YOLO-SOLANO AIR QUALITY MANAGEMENT DISTRICT

RULE 2.35 - PHARMACEUTICAL MANUFACTURING OPERATIONS
(Revised August 13, 1997)

INDEX

100 GENERAL

101 PURPOSE

102 APPLICABILITY

110 EXEMPTION - SMALL FACILITIES

111 EXEMPTION - ETHYLENE OXIDE STERILIZERS


200 DEFINITIONS

201 COSMETICS MANUFACTURING PLANT

202 IN-PROCESS TANK

203 OVERALL CONTROL EFFICIENCY

204 PHARMACEUTICAL MANUFACTURING PLANT

205 VOLATILE ORGANIC COMPOUND (VOC)

300 STANDARDS

301 REACTORS, DISTILLATION COLUMNS, CRYSTALLIZERS, AND CENTRIFUGES

302 SEPARATION OPERATIONS

303 STERILIZERS

304 IN-PROCESS TANKS

305 AIR DRYERS

306 BULK LOADING

307 STORAGE TANKS

308 OPERATING REQUIREMENTS

309 SURFACE PREPARATION AND CLEANUP SOLVENT

400 ADMINISTRATIVE REQUIREMENTS

401 COMPLIANCE SCHEDULE

500 MONITORING AND RECORDS

501 SMALL-USER RECORDS

502 ORGANIC COMPOUND PROCESSING RECORDS

503 EMISSION CONTROL EQUIPMENT RECORDS

504 TEST METHODS

505 SOLVENT WASTE/RESIDUE DISPOSAL RECORDS





100 GENERAL


101 PURPOSE: The purpose of this Rule is to limit the emissions of volatile organic compounds from the manufacture of pharmaceutical and cosmetic products or devices.

102 APPLICABILITY: The provisions of this Rule shall apply to the following:

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

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

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

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

110 EXEMPTION - SMALL FACILITIES: The requirements of Sections 301, 302, 303, 305, 306, 307, and 502 of this Rule shall not apply to facilities that emit, at the design production rating, less than 10 pounds per day of volatile organic compounds provided the requirements of Section 501 are met. (Calculations shall not include surface preparation and cleanup solvent).

111 EXEMPTION - ETHYLENE OXIDE STERILIZERS: Ethylene oxide sterilizers which are subject to the provisions of Rule 9.4, ETHYLENE OXIDE STERILIZERS AND AERATORS, are exempt from the provisions of Section 303.


200 DEFINITIONS

201 COSMETICS MANUFACTURING PLANT: Any plant producing or blending chemicals for use in cosmetic products and/or manufacturing cosmetics products. Any facility or operation that has 2844 as their Standard Industrial Classification Code. Cosmetic manufacturing plants may include, but are not limited to, establishments primarily engaged in manufacturing perfumes (natural and synthetic), cosmetics, toilet preparations, shampoos and shaving products, and the blending and compounding of perfume bases.

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

203 OVERALL CONTROL EFFICIENCY: The control efficiency multiplied by the capture efficiency.

204 PHARMACEUTICAL MANUFACTURING PLANT: Any plant producing or blending chemicals for use in pharmaceutical products and/or employing chemical processes in the manufacture of pharmaceutical products or medical devices. Any facility or operation that has 283 as the first three digits of their Standard Industrial Classification Code. Pharmaceutical manufacturing plants may include, but are not limited to, establishments primarily engaged in manufacturing, fabricating, or processing medicinal chemicals and pharmaceutical products for human or veterinary use.

205 VOLATILE ORGANIC COMPOUND (VOC): Any compound containing at least one atom of carbon, except those compounds exempted under Section 214 of Rule 1.1, General Provisions and Definitions.


300 STANDARDS

301 REACTORS, DISTILLATION COLUMNS, CRYSTALLIZERS, AND CENTRIFUGES: A person shall not emit more than 10 pounds per day of volatile organic compounds from any reactor, distillation column, crystallizer, or centrifuge unless such emissions are reduced by one of the following:

301.1 An emissions control system with an overall control efficiency of 85% or more as determined by Sections 504.3 and 504.5 of this Rule.

301.2 Alternatively, surface condensers for the control of volatile organic compounds having the outlet gas temperature controlled as set forth in Table 1.


Table 1

Vapor Pressure of Liquid Volatile Organic Compounds

at 20o C (68o F)

Maximum Condenser Outlet Gas Temperature

mm Hg

Psia

oC

oF

26 - 52

0.5 - 1.0

25

77

52 - 78

1.0 - 1.5

10

50

78 - 150

1.5 - 2.9

0

32

150 - 300

2.9 - 5.8

- 15

5

> 300

> 5.8

- 25

- 13

302 SEPARATION OPERATIONS: A person shall not emit more than 10 pounds per day of volatile organic compounds from any rotary vacuum filter or any other filter or separation device having an exposed liquid surface where the liquid contains volatile organic compounds with a combined vapor pressure of 26 mm Hg (0.5 psia) or more at 20o C (68o F) unless such emissions are reduced by an emissions control system with an overall control efficiency of 85% or more on a mass basis as determined per Sections 504.3 and 504.5 of this Rule.

303 STERILIZERS: A person shall not operate any chemical sterilizer using gaseous volatile organic compounds unless emissions of volatile organic compounds from any such sterilizer exceeding 10 pounds per day are reduced by an emissions control system with an overall control efficiency of 85% or more on a mass basis as determined per Sections 504.3 and 504.5 of this Rule.

304 IN-PROCESS TANKS: A person shall not use in-process tanks for material containing volatile organic compounds unless a cover is provided. These covers must remain closed unless production, sampling, maintenance, loading, or unloading operations require operator access.

305 AIR DRYERS: A person shall not emit more than 10 pounds per day of volatile organic compounds from any air dryer unless such emissions are reduced by at least by an emissions control system with an overall control efficiency of 85% or more on a mass basis as determined per Sections 504.3 and 504.5 of this Rule.

306 BULK LOADING: A person shall not transfer organic liquids having a vapor pressure greater than 212 mm Hg (4.1 psia) at 20o C (68o F) from any rail car or tank truck into any storage tanks with a capacity greater than 2,000 gallons unless volatile organic compound emissions during transfer are reduced by a vapor recovery system with an overall control efficiency of 90% or more on a mass basis as determined per Section 504.4 of this Rule.

307 STORAGE TANKS: All storage tanks that store organic liquids with a vapor pressure greater than 78 mm Hg (1.5 psia) at 20o C (68o F) shall be equipped with pressure/vacuum vents set at a minimum of ± 2 mm Hg (± 0.03 psia).

308 OPERATING REQUIREMENTS: An operator shall repair all vapor and liquid leaks from which volatile organic compounds can be observed to be running or dripping. The repair shall be completed the first time the equipment is off-line for a period long enough to complete the repair, but not longer than 48 hours after detection of the vapor or liquid leak.

309 SURFACE PREPARATION AND CLEANUP SOLVENT: The requirements of this Section shall apply to any person using liquids containing volatile organic compounds for surface preparation and cleanup:

309.1 A person shall use closed containers for the storage or disposal of cloth or paper used for solvent surface preparation and cleanup.

309.2 A person shall store fresh or spent solvent in closed containers.

309.3 All solvent containers, including those containers with waste solvent and solvent residue, shall be labeled to indicate the type of solvent in the container.

309.4 The disposal of waste solvent and solvent residue shall be by one of the following methods:

  1. A commercial waste solvent reclamation service licensed by the State of California; or
  2. A facility that is federally or state licensed to treat, store, and dispose of such waste; or
  3. Recycling in conformance with Section 25143.2 of the California Health and Safety Code.

400 ADMINISTRATIVE REQUIREMENTS

401 COMPLIANCE SCHEDULE: Any person who must modify existing sources or equipment in order to comply with the requirements of Section 300 shall comply with the following increments of progress:

401.1 Submit an application for Authority to Construct to the District within one year of September 14, 1994.

401.2 Submit a status report to the District stating the progress of the modification within 18 months of September 14, 1994.

401.3 Be in compliance with all the requirements of this Rule within two years from September 14, 1994.


500 MONITORING AND RECORDS

501 SMALL-USER RECORDS: Any person seeking to satisfy the conditions of Section 110 shall comply with the following requirements:

501.1 The use shall keep records on a daily basis which show the types and amounts of volatile organic compounds used.

501.2 Such records shall be retained and available for inspection by the Air Pollution Control Officer for the previous two year period.

502 ORGANIC COMPOUND PROCESSING RECORDS: Any person subject to the requirements of Sections 301, 302, 303, or 305 shall keep records for each source that does not require air pollution abatement equipment. These records shall contain the following information:

502.1 A person shall maintain a current list of volatile organic compounds in use including the vapor pressure of each compound at 20o C (68o F).

502.2 A person shall keep records on a daily basis which show the types and amount of volatile organic compounds used.

502.3 Such records shall be retained and available for inspection by the Air Pollution Control Officer for the previous two year period.

503 EMISSION CONTROL EQUIPMENT RECORDS: Any person complying with the requirements of Section 300 by using air pollution control equipment shall maintain daily records of key system operating parameters, such as temperatures, pressures, and/or flow rates, for the emission control equipment. These records shall be retained and available for inspection by the Air Pollution Control Officer for the previous two year period.

504 TEST METHODS:

504.1 VOC Content: The volatile organic compound content of liquids and solvents subject to the provisions of this Rule, excluding exempt compounds, shall be determined by procedures contained in EPA Reference Test Method 24 (40 CFR 60, Appendix A).

504.2 Exempt Compounds: Measurement of exempt compounds shall be conducted and reported in accordance with ASTM Test Method D 4457-85.

504.3 Control Efficiency: The determination of control efficiency shall be determined in accordance with EPA Reference Test Methods 25, 25A, 25B, or California Air Resources Board Method 100, as applicable.

504.4 Vapor Recovery System Efficiency: The control efficiency of vapor recovery systems shall be determined in accordance with California Air Resources Board Method 202.

504.5 Capture Efficiency: Capture efficiency determinations for emissions control systems shall be in accordance with 40 CFR 52.741(a)(4)(iii).

504.6 Solvent Composition: The identity of components in liquids subject to the provisions of this Rule shall be determined by EPA Reference Test Method 18 (40 CFR 60, Appendix A), ASTM Method E168-67, ASTM Method E169-87, or ASTM Method E260-85, as applicable.

504.7 Vapor Pressure: The vapor pressure of liquids subject to the provisions of this Rule shall be determined by ASTM Test Method D2879-86 or may be obtained from a public source such as: Boublik, T., V. Freid and E. Hala, "The Vapor Pressure of Pure Substances", Elsevier Scientific Publishing Co., New York (1973), Perry's Chemical Engineer's Handbook, McGraw-Hill Book Company (1984), CRC Handbook of Chemistry and Physics, Chemical Rubber Publishing Company (1986-87), and Lange's Handbook of Chemistry, John A. Dean, editor, McGraw-Hill Book Company (1985).

505 SOLVENT WASTE/RESIDUE DISPOSAL RECORDS: Any person subject to the requirements of Section 309.4 of this Rule shall maintain the following records concerning the disposal of solvent waste and solvent residue:

505.1 The date, type, and amount of solvent waste or residue removed; and

505.2 The identification of the licensed facility for each solvent waste or residue disposal.

505.3 Such records shall be retained and available for inspection by the Air Pollution Control Officer for the previous two year period.