Buyer guide
Aseptic filling suite layout: grade A and B rooms and flows
In an aseptic filling suite the filling zone is grade A, inside a grade B background room unless an isolator is used. Plan separate one-way routes for people, materials and waste before you draw rooms.
By ZY Cleanroom · Updated · Sources at the end of the page
Grades by activity
| Grade | Example activity (Annex 1, Table 4) |
|---|---|
| A | Aseptic filling and sealing, aseptic assembly of filling equipment, loading a lyophilizer |
| B | Background to grade A when there is no isolator, protected staging of items for grade A |
| C | Preparation of solutions to be filtered |
| D | Cleaning of equipment, handling of cleaned components |
Background by technology
| Technology | Minimum background (Annex 1) |
|---|---|
| Open filling line with a grade A zone | Grade B (para 4.4) |
| RABS | Grade B (para 4.20) |
| Open isolator | Grade C (para 4.20) |
| Closed isolator | Grade D (para 4.20) |
Match the grades to ISO classes
FDA (2004) uses ISO classes. It asks for ISO 5 in the critical area and at least ISO 7 in the area next to the line, measured under dynamic conditions. ISO 8 suits less critical work such as equipment cleaning. The isolator background is a risk decision justified in the contamination control strategy.
Flows
People enter through change rooms that act as airlocks. Grade steps up, for example from D to C to B (Annex 1, paras 4.1 and 4.12). Separate entry and exit change rooms for grade B are desirable. In general, hand washing belongs only in the first stage.
Materials enter grade A or B by one-way routes. Where possible, items pass through double-ended sterilisers sealed into the wall (para 4.11). Waste, samples and removed items leave by a separate one-way route, or by time separation set by procedure.
Partly stoppered vials go to a lyophilizer under grade A at all times, or in closed trays where validation supports it (para 8.126). FDA asks for ISO 5 protection between the filling line and the lyophilizer. Crimping equipment that sheds many particles belongs at a separate station with air extraction (para 8.26).
Air and pressure
Adjacent grades keep at least 10 Pa as a guidance value (para 4.14). FDA gives examples of at least 10 to 15 Pa, and at least 12.5 Pa from the aseptic room to an unclassified room.
Unidirectional air should be 0.36 to 0.54 m/s at the working position (para 4.30). FDA gives 0.45 m/s with a range of plus or minus 20%, which is the same range. Airflow visualisation is needed at rest and in operation, including where closed filled products leave through a small opening to a lower grade (para 4.15).
Surfaces and services
Grades A and B have no sinks or drains (para 4.9). FDA calls drains inappropriate in classified areas except ISO 8, with rare exceptions. Keep ledges, shelves and cupboards to a minimum. Sliding doors may be undesirable (para 4.6). Provide windows or remote cameras to observe grades A and B from outside (para 4.17).
Example: route sequence
Example only. One possible sequence for a vial line. Annex 1 does not set the number or order of rooms.
| Route | Sequence |
|---|---|
| People | Unclassified, grade D change, grade C change, grade B change, grade B filling room |
| Components | Cleaned in grade D, sterilised in a double-door autoclave sealed into the grade B wall, then into grade A |
| Waste and samples | Grade B, separate exit airlock, grade C, grade D |
Who approves the room
Your regulator judges the facility, not the contractor. The contractor builds to your room data sheet and supplies test data. To have a room list reviewed, send it to ZY Cleanroom, a cleanroom design-and-build contractor.
Questions
Common questions
What grade is an aseptic filling room?
The filling zone is grade A. For a traditional or RABS line, the background room is grade B (Annex 1, paras 4.4 and 4.20).
Can an isolator sit in a lower-grade room?
Yes, if justified. Annex 1 (para 4.20) gives a minimum of grade C for open isolators and grade D for closed isolators, based on risk assessment.
How many airlocks does a filling suite need?
Annex 1 gives no count. It asks for airlocks for people and materials moving between grades, separate where practical (para 4.12).
Do I need windows into the filling room?
Annex 1 (para 4.17) asks that grades A and B can be observed from outside, through windows or remote cameras.
Related guides
- Contamination control strategy: what the building and air must provide
- Cell and gene therapy cleanroom design: grades, segregation and flows
- Upgrading an existing cleanroom for EU GMP Annex 1: gap list
- USP <797> compounding cleanroom for hospital pharmacy
- Turnkey cleanroom contractor
- Room list builder
Sources
- EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products (published 25 August 2022, applied from 25 August 2023; checked 31 October 2026)
- FDA, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice (September 2004, nonbinding; checked 31 October 2026)
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