The Technical Vault
Sterile 70% IPA (WFI) · Bulk Format for Documented Programs · Dispensing Discipline Required
CiDehol® ST 8301 Sterile 70% Isopropyl Alcohol Solution — 1 Gallon Bottles (4/Case)
CiDehol ST 8301 (Decon Laboratories) is a sterile, ready-to-use solution of 70% (v/v) USP isopropyl alcohol blended with
30% (v/v) Water-for-Injection (WFI), USP, designed for sterile cleanroom cleaning and disinfection workflows where
process consistency, sterility assurance, endotoxin control, and lot documentation are critical. The solution is
0.2 µm filtered, bottled and individually double-bagged in a cleanroom, and gamma-irradiated to SAL 10−6.
Each case includes lot-specific documentation supporting QC, irradiation, sterility testing, and bacterial endotoxin limits.
At-a-glance (published attributes)
- Product / SKU: CiDehol ST 8301
- Concentration: 70% IPA, USP (v/v) / 30% WFI, USP (v/v)
- Filtration: 0.2 µm filtered
- Sterility assurance: Gamma-irradiated to SAL 10−6
- Packaging discipline: Bottled and individually double-bagged within a cleanroom
- Endotoxin control: Lot tested by LAL; WFI endotoxin criterion stated as < 0.25 EU/mL
- Sterility testing: USP 14-day sterility test (lot testing)
- EPA registration: EPA Reg. No. 56753-1
- Pack size: Four (1-gallon) bottles per case
- Typical shelf life: 2 years (see label/expiration)
- Shipping / hazmat: Ground shipping only; commercial address only; hazmat charge per case
1) Where sterile 70% IPA fits (and where it does not)
Sterile 70% IPA is widely used as a routine or intermediate disinfectant step for hard, non-porous surfaces in ISO-classified environments.
The 1-gallon format is most often selected when a facility needs higher throughput while maintaining sterile supply chain control
and lot documentation—typically for staging areas, cleaning support operations, and high-use wipe-down stations.
Important scope note (accuracy-first)
70% IPA is not a sporicide. Strong programs commonly use sterile IPA as a frequent “daily driver,” while rotating a
sporicidal disinfectant on a defined schedule per SOP and risk assessment.
2) Standards alignment (USP, ISO, Annex 1) — educational reference
Cleanroom standards consistently emphasize: (1) clean and disinfected surfaces, (2) trained personnel using appropriate garb/PPE, and
(3) documented, validated procedures. USP <797> and USP <800> expect cleaning/disinfection steps to be governed by SOPs,
including agent selection and PPE. EU GMP Annex 1 reinforces contamination control strategy (CCS), validated disinfection processes,
and disciplined operator behavior in Grade A/B environments. ISO cleanroom operations guidance supports a formal operations control program covering
personnel practices, cleaning, and material movement.
Key compliance reality: standards do not mandate a specific brand or container. Facilities must select, validate, document, and train
on the products, dispensing method, wipe technique, and contact-time expectations used in their rooms.
3) Bulk format = dispensing discipline (this is where sterile programs fail)
The 1-gallon format can be a smart standardization move—but only if the facility controls how the solution is dispensed.
Audit findings frequently trace back to bulk alcohol process drift: decanting into unqualified bottles, topping off partially used sprayers,
missing lot traceability, and uncontrolled “clean introduction” steps.
Best-practice controls to define in your SOP
- Qualified containers only: If transferring into spray bottles, use facility-qualified, cleanroom-appropriate bottles and triggers rated for IPA.
- No “top-off” behavior: Do not refill partially used bottles unless your SOP explicitly allows it under validated controls.
- Maintain traceability: Preserve lot and expiration traceability from the source container to point-of-use containers (labels/logs as defined).
- Staged de-bagging: Remove outer packaging layers in the correct gowning/airlock locations per SOP before introducing into higher grade areas.
- Defined change-out rules: Establish bottle change triggers (time-based, contamination, leaving the area, exterior contact, trigger failure).
4) Application technique (repeatability beats “more alcohol”)
A. Prefer “spray-to-wipe” in critical zones
Many facilities apply IPA onto a sterile wiper (rather than spraying broadly into airflow) to improve control, reduce overspray,
and minimize aerosolization near sensitive process areas.
B. Wipe pattern discipline
Use straight-line, overlapping strokes. Rotate to a clean wipe face frequently to avoid re-depositing soils.
Replace the wipe when it becomes loaded, over-saturated, or contacts a non-controlled surface.
C. Contact time is defined by your SOP/validation
Maintain visible wetness for the contact time your SOP specifies (if the step is disinfection/sanitation, not just cleaning).
High airflow and warm surfaces shorten wetness—application method and wipe choice often determine whether your validated wet-contact condition is met.
5) Donning discipline & PPE interface control
In critical environments, deviations are commonly linked 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 solutions into ISO-classified areas.
Many aseptic programs don sterile gloves last, then sanitize gloved hands with sterile IPA at defined intervals per SOP.
6) Suggested system pairings (validated-program logic)
CiDehol ST 8301 is typically paired with sterile consumables engineered for controlled wiping and low residue transfer.
Final selection must match your ISO class, residue limits, disinfectant rotation strategy, and SOP validation.
7) Why facilities standardize the 1-gallon sterile IPA format
- Throughput: supports high-use wipe-down stations and frequent replenishment without constant small-bottle change-outs.
- Program consistency: ready-to-use concentration reduces variability versus in-house mixing or non-sterile decanting practices.
- Documentation discipline: lot paperwork supports QA release, traceability, investigations, and audit readiness.
- Controlled entry packaging: individually double-bagged bottles support staged de-bagging SOPs.
8) Safety and handling (non-negotiables)
Flammability, ventilation, and hazmat controls
70% IPA is a highly flammable liquid and vapor. Control ignition sources, use appropriate ventilation, and follow your facility’s
chemical hygiene and EHS program. Align receiving/shipping controls with your site program (ground-only, commercial receiving, hazmat handling).
Always refer to the current SDS and manufacturer documentation for storage, spill response, and disposal guidance.
Revision control
Technical Vault entry (SOSCleanroom): Review whenever manufacturer TDS/SDS changes, or when your facility updates ISO/USP/Annex 1 interpretations,
cleaning SOPs, disinfectant rotation strategy, dispensing controls, or validation parameters.
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. Cleaning agents, contact times, wiping techniques, dispensing/transfer methods,
PPE requirements, disinfectant rotation, EPA claims/uses, 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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