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Sanihol ST 8116 Sterile 70% Denatured Ethanol Solution (16 oz.)

Sanihol ST 8116 Sterile 70% Ethanol Solution – Denatured Ethanol Disinfectant (16 oz.)

$176.03
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SKU:
8116
Availability:
Stock Item
Shipping:
Calculated at Checkout
Solution Type:
Ethanol
Sterile:
Yes
Quantity Option (Case):
12 Bottles

Sanihol ST 8116 Sterile 70% Denatured Ethanol Solution (16 oz. Spray Bottle) — Sterile Cleanroom Disinfectant

Sanihol ST 8116 is a sterile, ready-to-use 70% (v/v) denatured ethanol solution intended for critical cleanroom cleaning and disinfection where a sterile, non-pyrogenic alcohol solution is required. It is commonly used for routine wipe-downs, spot cleaning, and disinfection of hard, non-porous surfaces and equipment in pharmaceutical, biotechnology, medical device, and other controlled environments where documentation discipline and lot traceability matter.

Shipping note: This item is classified as a Consumer Commodity (ORM-D) and is restricted to Ground transportation only. Follow your site SOPs, the EPA label, and local regulations for storage, handling, and use.

Specifications:
  • Product: Sterile 70% (v/v) denatured ethanol solution (ready-to-use)
  • SKU: 8116
  • Size: 16 oz. spray bottle
  • Case pack: 12 bottles per case (16 oz. trigger spray bottles)
  • Filtration: Filtered to 0.2 microns (0.2 µm)
  • Packaging: Bottled and double-bagged in a cleanroom; documentation provided for lot traceability
  • Sterilization: Gamma-irradiated to a sterility assurance level (SAL) of 10-6
  • Sterility testing: USP 14-day sterility test (each lot, prior to release)
  • Endotoxin: Each lot tested for bacterial endotoxins; lots are guaranteed < 0.25 EU/mL (WFI endotoxin criterion)
  • EPA registration: EPA Reg. No. 56753-2
  • Shelf life: 2 years from date of manufacture (see product labeling for expiration date)
  • Storage: Do not store above 120°F; keep container tightly closed when not in use
About the Manufacturer: 

Sanihol ST is produced by Decon Laboratories, Inc. (Decon Labs), a long-established manufacturer of contamination-control chemistries and cleanroom-support solutions. In this sterile alcohol format, the manufacturer positions Sanihol ST around repeatability and qualification readiness: controlled filtration, cleanroom packaging practices, gamma irradiation to a defined SAL, and lot-level test documentation for sterility and bacterial endotoxins.

 

SOSCleanroom has been a distributor of Decon for over 10 years supporting cleanrooms across the United States. If you are qualifying a sterile alcohol for a specific area (ISO cleanroom, aseptic suite, or controlled manufacturing line), our team can help you align packaging, documentation, and delivery cadence to your program needs.

Sanihol ST Features:
  • Sterile 70% (v/v) denatured ethanol solution for controlled-environment cleaning and disinfection
  • Filtered to 0.2 microns (0.2 µm)
  • Bottled and double-bagged within a Class 100 cleanroom environment (per manufacturer documentation)
  • Gamma-irradiated to SAL 10-6 to support sterility assurance
  • Each lot tested via USP 14-day sterility test and for bacterial endotoxins prior to release
  • Lot-specific documentation provided (QC, irradiation, sterility, endotoxin results); QR code on each case links to lot documentation
  • EPA-registered disinfectant (EPA Reg. No. 56753-2)
Sanihol ST Benefits:
  • Qualification-friendly: Defined filtration, gamma sterilization, and lot documentation help support validation/qualification workflows.
  • Operational consistency: Ready-to-use sterile alcohol reduces variability versus field-mixing and helps standardize operator practice.
  • Program confidence: Lot-level sterility and endotoxin testing supports higher-control areas where audit-readiness matters.
  • Fast turnaround cleaning: Alcohol solutions typically evaporate without a rinse step (verify surface compatibility and your site cleaning/disinfection SOP).
Ingredients (by volume):
  • 63.4% Ethyl Alcohol
  • 3.2% Methyl Alcohol
  • 3.4% Isopropyl Alcohol
  • 30% USP Purified Water
Typical disinfection and sanitizing guidance (follow label + site SOP):
  • Ready to use: Do not dilute. Pre-clean heavy soil or gross filth before application.
  • Application distance: Hold bottle upright, about 6–8 inches from the surface, and spray away from eyes and face.
  • Disinfection contact time: Keep surface wet for a minimum of 10 minutes (then air dry, or after 10 minutes wipe dry with a sterilized cloth/wiper if needed).
  • Sanitizing contact time: 5 minutes on hard, non-porous surfaces (per manufacturer efficacy guidance).
  • Target organisms (per AOAC efficacy testing): Pseudomonas aeruginosa (ATCC 15442) and Staphylococcus aureus (ATCC 6538) in 10 minutes (with organic load); sanitizer efficacy includes Staphylococcus aureus (ATCC 6538) and Enterobacter aerogenes (ATCC 13048) in 5 minutes (with organic load).
Best-Practice Use:
  • Ventilation: Use in a well-ventilated area and keep away from ignition sources (flammable liquid).
  • Wipe discipline: When wiping, use clean, low-linting wipers and straight-line strokes; rotate wipe faces to avoid re-depositing contamination.
  • Wet-time control: For disinfection steps, manage dwell time (surface must remain visibly wet for the required contact time).
  • Change-out triggers: Replace wipers promptly when they become visibly soiled or begin streaking.
  • Documentation: Retain lot documentation as required by your quality system (sterility/endotoxin/irradiation records).
Selection Notes (Sanihol ST sterile ethanol vs. other alcohol options):
  • Sterile vs. non-sterile alcohol: Choose sterile alcohol solutions when your area classification, product contact risk, or quality system requires sterility and traceable documentation.
  • Ethanol vs. IPA: Ethanol and IPA are both commonly used in contamination control programs; choose based on residue profile, surface compatibility, and your validated cleaning/disinfection SOP.
  • Spray bottle vs. larger formats: 16 oz spray bottles support point-of-use cleaning; larger containers can reduce packaging handling when you have dedicated dispensing controls in place.
Other Similar Decon Products Available From SOSCleanroom.com

Decon alcohol solutions

Notes: Need help selecting sterile vs. non-sterile alcohol, ethanol vs. IPA, or bottle vs. bulk formats for your controlled-area workflow? Contact SOSCleanroom for practical guidance based on your surface set, residue type, area classification, and validated cleaning/disinfection approach.

If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574.

Product page updated: Jan. 7, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault Sterile 70% Denatured Ethanol (EtOH) · EPA-Registered Claims · Wet-Contact-Time Discipline · ISO/USP/Annex 1 Mindset

Decon SaniHol® ST 8116 Sterile 70% Denatured Ethanol Solution (16 oz Trigger Spray) — 12/Case

SaniHol ST 8116 is a sterile, ready-to-use 70% (v/v) denatured ethanol solution designed for controlled-environment cleaning and disinfection where teams need sterile packaging, lot documentation, and repeatable use claims. The product is 0.2 µm filtered, bottled and double-bagged in a cleanroom, and gamma-irradiated to SAL 10−6. Each lot is tested prior to release using a USP 14-day sterility test and bacterial endotoxin (LAL) testing with a stated endotoxin target aligned to WFI limits (< 0.25 EU/mL). The 16 oz trigger format is commonly selected to avoid decanting and to keep daily use aligned to validated, documented handling.

At-a-glance (published attributes)
  • Product: Sterile 70% (v/v) denatured ethanol solution (ready-to-use)
  • SKU: 8116
  • Format: 16 oz trigger spray bottle
  • Case pack: 12 bottles per case
  • Filtration: 0.2 µm filtered
  • Packaging: Bottled and double-bagged in a cleanroom; lot documentation provided (QR-linked documentation on case)
  • Sterilization: Gamma-irradiated to SAL 10−6
  • Lot release testing: USP 14-day sterility test + bacterial endotoxin (LAL) testing prior to release
  • Endotoxin criterion: Manufacturer-stated guarantee < 0.25 EU/mL (WFI endotoxin criterion)
  • EPA registration: EPA Reg. No. 56753-2
  • Shelf life: 2 years from date of manufacture (expiration date on label)
  • Storage: Do not store above 120°F; keep container tightly closed when not in use
  • Shipping note: Ground transportation only (consumer commodity classification noted on listing)

1) Where sterile denatured ethanol fits (and where it does not)

In many contamination-control programs, alcohol is an “every-shift” tool due to fast evaporation and practical coverage for benches, carts, stainless panels, and equipment exteriors. SaniHol ST 8116 is chosen when the task requires a sterile alcohol with strong documentation controls (cleanroom packaging, terminal sterilization, and lot-level sterility/endotoxin results) rather than general-purpose non-sterile alcohol.

Important scope note (accuracy-first)

Alcohol solutions are widely used for routine disinfection/sanitation, but they are not sporicides. Spore control typically requires a separate sporicidal step in a validated rotation strategy (per SOP/CCS).

2) Standards alignment (USP, ISO, Annex 1) — educational reference

USP <797> and USP <800> expect cleaning/disinfection activities to be governed by SOPs that define agents, technique, frequencies, and PPE. EU GMP Annex 1 reinforces contamination control strategy (CCS), validated cleaning/disinfection, and disciplined operator behavior in Grade A/B. ISO cleanroom operations guidance supports an operations control program covering personnel practices, cleaning, and material movement.

Key compliance reality: these frameworks do not “approve” a specific alcohol brand. Your site must select, validate, document, and train on the exact product, wet contact time, and wiping method used in your rooms.

3) What drives real performance: wet contact time + wipe discipline

The most common operational failure with alcohols is contact time collapse: spray once, wipe immediately, and move on. If your SOP uses this product as a disinfectant/sanitizer step, the execution must preserve full coverage and required wet time.

Published use expectations to align in SOP (verify current label / tech sheet)
  • Disinfectant step: minimum 10-minute wet contact time on hard, non-porous surfaces (published guidance).
  • Sanitizer step: 5-minute wet contact time (published guidance).
  • Technique: apply to achieve full coverage; re-wet as needed in high airflow/warm zones; avoid wiping dry before the required wet time unless your SOP explicitly allows post-contact wipe-off.

4) Composition (why “denatured” matters)

SaniHol ST is a denatured ethanol blend. The manufacturer lists the formulation (by volume) as: 63.4% ethyl alcohol, 3.2% methyl alcohol, 3.4% isopropyl alcohol, and 30% USP purified water. From a contamination-control perspective, the “build” is as much about process controls (filtration, cleanroom packaging, irradiation, documentation) as it is about chemistry.

5) Donning discipline & PPE interface control

In critical environments, deviations often trace to touch events and interface gaps (adjusting eyewear/hoods, contacting non-controlled objects, poor glove–sleeve overlap). Ensure personnel are fully gowned before introducing sterile alcohols into higher grade areas. Many aseptic programs don sterile gloves last and sanitize gloved hands with sterile alcohol per SOP.

6) System pairings (validated-program logic)

Sterile alcohol performance in cleanrooms is inseparable from the wiper and PPE system. Final selection must match your ISO class, surface set, residue limits, and your SOP validation.

7) Common failure modes (what to watch in audits)

  • Wet-time failure: spraying and wiping dry immediately (surface never remains wet long enough to meet the required dwell time).
  • Cross-contamination wiping: using one saturated wiper face across large areas, redistributing soils/bioburden.
  • Using alcohol as a heavy-soil remover: visible soil often requires a pre-clean step; soil load can reduce disinfection performance.
  • Unqualified sequencing: mixing chemistries on the same surface without validated order (efficacy/residue risk).
  • Storage drift: heat exposure above published limits (accelerated evaporation/container stress).

8) Safety and handling (non-negotiables)

Flammability & SDS control

Denatured ethanol solutions are highly flammable. Control ignition sources, manage hot surfaces, and ensure appropriate ventilation. Always refer to the current SDS and the manufacturer’s current label/tech sheet for hazards, handling, spill response, and disposal guidance.

Disclaimer: This Technical Vault content is provided for educational and reference purposes only. It does not constitute regulatory, quality, engineering, environmental health & safety, or legal advice. Disinfectant selection, EPA label compliance, required wet-contact time, application technique, residue controls, rotation strategy, PPE requirements, and all related procedures must be defined, validated, and documented by the end user in accordance with internal SOPs, risk assessments, and applicable standards and regulations. Always follow manufacturer instructions and the current label/TDS/SDS.

© 2026 SOS Supply. All rights reserved.