The Technical Vault
Sterile RTU Sporicide · Hydrogen Peroxide + Peracetic Acid Actives · Dwell-Time Discipline · ISO / USP / EU GMP Annex 1 Alignment
Total-Shield Plus HG® Sporicidal Disinfectant (Sterile) — 32 oz Pour-Spout Bottles (6/Case)
Total-Shield Plus HG® (Sterile) is a ready-to-use (RTU), one-step cleaner/disinfectant with sporicidal/sterilant positioning for
hard, non-porous surfaces in critical environments. This sterile offering is supplied as 6 × 32 oz pour-spout bottles per case
(SOS SKU 877587HG32). The chemistry is based on hydrogen peroxide + peracetic acid actives and is often deployed as part of a
validated sporicide rotation program (scheduled spore-control events) or event-driven remediation where audit-grade execution and documentation matter.
At-a-glance (published attributes)
- Brand: Total-Shield
- Product: Total-Shield Plus HG® Sporicidal Disinfectant (Sterile)
- SOS SKU: 877587HG32
- Case pack: 6 bottles/case
- Bottle size: 32 fl. oz. (pour-spout top)
- Solution type: Sporicide
- Formula: Ready-to-use (RTU) — no dilution or mixing
- Sterile: Yes
- Active ingredients: Hydrogen peroxide, peracetic acid
- Total actives: 6.74%
- Typical pH: 1.5 – 2.5
- Appearance / odor: Clear liquid; mild (fresh mint scent)
- EPA Reg. No.: 58300-25-96853
- EPA Est. No.: 58300-FL-1
- Shelf life (unopened): 24 months
- Beyond-use after opening: 6 months
- Made in: USA
- Availability (listing): 7–14 business days
1) Where a sterile sporicide fits (and why Annex 1 expects one)
Alcohols and many routine disinfectants are not reliably sporicidal. In EU GMP Annex 1 and in high-control programs aligned with USP
(<797> / <800>), the expectation is not just “clean,” but validated microbial control executed via SOPs and training.
Sporicides are typically used on a scheduled rotation (e.g., periodic spore-control events) and after maintenance or excursions, where a defensible,
label-driven kill claim is required.
Important scope note (accuracy-first)
Sporicides are typically more chemically aggressive than alcohols/quats. Surface compatibility, residue management, operator protection,
and dwell-time execution must be defined and validated in your SOP before routine use.
2) The #1 performance variable: wet-contact (dwell) time
In audits, most “disinfectant failures” are process failures: the surface was never kept wet long enough, wiping re-deposited soil,
or application drift occurred between shifts. For sporicides, this is even more critical.
Your SOP must require surfaces to remain visibly wet for the full label contact time for the organisms and surfaces that matter to your risk assessment.
Audit-grade application method (repeatable and teachable)
- Control overspray: in ISO-critical zones, many teams use a wet-to-wipe method (apply to a sterile wiper, then wipe) to reduce aerosolization near airflow paths (follow label/SOP).
- One direction + overlap: straight-line strokes with overlap; rotate to a clean wipe face frequently.
- Segmentation: break large areas into zones so dwell time is realistic; re-wet as needed to maintain wetness.
- Soil management: if visible residue/soil is present, define a pre-clean step; soil can reduce disinfectant effectiveness.
3) Residue and “finish-step” logic (define it, don’t improvise)
Hydrogen peroxide/peracetic acid chemistries may require a validated residue management approach depending on your surface set and process sensitivity.
If your SOP includes a post-dwell removal or “finish” step, define it explicitly (what chemistry, what wiper, what sequencing, and when).
- Common finish option (when allowed by SOP): sterile 70% IPA wipe-down after full sporicide dwell time.
- Alternative (when residue limits require): sterile purified water wipe-down (facility-qualified) after full dwell time.
- Rule: never shorten dwell time to “get to the finish step faster.”
4) Why the 32 oz pour-spout format matters (dispensing discipline)
The pour-spout bottle is typically used for controlled dispensing onto sterile wipes/pads. This can reduce overspray and improve consistent saturation,
but only if the facility defines dispensing controls (no top-offs, no mixing, no unlabeled secondary containers, clear beyond-use dating once opened).
The listing notes a 6-month beyond-use date after opening—your SOP should enforce open-date labeling and disposal rules.
5) Donning discipline & PPE interface control
Sporicides increase splash and chemical exposure risk. Personnel should be fully gowned before introducing the chemistry into higher-grade areas,
and any touch events (adjusting goggles/hood/mask) should trigger defined recovery steps. Align glove selection and eye/face protection to both
cleanroom containment and chemical compatibility requirements (per manufacturer SDS and facility EHS).
6) Suggested system pairings (sterile solution + sterile tools + PPE barrier)
The “system” matters: solution + wiper + PPE + technique. Below are common pairings for validated programs; final selections must match your ISO class,
residue limits, and SOP validation.
7) Common failure modes (what QA will flag)
- Dwell-time collapse: wiping dry early or failing to re-wet to maintain full label time.
- Re-deposition: using the same wipe face over large areas; dragging soil across zones.
- Uncontrolled dispensing: top-offs, mixed lots, or unlabeled point-of-use containers.
- Compatibility misses: damage to sensitive plastics/metals or residues affecting processes due to unqualified use.
- PPE drift: insufficient eye/face protection or undocumented touch-event recovery.
8) Safety and handling (non-negotiables)
Oxidizer chemistry + SDS control
Hydrogen peroxide and peracetic acid solutions are oxidizing chemistries and can be corrosive/irritating.
Always follow the current EPA label and current SDS for required PPE, ventilation, storage, spill response, and disposal.
Confirm surface compatibility before broad deployment.
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, EPA label compliance, organism-specific wet-contact time,
application technique, surface compatibility, residue management, dispensing/transfer controls, PPE requirements, and disinfectant rotation strategy 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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