The Technical Vault
Sterile 70% IPA · WFI-Based Discipline · ISO/USP/Annex 1 Mindset
CiDehol® ST 8332 Sterile 70% Isopropyl Alcohol (IPA) Solution (32 oz. Trigger Spray) — 12 Bottles/Case
CiDehol ST 8332 is a sterile, ready-to-use 70% (v/v) USP isopropyl alcohol solution intended for sterile cleanroom cleaning and
disinfection use. Decon Labs positions the CiDehol ST family around repeatable contamination-control discipline—including
0.2 µm filtration, Class 100 cleanroom packaging with double-bag transfer control, gamma irradiation to SAL 10−6,
and lot-release testing for sterility and bacterial endotoxins prior to release. The 32 oz trigger-spray format supports routine wipe-downs,
pass-through prep, and point-of-use applications where a sterile alcohol and traceable paperwork are required by SOP.
At-a-glance (published attributes)
- Manufacturer: Decon Laboratories, Inc. (Decon Labs)
- Catalog / SKU: 8332
- Ingredients (as listed): 70% Isopropyl Alcohol, USP; 30% Purified Water, USP
- Water quality positioning (CiDehol ST family): WFI-based (per product family positioning / Technical Vault listing)
- Filtration: Filtered to 0.2 µm
- Cleanroom processing: Packaged in a Class 100 cleanroom; bottled and double-bagged for controlled transfer
- Sterilization: Gamma irradiated to SAL 10−6
- Lot release testing: USP 14-day sterility test; bacterial endotoxin testing (LAL) prior to release
- Regulatory (per manufacturer documentation): EPA Reg. No. 56753-1
- Documentation: Lot-specific traceable documentation shipped with each case (QC, irradiation, sterility, endotoxin limits)
- Package size: 32 oz trigger spray bottle
- Case unit: 12 bottles per case
- Shipping constraint: Ground shipping only (Consumer Commodity ORM-D)
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 and
documentation-driven environments. It is commonly applied through spray-to-wipe processes using sterile, low-linting wipers for controlled wetting,
consistent wipe patterns, and residue management.
Important scope note (accuracy-first)
70% IPA is not a sporicide. Many validated programs use sterile IPA for routine/intermediate steps and rotate a sporicidal agent
on a defined schedule (per SOP/CCS). Always follow your facility’s validated contamination control strategy.
2) Standards alignment (ISO, USP, Annex 1) — educational reference
Across regulated cleanroom frameworks, the recurring requirements are consistency, documentation, and trained behavior:
USP <797> and USP <800> expect cleaning/disinfection activities to be controlled through SOPs using suitable agents and appropriate PPE.
EU GMP Annex 1 emphasizes an overarching contamination control strategy (CCS), validated disinfection processes, and disciplined operator practices in
Grade A/B environments. ISO cleanroom operations guidance supports an operations control program that includes personnel practices, cleaning, and material movement.
Key compliance reality: these standards do not mandate a specific brand or bottle size. Facilities must select, validate, document, and train
on the products and techniques used in their rooms.
3) Best-practice use (repeatability beats “more alcohol”)
A. Spray-to-wipe control
Many facilities apply IPA onto a sterile wiper (rather than spraying broadly into airflow) to improve control and reduce aerosolization.
This is especially relevant near open components, airflow paths, or warm surfaces where flash-off is rapid.
B. Wipe technique: single-pass, unidirectional, overlapping
Use straight-line strokes with overlap. 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. Wet contact time must match your SOP/validation
If your SOP specifies a wet-contact time, keep surfaces visibly wet for the required duration (re-wet as needed per SOP). In high airflow or warm areas,
application method and wipe choice often determine whether wetness is maintained long enough to meet your validated requirement.
4) Donning discipline & PPE interface control (where deviations really occur)
In critical environments, findings are frequently linked to touch events and interface gaps (adjusting eyewear/hoods, poor glove–sleeve overlap,
or contacting non-controlled objects). 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.
5) Suggested system pairings (validated-program logic)
CiDehol ST 8332 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.
6) Why teams standardize this 32 oz “documented” sterile IPA format
- Repeatability: ready-to-use concentration and controlled packaging reduce variability associated with decanting/mixing.
- Transfer discipline: double-bag packaging supports staged de-bagging and pass-through controls (per SOP).
- Audit readiness: lot-specific documentation supports QA release, investigations, and routine recordkeeping.
- Operational efficiency: 32 oz reduces bottle change-outs in high-use wipe-down areas without moving to bulk dispensing.
7) Safety and handling (non-negotiables)
Flammability & SDS/TDS control
70% IPA is a highly flammable liquid and vapor. Control ignition sources, use appropriate ventilation, and follow your facility’s chemical hygiene
program. Always refer to the current SDS and current TDS for hazard classification, handling, storage, spill response, and disposal guidance.
(Shipping and carrier classifications can change; align with your receiving/EHS program.)
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, 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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