https://www.iso.org/standard/53394.html
- EU GMP Annex 1 (aseptic gowning expectations context): 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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