SACRAMENTO METROPOLITAN AIR QUALITY MANAGEMENT DISTRICT

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.