Before a cleanroom is designed, built, or requalified after a significant change, somebody has to decide what grade and ISO class the room or operation actually needs. This document is that decision, made explicit: it maps where the product, container, or closure is exposed, scores the factors that drive the grade up or down, records the decision and its rationale, and states the residual risk. Replace every <<FILL: ...>> placeholder, run the assessment with a cross-functional team, and route it through document control. A filled specimen follows. This is educational reference content, not regulatory advice; confirm the current text of Annex 1 and ISO 14644 before you rely on it.
Why this assessment exists
A grade assigned by analogy to the nearest existing room, rather than by tracing the actual process, is one of the more common gaps found in a cleanroom qualification file: the room passes every physical test for the grade it was assigned, but nobody can show why that grade, rather than a stricter or looser one, was the right answer for this specific operation. EU GMP Annex 1 expects the grade and the contamination control strategy to reflect where the product and its direct-contact surfaces are genuinely exposed, and where barrier technology changes that exposure. This assessment documents that reasoning before the qualification protocol is written, so the protocol tests the grade the process actually needs rather than the grade someone guessed at.
Document control header
| Field | Entry |
|---|---|
| Assessment title | Cleanroom Grade/Classification Assignment, <<FILL: room / operation / line>> |
| Document number | <<FILL: RA-ID>> |
| Version / date | <<FILL>> |
| Feeds | <<FILL: URS ID; qualification protocol ID; Contamination Control Strategy ID>> |
| QRM method | Risk-factor scoring adapted for grade/classification assignment |
| Team (cross-functional) | <<FILL: Process/Manufacturing SME, Facilities/HVAC, Microbiology, QA, Validation>> |
1. Scope
This assessment covers the grade and ISO class assignment for <<FILL: room, suite, or specific operation>>, including <<FILL: new build / modification / repurposing, as applicable>>. It does not cover the physical test methods used to qualify the room once the grade is assigned, which are addressed in <<FILL: qualification protocol ID>>, and it does not replace the site’s overall contamination control strategy, which this assessment feeds.
2. Process mapping: where is the product actually exposed
List every discrete step in the operation and classify its exposure state before scoring. This table is the factual basis the scoring in section 3 depends on.
| Step | Product/container/closure state | Barrier present? | Exposure type |
|---|---|---|---|
<<FILL: e.g. component wash>> | <<FILL: closed / not yet sterile>> | <<FILL: No>> | <<FILL: general handling>> |
<<FILL: e.g. filter/bag aseptic connection>> | <<FILL: briefly open at the connection>> | <<FILL: Yes, RABS glove port>> | <<FILL: direct exposure point>> |
<<FILL: e.g. filling and stoppering>> | <<FILL: open, product exposed>> | <<FILL: No / isolator>> | <<FILL: direct exposure point>> |
3. Scoring scales
Exposure severity (E), how directly this step exposes sterile product, container, or closure to the environment:
| Score | Meaning |
|---|---|
| 1 | No exposure; product or component remains closed, sealed, or not yet rendered sterile throughout the step. |
| 2 | Indirect exposure; a failure here could reach the sterile product through a subsequent step, but nothing is open to room air at this step itself. |
| 3 | Direct exposure; the sterile product, an open container, or an aseptic connection is open to the surrounding environment during this step. |
Barrier mitigation (B), how much a RABS, isolator, or equivalent barrier reduces the practical exposure at this step:
| Score | Meaning |
|---|---|
| 1 | No barrier; the operator and the open product/container share the same air. |
| 2 | Partial barrier (open RABS or equivalent); access is restricted but the background air is shared. |
| 3 | Full barrier with qualified decontamination and leak-tight enclosure (closed RABS or isolator); operator access is through tested gloves only. |
Process criticality (C), the consequence if contamination control fails at this step:
| Score | Meaning |
|---|---|
| 1 | Low; downstream processing (for example terminal sterilization or further purification) would detect or remove most contamination risk. |
| 2 | Medium; some downstream mitigation exists but is not a complete safeguard. |
| 3 | High; this step is the last point before the product is sealed, with no downstream safeguard against a contamination event here. |
4. Risk factor assessment table
For each step from section 2, record the scores and the resulting grade recommendation.
| Step | E | B | C | Grade recommendation | Rationale |
|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: e.g. Grade D>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: e.g. Grade A, RABS background Grade B>> | <<FILL>> |
Use this logic to translate scores to a grade recommendation, and document any deviation from it with its own rationale:
- E = 3 (direct exposure) with B = 1 (no barrier): Grade A for the exposure point itself; Grade B for the immediately surrounding operator space.
- E = 3 with B = 3 (full qualified barrier): the exposure point keeps Grade A; the background may step down to Grade B (RABS) or Grade C/D (isolator, justified by decontamination, leak, and glove integrity data).
- E = 2 (indirect exposure) and C = 3 (high criticality, no downstream safeguard): Grade C.
- E = 1 (no exposure) regardless of C: Grade D, with the specific operating limit set by the contamination control strategy rather than predetermined.
5. Decision
| Field | Entry |
|---|---|
| Overall grade/classification assigned per room or zone | <<FILL>> |
| Any step assigned a grade outside the default logic above | <<FILL: step and rationale, or "None">> |
| Barrier-technology background reduction claimed | <<FILL: Yes/No; if Yes, cite the decontamination/leak/glove data supporting it>> |
| Decision made by | <<FILL: cross-functional team, date>> |
6. Mitigations and actions
| Mitigation / action | Owner | Due date | Status |
|---|---|---|---|
<<FILL: e.g. complete isolator decontamination cycle validation before claiming Grade C background>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
7. Residual risk statement and acceptance
State the residual risk after mitigations and whether it is acceptable to proceed to design/qualification at the assigned grade.
| Field | Entry |
|---|---|
| Residual risk statement | <<FILL>> |
| Acceptable to proceed? | <<FILL: Yes/No>> |
| Conditions on acceptance (if any) | <<FILL>> |
8. Acceptance criteria
This assessment is acceptable when all of the following are true:
- Every process step with any product, container, or closure exposure is mapped and scored, not just the obviously critical ones.
- Every grade assigned outside the default scoring logic carries its own documented rationale.
- Any barrier-technology background reduction is supported by cited decontamination, leak, and glove integrity data, not assumed.
- The assigned grade is fed into the URS and the contamination control strategy before the qualification protocol is written.
9. References
EU GMP Annex 1 (2022), the grade A-D scheme and the contamination control strategy requirement it carries. ISO 14644-1:2015, Classification of air cleanliness by particle concentration. ICH Q9, Quality Risk Management, for the risk-assessment framework this document adapts.
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
The following shows the assessment completed for an example aseptic compounding operation, so you can see the level of detail an inspector expects. The company, process, and specifics are illustrative; replace them with your own.
| Step | E | B | C | Grade recommendation | Rationale |
|---|---|---|---|---|---|
| Component receipt and wash | 1 | 1 | 1 | Grade D | Components remain sealed in outer packaging; general handling with no product exposure. |
| Sterile filter to bag connection (RABS glove port) | 3 | 2 | 3 | Grade A at connection; Grade B background | Fluid path briefly open at the connection, the last step before sealing; open RABS restricts access but shares background air, so the connection itself stays Grade A rather than being downgraded by the partial barrier. |
| Final bag sealing (inside isolator) | 3 | 3 | 3 | Grade A at seal point; Grade C background | Direct exposure at the seal point; full qualified isolator with validated VHP decontamination and glove integrity program supports a Grade C background instead of Grade B. |
Decision: Grade A assigned to both direct exposure points; Grade B background for the RABS-covered connection; Grade C background for the isolator-covered seal step, contingent on the isolator’s decontamination cycle validation and glove integrity program being current (mitigation tracked in section 6). Residual risk judged acceptable to proceed to design, conditional on that validation closing before the room is used for product.
Common inspection findings this assessment prevents
- A grade assigned by matching the nearest existing room, with no documented trace back to this process’s actual exposure points.
- A barrier technology background reduction claimed with no decontamination, leak, or glove integrity data on file to support it.
- A step with indirect exposure (E = 2) overlooked entirely because nobody mapped it, only the obviously open steps.
- A risk assessment performed after the room was already built and qualified, so it reads as a justification for an existing decision rather than the basis for one.
How to adapt this assessment
- Map every step of your actual process in section 2 before scoring anything; do not start from an assumed grade.
- Adjust the scoring scales in section 3 if your site’s QRM framework uses a different scale (for example a 1-5 severity/occurrence/detectability model); keep the underlying exposure logic.
- Route any barrier-technology background reduction through your isolator or RABS qualification program and cite the specific record in section 5.
- Feed the decision in section 5 directly into the URS and the contamination control strategy before the qualification protocol is drafted.