Linda Markarian Safety Health Environment Manager Avecia Biotechnology, Inc'

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Linda MarkarianSafety Health Environment
ManagerAvecia Biotechnology, Inc.

Environmental ExpoMay 6, 2002

• MACT Standards
• Pharmaceuticals Production

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INTENT
Control emissions to the level achievable by the
Maximum Achievable Control Technology
(MACT) OR Reduce generation of emissions by
using pollution prevention strategies
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APPLICABILITY

• Any pharmaceutical manufacturing operation (as
  defined) that
• meets the criteria
• Manufacture a pharmaceutical product
• Are located at a plant site that is a major
  source
• Process, uses, or produce a HAP

Must exceed 10 tons/yr of an individual HAP
or 25 tons/yr of combined HAP
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DEFINITIONS

• Pharmaceutical Product
• Any product described in SIC 2833 or 2834
• Any material whose process is described by
• NAICS 325411 or 325412
• A finished dosage form of a drug (ex. Capsule,
  tablet or
• solution that contains an active ingredient
  generally )

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DEFINITIONS

• Pharmaceutical Product (contd)
• Components (excluding excipients) whose
  intended primary use is
• Furnish pharmacological activity
• Have direct effect in the diagnosis, cure,
  mitigation, treatment or
• prevention of disease or
• Affect the structure of any function of the body
  of man or other
• animals.
• Includes drug components such as raw starting
  materials or precursors that undergo chemical
  change or processing before becoming active
  ingredients.

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APPLICABILITY
Does not apply to Research Development
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APPLICABILITY
Existing Sources 3 years from date of
promulgation (Sept. 21, 1998) New
Sources Required to comply upon startup.
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SCOPE
Air emissions of HAP compounds originate from
breathing and withdrawal losses from storage
tanks, venting of process vessels, leaks from
piping and equipment used to transfer HAP
compounds and volatilization of HAPs from
wastewater sources.
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4 MAJOR PROVISIONS

• Process Vents
• Storage Tanks
• Equipment Components (LDAR or Leaks)
• Wastewater

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PROCESS VENTS

• New Sources
• 98, by weight, control for vents in process
• w/uncontrolled emissions gt 400 lbs/yr

• Existing Source
• lt 2,000 lbs/yr from sum of all process vents w/in
  a
• process considering control
• Note limited to 7 processes/yr per facility
• OR
• Meet 93 overall control

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PROCESS VENTS

• Alternative Existing or New
• Route all vents from a process to a control
  device
• Achieving outlet concentrations of
• TOC lt 20 ppmv
• Hydrogen halides halogen lt 20 ppmv
• Any process vents w/in a process that are not
  routed
• to the control device are subject to 93 and 98,
• respectively.

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STORAGE TANKS
New existing sources Tanks gt 10,000 gallons
and tanks storing material with a v.p. gt
1.9 p.s.i. Required control Tanks gt 10,000
gallons and lt 20,000 gallons reduce emissions by
90 Tanks gt 20,000 gallons must reduce by 95
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STORAGE TANKS

• Control Systems
• Internal floating roof with specified seals and
  fittings
• External floating roof
• External floating roof covered to an internal
  floating roof
• A closed vent system w/90 or 95, respectively,
  efficient
• control device.
• OR

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STORAGE TANKS
Controls (contd) Route storage tank vents
through control device and achieve lt 20
ppmv TOC concentration lt 20 ppmv Hydrogen
halide
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EQUIPMENT COMPONENTS

• Affected Equipment
• Closed vent transport systems, vapor collection
  systems
• bypass lines
• Tank or container covers, fixed roofs
  enclosures
• _at_ 5 HAP content _at_ gt 300 hours/year
• pumps, agitators, compressors, valves,
  connectors,
• pressure relief devices, open ended valves and
  lines,
• sampling connection systems.

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EQUIPMENT COMPONENTS

• Requirements
• Periodic field monitoring
• Design specifications
• Visual monitoring
• Pressure test alternative
• Enclosed-vent process unit alternative
• Closed vent system control device bypasses
• Repair of leaks

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WASTEWATER
Not all HAPs are regulated under MACT waste
water regulations Partially soluble HAP (PS
HAP) Common industry examples Methylene
Chloride and Toluene Soluble HAP (S
HAP) Common industry examples Methanol and
Acetonitrile
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WASTEWATER
Definitions Wastewater Stream Water that is
discarded from a PMPU through a single POD, that
contains Annual Avg. Conc gt 5 ppmw PS and/or S
HAP, and Annual Load gt 0.05 kg/yr. Note
Includes streams generated by both process
operations and maintenance activities. POD
(Point of Determination) Point where a
wastewater stream exits the process,
storage tank or last recovery device.