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Sanihol ST 8101 Sterile 70% Denatured Ethanol Solution (1 Gallon)

Sanihol ST 8101 Sterile 70% Denatured Ethanol Solution (1 Gallon Bottle, 4/Case)

$186.03
(No reviews yet)
SKU:
8101
Availability:
10 - 14 Business Days
Shipping:
Calculated at Checkout
Solution Type:
Ethanol
Sterile:
Yes
Quantity Option (Case):
4 Bottles

Sanihol® ST 8101 Sterile 70% Denatured Ethanol (EtOH) Solution (1 Gallon Bottle, 4/Case) — Non-Pyrogenic, Double-Bagged Alcohol for Cleanroom Disinfection

Sanihol® ST 8101 is a sterile, ready-to-use 70% (v/v) denatured ethanol solution designed for sterile cleanroom cleaning and disinfection workflows where a sterile, non-pyrogenic alcohol is required. It is made with Water-For-Injection (WFI), filtered to 0.2 microns, bottled and double-bagged in a controlled cleanroom environment, and gamma-irradiated to a sterility assurance level (SAL) of 10-6. Each lot is tested for sterility via the USP 14-day sterility test and for bacterial endotoxins prior to release, and each case ships with traceable lot-specific documentation.

Hazmat shipping note: This item is considered a Hazardous shipment and can only be shipped Ground. A $35.00 Hazmat shipping charge is added for each package/case, and shipment is restricted to Ground shipping ONLY to a commercial address ONLY.

Documentation discipline: A QR code is typically provided on each case to access lot-specific documentation (QC, irradiation, sterility, and bacterial endotoxin limits). Keep these documents with your QA files when required by SOP.

Specifications:
  • Manufacturer: Decon Laboratories, Inc. (Decon Labs)
  • Product / SKU: Sanihol ST 8101
  • Solution type: Ethanol (denatured ethanol solution)
  • Sterile: Yes
  • Concentration: 70% (v/v) denatured ethanol solution
  • WFI / non-pyrogenic controls: Made with Water-For-Injection (WFI); lots are tested for bacterial endotoxins prior to release
  • Filtration: 0.2 micron filtered
  • Sterilization: Gamma-irradiated to SAL 10-6
  • USP sterility testing: USP 14-day sterility test (each lot)
  • EPA registration: EPA Reg. No. 56753-2
  • Case unit: Four (1 Gallon) bottles per case
  • Availability: 10 – 14 business days
  • Weight (case): 33.00 lbs
  • Shelf life: 2 years (manufacturer specification)
  • Ingredients (by volume): 63.4% ethyl alcohol; 3.2% methyl alcohol; 3.4% isopropyl alcohol; 30% USP purified water
About the Manufacturer: 

Decon Labs manufactures contamination-control solutions used in cleanrooms and controlled environments, with an emphasis on packaging discipline and documentation support. Sanihol ST is positioned for pharmaceutical, biotechnology, and medical device facilities where sterile alcohol solutions and lot-level traceability support validated cleaning and disinfection programs.

 

SOSCleanroom has been a distributor of Decon for over 10 years supporting cleanrooms across the United States—helping teams maintain consistent daily cleaning programs with dependable supply, responsive service, and straightforward access to SDS/TDS documentation.

Sanihol ST Features:
  • Sterile, ready-to-use 70% (v/v) denatured ethanol solution (do not dilute unless your SOP explicitly allows)
  • Made with WFI; lot release includes sterility and bacterial endotoxin testing
  • 0.2 micron filtered; bottled and double-bagged for controlled transfer workflows
  • Gamma-irradiated to SAL 10-6
  • EPA-registered hard surface disinfectant (EPA Reg. No. 56753-2)
  • Lot-specific documentation provided per case (QC, irradiation, sterility, endotoxin limits)
Efficacy and contact time guidance (label/TDS driven):
  • Disinfection (hard, non-porous surfaces): Maintain the surface wet for a minimum of 10 minutes, then allow to air dry or wipe dry with a sterilized cloth/wiper if needed.
  • Sanitizing (hard, non-porous surfaces): 5-minute contact time on listed compatible surfaces and areas (see TDS for examples and conditions).
  • Important: Pre-clean heavy soil/gross filth before application. Always follow your site SOP and the current TDS/label for approved uses and contact times.
Common Applications:
  • ISO/GMP cleanroom wipe-downs where a sterile alcohol solution is required by SOP
  • Disinfection of benches, carts, pass-through surfaces, work surfaces, and equipment exteriors (hard, non-porous surfaces)
  • Gowning and controlled transition areas where sterile chemistry and double-bag packaging support transfer discipline
  • Routine alcohol step within a validated cleaning/disinfection program (per site validation and environmental monitoring trends)
Best-Practice Use:
  • Flammables control: Denatured ethanol is flammable. Keep away from heat, sparks, and open flame. Use only in a well-ventilated area and follow SDS and site EHS requirements.
  • Packaging discipline: For sterile areas, maintain double-bag integrity until point-of-use per your transfer SOP; avoid staging opened bottles in uncontrolled zones.
  • Contact time control: Apply enough solution to keep the surface visibly wet for the full required contact time; re-wet edges if they dry early.
  • Wipe technique: Use clean, low-linting wipes (no wiper is truly “lint-free” in every process condition). Wipe in straight lines, fold to create clean faces, and replace wipes when loaded or streaking begins.
  • Compatibility check: Validate on sensitive plastics, coatings, labels, and adhesives as part of your internal cleaning validation.
  • Traceability: Record lot/expiration where required and retain lot-specific documentation with batch/room records when applicable.
Selection Notes (Sterile gallon case vs. other alcohol options):
  • Sterile vs. non-sterile ethanol: Choose Sanihol ST when sterility/non-pyrogenic controls and lot documentation are required. Use non-sterile denatured ethanol where SOP does not require sterility.
  • 1-gallon case vs. smaller bottles: Select 1 gallon cases for higher consumption and refill workflows (with qualified dispensing controls). Select smaller trigger-spray sizes for point-of-use convenience and reduced decanting steps.
  • Rotation strategy: Alcohol is often used as a routine step within a broader disinfectant rotation plan. Align chemistry selection to your validated program and microbial/environmental monitoring trends.

Documentation Links:

Other Similar Products Available From SOSCleanroom.com

Decon Alcohol Solutions

Notes: Denatured ethanol solutions are flammable and require ventilation and ignition-source control. For sterile areas, maintain transfer discipline, track lot/expiration, and retain lot documentation as required by your quality system.

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. 8, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault Sterile 70% Denatured Ethanol (EtOH) · WFI / Non-Pyrogenic Controls · Bulk Throughput + Dispensing Discipline · ISO / USP / Annex 1 Mindset

Decon Sanihol® ST 8101 — Sterile 70% Denatured Ethanol Solution (1 Gallon Bottles, 4/Case)

Sanihol ST 8101 is a sterile, ready-to-use 70% (v/v) denatured ethanol solution designed for controlled-environment cleaning and disinfection workflows where a sterile, non-pyrogenic alcohol is required by SOP. It is made with Water-For-Injection (WFI), filtered to 0.2 microns, bottled and double-bagged in a controlled cleanroom environment, and gamma-irradiated to a sterility assurance level (SAL) of 10−6. Each lot is tested for sterility via the USP 14-day sterility test and for bacterial endotoxins prior to release, and each case supports lot-traceable documentation for QA files.

At-a-glance (published attributes)
  • SKU: 8101
  • Solution type: Denatured Ethanol (EtOH)
  • Concentration: 70% (v/v) denatured ethanol solution (ready-to-use)
  • Sterile: Yes
  • WFI / non-pyrogenic controls: Made with WFI; lots are tested for bacterial endotoxins prior to release
  • Filtration: 0.2 micron filtered
  • Sterilization: Gamma-irradiated to SAL 10−6
  • USP sterility testing: USP 14-day sterility test (each lot)
  • EPA registration: EPA Reg. No. 56753-2
  • Packaging: Double-bagged for controlled transfer
  • Format: 1 gallon bottles (3.8 L)
  • Case pack: Four (1 gallon) bottles per case
  • Shelf life: 2 years (expiration on label)
  • Ingredients (by volume): 63.4% ethyl alcohol; 3.2% methyl alcohol; 3.4% isopropyl alcohol; 30% USP purified water
Shipping controls (plan receiving)

This item is listed as Hazmat and restricted to Ground shipping only to a commercial address only. A $35.00 Hazmat shipping charge per case is applied (per listing). Build these constraints into reorder planning for critical programs.

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

Sterile alcohol is commonly used for routine/intermediate disinfection and wipe-down of hard, non-porous surfaces (benches, carts, pass-through interiors, equipment exteriors, stainless panels) when the site requires sterile-packaged chemistry. Sanihol ST is often staged as a “repeatable daily touch” agent in ISO-classified areas—provided the facility controls technique, dwell time, and contamination interfaces.

Important scope note (accuracy-first)

70% alcohol is not a sporicide. Many validated programs use sterile alcohol for routine steps and implement a separate sporicidal agent on a defined schedule (rotation) based on risk assessment and contamination control strategy (CCS).

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

Regulated cleanrooms are evaluated on process control: written procedures, trained behavior, documentation, and repeatable execution. USP <797> and USP <800> expect cleaning/disinfection to be SOP-driven (agents, technique, frequencies, PPE). EU GMP Annex 1 emphasizes a contamination control strategy (CCS), validated cleaning/disinfection, and disciplined operator practices in Grade A/B. ISO cleanroom operations guidance supports an operations control program covering personnel practices, cleaning, and material movement.

Key compliance reality: standards do not mandate a specific alcohol brand. Facilities must select, qualify, validate, document, and train on the exact product, wipe method, and wet-contact expectations used in their rooms.

3) Dwell time discipline (disinfection intent must be executed, not assumed)

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

Published contact-time guidance (verify current label/TDS)
  • Disinfection (hard, non-porous surfaces): keep surface wet for a minimum of 10 minutes, then allow to air dry or wipe dry with a sterilized wiper if needed.
  • Sanitizing (hard, non-porous surfaces): 5-minute contact time on listed compatible surfaces/areas (see TDS conditions).
  • Reality check: in high airflow zones, alcohol can flash off fast—wiper choice and re-wetting determine whether you meet validated conditions.

4) Bulk gallon format: throughput is good—dispensing discipline is mandatory

Bulk containers reduce change-outs and support lot continuity, but they increase audit exposure if teams improvise dispensing. Define in SOP how Sanihol ST 8101 is dispensed (direct-to-wiper, controlled pour, or transfer into qualified bottles) and how you prevent top-offs, mixed lots, and missing expiration tracking.

Controls to include (common audit-grade practices)
  • Qualified containers only: if transferring, use cleanroom-appropriate bottles/triggers rated for alcohol and approved by your site.
  • No “top-off” behavior: do not refill partially used containers unless your SOP allows it under validated controls.
  • Traceability: preserve lot/expiration linkage from source bottle to point-of-use containers (labels/logs per SOP).
  • Staged de-bagging: remove outer bags in the correct airlock/transition locations before introducing into cleaner zones.
  • Documentation retention: capture/retain lot documentation (QC, irradiation, sterility, endotoxin limits) per SOP.

5) System pairings (sterile alcohol + sterile tools + PPE barrier)

Sterile alcohol performance is inseparable from the wiper and PPE interface. Choose tools that match your residue limits, particle sensitivity, and ISO grade—and validate the method in your SOP.

6) Common failure modes (what auditors and QA teams watch)

  • Wet-time failure: wiping dry immediately when disinfection intent requires dwell time.
  • Cross-contamination wiping: using a loaded wipe face over large areas (re-deposition).
  • Dispensing drift: refilling (“top-off”), mixing lots, or unlabeled secondary containers.
  • Transfer drift: bypassing staged de-bagging or staging sterile-packaged bottles on non-controlled surfaces.
  • PPE touch events: adjusting hood/mask/eyewear with gloved hands without defined recovery steps.

7) Safety and handling (non-negotiables)

Flammability + SDS control

Denatured ethanol solutions are highly flammable. Control ignition sources, ensure appropriate ventilation, and follow your facility EHS program. Always refer to the current SDS and the current label/TDS 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. Alcohol use as a cleaner/disinfectant, EPA label compliance, required wet-contact time, wipe technique, dispensing/transfer controls, PPE requirements, and disinfectant rotation strategy 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 SDS/TDS/label.

© 2026 SOS Supply. All rights reserved.