SACAQMD RULE 455 PHARMACEUTICALS MANUFACTURING
LAST REVISED 09/05/96


RULE 455 PHARMACEUTICALS MANUFACTURING

Adopted 7-23-81

(Amended 11-29-83, 9-5-96)

INDEX

100 GENERAL



200 DEFINITIONS

300 STANDARDS



400 ADMINISTRATIVE REQUIREMENTS



500 MONITORING AND RECORDS (NOT INCLUDED)



100 GENERAL

101 - PURPOSE: To limit emissions of volatile organic compounds from pharmaceutical manufacturing operations.

110 - APPLICABILITY: The provisions of this rule shall apply to:

111 - EXEMPTIONS: The provisions of this rule shall not apply to facilities that emit, at the design production rating, 15 pounds per day or less of volatile organic compounds.


200 DEFINITIONS

201 - COSMETICS MANUFACTURING PLANT: Any plant producing or blending chemicals for use in cosmetic products and/or manufacturing cosmetic products by chemical processes.

202 - IN PROCESS TANKS: Containers used for mixing, blending, heating, reacting, holding, crystallizing, evaporating, or cleaning operations in the manufacture of pharmaceuticals or cosmetics.

203 - PHARMACEUTICAL MANUFACTURING PLANT: Any plant producing or blending chemicals for use in pharmaceutical products and/or manufacturing pharmaceutical products by chemical process.

204 - VOLATILE ORGANIC COMPOUND (VOC): For the purposes of this rule, "volatile organic compound" has the same meaning as in Rule 101--GENERAL PROVISIONS AND DEFINITIONS.


300 STANDARDS

301 - EQUIPMENT REQUIREMENTS: A person shall conform to the following equipment requirements:

Absolute Vapor Pressure

of VOC at 20oC

Maximum Condenser Outlet

Gas Temperature (oC)

0.5 psi to 1.0 psi

25

1.0 psi to 1.5 psi

10

1.5 psi to 2.9 psi

0

2.9 psi to 5.8 psi

-15

over 5.8 psi

-25

310 - OPERATING REQUIREMENTS: A person shall conform to the following operation requirements:


400 ADMINISTRATIVE REQUIREMENTS

401 - EFFECTIVE DATES: The owner or operator of any pharmaceutical or cosmetics manufacturing facility subject to this rule shall comply with the provisions of this rule on or before January 1, 1983.

402 - PLANTS IN COMPLIANCE: The provisions of Rule 441 shall not apply to processes in compliance with this rule.