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Ashrae - Understing Clean Room Design
Ashrae - Understing Clean Room Design
Understanding
Pharmaceutical
Cleanroom Design
By John Zhang, P.E.
proper HVAC system is a critical part of pharmaceutical cleanroom more than 10,000 particles of 0.5 µm or
A design. Even though various design guidelines and standards are
larger per ft3 (0.02832 m3) of air volume.
The particle count in a cleanroom is pe-
available, there is no clear-cut guidance for many crucial HVAC design riodically tested to maintain the valid-
parameters, particularly air changes per hour for a specific class of ity of a cleanroom.
cleanrooms. FDA guidelines1 only specify a minimum of 20 air changes Cleanroom Fundamentals
per hour for controlled areas without providing any specifics. The fundamentals of cleanroom de-
sign are to control the concentration of
A recently published ISO Standard2 100 air changes per hour for all ISO 7 airborne particles. The particulate mat-
does provide some guidelines on the air (Class 10,000) cleanrooms while others ter come from several sources: the sup-
change rates, but only for the microelec- use as low as 30 for the same classifica- ply air; the internal particle generation;
tronic industry. This standard-specified tion. The question naturally arises: how and infiltration from adjacent spaces. To
air-change rate is 10 to 20 for Class 8 can a design professional reach proper control these airborne particles, all three
(equivalent to Class 100,000 in Fed parameters with a set of given conditions sources need to be controlled.
209E,4 which has been repealed and re- when designing a cleanroom HVAC sys-
Supply Air Controls
placed with ISO 14644-1), a deviation tem? This article attempts to address this
from the earlier FDA guideline, further- question by looking into the fundamen- Particles from the supply air are easily
ing the confusion. tals of cleanroom HVAC systems. controlled by using HEPA (high-efficiency
The ISPE Baseline Guide for sterile A cleanroom is defined in the new ISO particulate air) filters. Most HEPA filters
facilities3 did try to cover this important standard as, “A room in which the con- have a minimum efficiency of 99.97%
design aspect by devoting Section 15.4 centration of airborne particles is con- tested on 0.3 micron particles. In other
to address the calculation of air-change trolled, and which is constructed and used words, only less than 0.03% of all particles
rate. Unfortunately, this section has only in a manner to minimize the introduc- of 0.3 microns or larger can get through
a subtitle and not the actual equation. tion, generation, and retention of par- such a filter. So if the return air contains
As a result, different pharmaceutical and ticles inside the room, and in which other 10,000 particles per ft3 (353 000 particles
biotech companies are using their own relevant parameters, e.g., temperature, per m3), its concentration would be re-
guidelines to approach cleanroom HVAC humidity, and pressure, are controlled as About the Author
design, leading to a range of scattered necessary.” 2 For example, an ISO 7 John Zhang, P.E., is a lead mechanical engineer
design parameters. For example, some use cleanroom is controlled to allow not with IDC in Portland, Ore.
v = g (x − s ) = 60 × 1,000 (1,000 − 3)
Impact of Pressurization
= 60 air changes per hour
One of the most important parameters in cleanroom HVAC
When operators are present and the space has to be vali- design is room differential pressure. It is easily understood
dated as operational, an ISO 6 room requires much higher air that by maintaining positive pressure over its adjacent space,
changes than 60 as discussed here. the infiltration of less clean air into a cleanroom is minimized.
All guidelines recommend a 0.05 in. (12.5 Pa) differential across
Air-Change Rate for an ISO 5 Space doors separating rooms with different classification. Absolutely
The analyses so far were based purely on the dilution prin- nothing is wrong with this design philosophy and close atten-
ciple that is applicable to only ISO 6 and beyond. For ISO 5 tion should be paid to it.