GMP 标准

GMP A  (ISO 5 )

In theory, for a classified room (not just below a LAFW hood) to reach ISO class 5 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, followed by an ISO 6 to finally get into the ISO class 5 cleanroom.

In reality, however, you can reach an ISO 5 cleanroom with 2 or 3 airlocks. The optimal layout depends on the process taking place inside the cleanroom, the size of the room, the number of people working inside, the equipment inside, etc.

The filtered air sweeps down the room in a unidirectional way, at a velocity generally between 0.3 m/s and 0.5 m/s, and exits through the floor, removing the airborne contamination from the room. Cleanrooms using unidirectional air flow are more expensive than non-unidirectional ones, but can comply with more stringent classifications, such as ISO 5 or lower.

• ISO 5 zone | 240–360 air changes per hour

• ISO 6 zone | 90–180 air changes per hour

• ISO 7 zone | 30–60 air changes per hour

• ISO 8 zone | 15–25 air changes per hour (ante-room)

Some of our ISO 5 Cleanroom past projects :

ISO 5 Nanofabrication cleanroom facility

GMP B  (ISO 6 )

In theory, for an entire room to reach ISO 6 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, to finally get into the ISO 6, as shown in the image.

In reality however, you can reach an ISO 6 cleanroom with 1 (recommendation is 2) airlock. Again, it depends of the size of the room, the process taking place inside the cleanroom, the number of people working inside, the equipment inside, etc.

Unidirectional air flow is sometimes recommended to reach ISO 6 classification. For a room of less than 4–6 meters in width (depending on the activities taking place inside the cleanroom), air returns can be positioned on the side of the walls instead of in the floor. Installing air returns in the floor is more expensive.

• ISO 6 zone | 90–180 air changes per hour

• ISO 7 zone | 30–60 air changes per hour

• ISO 8 zone | 15–25 air changes per hour (ante-room)

Some of our past ISO 6 cleanroom projects:

Biopharmaceutical cleanrooms

Animal laboratories ISO 6 cell production cleanrooms

GMP C  (ISO 7 )

This is one of the most common classes of cleanrooms. If you need an ISO 7 cleanroom, you should consider having an ISO 8 airlock/gowning room prior to entering the ISO 7 room. The air changes per hour will vary in both rooms as described below.

• ISO 7 zone | 30–60 air changes per hour

• ISO 8 zone | 15–25 air changes per hour (ante-room)

Non-unidirectional air flow Some of our ISO 7 Cleanroom past projects :

Clinical Manufacturing Facility for Cell and Gene Therapy – CGMP cleanroom

ISO 7 cleanroom for Nutraceutical Industry

Clinical Trials – Drug Development cleanroom

ISO 7 sterile compounding non-hazardous facility

In-Hospital compounding cleanroom – ISO 7 ( USP-797 )

GMP D  (ISO 8 )

Let’s assume that an unclassified space (office or lab) is ISO 9. In this case, you can directly enter an ISO 8 cleanroom, without an airlock. Depending on the production process inside the cleanroom, however, you may have to add a gowning room.

• ISO 8 zone | 15–25 air changes per hour

Non-unidirectional air flow Some of our ISO 8 Cleanroom past projects :

ISO 8 cleanroom for Pharmaceutical Manufacturing

Cleanroom for Pharmaceutical Industry

Cleanroom wall addition for Medtech Manufacturer

ISO 8 cleanroom for Medical Device Manufacturing