SACAQMD RULE 455 PHARMACEUTICALS MANUFACTURING          
LAST REVISED 07/23/81          

          SACRAMENTO METROPOLITAN AQMD                RULES AND REGULATIONS
                              RULE 455 PHARMACEUTICALS MANUFACTURING
                                         Adopted 7-23-81

                                              INDEX

          100 GENERAL
              101  PURPOSE
              110  APPLICABILITY
              111  EXEMPTIONS

          200 DEFINITIONS
              201  VOLATILE ORGANIC COMPOUNDS (VOC)
              202  PHARMACEUTICAL MANUFACTURING PLANT
              203  COSMETICS MANUFACTURING PLANT
              204  IN PROCESS TANKS

          300 STANDARDS
              301  EQUIPMENT REQUIREMENTS
              310  OPERATING REQUIREMENTS

          400 ADMINISTRATIVE REQUIREMENTS
              401  EFFECTIVE DATES
              410  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  VOLATILE  ORGANIC COMPOUNDS: (VOC)  Compounds of carbon,
                   excluding  carbon  monoxide,  carbon  dioxide,  carbonic
                   acid,  metallic   carbides   or   carbonates,   ammonium
                   carbonate,  ethane,  1,  1, 1 trichloroethane, methylene
                   chloride,  and trichlorotrifluoroethane,  that  have  an
                   absolute vapor  pressure greater than 26 mm Hg (0.5 psi)
                   at 20o Celsius (C).

              202  PHARMACEUTICAL MANUFACTURING PLANT:  Any plant producing
                   or blending chemicals for use in pharmaceutical products
                   and/or manufacturing pharmaceutical products by chemical
                   process.

              203  COSMETICS  MANUFACTURING  PLANT:  Any plant producing or
                   blending chemicals for use  in  cosmetic products and/or
                   manufacturing cosmetic products by chemical processes.

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

          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:


                            Absolute Vapor         Maximum Condenser
                            Pressure               Outlet
                            ------------------------------------------ 
                            of VOC at 20oC         Gas Temperature (C)


                            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


                   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.

              410  PLANTS IN COMPLIANCE:   The provisions of Rule 441 shall
                   not apply to processes in compliance with this rule.