The Technical Vault
Sterile Quat Disinfectant · 1-Gallon Throughput · Dwell-Time Discipline · ISO/USP/Annex 1 Mindset
Texwipe TX652 TexQ® Sterile Disinfectant (Ready-to-Use) — 1 Gallon Bottle (4/Case)
Texwipe TX652 is a sterile, ready-to-use TexQ® quaternary ammonium (Quat / QAC) one-step cleaner/disinfectant supplied in a
1-gallon (3.8 L) bottle format for higher-throughput cleaning and disinfection of hard, non-porous surfaces in controlled environments.
The TexQ RTU line is positioned around repeatable execution: no on-site dilution, 0.2 µm filtration, gamma irradiation for sterile-use workflows,
and a functional-use label designed to support practical documentation discipline (open date + operator initials).
At-a-glance (published attributes)
- Part number: TX652
- Product family: TexQ® Disinfectant (Ready-to-Use)
- Solution type: Quaternary Ammonium (Quat / QAC)
- Sterile: Yes (gamma irradiated; sterility assurance framework noted as SAL 10−6)
- Format: Ready-to-use (no dilution required)
- Container size: 1 gallon bottle (3.8 L)
- Case pack: Four (1 gallon) bottles per case
- Filtration (manufacturer literature): 0.2 µm filtered
- Fragrance / dye: Dye free; fragrance free
- pH (manufacturer literature): Neutral pH
- Efficacy positioning (manufacturer literature): broad-spectrum bacteria/virus/fungi efficacy; 61 kill claims; mold/mildew control when used as directed
- Contact time guidance: label/TDS lists organism-specific dwell times (examples vary; build SOP around your target organisms and required wet time)
- Functional-use label: supports recording date opened and operator initials
- Shelf life: 2 years (expiration date on label), including after opening/dispensing, per manufacturer TDS
- Regulatory positioning: EPA-registered, one-step cleaner/disinfectant (follow the current label for claims, dwell times, and directions)
- Country of origin (manufacturer literature): Made in USA
- Sales restriction: Intended for sale only in the United States
1) Where TX652 fits in a contamination control strategy
Quat disinfectants are commonly selected as a routine disinfectant step for hard, non-porous surfaces (equipment exteriors, work tables, carts, racks,
shelving, stainless, glass, and qualified plastics). The TX652 1-gallon format is typically used when programs scale: fewer bottle change-outs, steadier lot continuity,
and fewer mid-shift substitutions that can create change-control noise.
Important scope note (accuracy-first)
A quat disinfectant is not automatically a sporicide. Many validated programs use quat chemistry for routine steps and add a separate sporicidal
chemistry on a defined schedule as part of a documented rotation strategy (per CCS/SOP and risk assessment).
2) Standards alignment (USP, ISO, Annex 1) — educational reference
In regulated cleanrooms, performance is audited as process control: written procedures, trained behavior, and repeatable execution.
USP <797> and USP <800> expect cleaning/disinfection activities to be governed by SOPs (agent selection, technique, frequencies, PPE).
EU GMP Annex 1 emphasizes contamination control strategy (CCS), validated disinfection processes, and disciplined operator practices.
ISO cleanroom operations guidance supports an operations control program covering personnel practices, cleaning, and material movement.
Key compliance reality: standards do not “approve” a specific disinfectant brand. Your facility must select, qualify, document, and train
on the exact chemistry, dwell time, and wiping method used in your rooms.
3) 1-gallon format = dispensing discipline (define this in SOP)
Bulk containers help throughput, but they also create audit risk if teams “freestyle” how solution is dispensed. A strong program defines
how TX652 is applied (direct pour to wiper, dispensing into qualified bottles, or controlled application tools) and prevents process drift.
Controls to include (common audit-grade practices)
- Qualified containers only: if transferring, use cleanroom-appropriate, facility-qualified bottles/triggers rated for QAC chemistry.
- No “top-off” behavior: do not refill partially used bottles unless your SOP allows it under validated controls.
- Traceability: keep lot/expiration linkage from the original bottle to point-of-use containers (labels/logs per SOP).
- Open-date discipline: use the functional label fields (open date + operator initials) as part of zone control and investigation readiness.
- Return rules: define what happens if a bottle exits a higher-grade zone (return vs. discard) and how exterior contamination is managed.
4) What drives real performance: dwell time + wipe discipline
Disinfectants most often “fail” operationally due to missed wet-contact time, poor wipe technique (re-deposition), and uncontrolled overspray.
Build your method around one defensible rule: keep the surface visibly wet for the full dwell time required by the current label/TDS claims relevant to your risk assessment.
Best-practice wiping method (repeatable, teachable)
- Control overspray: in sensitive zones, many teams wet a sterile wiper and apply to the surface rather than spraying into airflow (follow label and facility policy).
- One direction + overlap: straight-line strokes with overlap; rotate to a fresh wipe face frequently.
- Clean-to-less-clean sequencing: top-to-bottom and inside-to-outside patterns reduce cross-contamination.
- Residue control (if required): if your method includes a “finish” step, define and qualify it (many programs use sterile 70% IPA wipe-down per SOP).
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 disinfectants into ISO-classified areas, and define glove sanitization,
re-entry, and touch-event recovery steps in SOPs.
6) Suggested system pairings (consistent wipe-down discipline)
TX652 is most effective when paired with sterile, low-linting cleanroom wipers and a validated PPE barrier system. Final selection must match your ISO class,
residue limits, and SOP validation.
7) Receiving & QA quick-checks (practical)
- Confirm case count (4 bottles) and container integrity (caps, seals, no leakage).
- Verify legible lot and expiration markings and file the current TDS/SDS/label revision per your documentation practice.
- Train one standard wipe pattern and spot-check technique on the floor—most failures are behavioral, not chemical.
8) Safety and handling (non-negotiables)
SDS control + chemical sequencing
Always follow the current EPA label and current SDS for hazards, PPE, ventilation, spill response, and disposal guidance.
Do not assume chemistry-to-chemistry compatibility; define any sequencing (e.g., follow-on sterile IPA finish step) in your SOP and qualify it on your real surface set.
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, organism-specific wet-contact time,
application technique, residue controls, rotation strategy, transfer/dispensing controls, 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.
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