The Technical Vault
Sterile 70% IPA (USP-Grade Blend) · Bulk Throughput · Lot Traceability · ISO/USP/Annex 1 Mindset
Texwipe TX3290 Sterile 70% Isopropanol Alcohol Solution — 1 Gallon Bottles (4/Case)
Texwipe TX3290 is a sterile, ready-to-use 70% (v/v) isopropanol solution supplied in economical 1-gallon poly bottles for higher-throughput
wipe-down and pass-through cleaning in controlled environments. The solution is a 70/30 blend of USP-grade isopropanol and USP-purified water,
filtered through a 0.22 micron filter, filled in an ISO Class 5 environment, double-bagged, and gamma irradiated to a SAL 10−6.
The bulk format is ideal when you want fewer change-outs, steadier lot continuity, and a controlled method to dispense into qualified secondary containers (per SOP).
At-a-glance (published attributes)
- Part number: TX3290
- Solution type: Sterile 70% isopropyl alcohol (IPA)
- Blend composition: 70% (v/v) USP-grade isopropanol + 30% (v/v) USP-purified water
- Sterile: Yes
- Filtration: 0.22 micron (submicron) filtration
- Filling environment: ISO Class 5 (manufacturer guidance)
- Sterility assurance: Gamma irradiated to SAL 10−6
- Container: 1 gallon (3.8 L) poly bottle
- Case pack: Four (1 gallon) bottles per case
- Handling note: Hazmat / Ground shipping only (per listing)
1) Where sterile 70% IPA fits (and where it does not)
Sterile 70% IPA is commonly used as a routine/intermediate disinfectant step and as a practical wipe-down solvent for removing many light surface contaminants
on hard, non-porous surfaces (method-dependent). It is frequently used for pass-through wipe-down steps and controlled “finish” wipes where low residue and
consistent supply chain controls matter.
Important scope note (accuracy-first)
70% IPA is not a sporicide. Many validated programs use sterile IPA for routine steps and rotate in a sporicidal disinfectant on a defined schedule
per SOP/contamination control strategy (CCS).
2) Standards alignment (USP, ISO, Annex 1) — educational reference
Regulated cleanrooms are evaluated on process control: written procedures, trained behavior, and repeatable execution. USP <797> and USP <800>
expect cleaning/disinfection to be SOP-driven (agents, technique, frequencies, PPE). EU GMP Annex 1 emphasizes contamination control strategy (CCS), validated cleaning/disinfection,
and disciplined operator practices in Grade A/B environments. 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. Your facility must select, validate, document, and train on product choice, wipe technique,
and any wet-contact expectations used in your areas.
3) 1-gallon format = dispensing discipline (define this in SOP)
Bulk sterile alcohol improves throughput—but can create audit risk if teams improvise dispensing. Strong programs define how TX3290 is dispensed (to wipers, into qualified bottles,
or via qualified dispensing tools), and prevent process drift (top-offs, mixed lots, 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 bottles 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 packaging layers in the correct airlock/transition locations per SOP before entering cleaner zones.
- Change-out rules: define triggers (time-based, leaving the room, exterior contamination, cap left open, dispenser failure).
4) Best-practice use (repeatability beats “more alcohol”)
Wipe method that holds up in critical environments
- Spray/pour-to-wipe control: wet the sterile wiper (damp, not dripping) to reduce overspray/aerosolization near airflow paths.
- One direction + overlap: straight-line strokes with overlap; rotate to a fresh wipe face frequently to prevent re-deposition.
- Clean-to-less-clean sequencing: top-to-bottom and inside-to-outside patterns reduce cross-contamination.
- Wet-contact expectation: if your SOP requires a wet-contact time, keep surfaces visibly wet for that duration (re-wet as needed).
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) Practical selection notes (why teams choose gallon bulk)
- Fewer change-outs: supports high-consumption areas and reduces mid-shift substitutions.
- Lot continuity: easier to standardize a work period on fewer lots for investigation-ready traceability.
- Economy: bulk packaging typically lowers cost-per-ounce vs. trigger sprays when controlled dispensing is already in place.
7) Safety and handling (non-negotiables)
Flammability + SDS control
70% IPA is a highly flammable liquid and vapor. Control ignition sources, use appropriate ventilation, and align receiving/handling controls with your EHS program.
Always refer to the current SDS/TDS and your internal SOP for storage, spill response, and disposal.
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, wipe technique,
transfer/dispensing controls, PPE requirements, disinfectant rotation strategy, 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 SDS/TDS.
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