c. Maintain negative pressure in the room by exhausting a minimum of 15% of more
air than supply air.
d. Monitor room temperature, relative humidity and pressure via monitoring devices.
e. Provide a dedicated 100% general exhaust system and a dedicated biological
safety cabinet exhaust system through roof. The fans should be roof mounted with
their own independent duct work.
f. Provide HEPA filters with pre-filters for the general exhaust system. The filters
should be accessible from out side the room.
g. Maintain indoor temperature of 64-72 degrees F with 40-60% RH and with
individual room temperature control. However, provide system capacity to maintain
indoor temperature of 62-72 degrees F with 40-60% RH.
h. Provide minimum filtration of pre-filters 30% and HEPA after-filters for the supply
air. The filters should be accessible for maintenance from outside the room.
10. Provide hand hygiene facilities in the ante room and touchless controls to the extent
possible to avoid recontamination of hands. Consider items such as automatic controls for
entrance door between the Anteroom and the clean room. The controls should be on
emergency power. Provide electronic devices or photo sensors with time delays for light
switches and towel dispensers with electronic sensors. The electronic sensors should be in
front of the faucets facing the user to allow water to be run long enough to come to
temperature before immersing hands.
11. Provide a dedicated housekeeping aid closet for the clean room.
12. Provide clothing hooks in the ante room on the way to the Clean room.
F. REFERENCES:
1. http://www.ashp.org/sterileCpd
2. http://vaww.ceosh.med.va.gov
3. United States Pharmacopeia General Chapter <797> `Pharmaceutical Compounding
Sterile preparations"; USP 27 NF, Rockville, MD; United States Pharmacopeia Convention:
2004: 2350-2370.
4. E-mail: VHA USP 797 Workgroup
5. Technical Information Library (TIL): Access HVAC Design Manual for Hospital Projects @
http://www.va.gov/facmgt/standard for ventilation requirements for Bio-safety Class II Cabinets.
Refer to Paragraph 2.11.3.4 in the HVAC Design Manual.
6. ASHRAE Journal September 2004, Article" Understanding Pharmaceutical Clean room
Design".
7. Under Secretary for Health Information Letter `Airborne Particle Assessment of
Pharmaceutical Clean rooms'.
8. Under Secretary for Health Information Letter `Microbiological Assessment of
Pharmaceutical Clean rooms'.
G. CREDITS:
1. Vaiyapuri Subramaniam, Pharm.D., M.S., FCP, FASHP, FASCP Assoc. Chief Consultant,
Adverse Drug Event Programs Pharmacy Benefits Management SHG (119).
2. David E. Zacher, RPh, MHA, Chief Pharmacy Service, Hines VA Hospital
3. Philip W. Coggins RPh, IV/PI/BCMA Pharmacy Program Manager
4. Richard A. McCrone, Engineer, VHA, VACO, 10NB.
5. Vernon Wilkes, Industrial Hygienist, VHA, VACO, 10NB
6. USP <797> PBM SHG Work Group
Previous Page
