The Technical Vault
Sterile 70% Denatured Ethanol · ISO Class 5 Fill · SAL 10−6 Irradiation · Wipe-Technique Discipline for ISO/USP/Annex 1 Programs
Texwipe TX3267 Sterile 70% Denatured Ethanol (EtOH) Solution — 16 fl. oz. Adjustable Trigger Spray
Texwipe TX3267 is a sterile, ready-to-use 70% denatured ethanol (EtOH) solution designed for controlled-environment wipe-downs where a
sterile alcohol is required by SOP (e.g., sterile-suite disinfection steps, pass-through decontamination, and routine surface preparation).
TX3267 is 0.2 µm filtered, filled in an ISO Class 5 environment, individually double-bagged for transfer control, and
gamma irradiated to a sterility assurance level (SAL) of 10−6. Each lot is positioned for audit-friendly control with
lot traceability, endotoxin testing, and shipment documentation.
At-a-glance (key published attributes)
- Part number: TX3267
- Solution: Sterile 70% denatured ethanol (EtOH), ready-to-use
- Filtration / fill: 0.2 µm filtered; filled in an ISO Class 5 environment
- Sterility assurance: Gamma irradiated to SAL 10−6
- Packaging: Individually double-bagged for sterile-suite transfer control
- Documentation: Lot traceability + shipment documentation (Certificates of Irradiation, Compliance, and Analysis)
- Lot testing: Endotoxin testing stated by manufacturer
- Dispensing: Adjustable trigger spray (jet or spray)
- Format / size: 16 fl. oz. bottle
- Residue note: Evaporates leaving extremely low residue (surface/application dependent)
1) Where sterile 70% ethanol fits (and where it does not)
Sterile alcohol is commonly used as a routine/intermediate disinfectant and wipe-down solvent on hard, non-porous surfaces in controlled environments.
TX3267 is typically selected when you need (a) a sterile packaged alcohol for use inside higher grade areas, and (b) documentation that supports
contamination-control accountability across shifts.
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
In regulated cleanrooms, compliance is evaluated as process control: written procedures, trained operator behavior, documentation, and repeatable execution.
USP <797> and USP <800> expect cleaning/disinfection activities to be governed by SOPs (agents, methods, frequencies, and PPE).
EU GMP Annex 1 emphasizes contamination control strategy (CCS), validated 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 any wet-contact expectations used in their rooms.
3) Application technique that holds up in critical environments
A. Prefer “spray-to-wipe” in ISO-critical zones
In higher grade areas, many facilities apply sterile alcohol onto a sterile, low-linting wiper and then wipe the surface.
This improves saturation control and reduces overspray/aerosolization near airflow paths and open components.
B. Unidirectional wipe discipline
Use straight-line, overlapping strokes; rotate to a clean wipe face frequently. Avoid re-depositing soils by dragging a loaded wipe across a large area.
Replace wipes when they become visibly soiled, over-saturated, or contact a non-controlled surface.
C. Wet-contact time must be defined by SOP
If your SOP uses alcohol as a disinfection/sanitation step, keep the surface visibly wet for the required contact time (re-wet as needed).
In high airflow environments, alcohol can flash off quickly—technique and wiper selection determine whether you meet validated conditions.
4) Double-bag transfer control (make it real, not symbolic)
TX3267 is individually double-bagged to support staged de-bagging. The value of this packaging is only realized when your facility
removes outer bags in the correct transition zones (per SOP) and prevents “shortcuts” that compromise surfaces or packaging integrity.
5) Suggested system pairings (validated-program logic)
Sterile alcohol performance is inseparable from the wiper and PPE system. Final selection must match your ISO class, residue limits,
and SOP validation.
6) Common failure modes (what to watch in audits)
- Wet-time failure: spraying and wiping dry immediately when SOP expects a disinfectant contact time.
- Cross-contamination wiping: using one loaded wipe face across large areas (re-deposition).
- Improper staging: bypassing staged de-bagging or placing sterile-packaged bottles on non-controlled surfaces.
- 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’s EHS program.
Always refer to the current SDS and your internal SOP for storage, 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, any required wet-contact time, wiping technique,
transfer/handling 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.
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