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Bioburden Reduction in Clean Room Facilities
For Clean Room designs, Air Flow is the most critical process of maintaining the
standards imposed by the regulating authorities. Its purpose is to purge out
accumulated particles (viable and non-viable) with HEPA-filtered air.
Clean Rooms carry a classification designation dictated by the manufacturing
process or intent of the area, i.e. Sterile Product Manufacturing, Sterile
Holding Areas, Gown-In Rooms, Airlocks, etc., and the US federal classifications
range from 1 through 100,000 (or 100 K).
A summary of the USP Standard for Airborne Bioburden in Clean Rooms is as follows:
| Clean Room Class |
Colony-Forming Units/ft3 |
| 100 |
0.1 |
| 10,000 |
0.5 |
| 100,000 |
2.5 |
Catalyx's proposal to Clean Room designers and operators is to supplement existing
HEPA filtration with UV/PCO.
UV has been proven to inactivate various bacteria and viruses when properly designed,
installed, and tested. The following table provides some examples, including
the corresponding UV Fluence (dosage). When UV is coupled with a PCO filter, complete
viable destruction is possible, while reducing volatile organics and amines.
UV Energies Required to Provide Log 3 (99.9%)
Inactivation of Common
Bacteria and Viruses
| Microorganism |
UV (mwatts*sec/cm2) |
| Bacillus Anthracis |
9,000 |
| Bacillus Subtilis (vegetative) |
11,000 |
| Bacillus Subtilis (SPORES) |
58,000 |
| Escherichia Coli |
7,000 |
| Legionella |
6,000 |
| Mycobacterium Tuberculosis (TB) |
10,000 |
| Staphylococcus (various) |
10,000 |
| Streptococcus Lactia |
7,000 |
| Hepatitus Virus |
8,000 |
| Influenza Virus |
7,000 |
| Pollo Virus |
21,000 |
| Rota Virus |
24,000 |
Various MOLD Spores
(e.g., penicillum and aspergillus) |
22,000 to 330,000 |
A FRESH+™ system will provide in-line disinfection of air between the
air handler and the terminal filters. This disinfection process will reduce the
bioburden loading onto the duct interiors, filters, and filter housings, which
may save the operators from downtime for periodic sanitizing.
Standard modules are available for airflow rates of 3,000 to 5,000 cfm, however, the
modules are grouped in housings to handle much higher airflow capacities.
For biopharmaceutical facilities, Catalyx supports the Validation of their FRESH+™
system with full documentation packages. Spare parts and calibration services are
readily available.
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Catalyx technologies, llc •
PO Box 137 •
Media, PA 19063 •
Ph 610-892-9405
Fax 610-892-9407 •
www.catalyxtech.com |
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