Kimtech™ A5 coverall format (illustration). Select size on the product page for exact code.
1) What this garment is designed to do
Cleanroom garments do not “make” a cleanroom clean—your HVAC, filtration, cleaning program, and behavior controls do.
What apparel does is reduce one of the biggest contamination sources in any controlled environment: people.
Disposable coveralls like Kimtech™ A5 are positioned to help reduce shedding and transfer risk during routine operations in controlled environments when paired with a disciplined gowning (donning) program.
2) Where the manufacturer positions non-sterile A5 apparel
Manufacturer catalogs commonly position non-sterile A5 cleanroom apparel for ISO Class 6–8 controlled environments and bioburden-control areas
supporting non-sterile pharmaceutical manufacturing, biomedical research, compounding support, and biotechnology workflows (program- and equipment-dependent).
- Non-sterile cleanroom environments where sterility is not required by SOP.
- Operations that benefit from breathable disposable apparel to support compliance and comfort.
- Gowning rooms where throughput favors bulk case formats (25/Case).
3) Construction and design notes (what matters in use)
The A5 platform is built around breathable SMS construction and a cleanroom-focused layout intended to support consistent coverage during movement.
In practice, design features that typically matter most are: how sleeves stay in place (thumb loops), how closures are protected (zipper coverage), and how seams hold up across repeated bending, reaching, and material handling.
The manufacturer also publishes a sizing/design comparison for A5 coveralls (Reflex* design concept) that is positioned to reduce tear risk at typical stress points and improve fit room through the torso and seat—important because poor fit drives operator “adjustments,” which increases touch risk.
4) Ordering guide (bulk-packed A5 coveralls)
This SOSCleanroom product page is the parent listing for the bulk-packed A5 program. Select your size above for the exact code and price.
The manufacturer bulk program is commonly represented as 25 coveralls per case, with size-specific codes.
| Size option |
Manufacturer bulk code |
Case pack |
| Small |
49831 |
25/Case |
| Medium |
49832 |
25/Case |
| Large |
49833 |
25/Case |
| XL |
49834 |
25/Case |
| 2XL |
49835 |
25/Case |
| 3XL |
49836 |
25/Case |
| 4XL |
49837 |
25/Case |
| 5XL |
49838 |
25/Case |
| 6XL–8XL |
49841 |
25/Case |
5) ISO-first gowning (donning) discipline — how apparel actually reduces contamination
ISO cleanroom control is built on defined cleanliness classes and operational controls. ISO 14644-1 defines classification of air cleanliness by particle concentration, and ISO 14644-5 describes operational controls—including a personnel management program that includes a gowning program.
The key point: the garment only helps if you put it on in a way that minimizes contact with the outside surfaces and prevents floor-contact events.
Practical donning sequence (general template — follow your SOP)
- Prep: remove jewelry; secure personal items; verify correct size; inspect package integrity; sanitize hands per SOP.
- Hair/face control first: don bouffant/hood, beard cover (if applicable), and mask as required by your classification and risk assessment.
- Coverall handling rule: touch the inside only; avoid “shaking” garments; keep sleeves/legs controlled to prevent floor contact.
- Legs then torso: step in one leg at a time while seated/controlled; bring garment up without dragging; then insert arms.
- Secure closures: close zipper fully; ensure zipper flap is positioned; use thumb loops if your SOP specifies to keep sleeves from riding up.
- Final checks: confirm full coverage; correct fit; no tears; then proceed to glove/boot integration steps per SOP and room grade.
The most common contamination failures during gowning are (a) touching the outside of the coverall with bare hands, (b) allowing legs/sleeves to contact the floor, and (c) re-adjusting fit repeatedly after entry. Fit and disciplined handling are the control points.
6) EU GMP Annex 1 overlay — what changes in sterile manufacturing expectations
If you operate under EU GMP Annex 1 expectations for sterile medicinal products, gowning is treated as a critical contamination control element—not a “PPE formality.”
Annex 1 emphasizes training/qualification, periodic assessment, and direct controls on sterile garments and gloves for higher-grade areas.
- Qualification and requalification: Annex 1 expects gowning qualification with regular reassessment (commonly at least annually) and ongoing evaluation of adherence.
- Garment integrity and visual checks: garments should be visually checked for integrity and replaced when damaged; this is explicitly called out as a contamination prevention control.
- Higher-grade (A/B) reality: Annex 1 describes sterile gloves and expects sterile gowning practices and materials appropriate to the critical zone and background area, with disinfection practices aligned to the CCS (Contamination Control Strategy).
- Bottom line: non-sterile bulk apparel may be appropriate for Grade C/D support areas (SOP-dependent), but sterile programs are typically required for Grade A/B work.
7) Common failure modes (and how to prevent them)
- Floor-contact events: seated donning, controlled leg insertion, and keeping cuffs lifted prevents “dragging contamination” upward.
- Touching the outside surface: treat the outside as “product-contact risk.” Handle from the inside; don slowly and deliberately.
- Fit-driven re-adjustment: correct sizing reduces post-entry adjustments that increase touch events.
- Tears at stress points: follow manufacturer sizing guidance; avoid overreaching; replace damaged garments immediately.
8) Closest alternatives (selection logic)
Alternatives are usually driven by packaging control and sterility requirements:
- A5 individually packed (non-sterile): tighter point-of-use handling control where SOP requires it.
- A5 sterile coveralls: when sterile garment presentation/documentation is required (aseptic programs).
- A8 non-sterile coveralls: when a different apparel tier aligns better to your cleanliness target and comfort/compliance requirements.
9) SOSCleanroom note about SOPs
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, products, equipment, cleanroom classification, and regulatory obligations.
Always confirm suitability, documentation needs, and acceptance criteria using your internal quality system and documented methods.
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 processes and risk profile.
10) Source basis (manufacturer datasheets + standards)
- SOSCleanroom product page (A5 bulk parent): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-a5-non-sterile-cleanroom-coveralls-bulk-packed/
- Manufacturer catalog (Kimtech™ Scientific Apparel Catalog): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/Scientific%20Apparel%20Catalog.pdf
- Manufacturer size guidance (A5 Coveralls Size Guide / Reflex* design): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/A5%20Sterile%20Apparel/Coveralls/A5%20Sterile%20Apparel-%20Coveralls%20Size%20Guide.pdf
- ISO 14644-1 (classification): https://www.iso.org/standard/53394.html
- ISO 14644-5 (operations; includes gowning program concept): https://www.iso.org/standard/88599.html
- EU GMP Annex 1 (sterile manufacture; gowning expectations): 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
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