The Technical Vault
Sterile Hydrogen Peroxide Sporicidal · Double-Bagged RTU · Rotation Discipline · ISO / USP / EU GMP Annex 1 Alignment
Decon Peroxigen® ST 9716 — Sterile 6% Hydrogen Peroxide Sporicidal Disinfectant (16 oz Trigger Spray)
Peroxigen ST 9716 is a sterile, ready-to-use 6% hydrogen peroxide sporicidal disinfectant designed for
periodic and event-driven microbial control in critical cleanroom environments.
It is 0.2 µm filtered, filled and double-bagged in a controlled environment, and
gamma-irradiated to a sterility assurance level (SAL) of 10−6.
This chemistry is commonly used as part of a validated disinfectant rotation strategy to address
spores and resistant organisms not reliably controlled by alcohols or quats.
At-a-glance (published attributes)
- Product: Peroxigen® ST
- SKU: 9716
- Active chemistry: 6% Hydrogen Peroxide (H₂O₂)
- Function: Sporicidal disinfectant (ready-to-use)
- Sterility: Gamma irradiated to SAL 10−6
- Filtration: 0.2 µm filtered prior to filling
- Packaging: Individually double-bagged for controlled transfer
- Format: 16 oz adjustable trigger spray
- EPA registration: EPA-registered disinfectant (follow current label for claims)
- Shelf life: 2 years from date of manufacture (expiration on bottle)
1) Where a sterile hydrogen peroxide sporicide fits
Hydrogen peroxide sporicides are not daily cleaners. They are typically deployed as
scheduled rotation agents or in response to excursions, maintenance activities,
or higher-risk operations. In ISO 5 / EU Grade A–B areas, Annex 1 and USP expectations
focus on documented effectiveness against resistant organisms within an overall
contamination control strategy (CCS).
Important scope note
Sporicides are chemically aggressive compared to routine disinfectants.
Surface compatibility, residue management, and operator protection must be
addressed in SOPs and validated before routine use.
2) Standards alignment — why sporicides are expected
EU GMP Annex 1 explicitly expects disinfectant programs to include agents
effective against spores as part of a documented CCS. USP <797> and
<800> require facilities to maintain clean and disinfected surfaces
using agents appropriate to the risk profile. ISO cleanroom operational guidance
reinforces validated cleaning processes, rotation strategies, and trained behavior.
Key reality: no standard mandates a specific sporicide brand. Facilities must
select, validate, document, and train on the chemistry, dwell time, sequencing,
and PPE controls used.
3) Dwell time discipline (where sporicides succeed or fail)
Sporicidal efficacy depends on maintaining the required wet contact time.
Hydrogen peroxide solutions can evaporate or decompose if improperly applied.
Surfaces must remain visibly wet for the full dwell time stated on the current EPA
label and validated by your SOP.
Operational best practices
- Apply via spray-to-wipe or controlled spray to avoid aerosolization.
- Re-wet surfaces as needed to maintain full dwell time.
- Do not wipe dry early unless SOP defines a post-dwell removal step.
- Follow with a validated residue-removal step if required (often sterile IPA or sterile water).
4) Donning discipline & PPE interface control
Because sporicides present increased chemical and splash risk, personnel must be
fully gowned prior to use. Eye protection, appropriate sterile gloves,
and full garment containment are commonly required. Touch events (adjusting goggles,
hood, or mask) must trigger defined recovery steps.
5) System pairings (rotation-ready workflow)
6) Common failure modes
- Using sporicide like a daily cleaner (overuse).
- Failure to maintain dwell time.
- Skipping residue removal where required.
- Inadequate PPE for splash exposure.
7) Safety & handling
Oxidizer & SDS control
Hydrogen peroxide is a strong oxidizer. Avoid incompatible materials,
control splash risk, and follow the current SDS and EPA label for handling,
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. Sporicidal disinfectant selection, dwell times,
surface compatibility, residue management, PPE requirements, and rotation strategy
must be defined, validated, and documented by the end user in accordance with internal
SOPs, risk assessments, and applicable regulations. Always follow the current EPA label
and SDS.
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