SACRAMENTO METROPOLITAN AIR QUALITY MANAGEMENT DISTRICT

RULE 455 - PHARMACEUTICALS MANUFACTURING
(Adopted 7-23-81; Amended 11-29-83, 9-5-96)

INDEX

100 GENERAL

101 PURPOSE

110 APPLICABILITY

111 EXEMPTIONS

200 DEFINITIONS

201 COSMETICS MANUFACTURING PLANT

202 IN PROCESS TANKS

203 PHARMACEUTICAL MANUFACTURING PLANT

204 VOLATILE ORGANIC COMPOUND (VOC)

300 STANDARDS

301 EQUIPMENT REQUIREMENTS

310 OPERATING REQUIREMENTS

400 ADMINISTRATIVE REQUIREMENTS

401 EFFECTIVE DATES

402 PLANTS IN COMPLIANCE

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:

110.1 The manufacture of pharmaceutical and cosmetic products by chemical processes.

110.2 The production and separation of medicinal chemicals such as antibiotics and vitamins from microorganisms.

110.3 The manufacture of botanical and biological products by the extraction of organic chemicals from vegetative materials or animal tissues.

110.4 The formulation of pharmaceuticals into various dosage forms such as tablets, capsules, injectable solutions or ointments, that can be taken by the patient immediately and in an accurate amount; and the formulation of cosmetics into configurations intended for consumer use.

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:

301.1 A person shall not use reactors, distillation columns, crystallizers, centrifuges emitting more than 15 pounds per day of VOC for each permit unit unless the vents are equipped with surface condensers or equivalent control devices.

301.2 A person shall not use surface condensers for the control of organic gases unless the condenser outlet gas temperature is controlled as shown in the following table:

301.3 Equivalent control devices may be used with the approval of the Air Pollution Control Officer. Equivalent control is achieved when VOC emissions are reduced by at least as much as would have occurred using a surface condenser per Subsection 301.2.

301.4 A person shall not use centrifuges, rotary vacuum filters, or devices having an exposed liquid surface where the liquid contains VOC having a total VOC vapor pressure of 0.5 psi or more at 20oC, unless such devices incorporate a hood or enclosure with a delivery system or ductwork to collect VOC emissions, exhausting to a carbon adsorber, or equivalent control method approved by the Air Pollution Control Officer.

301.5 A person shall not use in-process tanks for material containing VOC unless an apparatus or cover which prevents VOC evaporation is provided for the tank. The cover shall be closed or in place on the tank at all times except while loading or unloading the tank.

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

310.1 A person shall not use air dryers or production equipment exhaust systems that emit 330 pounds per day or more of volatile organic compounds for each basic permit unit unless the emission of such organic materials into the atmosphere has been reduced by at least 90% by weight.

310.2 Notwithstanding the provisions of Subsection 310.1 of this rule a person using air dryer or production equipment exhaust systems that emit less than 330 pounds per day of volatile organic compounds shall reduce the emissions of such organic materials into the atmosphere to less than 33 pounds per day.

310.3 A person shall not transfer VOC having a vapor pressure greater than 4.0 psi at 20oC, from any truck or rail car into any storage tank of a 2,000 gallons capacity or greater, unless VOC emissions during transfer are reduced by 90% by weight.

310.4 A person shall install pressure/vacuum vents set at + 0.03 psig on all storage tanks that store VOC with a vapor pressure greater than 1.5 psig at 20oC, unless a more effective control system, approved by the Air Pollution Control Officer, is used.

310.5 A person shall repair all leaks from which a liquid, containing VOC, can be observed to be running or dripping. The repair shall be completed the first time the equipment is off-line for a period of time long enough to complete the repair.

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.