New York Codes, Rules and Regulations › Title 6 - DEPARTMENT OF ENVIRONMENTAL CONSERVATION › Chapter III - AIR RESOURCES › Subchapter A - PREVENTION AND CONTROL OF AIR CONTAMINATION AND AIR POLLUTION › Part 233 - PHARMACEUTICAL AND COSMETIC MANUFACTURING PROCESSES › Section 233.2 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) For the
				  purposes of this Part, the general definitions and requirements of Part 200 of
				  this Title shall apply.
(b) For the
				  purpose of this Part, the following definitions shall apply:
(1) Annual. Refers to a period of time based
				  upon a calendar year commencing January 1st and terminating midnight December
				  31st.
(2) Condenser. A device which
				  cools a gas stream to a temperature at which all or some of the vaporized
				  volatile organic compounds in the gas stream will condense and will be
				  removed.
(3) Cosmetic manufacturing
				  process. Any process producing or blending chemicals for use in cosmetic
				  products and/or manufacturing cosmetic products by chemical processes. Cosmetic
				  products include, but are not limited to, colognes, perfumes, and nail
				  polish.
(4) Control system. Any
				  control devices, including, but not limited to condensers, which are designed
				  and operated to reduce the quantity of contamiants, including but not limited
				  to volatile organic compounds emitted to the atmosphere.
(5) In-process tank. Containers used for
				  mixing, blending, heating, reacting, holding, crystallizing, evaporating or
				  cleaning operations in the manufacture of pharmaceuticals.
(6) Lower Orange County metropolitan area.
				  The area including the towns of Blooming Grove, Chester, Highlands, Monroe,
				  Tuxedo, Warwick and Woodbury.
(7)
				  New York City metropolitan area. All of the city of New York, and Nassau,
				  Suffolk, Westchester and Rockland Counties.
(8) Pharmaceutical manufacturing process. Any
				  process involving the manufacture of pharmaceutical products and intermediates,
				  including but not limited to, the following operations:
(i) the manufacture of pharmaceutical
				  products and intermediates by chemical synthesis;
(ii) the production and separation of
				  medicinal chemicals including, but not limited to, antibiotics and vitamins
				  from microorganisms;
(iii) the
				  manufacture of botanical and biological products by the extraction of organic
				  chemicals from vegetative materials or animal tissues; or
(iv) the formulation of pharmaceuticals into
				  various dosage forms including, but not limited to, tablets, capsules,
				  injectable solutions or ointments, that are to be taken by the patient
				  immediately and in accurate amounts.
(9) Potential to emit. The maximum capacity
				  of an air contamination source to emit any air contaminant under its physical
				  and operational design. Any physical or operational limitation on the capacity
				  of the facility or air contamination source to emit any air contaminant,
				  including air pollution control equipment and/or restriction on the hours of
				  operation, or on the type or amount of material combusted, stored, or processed
				  shall be treated as part of the design only if the limitation is contained in
				  enforceable permit conditions. Fugitive emissions, to the extent that they are
				  quantifiable, are included in determining the potential to emit.
(10) Production equipment exhaust system. A
				  device for collecting and directing volatile organic compound fugitive
				  emissions from reactor openings, centrifuge openings, and other vessel openings
				  out of the work area for the purpose of protecting workers from exposure and/or
				  to reduce vapor concentrations below the lower explosive limit.
(11) Reactor. A vat or vessel, which may be
				  jacketed to permit temperature control, designed to control chemical
				  reactions.
(12) Separation
				  operation. A process that separates a mixture of compounds, including liquids
				  and/or solids into two or more components. Specific mechanisms include
				  extraction, centrifugation, filtration and crystallization.
(13) Synthesized pharmaceutical manufacturing
				  process. Any process involving the manufacture of pharmaceutical products and
				  intermediates by chemical synthesis. The production and recovery of materials
				  produced via fermentation, extraction of organic chemicals from vegetative
				  materials or animal tissues, and formulation and packaging of the product are
				  not considered to be synthesized pharmaceutical manufacturing
				  processes.