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EU GMP Annex 1 Cleanroom Grades Reference (A, B, C, D)

This table puts the EU GMP Annex 1 grades A to D next to the ISO 14644-1 classes people use when they commission and classify a cleanroom. Use the search box to find a grade, a parameter or an operation and export the filtered rows to Excel or PDF.

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SourceGrade or classConditionParameterLimitTypical use
EU GMP Annex 1
Grade A
At rest
Particles >= 0.5 um per m3
3,520
Filling zone, open sterile product, aseptic connections
EU GMP Annex 1
Grade A
In operation
Particles >= 0.5 um per m3
3,520
Filling zone, open sterile product, aseptic connections
EU GMP Annex 1
Grade A
At rest
Particles >= 5 um per m3
Not specified
Filling zone, open sterile product, aseptic connections
EU GMP Annex 1
Grade A
In operation
Particles >= 5 um per m3
Not specified
Filling zone, open sterile product, aseptic connections
EU GMP Annex 1
Grade B
At rest
Particles >= 0.5 um per m3
3,520
Background room for a Grade A zone
EU GMP Annex 1
Grade B
At rest
Particles >= 5 um per m3
Not specified
Background room for a Grade A zone
EU GMP Annex 1
Grade B
In operation
Particles >= 0.5 um per m3
352,000
Background room for a Grade A zone
EU GMP Annex 1
Grade B
In operation
Particles >= 5 um per m3
2,930
Background room for a Grade A zone
EU GMP Annex 1
Grade C
At rest
Particles >= 0.5 um per m3
352,000
Preparation of solutions for filtration, component handling
EU GMP Annex 1
Grade C
At rest
Particles >= 5 um per m3
2,930
Preparation of solutions for filtration, component handling
EU GMP Annex 1
Grade C
In operation
Particles >= 0.5 um per m3
3,520,000
Preparation of solutions for filtration, component handling
EU GMP Annex 1
Grade C
In operation
Particles >= 5 um per m3
29,300
Preparation of solutions for filtration, component handling
EU GMP Annex 1
Grade D
At rest
Particles >= 0.5 um per m3
3,520,000
Handling of components after washing, terminally sterilised product preparation
EU GMP Annex 1
Grade D
At rest
Particles >= 5 um per m3
29,300
Handling of components after washing, terminally sterilised product preparation
EU GMP Annex 1
Grade D
In operation
Particles
Not predetermined, set by risk assessment
Handling of components after washing, terminally sterilised product preparation
EU GMP Annex 1
Grade A
In operation
Active air sample, cfu per m3
No growth
Recommended microbial action limit
EU GMP Annex 1
Grade A
In operation
Settle plate 90 mm, cfu per 4 hours
No growth
Recommended microbial action limit
EU GMP Annex 1
Grade A
In operation
Contact plate 55 mm, cfu per plate
No growth
Recommended microbial action limit
EU GMP Annex 1
Grade A
In operation
Glove print 5 fingers, cfu per glove
No growth
Recommended microbial action limit
EU GMP Annex 1
Grade B
In operation
Active air sample, cfu per m3
10
Recommended microbial action limit
EU GMP Annex 1
Grade B
In operation
Settle plate 90 mm, cfu per 4 hours
5
Recommended microbial action limit
EU GMP Annex 1
Grade B
In operation
Contact plate 55 mm, cfu per plate
5
Recommended microbial action limit
EU GMP Annex 1
Grade B
In operation
Glove print 5 fingers, cfu per glove
5
Recommended microbial action limit
EU GMP Annex 1
Grade C
In operation
Active air sample, cfu per m3
100
Recommended microbial action limit
EU GMP Annex 1
Grade C
In operation
Settle plate 90 mm, cfu per 4 hours
50
Recommended microbial action limit
EU GMP Annex 1
Grade C
In operation
Contact plate 55 mm, cfu per plate
25
Recommended microbial action limit
EU GMP Annex 1
Grade D
In operation
Active air sample, cfu per m3
200
Recommended microbial action limit
EU GMP Annex 1
Grade D
In operation
Settle plate 90 mm, cfu per 4 hours
100
Recommended microbial action limit
EU GMP Annex 1
Grade D
In operation
Contact plate 55 mm, cfu per plate
50
Recommended microbial action limit
ISO 14644-1
ISO Class 5
Any
Particles >= 0.5 um per m3
3,520
Equivalent of Grade A and Grade B at rest
ISO 14644-1
ISO Class 6
Any
Particles >= 0.5 um per m3
35,200
Intermediate class, not an Annex 1 grade
ISO 14644-1
ISO Class 7
Any
Particles >= 0.5 um per m3
352,000
Equivalent of Grade B in operation and Grade C at rest
ISO 14644-1
ISO Class 8
Any
Particles >= 0.5 um per m3
3,520,000
Equivalent of Grade C in operation and Grade D at rest

Values reflect the 2022 revision of EU GMP Annex 1 and ISO 14644-1 limits at 0.5 um. Particle limits are per cubic metre. Microbial values are recommended action limits, not pass/fail specifications for every site. Always confirm against the current official text and your contamination control strategy.

Trend cleanroom excursions from your own data

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How to use the reference

Type a grade such as Grade B into the search field to see every limit that applies to it, or type a parameter such as settle plate to compare microbial limits across grades. Each row states the condition, at rest or in operation, because Annex 1 sets different particle limits for the two states. Export the filtered view when you need a table for a qualification protocol, an environmental monitoring SOP or a deviation assessment.

At rest versus in operation

At rest means the installation is complete, equipment is running as defined and no operating personnel are present. In operation means the room is running the defined process with the specified number of people. Grade A has the same 0.5 um particle limit in both states, which is why the zone is protected by unidirectional airflow. Grade B is tight at rest but allows a much higher count in operation, so a Grade B room that passes at rest can still fail while people are working in it.

Particles and microbial limits are separate controls

Particle counts show how well air handling and gowning control the environment. Microbial results show viable contamination. A room can meet its particle limit and still show growth on contact plates, and the reverse is possible after a cleaning or sanitisation failure. Annex 1 expects both to be trended and tied to the contamination control strategy.

  • Classify with particle counts under ISO 14644-1 methods.
  • Monitor viable air, surfaces and personnel routinely.
  • Review excursions and trends, not only single failures.

Common mistakes

The most frequent error is quoting 5 um limits for Grade A from the older 2008 text. The 2022 revision does not specify a 5 um limit for Grade A, although the contamination control strategy may still require one. Another is mixing up cfu per plate with cfu per 4 hours for settle plates, and treating action limits as the only trigger when alert levels and trends are set lower.

Frequently Asked Questions

Which cleanroom grade is equivalent to ISO 5?

Grade A, and Grade B at rest, align with ISO Class 5 for particles of 0.5 um and larger, which has a limit of 3,520 per cubic metre. Grade B in operation and Grade C at rest align with ISO Class 7, and Grade C in operation and Grade D at rest align with ISO Class 8.

Does Annex 1 set a 5 um limit for Grade A?

In the 2022 revision, the 5 um limit for Grade A is not specified in the classification table. A site can still include 5 um monitoring if its contamination control strategy or historical trends justify it. Check the current official text before writing a protocol.

Are microbial limits in this table mandatory?

They are the recommended action limits in Annex 1 for in operation monitoring. Sites normally set alert levels below them, based on trending. A single result above an action limit requires investigation, and a Grade A result of any growth is treated as an event.

Is this the same as US FDA aseptic guidance?

No. FDA aseptic processing guidance uses ISO 5, ISO 7 and ISO 8 designations and its own recommended limits. The classes overlap with Annex 1, but the wording, sampling expectations and some limits differ. Use the document your regulator and markets require.

If your cleanroom monitoring results live in LIMS, a historian or ERP quality tables, Netray can build a private on-prem view that trends excursions by grade and room without sending data outside your network.

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