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Kimtech Pure A5 Sterile Cleanroom Coveralls

Kimberly-Clark Kimtech Pure A5 Sterile Cleanroom Coveralls

$548.91 - $840.77
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SKU:
Kimtech 8880x
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Quantity Option (Case):
25 Coveralls

KIMTECH PURE* A5 Sterile Cleanroom Coveralls (25/Case) — CLEAN-DON* Technology for ISO Class 5+ gowning workflows

KIMTECH PURE* A5 Sterile Cleanroom Coveralls are single-use, sterile coveralls engineered to reduce contamination risk during donning and throughout critical-area work. The coverall is constructed from breathable SMS (Spunbond Meltblown Spunbond) polypropylene and is positioned by the manufacturer for ISO Class 5 or higher cleanrooms. Each garment is supplied triple-bagged, vacuum packaged, includes a sterility indicator, and is labeled with an expiration date (5-year shelf life). CLEAN-DON* Technology is designed to help operators avoid touching the outside of the garment and to minimize contact with the floor during gowning.

Receiving / QA note: Manufacturer documentation for this sterile apparel family includes Certificates of Compliance and Certificates of Irradiation available via the manufacturer’s online documentation portal (referenced by the manufacturer for this sterile apparel program). Confirm requirements against your internal SOP and receiving checklist before qualification.

Specifications:
  • Product type: Sterile cleanroom coverall (single-use)
  • Fabric: 100% polypropylene breathable SMS (Spunbond Meltblown Spunbond)
  • Recommended environment: ISO Class 5 or higher cleanroom applications (manufacturer positioning)
  • Technology: CLEAN-DON* Technology (inside-out fold + visual handling cue; reduces outside-touch and floor-contact risk during gowning)
  • Design elements (manufacturer-stated): Bound seams; REFLEX* design; tunneled elastic waist; elastic wrists/ankles; built-in thumb loops; zipper closure with flap
  • Packaging: Triple-bagged; vacuum packaged; includes sterility indicator
  • Sterility / shelf life: Sterile; expiration date shown; 5-year shelf life (manufacturer stated)
  • Case pack: 25 coveralls per case
  • Compliance (manufacturer-stated): CE Category III — Type 5/6 (as listed by manufacturer for this apparel family)
  • Documentation: Manufacturer references online access to Certificates of Compliance and Certificates of Irradiation for sterile apparel program
  • Size selection: Use the manufacturer size guide for fit selection before qualification
About the Manufacturer:

KIMTECH PURE* A5 sterile cleanroom apparel is produced by Kimberly-Clark Professional under the Kimtech™ brand. This sterile apparel platform emphasizes contamination control through multi-layer packaging, sterile processing, and donning-friendly garment handling cues that reduce the most common operator-driven contamination pathways.

 

For controlled environments, the garment is only part of the contamination-control program. Outcome depends heavily on gowning technique, personnel behavior, material transfer discipline, and SOP compliance. SOSCleanroom supports qualification workflows with dependable supply and practical selection guidance grounded in real cleanroom routines.

Key Features:
  • Breathable SMS polypropylene construction for comfort and barrier performance
  • CLEAN-DON* Technology designed to reduce outside-touch and floor-contact during donning
  • Built-in thumb loops to help prevent sleeve rollback and wrist exposure
  • Multi-layer contamination-control packaging: triple-bagged and vacuum packaged
  • Sterility indicator and expiration date on packaging for audit-ready traceability
  • Manufacturer references online access to CoC and Certificate of Irradiation for sterile apparel program
Benefits (Why facilities choose sterile single-use coveralls):
  • Reduces gowning-related variability: consistent packaging and donning cues help standardize operator technique.
  • Supports critical-area entry controls: sterile garment format aligns with programs requiring sterile apparel and documented packaging integrity checks.
  • Closes common contamination gaps: thumb loops, elastic closures, and a full-body coverall format help reduce particle escape pathways.
  • Audit-friendly: expiration dating + sterility indicator + manufacturer documentation pathway support QA review.
Common Applications:
  • ISO Class 5+ cleanroom gowning programs where sterile apparel is required by SOP
  • Aseptic processing and sterile-area support operations (site-specific qualification required)
  • Critical assembly, inspection, and packaging workflows where people are the dominant contamination source
  • Material transfer and staging in controlled environments when full-body coverage is mandated
Best-Practice Use (Donning discipline matters):
  • Follow the manufacturer’s CLEAN-DON* sequence: use the internal handling cue (blue indicator line) to avoid contacting the outside of the garment.
  • Move slow and deliberate: rushing increases floor contact and outside-touch events.
  • Do not “re-seat” sleeves by grabbing the exterior: use thumb loops and interior handling whenever possible.
  • Inspect before entry: packaging integrity, sterility indicator status, and zipper/closure integrity should be checked per SOP.
  • Glove strategy is SOP-driven: many sterile programs require sanitizing or changing gloves during gowning and/or double-gloving prior to critical operations.

Workflow tip: Keep the gowning bench and pass-through contact surfaces controlled. Many facilities pair gowning with routine wipe-downs using sterile IPA and low-linting wipers to reduce transfer of residues and particles. If you need help selecting compatible sterile wipes/wipers and swabs for gowning-area controls, SOSCleanroom can assist.

Selection Notes:
  • Sterile vs. clean-processed (non-sterile): choose sterile when SOP requires sterile apparel with sterility indicators and sterile packaging controls.
  • Coverall vs. gown: coveralls provide full-body containment and reduce open-gap pathways (waist, back, and lower leg exposure), subject to fit and glove/boot integration requirements.
  • Fit matters: use the manufacturer size guide to avoid mobility restrictions that create tear risk or rework during donning.
Other Similar Products Available From SOSCleanroom.com

Cleanroom Coveralls & Apparel (Related Options)

Recommended Gowning-Area Contamination-Control Pairings

Notes: The correct sterile coverall is the one that matches your cleanroom classification, process risk, and SOP-driven gowning sequence — including hood/mask/boot/glove integration and change frequency.

If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.

Product page updated: Jan. 13, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault
By SOSCleanroom
KIMTECH PURE* A5 Sterile Coverall ISO Class 5+ Positioning CLEAN-DON* Donning Cues Triple-Bag + Vacuum Pack 25/Case
KIMTECH PURE* A5 Sterile Cleanroom Coveralls — why “donning technique” is as important as garment choice
Why ISO cleanroom standards come first

Cleanrooms are classified by airborne particle concentration under ISO standards. ISO 14644-1 defines classification of air cleanliness by particle concentration (cleanrooms and clean zones), providing the baseline context for why personnel behavior and gowning are controlled so tightly. ISO 14644-5 then addresses operations — including personnel management, entry/exit, training, and a gowning programme — because “people” are typically the dominant contamination source in most controlled environments.

What this product is (manufacturer-stated)

KIMTECH PURE* A5 Sterile Cleanroom Coveralls are single-use sterile coveralls constructed from breathable SMS polypropylene and positioned by the manufacturer for ISO Class 5 or higher cleanroom use. The garment is supplied triple-bagged and vacuum packaged with a sterility indicator and an expiration date (5-year shelf life). The coverall design includes bound seams, REFLEX* design, tunneled elastic waist, elastic wrists/ankles, zipper closure with flap, and built-in thumb loops. CLEAN-DON* Technology is intended to help reduce contamination risk during donning by minimizing the chance of touching the outside of the garment or allowing the garment to contact the floor.

Where sterile coveralls matter most
  • ISO Class 5+ cleanrooms where sterile apparel is specified by SOP for critical operations or cleanroom entry.
  • Aseptic processing support activities where personnel are a primary contamination vector and sterile apparel is used to reduce risk.
  • High-sensitivity assembly, inspection, packaging, and staging where full-body coverage reduces particle escape paths.
  • Programs requiring sterility indicators, expiration dating, and documentable sterile packaging controls.
Specifications in context (what QA typically cares about)
Attribute KIMTECH PURE* A5 Sterile Coveralls
Fabric Breathable SMS polypropylene (100% polypropylene)
Recommended environment Positioned for ISO Class 5 or higher cleanrooms
Packaging controls Triple-bagged; vacuum packaged; sterility indicator
Shelf life / dating Expiration date shown; 5-year shelf life (manufacturer stated)
Donning risk controls CLEAN-DON* cues: inside-out fold + internal handling cue; snaps help reduce floor contact; thumb loops reduce sleeve rollback
Case pack 25/Case
Compliance (stated) CE Category III — Type 5/6 (manufacturer stated)
Documentation pathway Manufacturer references online access to CoC and Certificate of Irradiation for sterile apparel program
Donning education (ISO-driven hygiene discipline)

ISO cleanroom operations emphasize controlled entry/exit, training, and a gowning programme because contamination is often introduced by people. The goal of gowning is not “looking covered” — it is preventing particle and microbial shedding from hair, skin, and clothing into the controlled airflow environment. In practice, the highest-risk moments are: opening the garment, stepping in, pulling arms through, and zipping — because the outside can be touched and the garment can contact the floor.

Manufacturer CLEAN-DON* sequence (coveralls) — simplified, step-by-step
  1. Pre-entry: remove jewelry and cosmetics; don hair net and shoe covers.
  2. Hand hygiene + first sterile gloves: wash hands and don the first pair of sterile gloves (sanitize gloves during gowning if your SOP requires).
  3. Mask + hood: apply mask and hood, assuring a snug fit.
  4. Open vacuum pack: tear at the notched edge; do not drag the garment across non-controlled surfaces.
  5. Hold the internal cue: grasp the blue indicator line located on the inside middle back.
  6. Unfold correctly: gently unfold using the blue line; garment is already folded inside-out and unzipped; arms/legs are pre-drawn and snapped in place.
  7. Legs first: hold garment at waist; insert one leg and point toe through opening until snap releases; repeat for the other leg.
  8. Arms next: insert one arm and extend until snap releases; repeat for the other arm; slip thumbs through thumb loops.
  9. Zip closure: cross legs and zip up the coverall; ensure zipper flap is seated per SOP.
  10. Finish gowning: add boot covers; complete with goggles and a second pair of sterile gloves (if required by SOP).
EU GMP Annex 1 overlay (sterile manufacturing expectations)

If your operation is aligned to EU GMP Annex 1 (sterile medicinal products), gowning expectations become more explicit and more conservative than many general cleanroom programs. Annex 1 specifies that gowning and hand washing must follow a written procedure, and it details grade-dependent clothing elements and integrity controls. For Grade B (background to Grade A), Annex 1 calls for items including sterilized head coverings, face masks, sterilized one-piece suits, sterilized boots/overshoes, and sterilized gloves, with attention to garment integrity and glove change practices.

Annex 1 practical takeaways (selected concepts)
  • Maintain written gowning/hand washing procedures and train to them.
  • Use grade-appropriate garments that minimize shedding and prevent ingress of contaminants.
  • Check garment integrity before/after use and manage reuse/change frequency per risk-based approach (where allowed).
  • Change sterile gloves regularly and manage disinfection/sanitization steps per procedure.
Common failure modes (and how to reduce them)
  • Outside-touch events: re-train to “hold only the internal cue” and use thumb loops instead of grabbing exterior sleeves.
  • Floor contact during donning: slow down; use the snap-assisted leg/arm expansion sequence; do not “shake out” the garment.
  • Incomplete closure: confirm zipper fully seated and flap positioned; treat closure as a contamination gap if not secured.
  • Glove strategy mismatch: align glove sanitization/double-glove sequence to SOP and Annex 1 expectations where applicable.
  • Fit issues: too tight increases tear risk; too loose increases snag/floor contact risk; use size guide for qualification.
Closest competitor set (how to compare fairly)

Compare sterile coveralls by: sterile packaging discipline (vacuum + multi-layer bags), documented shelf life/expiration labeling, donning risk controls (inside-out fold + handling cue), and documentation availability (CoC / irradiation certificate access). “Sterile coverall” is not a commodity category once audits and aseptic behaviors are considered.

SOSCleanroom note about SOP’s

The Technical Vault is written to help customers make informed contamination-control decisions and improve day-to-day handling technique. It is not your facility’s Standard Operating Procedure (SOP), batch record, or validation protocol.

Customers are responsible for establishing, training, and enforcing SOPs that fit their specific risks, cleanroom classification, regulatory obligations, and quality system. Always confirm material suitability, sterility requirements, gowning order, glove strategy, and acceptance criteria using your internal documentation and qualified methods.

If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.

Source basis
  • SOSCleanroom product page (KIMTECH PURE A5 sterile coveralls): https://www.soscleanroom.com/product/2-7-export/kimberly-clark-kimtech-pure-a5-sterile-cleanroom-coveralls/
  • Manufacturer TDS (A5 Cleanroom Sterile Apparel — Coveralls): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/A5%20Cleanroom%20Sterile%20Apparel%20TDS.pdf
  • Manufacturer Donning Poster (CLEAN-DON Technology): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/A5%20Donning%20Poster.pdf
  • Manufacturer Size Guide (A5 Coveralls): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/A5%20Sterile%20Apparel-%20Coveralls%20Size%20Guide.pdf
  • Kimtech apparel catalog (cleanroom classification table + gowning feature overview): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/Scientific%20Apparel%20Catalog.pdf
  • ISO 14644-1 (classification context): https://www.iso.org/standard/53394.html
  • ISO 14644-5 (operations / gowning programme context): https://www.iso.org/standard/88599.html
  • EU GMP Annex 1 (sterile manufacture gowning expectations): official EU publication source
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
If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.
Last reviewed: Jan. 13, 2026
© 2026 SOSCleanroom

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