This is a ready-to-use worksheet for qualifying the wipe itself, separate from the disinfectant chemistry. A coupon study proves the chemistry can kill; this worksheet proves the wipe your operators actually use delivers enough of that chemistry, spread evenly enough, to reach the qualified contact time on a real surface. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
Section 1: Identify the wipe and the chemistry study it supports
| Field | Entry |
|---|---|
| Wipe product, substrate, and supplier | <<FILL>> |
| Disinfectant / sporicide, concentration | <<FILL>> |
| Coupon study this wipe is meant to represent (reference) | <<FILL: protocol/report number>> |
| Was the coupon study’s disinfectant applied by pipette or by this wipe? | <<FILL>> |
If the coupon study applied disinfectant by pipette rather than by this wipe, treat Sections 2 through 4 below as mandatory before relying on the coupon study’s contact time for routine use with this wipe.
Section 2: Delivery volume per unit area (capacity test)
| Field | Entry |
|---|---|
| Method reference | <<FILL: e.g. IEST-RP-CC004.2 capacity test, or equivalent in-house method>> |
| Known wipe area tested | <<FILL: cm^2>> |
| Dry wipe mass | <<FILL: g>> |
| Saturated wipe mass | <<FILL: g>> |
| Liquid absorbed (saturated minus dry mass) | <<FILL: g>> |
| Volume delivered per unit area | <<FILL: mL / cm^2, or microliters / cm^2>> |
| Compared against the volume the coupon study applied per unit area | <<FILL: higher / lower / equivalent, with the numbers shown>> |
Section 3: Coverage uniformity on a real surface
| Field | Entry |
|---|---|
| Surface material tested | <<FILL>> |
| Wipe-stroke technique used (overlap percentage, direction) | <<FILL>> |
| Method to confirm uniform coverage (e.g. UV-tracer dye, fluorescent marker, visual wet-film mapping) | <<FILL>> |
| Dry or under-treated gaps observed between strokes? | <<FILL: Yes/No; if Yes, describe and revise the technique or the overlap>> |
Section 4: Achievable wet time with this wipe
| Field | Entry |
|---|---|
| Room / airflow condition during the test | <<FILL>> |
| Time surface stayed visibly wet after application with this wipe | <<FILL: minutes>> |
| Qualified contact time from the coupon study | <<FILL: minutes>> |
| Is the achievable wet time with this wipe at or above the qualified contact time? | <<FILL: Yes/No; if No, the wipe cannot support this contact time as qualified, escalate>> |
Section 5: Conclusion and sign-off
| Field | Entry |
|---|---|
| Overall conclusion | <<FILL: this wipe is / is not qualified to deliver the contact time proven in [coupon study reference]>> |
| If not qualified: corrective action (re-saturate wipe spec, revise overlap technique, repeat coupon study with this wipe) | <<FILL>> |
| Preparer | <<FILL: name, date>> |
| QA / Microbiology review | <<FILL: name, date>> |
Filled specimen
Section 1. Wipe: presaturated polyester/cellulose wipe, Supplier X, lot WPX-2026-09. Disinfectant: peracetic acid sporicide, 0.3 percent. Coupon study this wipe is meant to represent: PRT-MICRO-021. The coupon study applied disinfectant by pipette directly onto the coupon, not by this wipe, so Sections 2 through 4 are mandatory.
Section 2. Per IEST-RP-CC004.2 capacity test: 100 cm^2 wipe area, dry mass 4.10 g, saturated mass 10.85 g, liquid absorbed 6.75 g, delivery 0.0675 mL/cm^2. The coupon study’s pipette application delivered approximately 0.05 mL/cm^2. The wipe delivers more liquid per unit area than the pipette method, so delivery volume is not the limiting factor.
Section 3. Tested on a stainless steel panel representing the Grade B work surface. Technique: 50 percent overlapping S-pattern strokes. Coverage confirmed with a fluorescent tracer added to a reference batch of disinfectant; no dry or under-treated gaps observed under UV inspection.
Section 4. Tested in the Grade B room at operating airflow. Surface stayed visibly wet for 4 minutes 10 seconds with this wipe and technique. Qualified contact time from PRT-MICRO-021: 4 minutes. 4:10 is at or above 4:00.
Section 5. Conclusion: this wipe, at this saturation level and with the 50 percent overlap S-pattern technique, is qualified to deliver the 4-minute contact time proven in PRT-MICRO-021. Preparer: T. Suresh, 2026-09-18. QA/Microbiology review: R. Alvarenga, 2026-09-19.
Common mistakes this worksheet catches
- A coupon study validated with a pipette-applied liquid, carried into routine use on a pre-saturated wipe that was never confirmed to deliver the same film.
- Wipe-stroke overlap left to individual operator habit, with no coverage-uniformity check to catch dry gaps between strokes.
- Achievable wet time measured once, on a bench, and never repeated in the actual room’s airflow, where drying is faster.
- A wipe substrate or supplier change made by procurement with no one routing it back through this worksheet before the new wipe enters routine use.
How to adapt this worksheet
- Run this worksheet whenever the wipe substrate, saturation level, or supplier changes, not only at initial qualification.
- If more than one wipe-stroke technique is used across shifts or sites, qualify and document each technique separately; do not assume one technique’s result covers another.
- Attach this worksheet to the disinfectant qualification file alongside the coupon study and the surface/organism coverage matrix.