This is a ready-to-use coverage matrix. Its job is to make two gaps impossible to hide: a surface material that is in the room but in no qualification study, and an organism class (spores, mold) that no disinfectant in the rotation actually kills. It maps every surface and every organism class to the agent that covers it and the study that proves it, and it records the worst-case grouping rationale that lets one coupon represent several materials. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
Purpose
Provide a single traceable view from each cleanroom surface material and each organism class to (a) the qualified disinfectant or sporicide, (b) the qualification study reference, and (c) the qualified contact time, so coverage gaps and grouping rationales are explicit and reviewable at inspection.
How to build and maintain it
- List every surface material actually installed in each area and grade (walls, floors, work surfaces, transparent panels, flexible seals, equipment housings).
- Group materials only with a written worst-case rationale (a porous or harder-to-clean material represents an easier one); record the rationale, never group silently.
- List the organism classes to cover: vegetative bacteria, fungi (mold and yeast), bacterial spores, plus named facility isolates.
- For each surface group and organism class, enter the qualified agent, the study reference, and the qualified contact time.
- Confirm the rotation as a whole leaves no organism class uncovered; a rotation of two same-mechanism agents that both miss spores is a gap, not coverage.
- Update the matrix whenever a surface is added, a disinfectant changes, an isolate recurs, or a study is repeated.
Part A: Surface material coverage
| Surface material | Area / grade | Group / represents | Worst-case grouping rationale | Qualified agent(s) | Study reference | Qualified contact time |
|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Part B: Organism-class coverage and rotation
| Organism class | Example organisms | Routine agent (covers?) | Alternate agent (covers?) | Sporicide (covers?) | Study reference |
|---|---|---|---|---|---|
| Vegetative bacteria | <<FILL: S. aureus, P. aeruginosa, facility isolate>> | <<FILL: Y/N>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Fungi (mold / yeast) | <<FILL: A. brasiliensis, C. albicans, facility mold>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Bacterial spores | <<FILL: B. subtilis / Geobacillus>> | <<FILL: usually N>> | <<FILL: usually N>> | <<FILL: Y>> | <<FILL>> |
| Facility isolate(s) | <<FILL: named recurring isolates>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Part C: Rotation and sporicide cadence
| Field | Entry |
|---|---|
| Routine disinfectant(s) and cadence | <<FILL: agent, daily>> |
| Alternate disinfectant and cadence | <<FILL: different chemistry, cadence>> |
| Sporicide and cadence | <<FILL: agent, weekly in aseptic core / per CCS>> |
| Rotation rationale (which agent covers what) | <<FILL>> |
| Confirmed no organism class uncovered | Yes / No |
Acceptance criteria
The matrix is complete when every installed surface material appears with either its own study or a written worst-case grouping rationale, every organism class (including named facility isolates) is covered by at least one qualified agent, the rotation as a whole leaves no class uncovered, and each entry cites the study that proves it.
Filled specimen (extract)
Illustrative for a Grade B anteroom after adding polycarbonate windows.
Part A
| Surface material | Area / grade | Group / represents | Rationale | Qualified agent | Study ref | Contact time |
|---|---|---|---|---|---|---|
| Stainless steel 316L | Grade B | represents laminate work surface | Non-porous smooth; laminate easier to clean | Quat (routine), PAA (sporicide) | PRT-MICRO-021 | 4 min |
| Epoxy floor coating | Grade B | own study | Textured, harder to clean, not grouped | Quat, PAA | PRT-MICRO-021 | 5 min |
| Polycarbonate window | Grade B | own study (new) | New material, not previously covered | PAA (sporicide), quat | PRT-MICRO-034 | 4 min |
| Silicone gasket | Grade B | own study | Flexible, porous risk | Quat, PAA | PRT-MICRO-021 | 5 min |
Part B
| Organism class | Examples | Routine quat | Phenolic alt | PAA sporicide | Study ref |
|---|---|---|---|---|---|
| Vegetative bacteria | S. aureus, P. aeruginosa, facility Micrococcus | Y | Y | Y | PRT-MICRO-021/034 |
| Fungi | A. brasiliensis, facility mold | Partial | Y | Y | PRT-MICRO-021/034 |
| Bacterial spores | B. subtilis | N | N | Y | PRT-MICRO-034 |
Part C: routine quat daily, phenolic weekly alternate, peracetic-acid sporicide weekly in the aseptic core; rotation rationale documents that the quat and phenolic cover vegetative bacteria and fungi and the PAA covers the spore gap neither routine agent touches. No organism class uncovered: Yes.
The specimen makes the point of the matrix: the spore row shows N, N, Y across the three agents, which is exactly the check that proves the rotation is not two agents sharing the same blind spot.
Common inspection findings this matrix prevents
- A surface material installed in the room and in no study, with no grouping rationale.
- A rotation of two same-mechanism agents that both miss spores or mold, presented as coverage.
- A facility isolate that recurs in monitoring but was never in a challenge panel.
- Grouping of materials with no written worst-case rationale.
How to adapt this matrix
- Split Part A by area and grade if you run several classified rooms.
- Add columns for the recovery efficiency and mean log reduction per surface if you want the evidence inline.
- Link each study reference to the qualification protocol and report.
- Re-confirm the matrix at each requalification trigger (new surface, new isolate, formulation change, adverse EM trend).