DTIC ADA259431: Mixed-Bed, Ion Exchange Device for Water Purification

Survival, Water, Medical Field Manuals

Military Manuals

Defense Technical Information Center

Document text

AD 


CONTRACT  NO:  DAMD17-90-C-0090 


TITLE:  MIXED-BED,  ION  EXCHANGE  DEVICE  FOR  WATER  PURIFICATION 


PRINCIPAL  INVESTIGATOR:  Michael  A.  Taylor,  Ph.D. 


CONTRACTING  ORGANIZATION:  Sepratech 

2131  Las  Palmas  Dr.,  Suite  A 
Carlsbad,  California  92008 


REPORT  DATE:  October  1,  1990 


TYPE  OF  REPORT:  Phase  I  Final  Report 


PREPARED  FOR:  U.S.  ARMY  MEDICAL  RESEARCH  AND  DEVELOPMENT  COMMAND 

Fort  Detrick,  Frederick,  Maryland  21702-5012 


DISTRIBUTION  STATEMENT:  Approved  for  public  release; 

distribution  unlimited 


The  findings  in  this  report  are  not  to  be  construed  as  an 
official  Department  of  the  Army  position  unless  so  designated  by 
other  authorized  documents. 


93-00804  , 


REPORT  DOCUMENTATION  PAGE 


Form  Approved 
OMB  No  0704  01 88 


Public  reposing  Duroen  for  this  collection  of  information  is  estimated  to  average  1  nour  oer  resoorse  including  tne  time  tor  reviewing  instructions  searcning  e«<stmg  data  sources 
gathering  ana  maintaining  the  data  needed,  ano  completing  ana  reviewing  the  collection  ot  information  Sena  comments  reqaramg  this  buraen  estimate  or  any  otner  asoea  of  this 
collection  of  information,  including  suggestions  tor  reducing  this  Duraen  to  Washington  HeadQuarters  Services.  Directorate  tor  information  ODerations  ana  Reoorts.  12  IS  Jefferson 
Davis  Highway.  Suite  1204  Arlington.  V A  22202-4302.  and  to  the  Office  of  Management  and  Budget  Paperwork  Reduction  Project  (0704-0188).  Washington  DC  20503 


1.  AGENCY  USE  ONLY  ( Leave  blank)  2.  REPORT  DATE  3.  REPORT  TYPE  ANO  OATES  COVERED 

1  October  1990  Phase  I  Final  (4/2/90-10/2/90) 


4.  TITLE  AND  SU8TITLE  5.  FUNDING  NUMBERS 

Mixed-Bed,  Ion  Exchange  Device  for  Water  Contract  No. 

Purification  DAMD17-90-C-0090 


6.  AUTHOR(S) 


Michael  A.  Taylor,  Ph.D. 


65502A 

3P665502M802 . BA. 166 
WUDA346137 


7.  PERFORMING  ORGANIZATION  NAME(S)  AND  ADDRESS(ES) 

Sepratech 

2131  Las  Palmas  Drive,  Suite  A 
Carlsbad,  California  92008 


8.  PERFORMING  ORGANIZATION 
REPORT  NUMBER 


9.  SPONSORING  I  MONITORING  AGENCY  NAME(S)  AND  ADDRESS(ES) 

U.S.  Army  Medical  Research  &  Development  Command 
Fort  Detrick 

Frederick,  Maryland  21702-5012 


10.  SPONSORING '  MONITORING 
AGENCY  REPORT  NUMBER 


12a.  DISTRIBUTION  AVAILABILITY  STATEMENT 


12b  DISTRIBUTION  CODE 


Approved  for  public  release; 
distribution  unlimited 


14.  SUBJECT  TERMS 


Ion  Exchange;  Deionization;  Water  Purification; 
RA  II;  SBIR;  Phase  I;  Water  supply 


IS.  NUMBER  OF  PAGES 


16.  PRICE  CODE 


18  SECURITY  CLASSIFICATION  19.  SECURITY  CLASSIFICATION  20.  LIMITATION  OF  ABSTRACT 
OF  THIS  PAGE  I  OF  ABSTRACT  I 


nclassif ied 


NSN  7540-01-280-5500 


Standard  Form  298  (Rev  2-89) 

P»»\C'rO*0  t*  .INS:  Std  23*  8 
24S  02 


APPENDIX  A 


U.S.  DEPARTMENT  OF  DEFENSE 

SMALL  BUSINESS  INNOVATION  RESEARCH  (SBIR)  PROGRAM 
PROPOSAL  COVER  SHEET 

Failure  lo  till  in  all  appropriate  spaces  may  cause  your  proposal  lo  be  disqualified. 


TOPIC  NUMBER:  DAMD1  7-90-C-0  0  90 _ 

PROPOSALTITLE:  Mixed-Bed,  Ion  Exchange  Device  for  Water  Purification 


FIRM  NAME: _ Sepratech _ 

MAIL  ADDRESS:  2131  Las  Palmas  Dr.,  Ste.  A 


CITY: 


Carlsbad , 


STATE:  CA  ZIP:  9  2009 


PROPOSED  COST:  PHASE  I  OR  II:  I  PROPOSED  DURATION;  6 

PROPOSAL  -  IN  MONTHS  — 


BUSINESS  CERTIFICATION: 

►  A /a  you  a  small  business  as  described  in  paragraph  2.2? 

►  Are  you  a  minority  or  small  disadvantaged  business  as  defined  in  paiagraph  2.3? 


►  Are  you  a  woman-owned  small  business  as  described  in  paragrapn  2  u? 

►  Will  you  permit  the  government  to  disclose  the  information  on  Appendix  B,  if  your  proposal  does  not  result 
in  an  award,  to  any  party  that  may  be  interested  in  contacting  you  for  fu-ther  information  or  possible 
investment? 


YES 

0 

□ 

□ 

0 


□ 

0 

0 

□ 


►  Has  this  proposal  been  submitted  to  other  US  government  agency/agencies;  or  DoD  components,  or  other 
SBIR  Activity?  If  yes,  list  the  name(s)  of  the  agency,  DoD  component  or  other  SBIR  office  in  the  spaces  to 
the  left  below.  If  it  has  been  submitted  lo  another  SBIR  activity  list  the  Topic  Numbers  in  the  spaces  to  the 
right  below: 


0 


►  Number  of  employees  including  all  affiliates  (average  for  preceding  12  months) 


PROJECT  MANAGER/PRINCIPAL  INVESTIGATOR  CORPORATE  OFFICIAL  (BUSINESS) 

NAME: _ Michael  A. _ Taylor  ,  Ph  ._D .  NAME:  Mark  Sizelove  _ 


TITLE: _ Product  Development _ 1  • 1  _ President 


TELEPHONE:  (619  )  438-5233  _ TELEPHONE:  (  61  9  )  438-5233 _ 

For  any  purpose  other  than  to  evaluate  thr-  piooovnl.  t'-.i:.  tints  except  Append  x  A  and  B  shall  not  be  disclosed  outside  the  Government 
and  shall  not  be  duplicates,  used  or  disclosed  in  whole  or  in  part,  provided  thm  :t  a  contract  is  awarded  to  this  proposer  as  a  result  ot  or  in 
connection  with  the  submission  oi  this  data,  tha  Government  sh.il:  have  :he  right  to  duplicate,  use  or  discloso  the  data  to  the  extent 
provided  in  the  funding  agreement.  This  restriction  does  not  limit  :!>_■  Government's  right  to  uso  information  contained  in  the  data  if  it  is 
obtained  from  another  source  without  restriction.  The  data  subtect  'a  this  restriction  is  contained  on  the  pages  of  the  proposal  listed  on  the 
line  below. 


PROPRIETARY  INFORMATION: 


DISCLOSURE  PERMISSION  STATEMENTS:  All  data  on  Appendix:  A  iclo.tsapic.  /\JI  data  on  Appendix  B,  of  an  awarded  contract  are 
also  releasablo.  - 


- _ /ft? 

SIGNATURE  OF  PRINCIPAL  INVEST. 'GAT  OH  ”ue  d'jNATM.V'.  OFCORPORATeBygrJisS  OFFI 


OFFICIAL  DATE 


Nothing  on  inis  par,  >  prop-  -t  information  'data 

'  -  •  *  V  Nr, 


APPENDIX  B 


U.S.  Of- PART  ME  NT  CF  OFFENSE 

SMALL  BUSINESS  INNOVATION  RESEARCH  (SBIR)  PROGRAM 
PROJECT  SUMMARY 


TOPIC  NUMBER:  r,AMD1  7-90-C-0090 _ _ 

PROPOSAL  TITLE.  MjXed-Bed.  Ion  Exchange  Device  for  Water  Purification 


FIRM  NAME:  Sepratech 


PHASE  I  or  II  PROPOSAL  I 


Technical  Abstract  (Limit  your  abstract  to  200  words  with  no  classifiGd'or^lrophetarylnformation/data^™^^^™™1™ 
I .  PROJECT  SUMMARY 

The  purpose  of  this  contract  was  to  determine  the  feasibility  of  develop¬ 
ment  and  subsequent  production  of  a  small  ion  exchange  device  for  water 
purification  in  a  field  setting.  The  device  specifications  included:  a 
capacity  of  1  g  of  NaCl ;  flow  rates  of  20-25  or  200-300  ml/min;  removal  of 
dissolved  solids  to  less  than  1  mg/ml;  and  operation  in  any  orientation 
without  channel  formation. 

The  work  performed  included  selection  of  a  mixed-bed,  ion  exchange  resin 
combination  after  determination  of  working  capacities,  physical  characteris¬ 
tics,  and  resistance  to  temperature  stresses. 

Prototype  housing  design  included  analysis  of:  1.)  device  patents,  2.) 
flow  patterns,  3.)  bed  volume  changes,  4.)  connection  requirements,  and  5.) 
housing  materials;  Construction  included  development  of:  1.)  volixne  ccmpen- 
sating  frits,  2.)  inlet  and  outlet  covers,  3.)  component  design,  4.)  weld 
site  engineering,  and  5.)  manufacturing  procedures. 

Two  device  designs  were  used  to  construct  fully  functional  prototypes 
with  working  capacities  of  6.5  and  1.0  grams  of  NaCl.  These  devices  were  ef¬ 
fective  in  any  orientation  without  evidence  of  channel  formation  at  flow 
rates  of  275  and  25  ml/min  respectively. 


Anticipated  Benefits/Potential  Commercial  Applications  of  the  Research  or  Development 

Validation  of  the  prototype  indicated  that  these  devices  exceeded  the 
specifications  necessary  for  production  of  ultra-pure  water  in  any  setting. 
This  device  could  be  used  as  a  means  of  sampling  or  isolation  for  any  ap¬ 
plication  where  elimination  of  degradative  forces  could  increase  sampling  ac¬ 
curacy  . 

List  a  maximum  of  8  Key  Words  that  describe  the  Project. 

Ion  Exchange _  _ 


Deionization 


Water  Purification 


Nothing  on  this  pags  it  classified  or  proprietary  information/data 
Proposal  page  No.  2 


I  I .  DETAILED  PROJECT  OBJECTIVES 


A.  PRIMARY  OBJECTIVE 

The  primary  objective  of  this  project  was  to  determine  the  feasibility  of 
designing  and  constructing  a  Mixed-Bed,  Ion  Exchange  device  with  a  capacity 
of  1  gram  of  Sodiim  Chloride  frcm  source  water  containing  10  mg/ml  of  dis¬ 
solved  salts  at  flow  rates  up  to  300  ml/min.  The  device  must  be  equally  ef¬ 
fective  in  any  orientation  without  the  formation  of  channels  within  the 
separatory  bed,  and  must  maintain  a  uniformity  of  flow  to  maximize  capacity. 
Included  in  the  primary  objective  was  the  construction  of  working  prototypes 
to  exemplify  the  functional  potential  and  possibilities  of  mass  production  of 
these  devices. 


B.  OBJECTIVES  ACCOMPLISHED  TO  ACHIEVE  THE  PRIMARY  GOAL 

1.  Ion  Exchange  resin  selection  by: 

a.  Analysis  of  resins  by: 

1. )  Collection  of  manufacturers  published  and  unpublished  data  on 

resin  character i st i cs , 

2. )  Analysis  of  Resin  data, 

3. )  Determination  of  the  cost  effectiveness  of  resins,  and 

4. )  Selection  of  a  group  of  resins  for  further  testing. 

b.  Testing  of  resins  by: 

1. )  Obtaining  test  samples  of  resins,  and 

2. )  Testing  of  resins  for: 

a. )  Working  capacity; 

b. )  Resistance  to  temperature  stresses  at: 

(1.)  High  temperatures,  and 
(2.)  Freezing  and  thawing;  and 

c. )  Physical  changes  in  separatory  bed  volune  following  ex¬ 

posure  to  dissolved  salts. 


2.  Design  the  device  by: 

a.  Determination  of  whether  patented  Sepratech,  Ion  Exchange  device 

designs  and  technologies  could  be  effectively  incorporated  into  a 
device  designed  for  field  use  in  the  purification  of  RO  pretreated 
water,  and 

b.  Designing  the  device  housing  by: 

1.)  Determination  of  an  appropriate  flow  design  within  the  housing 
through : 

a. )  Analysis  of  existing  patent  designs  for  determination  of 

the  applicability  of  use  in  the  proposed  device, 

b. )  Determination  of  the  flow  designs  necessary  to  achieve  the 

specified  flow  rates, 

c. )  Determination  of  the  separatory  bed  volune  necessary  to 

achieve  a  working  capacity  sufficient  to  meet  the  water 
volune  production  specifications,  and 

d. )  Selection  of  appropriate  connections  for  use  in  field  set¬ 

tings  and  to  allow  adequate  flow  rates  to  achieve  the 
specified  volunes  of  water  output;  and 


DTIC  QUALITY  INSPECTED  6 


uiocr x  t i  u 1 1 on/ 

Availability  Codoa 
Avail  and/or 
Olat  Spoolal 

A  I  I 


□  □ 


2. )  Selection  of  an  appropriate  housing  material  by: 

a.)  Analysis  of  the  physical  and  chemical  characteristics  of 
various  potential  housing  materials  based  upon: 

(1.)  Impact  strength, 

(2.)  Resistance  high  and  low  temperature  stress, 

(3. )  Relative  cost, 

(3.)  Ease  of  manufacturing, 

(4.)  FDA  approval  for  use  in  contact  with  food  and  medical 
devices  based  upon  levels  of  extractibi 1 ity ,  and 
(5.)  Resistance  to  physical  and  chemical  stresses  as¬ 
sociated  with  use  in  a  field  setting,  i.e.  ozone  and 
ultraviolet  irradiation. 

3. )  Determination  of  an  effective  weld  site  design  adequate  to 

withstand  the  postulated  pressures  generated  within  the  device 
during  use  and  exposure  to  temperatures  reached  during 
autoclaving;  and 

c.  Design  the  housing  components,  including: 

1. )  Selection  and  development  of  an  effective  frit  material  which 

compensated  for  changes  in  separatory  bed  volune  during  opera¬ 
tion,  and 

2. )  Selection  and  acquisition  of  effective  inlet  and  outlet  covers 

capable  of  temperature  resistance  without  welding  to  the  hous¬ 
ing  ports  or  loosening  due  to  differences  in  expansion  coeffi¬ 
cients. 

3.  Construct  prototype  devices  by: 

a.  Selection  of  materials  for  prototype  construction, 

b.  Preparation  of  engineering  drawings  of  the  prototype, 

c.  Manufacture  of  prototype  weld  sites,  and 

d.  Manufacture  of  prototype  housings. 

4.  Test  manufacture  of  prototype  devices  to  determine  effective  methods  of 

assembly  and  construction. 

a.  Determination  of  the  most  effective  welding  machine  parameters  to  weld 

together  the  housing  components,  and 

b.  Determination  of  the  most  effective  procedures  to  fill  housing 

uniformly  without  gaps,  channels,  or  pockets. 

5.  Performance  of  validation  testing  of  the  prototype  working  capabilities; 

including: 

a.  Working  flow  rate  potential  during  use  as  the  separatory  bed  changes 

in  volune, 

b.  Working  capacity,  and 

c.  Demonstration  of  the  ability  of  the  device  to  remain  effective  in  any 

orientation  by  determination  of: 

1. )  Working  capacity  of  prone  devices 

2. )  Working  flow  rates  in  the  prone  position 

3. )  Absence  of  channel  formation  in  devices  in  the  prone  position 


4 


III.  WORK  CARR  I  ED  OUT 

A.  ION  EXCHANGE  RESIN  SELECTION 

Analysis  of  available  information  on  Ion  Exchange  resins 

The  initial  phase  of  this  project  was  the  selection  of  the  Ion  Exchange 
Resins  for  preparation  of  the  separatory  bed.  To  select  the  most  effective 
resin,  Ion  Exchange  resin  manufacturers  were  contacted  to  request  published, 
technical  data  on  any  resins  with  potential  for  use  in  water  purification. 
Although  all  strengths  of  resins  were  investigated,  it  was  felt  that  a  Mixed- 
Bed  combination  of  hydrogen  forms  of  strong  acid  and  free  base  or  hydroxide 
forms  of  strong  base  exchangers  provided  the  highest  degree  of  dissociation, 
therefore,  were  most  appropriate  for  this  application.  The  greater  degrees  on 
resin  dissociation  associated  with  strong  ion  exchange  resins  enabled  in¬ 
creased,  irreversible  ionic  interactions  between  resins  and  contaminating 
ions  within  the  feedwater.  Another  reason  for  the  preference  of  a  Mixed-Bed 
combination  of  strong  acid,  cationic  and  strong  base,  anionic  exchangers  was 
the  predetermination  that  disposability  was  preferable  over  regeneration. 

The  manufacturers  contacted  included:  Syborn  Incorporated;  Dow  Chemical 
Corp.;  Bio-Rad  Laboratories,  Inc.;  Rohm  &  Haas  Co.;  Mallinkrodt,  Inc.;  Pierce 
Chemical  Co.;  Signa  Chemical  Co.;  Aldrich  Chemical  Co.;  J.T. Baker  Chemical 
Co.;  Applied  Separations  Inc.;  Benson  Polymeries  Inc.;  ES  Industries  Inc.;  EM 
Science;  Alltech  Associates,  Inc.;  Pharmacia  LKB  Biotechnology,  Inc.; 
Macherey-Nagel ;  and  Baxter  Scientific  Products. 

The  data  obtained  from  ion  exchange  resin  manufacturers  were  evaluated 
for  the  following  criteria: 

1.  Compliance  of  resin  composition  with  Code  of  Federal  Regulations 

21:173.25  for  use  in  preparation  of  food  and  medical  materials, 

2.  The  highest  thermal  resistance  (for  autoclaving  and  freeze-thawing) , 

3.  The  highest  capacity, 

4.  The  greatest  flow  potential, 

5.  The  particle  size, 

6.  The  greatest  resistance  to  fracture, 

7.  The  least  response  to  osmotic  shock,  i.e.  swelling  when  saturated  with 

dissociated  ions,  and 

8.  The  relative  cost  per  volume. 

Selection  of  resins  for  further  testing 

Following  completion  of  the  analysis  of  all  available  information  on  in¬ 
vestigated  resins,  the  ion  exchange  resins  listed  in  Table  1.  were  selected 
for  further  testing. 

Obtain  resin  samples  for  further  analysis 

Seventeen  test  resin  samples  were  obtained  after  persistent  requests  from 
5  of  the  listed  manuf acturers .  Two  samples  of  particular  interest  were  not 
received  until  the  project  term  was  near  completion.  Ecotec,  Inc.  provided 
separate  cationic  and  anionic  exchange  resins.  These  resins  were  of  interest 
because  they  were  the  smallest  sized  particle  of  all  industrial  resins.  In 
spite  of  the  reduction  in  particle  size  the  capacity  was  purported  to  be  un¬ 
changed.  Sybron  provided  the  mixed-bed  resin,  lonac  NM-201/SG.  This  resin 
combination  had  very  recently  been  brought  to  market.  This  was  described  as 
Sybron 's  highest  capacity,  nuclear  grade  of  mixed-bed  resin. 


5 


Table  1.  Ion  Exchange  Resins  Selected  for  Further  Testing 


Composition 

Manufacturer 

Resin 

Mixed  Bed  Resins 

Dow  Chemical 
Rohm  &  Haas 

Rohm  &  Haas 
Syborn 

Syborn 

Dowex  MR- 3 

Amber lite  MB-1 
Amber lite  IRN-150 
lonac  NM-60/60 
lonac  NM-201/SG 

Strong  Acid  Cationic 
Exchanger 

Bio-Rad  Lab 

Dow  Chemical 

Rohm  &  Haas 

Rohm  &  Haas 
Syborn 

Ecotec 

AG  50X8 

Dowex  HCR-S 

Amber lite  iR-120 
Amberlite  IRN-77 
lonac  C-267/SG 
Cationic  Resin 

Strong  Base  Anionic 

Exchanger 

Bio-Rad  Lab 

Dow  Chemical 

Rohm  &  Haas 

Rohm  &  Haas 
Syborn 

Ecotec 

AG  1X8 

Dowex  HCRW  2 
Amberlite  IRN-78 
Amber lite  1 RA- 400 
lonac  ASB-1P 
Anionic  Resin 

Resin  Testing 

Analysis  of  the  data  provided  by  resin  manufactures  indicated  that,  as 
postulated  in  the  proposal  application,  additional  testing  was  necessary  to 
select  a  resin  combination  capable  of  meeting  the  requirements  associated 
with  use  in  field  settings.  The  parameters  described  were  tested  for  the 
defined  reasons. 

The  following  tests  were  performed  on  the  resin  samples: 

Determination  of  the  working  capacity  of  selected  resins 

The  initial  capacity  testing  was  designed  to  be  performed  under  working 
conditions  with  fluid  passing  through  a  closed  vessel  rather  than  in  a  static 
condition,  as  in  a  slurry. 

The  standard  bead  size  for  resins  used  in  industrial  applications,  most 
commonly  range  from  16  to  50  mesh  size  or  roughly  0.3  to  1.18  nrm.  These  were 
relatively  large  particles.  Because  of  their  size,  the  amount  of  interstitial 
spaces  between  the  particles  was  also  relatively  large.  As  the  system  size 
(particularly  bed  height)  decreased  the  likehood  of  the  fluid  phase  passing 
through  the  systems  without  encountering  attractive  forces  associated  with 
the  resin  proport i onate 1 y  increased.  Thus,  the  capacity  of  separatory  bed  was 
dependent  upon  the  dimension  of  the  housing  as  well  as  the  flow  rate  through 
the  system.  These  characteristics  were  even  more  significant  in  smaller 
devices  with  minimal  bed  height.  Therefore,  the  working  capacity  under 
defined  conditions  were  unique  to  each  design  and  must  be  determined  empiri¬ 
cal  ly. 

One  way  of  maximizing  the  capacity  of  the  separatory  bed  was  through  the 
use  of  smaller  resin  particles.  This  was  our  initial  reason  for  investigating 
resins  carmonly  used  in  biotechnology  related  applications  where  must  smaller 


6 


fluid  volute  were  involved. 


Determination  of  resistance  to  temperature  stresses 
Resistance  to  high  temperatures 

In  order  to  assure  optimal  use  of  these  devices,  they  needed  the  longest 
shelf- life  possible,  therefore,  must  be  free  of  any  potential  pyrogens.  To 
assure  non- contamination  during  storage  these  devices  were  required  to  be 
sterilized  during  manufacture.  Therefore,  the  components  .and  resins  must  be 
able  to  withstand  the  temperatures  and  pressures  associated  with  autoclaving 
or  an  alternative  means  of  decontamination.  Potential  problems  resulting  from 
exposure  to  elevated  temperatures  included:  changes  in  the  strength  of  the 
housing  and  the  housing  weld,  loss  of  Ion  Exchange  bed  capacity,  and  degrada¬ 
tion  of  the  Ion  Exchanger  support.  This  testing  was  particularly  important 
for  hydroxyl  forms  of  anion  exchangers,  because  of  their  sensitivity  to 
diminished  capacity  at  elevated  temperatures . 

Resistance  to  freezing 

In  field  settings,  potential  exposure  to  temperatures  below  freezing 
would  be  inevitable,  therefore,  housing  and  resin  testing  included  exposure 
to  the  stresses  associated  with  freezing  and  thawing.  The  potential  problems 
associated  with  frigid  temperatures  included  increased  brittleness  of  the 
housings  and  the  fracture  of  the  particles  of  the  separatory  bed.  There  was 
also  the  potential  that  the  working  apacity  of  the  separatory  bed  would  be 
diminished  following  freezing. 

Determination  of  the  physical  changes  reins  during  use 

As  the  dissociated  ions  from  the  fluid  phase  were  removed  by  the  Ion  Ex¬ 
changers,  the  support  matrix  compresses.  This  results  in  diminished  bed 
volume.  In  order  to  provide  adequate  compensation  for  the  bed  volume  changes 
to  prevent  channel  formation,  the  amount  of  bed  volume  change  must  be  deter¬ 
mined  under  working  conditions.  Since  the  bed  volune  changes  were  a  function 
of  the  working  capacity,  these  characteristics  were  also  dependent  upon  the 
device  dimensions,  the  flow  rate,  and  the  test  conditions.  These  parameters 
must  be  determined  empirically. 

B.  DESIGN  THE  DEVICE  HOUSING 

Analysis  of  the  applicability  of  Sepratech  Ion  Exchange  patents 

Because  of  the  similarity  in  the  specifications  for  the  Ion  Exchange 
device  solicited  in  this  project  and  the  claims  of  Sepratech  patented  design 
of  Ion  Exchange  devices,  it  was  felt  that  the  patented  designs  were  poten¬ 
tially  applicable  to  the  project.  However,  it  was  necessary  to  analyze  the 
designs  to  determine  what  modifications  were  necessary  to  reach  the  proposed 
requirements.  Specifically,  the  flow  rates  were  to  be  increased,  therefore, 
it  was  necessary  to  determine  whether  the  closed  system  could  sustain  the 
defined  flow  rate.  It  was  also  necessary  to  define  whether  the  backpressure 
generated  within  the  flow  distribution  chamber  was  adequate  to  maintain  a 
uniformity  of  flow  in  larger  devices. 

Determination  of  an  appropriate  flow  design 

Following  review  of  the  patented  designs,  the  design  of  flow  through  the 


7 


proposed  prototype  devices  was  defined.  This  was  determined  by  review  of  the 
limits  of  flow  rate,  resulting  back  pressure,  bed  diameter,  and  bed  height  in 
relation  to  the  maintenance  of  the  uniformity  of  flow  within  the  system. 

Determination  of  the  housing  design  adequate  for  prototype  construction 

It  was  necessary  to  adapt  the  housing  design  to  provide  for  ease  of  con¬ 
struction  and  assembly  of  functional  prototypes.  The  ultimate  device  housing 
was  expected  to  be  constructed  of  two  injection  molded  pieces,  ultrasonical ly 
welded  together.  However,  the  prototype  was  constructed  of  five  separate 
pieces  and  assembled  with  four  ultrasonic  welds. 

Determination  of  the  separatory  bed  volume 

Following  analysis  of  separatory  bed  capacity  per  bed  volume  data 
provided  by  manufacturers  and  determined  by  preliminary  testing,  the  housing 
internal  volume  and  ratio  of  height  to  diameter  were  defined.  These  dimen¬ 
sions  took  into  considerations  expected  differences  in  working  capacities 
unique  to  each  device  and  the  test  conditions. 

Selection  of  appropriate  connections  for  use  in  field  settings 

To  assure  that  this  device  was  attached  with  the  other  portions  of  the  IV 
water  maker  securely,  aseptically,  and  easily,  an  appropriate  means  of  con¬ 
necting  portion  of  the  system  was  developed. 

Selection  of  an  appropriate  housing  material 

Devices  dedicated  to  medical  applications  in  field  settings  places  spe¬ 
cial  requirements  on  the  materials  used  to  construct  these  devices.  There¬ 
fore,  an  analysis  of  the  physical  and  chemical  characteristics  of  various 
potential  housing  materials  was  performed.  This  analysis  was  based  upon: 

1.  Impact  strength 

2.  Resistance  high  and  low  temperature  stress 

3.  Resistance  to  anticipated  working  pressures 

4.  Relative  cost 

5.  Ease  of  manufacturing 

6.  FDA  approval  for  use  in  contact  with  food  and  medical 

devices  based  upon  levels  of  extract ibi 1 ity. 

7.  Resistance  to  physical  and  chemical  stresses  associated  with 

use  in  a  field  setting,  i.e.  ozone  and  ultraviolet  ir¬ 
radiation. 

Determination  of  an  effective  weld  site  design 

Construction  of  prototypes  and  the  final  product  required  that  a  weld 
site  be  designed,  constructed,  and  validated.  This  weld  site  must  be  capable 
of  withstanding  at  least  4  times  the  working  pressures  postulated  to  occur 
within  the  device.  The  design  had  to  take  into  consideration  the  materials 
characteristics  an  housing  dimensions  to  assure  weld  uniformity  and  strength. 
To  construct  prototypes  of  this  weld  site  it  was  necessary  to  have  the 
cylinders  and  tops  machined  to  close  tolerances  (+/-  0.001  inches).  Depending 
upon  the  material  used  this  could  be  very  difficult,  particularly  if  extruded 
cylinders  were  used  in  prototypes  construction.  Extruded  materials  vary  con¬ 
siderably  in  dimensions. 


8 


C.  DESIGN  THE  HOUSING  COMPONENTS 


Selection  and  development  of  an  effective  frit  material 

Since  the  separatory  bed  volume  was  expected  to  diminish  cons i deraf  1 y 
during  operation,  the  volune  compensating  frit  material  must  be  designed  to 
meet  or  exceed  this  decreased  volume.  This  portion  of  the  device  design  wr_s 
critical  to  prevent  the  formation  of  channels  within  the  separatory  bed.  In 
addition  the  frit  must  have  sufficient  backpressure  to  force  fluids  entering 
the  device  to  the  periphery,  prior  to  passing  through  the  frit.  This  enhances 
the  uniformity  of  flow  within  the  device.  However,  the  backpressure  was  not 
to  be  excessive  in  order  to  minimize  the  total  backpressure  within  the  sys¬ 
tem.  The  frits  must  be  composed  of  materials  with  FDA/USP  approved  levels  of 
extractibi 1 ity  and  must  have  resistance  to  121  degrees  centigrade. 

Selection  and  acquisition  of  effective  inlet  and  outlet  covers 

Device  use  in  field  settings  recjired  that  the  inlet  and  outlets  be 
covered  securely  to  prevent  contamination.  The  covers  must  also  be  easily 
removable.  This  required  that  they  were  composed  of  dissimilar  materials. 

Like  materials  have  a  tendency  to  bind  and  even  weld  when  exposed  to  elevated 
temperatures.  The  covers  had  to  have  compatible  coefficients  of  expansion 
since  temperature  variation  could  result  in  the  loosening  of  covers. 

D.  CONSTRUCT  PROTOTYPE  DEVICES 

After  the  housing  design  was  decided  drawings  were  prepared  for  use  by 
the  contracted  machining  facilities.  Three  facilities  were  contracted  to  mill 
prototype  weld  sites.  This  enabled  comparative  analysis  of  each  facilities 
ability  to  perform  the  milling  of  the  complete  housings  to  the  desired 
tolerances.  Following  selection  of  a  single  facility,  75  prototypes  were 
machined  from  extruded  polycarbonate  cylinder  and  flat  stock. 

E.  TEST  MANUFACTURE  PROTOTYPE  DEVICES 

In  order  complete  assembly  of  functional  prototypes  it  was  necessary  to 
develop  effective  methods  of  assembly  and  construction,  including  the 
fol lowing: 

Define  the  most  effective  welding  procedures 

For  selection  of  the  machine  facility  for  prototype  milling  and  the  op¬ 
timization  of  ultrasonic  welds  on  prototypes  the  welding  procedures  had  to 
defined.  The  ultrasonic  weld  of  the  housings  components  required  the 

coordination  of  nine  separate  parameters.  The  gain  of  booster  had  to  be 
matched  with  the  frequency  of  the  welding  horn.  In  addition  the  speed  of  arm 
travel  had  to  be  matched  with  the  weld  time,  the  pretriggering  of  the  we  id 
cycle,  the  hydraulic  pressure  of  the  welding  arm,  the  welder  triggering  pres¬ 
sure,  and  the  end  of  weld  shut-off.  It  was  necessary  to  determine  the 

majority  of  these  settings  empirically  through  progressive  adjustments, 
weld  inspection,  and  pressure  testing. 

Determination  of  the  effective  cylinder  filling  procedures 

For  effective  function  the  housing  had  to  be  filled  uniformly  without 
gaps,  channels,  or  pockets.  Several  basic  methods  and  nunerous  variations 


9 


were  tested,  including  use  of  dry  or  wet  (slurried)  particles. 

F.  VALIDATE  THE  COMPLETED  PROTOTYPE  FUNCTIONAL  POTENTIAL 

Determination  of  the  working  flow  rate 

The  working  flow  rate  and  associated  backpressures  in  various  orienta¬ 
tions  were  determined  for  both  sized  prototypes  with  several  different 
separatory  beds.  This  testing  was  monitored  as  the  separatory  bed  volume 
changed  to  monitor  for  potential  breakthrough  due  to  channel  formation. 

Determination  of  the  working  capacity 

The  working  capacity  is  various  orientations  was  determined  for  both 
sized  prototypes  with  several  different  separatory  beds.  This  testing  was 
monitored  as  the  separatory  bed  volume  changed  to  monitor  for  potential 
breakthrough  due  to  channel  formation. 

IV.  RESULTS  OBTAINED 

A.  RESIN  OOST  ANALYSIS 
Cost  Analysis  of  Resins 

The  cost  of  the  resins  ccnrmonly  used  for  industrial  applications  ranged 
from  $82  to  $84  per  cubic  foot  for  anionic  exchangers  and  $218  to  $226  per 
cubic  foot  for  cationic  exchangers.  Performed  mixed  exchangers  were  frcm  $151 
to  $165.  Resins  of  the  same  support  composition  i.e.  styrene  linked  divinyl- 
benzene,  used  in  laboratory-scale  systems  were  priced  at  $45  to  $52  per  100 
grams.  This  resin,  swelled  at  ionic  saturation  had  a  bed  volume  of  150  ml  per 
100  grams.  Therefore,  the  price  per  cubic  foot  calculated  to  be  roughly  $9800 
per  cubic  foot.  The  later  resins  are  also  of  considerably  more  fragile  struc¬ 
ture,  therefore,  these  resins  were  not  felt  to  be  appropriate  for  this  ap- 
pl ication. 

We  were  unable  to  locate  industrial  resin  suppliers  manufacturing  par¬ 
ticles  smaller  than  the  16  to  50  mesh  size,  with  the  single  exception  of 
Ecctec  Inc.  Their  resin  sizes  were  from  100  to  200  mesh.  Because  their 
processes  reduce  resin  size  without  changing  the  per  particle  capacity,  the 
relative  capacity  of  an  equivalent  bed  volume  was  postulated  to  be  markedly 
increased. 

B.  RESIN  TEST.NG 
Capacity  testing 

The  baseline  working  capacity  of  resin  samples  was  initially  tested  in 
closed,  5  ml  vessels  at  slow  flow  rates  between  20  to  30  ml/min.  Weighed 
sample  of  resin  were  exposed  to  source  •.  ater  consisting  of  ultra-pure  water 
containing  100  mg/1  of  Sodium  Chloride.  The  effluent  frcm  the  test  device  was 
monitored  for  changes  in  TD5.  The  solution  was  recirculated  through  the  test 
sample.  Increased  TDS  was  taken  to  indicate  saturation  of  the  Ion  Exchange 
resins  in  this  test  system  under  the  defined  conditions.  From  the  volune  of 
water  passing  through  the  device  the  capacity  of  the  resin  was  calculated. 

The  Rohm  &  Haas,  Amberlite  IRN-150  and  the  Sybron,  lonac  NM-201/SG  had 
equivalent  capacities  23  mg  of  NaCl  per  ml  of  resin  at  test  device  saturation 
(Table  2.).  All  other  resin  samples  had  lower  capacities.  The  ability  to 


10 


remove  dissociated  ions  increased  as  the  flow  rates  were  decreased. 


Table  2.  WORKING  CAPACITY  TESTING 


RESIN 

BED  TYPE  GRADE 

WORKING  CAPACITY 
g  ions/g  resin 

g  ions/ml 

AMBERLITE  MB-1 

MIXED 

0.030 

0.020 

AMBERLITE  IRN-150 

MIXED  NUCLEAR 

0.033 

0.022 

DCWEX  MR-3 

MIXED  NUCLEAR 

0.030 

0.020 

DCWEX  MRS-C 

MIXED 

0.025 

0.017 

IONAC  NM-60/SG 

MIXED  NUCLEAR 

0.025 

0.017 

I0NAC  NM-201/SG 

MIXED  NUCLEAR 

0.032 

0.021 

ECOTEC  (REGENERATED)  MIXED 

0.005 

0.003 

AMBERLITE  IR-120 

CAT  IONIC-  NUCLEAR 

0.075 

0.050 

AMBERLITE  IRN-77 

CAT  1 ON  1 C-H 

0.095 

0.064 

DOMEX  HCR-S 

CAT  1  ON  1 C~H 

0.055 

0.037 

IONAC  C-201/SG 

CAT  1 ONI C-H 

0.086 

0.058 

E00TEC 

CAT 1  ONI C-H 

ND 

ND 

AMBERLITE  IRN-78 

ANIONIC-O  NUCLEAR 

0.065 

0.044 

AMBERLITE  IRA-400 

ANIONIC-OH 

0.075 

0.050 

DCWEX  SBR-P 

ANIONIC-OH 

0.053 

0.036 

IONAC  ASB-1P 

ANIONIC-OH 

0.060 

0.040 

EOOTEC 

ANIONIC-OH 

ND 

ND 

Defining  a  capacity  per  unit  volume  provided  what  was  likely  an  in¬ 
herently  erroneous  basis  for  comparison.  It  was  clear  that  the  resin  capacity 
was  a  relative  measure  of  the  mix  of  particle  sizes  within  a  given  range,  the 
regeneration  level,  and  the  level  of  hydration.  The  particle  size  in  the  16 
to  50  mesh  range  are  from  1.18  millimeters  to  0.3  millimeters.  Any  skewing  in 
the  distribution  made  a  significant  difference  in  the  bed  volume  to  capacity 
ratio.  The  regeneration  level  depended  upon  the  manufacturer,  however,  was 
also  dependent  upon  the  age  of  the  resin  with  labile  chemistries  (hydroxyl 
anion  exchangers).  The  level  cf  hydration  affected  the  particle  size,  there¬ 
fore,  the  bed  volume.  This  of  course  varied  considerably  as  the  dissociated 
salts  were  inmob i  1  i zed .  For  these  reasons  the  capacity  per  bed  volume  was 
likely  to  vary  significantly  depending  upon  the  conditions. 

The  working  capacity  of  the  Ecotec  resin  combination  was  purported  to  be 
roughly  6  times  the  working  capacity  of  the  Amberlite  IRN-150  and  lonac  NM- 
201/5G  samples.  The  working  capacity  was  based  upon  assumptions  provided  by 
the  manufacturer ,  related  to  equivalents  of  absorption  of  metal  ions  in  solu¬ 
tion. 

The  variation  in  manufacturers  data  and  the  observed  capacities  were  in 
part  attributed  to  the  size  of  the  test  vessel  and  test  conditions.  Under  all 
manufacturers  suggested  test  systems  the  bed  height  was  defined  as  a  minimun 
of  30  inches  tall,  with  flow  rates  greater  than  a  gallon/minute  (3.8 
1 iters/min) . 


11 


High  Temperature  Testing 

Following  exposure  of  weighed  resin  samples  to  121  degrees  Centigrade  for 
15  minutes  in  pressurized  steam,  no  observable  physical  changes  were  evident 
(Table  3.).  however,  there  was  seme  loss  of  working  capacity.  The  results  of 
testing  of  the  separate  cation  and  anion  exchangers  indicated  that  no  sig¬ 
nificant  loss  of  capacity  occurred  among  any  of  the  the  cationic  exchangers. 
The  capacity  loss  among  anionic  and  mixed-bed  exchangers  ranged  frem  5  to  15 
percent.  In  addition,  since  separate  samples  of  all  the  constituents  of  the 
mixed  bed  combinations  were  not  available  for  all  samples,  it  was  not  pos¬ 
sible  to  verify  that  the  loss  of  capacity  was  due  entirely  to  the  loss  of 
capacity  of  the  anion  exchangers. 

Freeze-Thaw  Testing 

Weighed  samples  of  resins  were  exposed  to  -20  degrees  Centigrade  for  12 
hours  then  allowed  to  return  to  rocm  temperature.  After  thawing  fractured 
resin  particles  were  evident  in  most  of  the  resin  samples  (Table  3.).  These 
fractured  particles  were  of  a  wide  range  in  sizes.  Analysis  of  the  particles 
indicated  that  the  fractured  particle  sizes  were  always  greater  than  100 
microns.  The  fractured  particles  constituted  a  very  small  fraction  of  the 
tested  vo lime.  Among  the  16  to  50  mesh  samples  weighed  samples  of  particles 
less  than  300  microns  was  never  greater  than  0.5%  of  the  bed  weight.  The 
amount  of  fractured  particles  observed  smong  the  Ecotec  resins  was  less  than 
with  other  resins.  No  particles  less  than  75  microns  were  observable  in  these 
test  samples.  Since  the  porosity  of  the  media  restraints  is  roughly  20 
microns  no  fractured  articles  frem  any  samples  penetrated  the  restraints. 

This  parameter  was,  therefore,  not  included  as  a  basis  for  resin  selection. 

No  changes  in  working  capacity  were  observed  among  test  samples  exposed 
to  below  zero  temperatures  (Table  3.) 

Resin  Swell  Testing 

Because  each  sample  of  resin  had  varied  degrees  of  hydration 
with  various  hydration  fluids,  the  swelling  characteristics  of  each  resin 
were  compared  between  identical,  5  gram  samples  of  resins.  One  resin  sample 
was  hydrated  in  excess  ultra-pure  water  containing  less  than  1.0  mg/1  of  to¬ 
tal  dissolved  water  (TDS).  The  other  weighed  sample  was  hydrated  in  excess  1 
M  Sodium  Chloride.  Both  samples  were  allowed  to  equilibrate  for  several  hours 
with  occasional  mixing.  Thereafter,  the  bed  volume  of  each  sample  was  detei — 
mined.  The  mean  results  were  listed  in  Table  4. 

The  greatest  degree  of  variation  in  bed  volume  was  seen  among  the  anion 
and  mixed  bed  exchangers,  which  was  roughly  double  that  of  the  cation  ex¬ 
changers.  This  was  somewhat  surprising  since  it  was  initially  postulated  that 
the  greatest  variation  would  occur  within  the  anion  exchangers.  It  was  fur¬ 
ther  postulated  that  the  change  in  bed  volume  of  the  mixed  bed  exchangers 
would  be  roughly  the  average  of  the  bed  volume  changes  of  the  single  resin 
samples.  This  was  proposed  since  the  mixed  bed  exchangers  were  composed  of 
combinations  of  the  individual  cation  and  anion  resins  tested.  It  was  of  note 
that  the  only  mixed  bed  sample  not  to  follow  this  pattern  was  the  Eco-Tec 
mixed  bed  resin.  This  sample  was  produced  by  combining  equivalent  weighed 
portions  of  the  individual  Eco-Tec  cation  and  anion  resins.  Also  of  note  was 
the  fact  that  the  weighed  samples  of  the  Eco-Tec  cation  resins  had  a  smaller 
bed  volume  than  the  other  manufacturers  resins.  This  could  have  been  ac¬ 
counted  for  by  the  considerably  smaller  particle  size  of  the  resin.  This 


12 


Table  3.  Effects  of  Temperature  Stress  on  Resin  Samples 

RESIN  BED  TYPE  GRADE  CHANGES 

PHYSICAL  CAPACITY 

TEMPERATURE  TEMPERATURE 

HIGH  LOW  PARTICLE  %  BY  HIGH  LOW 
SIZE  WEIGHTS  OF  ORIG. ) 
(tm) 


AMBERLITE  MB-1 

MIXED 

NC 

FINES 

> 

100 

< 

0.5 

87 

NC 

AMBERLITE  IRN-150 

MIXED  NUCLEAR 

NC 

FINES 

> 

100 

< 

0.5 

95 

NC 

DOWEX  MR-3 

MIXED  NUCLEAR 

NC 

FINES 

> 

100 

< 

0.5 

92 

NC 

DOWEX  MRS-C 

MIXED 

NC 

FINES 

> 

100 

< 

0.5 

85 

NC 

IONAC  NM-60/5G 

MIXED  NUCLEAR 

NC 

FINES 

> 

100 

< 

0.5 

86 

NC 

IONAC  NM-201/SG 

MIXED  NUCLEAR 

NC 

FINES 

> 

100 

< 

0.5 

92 

NC 

ECOTEC  (REGENERATED)  MIXED 

NC 

NC 

> 

75 

< 

0.5 

NC 

AMBERLITE  1R-120 

CATIONIC-  NUCLEAR 

NC 

FINES 

> 

100 

< 

0.5 

NC 

NC 

AMBERLITE  IRN-77 

CAT  1 ON  1 C-H 

NC 

F 1 NES 

> 

100 

< 

0.5 

NC 

NC 

DOWEX  HCR-S 

CAT 1 ON  1 C-H 

NC 

FINES 

> 

100 

< 

0.5 

NC 

NC 

IONAC  C-267/SG 

CAT  1 ON 1  C-H 

NC 

FINES 

> 

100 

< 

0.5 

NC 

NC 

ECOTEC 

CAT 1 ONI C-H 

NC 

FINES 

> 

100 

< 

0.5 

NC 

NC 

AMBERLITE  IRN-78 

ANIONIC-O  NUCLEAR 

NC 

FINES 

> 

100 

< 

0.5 

95 

NC 

AMBERLITE  IRA-400 

ANIONIC-OH 

NC 

FINES 

> 

100 

< 

0.5 

ND 

ND 

DOWEX  SBR-P 

AN  1  ON  1 C-OH 

NC 

FINES 

> 

100 

< 

0.5 

85 

NC 

IONAC  ASB-1P 

ANIONIC-OH 

NC 

FINES 

> 

100 

< 

0.5 

86 

NC 

EOOTEC 

ANIONIC-OH 

NC 

FINES 

> 

100 

< 

0.5 

ND 

NC 

ND  =  NOT  DONE 

NC  =  NO  CHANGE;  LESS  THAN  5%  DIFFERENCE 

Table  4.  Swell  Characteristics  of  Resins  Sanrples 


Resin 

Type 

Ultra-pure 

Water 

1  M  NaCl 

%  Change 

Af'BERL  1 TE  IRN-77 

CATION 

6.6 

5.75 

-12.9 

AMBERLITE  IR-120 

CATION 

6.3 

5.85 

-7.5 

IONAC  C-267/SG 

CATION 

6.5 

5.9 

-9.2 

IONAC  CFP-110 

CATION 

6.6 

6.0 

-9.0 

DOWEX  HCR-S 

CATION 

6.5 

6.0 

-7.7 

ECO-TEC 

CATION 

5.8 

5.2 

-10.3 

AMBERLITE  IRN-78 

ANION 

7.3 

5.3 

-27 .4 

IONAC  ASB-1P/5G 

ANION 

7.4 

5.5 

-25.7 

IONAC  A-641 

ANION 

7.0 

5.4 

-22.9 

DOWEX  5BR-0H 

ANION 

7.5 

5.8 

-22.0 

ECO-TEC 

ANION 

7.8 

6.6 

-15.4 

AMBERLITE  IRN-150 

MIXED 

7.3 

5.95 

-18.5 

AMBERLITE  MB-1 

MIXED 

8.4 

5.85 

-30.4 

IONAC  NM-60/SG 

MIXED 

7.9 

5.85 

-25.9 

DOWEX  MRS-C 

MIXED 

8.4 

5.85 

-22.0 

ECO-TEC 

MIXED 

6.6 

5.9 

-10.6 

13 


would  suggest  that  Eco-Tec  cation  exchanger  would  have  relatively  greater  ex¬ 
posed  surface  area  than  other  cation  exchangers.  In  contrast,  the  weighed 
sample  of  the  Eco-Tec  anion  exchanger  had  a  greater  bed  volume  than  the  other 
resins,  in  spite  of  the  smaller  particle  size.  This  would  suggest  that  this 
resin  had  a  greater  degree  of  porosity  than  all  other  anion  exchangers.  If 
the  structural  integrity  were  maintained  this  may  facilitate  flow  rate. 

Final  Resin  Selection 

Based  upon  the  results  of  analysis  of  manufacturers  data,  resin  testing 
and  cost  analysis,  three  resin  combinations  were  selected  to  be  incorporated 
into  prototype  devices.  These  mixed-bed  resin  combination  are  Rohm  &  Haas, 
Amber lite  IRN-150;  the  Sepratech  prepared  Mixed-Bed  combination  of  Ecotec 
anion  and  cation  exchangers;  and  Sybron,  lonac  NM-201/SG.  These  resins  were 
selected  because  of  the  relatively  low  backpressure  at  working  flow  rates, 
the  working  capacity  in  smaller  test  devices,  the  capacity  following  exposure 
to  elevated  temperatures ,  the  resistance  to  fracturing  at  low  temperatures , 
the  absence  of  impurities  associated  with  the  nuclear  grade,  and  the  cost. 
Although  the  Ecotec  resins  did  not  demonstrate  the  working  capacity  an¬ 
ticipated,  it  was  felt  that  the  particle  size  and  the  probability  of  enhance¬ 
ment  of  the  working  capacity  justified  further  investigation. 

C.  HOUSING  DESIGN 

Flow  Design 

Existing  patented  designs  of  similar  devices  were  reviewed  with  regards 
to  the  design  requirements  (internal  pressure  tolerance  and  potential  flow 
rate)  associated  with  either  of  the  proposed  reverse  osmosis  purification 
systems.  This  review  indicated  that  existing  flow  designs  and  housing  pres¬ 
sure  resistance  potentials  could  easily  be  applicable  for  use  in  prototype 
devices  of  the  approximate  size  proposed  within  this  contract. 

In  the  device  flow  design  (refer  to  Fig. 1-4)  the  fluid  enters  through  the 
inlet  and  is  dispersed  to  the  periphery  within  the  fluid  dispersal  chamber. 
This  dispersal  is  induced  by  the  backpressure  inherent  in  the  frit.  The  fluid 
passes  through  the  frit  and  into  the  separatory  bed  to  the  downstream  frit. 
Fluid  passing  through  the  frit  enters  the  fluid  collection  chamber  and  exits 
the  device  via  the  outlet.  By  forcing  the  fluid  to  the  periphery,  the  fluid 
passes  through  the  device  in  uniformily;  meaning  the  face  of  the  fluid  in  the 
separatory  bed  is  not  retarded  at  the  areas  away  from  the  inlet  and  outlet. 
The  uniformity  of  flow  maximizes  the  capacity  of  the  separatory  bed  through 
maximal  exposure  of  the  resin  to  the  fluid.  In  addition,  the  uniformity  of 
flow  enables  the  the  device  to  be  used  in  any  orientation.  Flow  through  the 
bed  is  also  maintained  as  the  bed  volume  contracted  by  frits  designed  to  ex¬ 
pand,  compensating  for  volume  changes  and  preventing  channel  formation. 

Housing  Design 

The  prototype  housing  was  decided  to  consist  of  three  major  components,  a 
cylinder  and  two  end  pieces.  The  resin  bed  was  to  be  contained  within  the 
cylinder.  The  resin  w as  to  be  prevented  from  existing  the  cylinder  by 
upstream  and  downstream  frits.  These  frits  were  also  to  have  the  capacity  to 
compensate  for  changes  in  bed  volume  as  the  resin  bound  free  ions  within  the 
fluid  as  it  passed  through  the  device.  Upstream  and  downstream  of  the  resin 
restraining  frits  were  to  be  fluid  dispersal  and  collection  chambers.  These 


14 


chambers  allowed  fluid  to  pass  through  the  device  without  the  generation  of 
vortices  or  dead  spaces,  while  maximizing  the  resin  exposure  to  the  fluid. 
Entry  and  exit  were  to  occur  through  an  inlet  in  the  top  and  an  outlet  from 
the  base  of  the  cy 1 i nder . 

It  was  determined  that  in  order  for  the  flow  to  the  distal  portions  of 
the  dispersal  chamber  the  height  of  this  chamber  should  have  been  extended. 

To  determine  the  internal  dimensions  and  resulting  flow  rates  and  back  pres¬ 
sures  of  the  prototype  cylinders,  other  factors  would  have  to  be  defined, 
i.e.  capacity /bed  volume  and  relative  swell /bed  volume. 

Housing  Internal  Volume 

The  results  of  working  capacity  test  indicated  that  to  achieve  a  produc¬ 
tion  capacity  of  100  liters,  the  required  separatory  bed  volume  for  a  16-50 
mesh  bead  ion  exchanger,  had  to  be  roughly  150  ml  and  25  ml  at  flow  rates  of 
200  to  300  ml/min  and  25  ml/min,  respectively.  This  included  enough  excess 
volume  to  provide  reasonable  assurance  that  the  proposed  production  capacity 
was  met. 

The  most  effective  volume  compensating  frit  design  constructed,  had  a  ex¬ 
panded  volume  sufficient  to  compensate  for  a  203>  reduction  in  total  bed 
volume.  If  necessary  this  could  have  been  increased.  The  nominal  height  of 
this  frit  was  0.42  inches  in  the  larger  prototype  device. 

The  outer  dimensions  of  the  housing  also  had  to  take  into  consideration 
the  thickness  of  the  housing  materials  for  each  of  the  end  pieces,  0.125 
inches  each.+ 

To  meet  these  criteria,  the  prototype  housings  were  constructed  to  be  5.5 
inches  in  height  by  1.5  inches  in  diameter  and  1.75  inches  in  height  and  1 
inch  in  diameter. 

Attachment  Sites 

To  afford  ease  of  attachment,  resistance  to  contamination,  and  pressure 
resistance,  the  upstream  and  downstream  attachment  sites  of  the  prototype 
device  were  decided  to  include  female  Leui — lock  fittings  centrally  located  at 
both  ends.  For  construction  of  prototypes;  injection  molded,  fittings  from 
analogous  devices  were  ultrasonical ly  welded  to  machined  prototype  tops. 

Tests  of  the  flow  rate  through  the  attachment  site  orifices  and  the  as¬ 
sociated  back  pressures  were  less  than  0.5  PS  I  at  345  ml/min  therefore  were 
acceptab 1 e . 

Housing  Material  Selection 

Preliminary  investigation  of  the  potential  housing  materials  indicated 
that  either  polypropylene  or  polycarbonate  were  most  appropriate  materials 
for  prototype  construction.  Polypropylene  provided  ease  of  machining, 
however,  was  considerably  more  difficult  to  ultrasonical ly  weld  effectively. 
Polycarbonate  was  more  easily  welded  and  was  more  transparent ,  but  was  likely 
to  be  more  difficult  to  machine  to  close  tolerances.  Polypropylene  or 
polycarbonate  devices  with  wall  thickness  of  0.125  inches  could  withstand 
system  pressures  up  to  150  PS I.  The  decision  was  made  to  use  polycarbonate 
for  construction  of  all  prototypes  housing  components. 

Weld  Sites 

Four  weld  sites  were  necessary  (Fig. 5).  These  sites  were  designed  to  be 
identical.  The  weld  sites  on  the  cylinder  ends  and  the  two  end  pieces  top 


15 


were  decided  to  be  shear  welded  together.  The  weld  sites  had  at  least  0.035 
inches  of  interference  initiated  at  the  contact  point  by  a  45  degree  angle. 
The  tolerances  between  adjoining  outer  and  inner  diameters  were  milled  to 
within  +/-  0.001  inches  to  provide  overall  tolerances  of  +/-  0.002  inches. 

Wall  Thickness  Necessary  for  Pressure  Resistance 

Prototype  devices  of  polycarbonate  were  constructed  of  materials  0.125 
inches  in  thickness.  This  was  deigned  to  be  more  than  adequate  to  endure  the 
projected  internal  pressures  encountered  within  the  envisaged  system,  in  ad¬ 
dition  this  provided  a  significant  level  of  impact  resistance  to  the  device. 

D.  COMPONENT  DESIGN 

Frit  Material  Selection 

Initially,  polypropylene  was  preselected  as  the  exclusive  component  of 
the  frit.  However,  further  analysis  indicated  that  considerably  greater 
volune  compensation  was  required  than  possible  from  existing  polypropylene 
frits.  Subsequently,  a  number  of  ccmbinations  of  materials  were  investigated, 
including  multiple  nylon  mesh,  cellulose  based  mesh,  ana  polypropylene  mesh. 
In  addition  the  initially  tested  frits  generated  a  pressure  drop  5.2  PSI . 

A  ccmbination  of  multiple  layers  of  cellulose,  nylon,  and  polypropylene 
were  determined  to  provide  sufficient  volume  compensation  while  minimizing 
the  associated  pressure  to  less  them  2.0  PSI .  The  downstream  frit  of  both 
device  were  designed  to  be  0.145  inches  in  height.  The  upstream  frit  of  the 
150  ml  device  was  designed  to  provide  a  minimum  expanded  height  of  0.775 
inches  and  a  compressed  height  of  0.275  inches. 

Port  Covers  for  Leur  Attachment  Sites 

Both  polypropylene  and  polycarbonate  covers  for  male  and  female  Leur- lock 
ports.  In  order  to  prevent  binding  of  the  covers  to  the  housing  dissimilar 
plastic  covers  were  used.  The  composition  of  these  covers  were  approved  by 
FDA/U5P  for  medical  use. 

c  n nryr/yryn c  i^vt  i  rs ki 

l_  •  r  r\  v  i  v  i  iru  \A/iioir\<A/i  ivii 

Prototype  Weld  Site  Construction 

Construction  of  prototypes  progressed  in  a  series  of  steps.  The  first 
step  was  to  design,  construct,  optimize,  and  test  the  weld  site  between  com¬ 
ponent  parts  of  the  housing.  Preliminary  prototype  weld  sites  of  several 
diameters  and  thicknesses  of  cylinders  were  constructed  of  polycarbonate. 

This  material  was  selected  because  of  the  ease  with  which  it  can  be  welded. 
Because  of  the  relative  rigidity  of  this  plastic,  it  provided  seme  difficulty 
in  machining.  However,  since  the  envisaged  device  was  proposed  to  be  injec¬ 
tion  molded,  it  was  felt  that  providing  a  solution  to  the  welding  problems 
would  easiest  to  begin  with  polycarbonate  prototypes  rather  than  alternative 
plastics,  i.e.  polypropylene.  Weld  sites  were  milled  into  cylinders  and  tops 
of  various  diameters.  In  these  prototypes,  connections  consisted  of  injection 
molded,  female  Leui — lock  fittings  were  welded  to  prototype  tops.  Ultrasonic 
welding  equipment  was  also  constructed  to  test  weld  these  housing.  This  in¬ 
cluded  bases  to  secure  the  components  in  trie  proper  orientation  and  welding 
horns  tuned  to  the  frequencies  necessary  for  each  weld. 

Test  procedures  were  standardized  for  the  different  wall  thicknesses  and 


16 


cylinder  diameters  as  well  as  nine  variables  associated  with  the  use  of  the 
ultrasonic  welder.  Following  optimization  of  the  equipment  and  welding  proce¬ 
dures  the  welded  housings  were  pressure  tested  with  compressed  gas.  The 
defined  weld  design  and  procedures  withstood  internal  pressures  greater  than 
100  PSI . 

Design  and  Construction  of  Prototypes 

The  two  different  sized  prototype  housings  were  machined  from  five  parts: 
a  single  cylinder,  two  end  pieces,  and  two  female  Leur-lock  fittings.  All 
materials  were  of  0.125  inch  thick  polycarbonate.  The  weld  sites  were  milled 
to  the  specifications  described  in  Figure  1.  and  were  within  tolerances  of 
0.002  inches.  The  same  weld  procedures  were  followed  as  determined  in  weld 
testing. 

Selection  of  Filling  Procedures 

Preliminary  testing  indicated  that  achieving  a  uniform  mixture  of  mixed- 
bed  components,  particularly  with  slurried  particles,  may  be  rather  dif¬ 
ficult.  However,  this  suggested  that  filling  housings  with  slurried  resins 
may  lead  to  separation  of  the  anion  and  cation  exchangers.  The  procedures 
selected  included  manual  filling  and  compacting  to  defined  pressures  of 
weighed  resin  aliquots.  The  150  ml  prototypes  were  filled  with  100  mg  of 
resin.  The  smaller  prototypes  were  filled  with  25  mg  of  resin. 

D.  PROTOTYPE  VALIDATION  TESTING 

Flow  rate 

Both  the  large  and  small  prototype  devices  were  capable  of  funtioning  at 
the  specified  flow  rates,  roughly  275  and  25  ml /min  respectively.  There  was 
considerable  variation  in  the  backpressure  associated  with  different 
separatory  beds  and  frit  configurations. 

Flow  rate  testing  indicated  that  even  though  the  Ecotec  resin  was  the 
smallest  particle  size  of  all  resins  samples  tested,  the  backpressure  at  the 
specified  flow  rates  were  the  least  of  all  resins  tested.  Because  of  this 
contradiction,  it  was  decided  that  this  resin  should  be  further  investigated. 
Capacity  testing  indicated  that  more  complete  regeneration  of  this  resin  to 
the  nydroxyi  derivative  was  necessary.  Efforts  to  attain  the  potential 
capacity  indicated  by  the  manufacturer  were  unsuccessful. 

Working  Capacity  Testing 

The  working  capacity  of  prototypes  of  various  separatory  beds  are  indi¬ 
cated  in  Table  5.  No  evidence  of  channel  formation  was  observed  during  any 
working  capacity  testing.  The  curves  of  ion  removal  from  source  water  were 
consistently  repetitive  until  the  ion  breakthrough  occurred.  The  flow  rates 
and  back  pressures  were  consistent,  without  detectable  variations  in  flow 
rate. 


17 


Table  5.  Working  Capacity  of  Completed  Prototypes 


Separatory 

Bed 

Volume 

(ml) 

Flow 

Rate 

(ml/min) 

Source 

Water 

(mg/1) 

Working 

Capacity 

(g/device) 

Back 

Pressure 

(PSI) 

R  &  H  IRN-150 

150 

275 

1000 

6.6 

5.7 

lonac  NM-201/SG 

150 

275 

1000 

5.2 

6.7 

Dowex  MR-3-C 

150 

275 

1000 

5.1 

6.0 

Ecotec 

150 

275 

N.D. 

N.D. 

5.1 

IR  &  H  IRN-150 

25 

25 

100 

1.0 

3.0 

R  &  H  IRN-150 

150 

07C 

L.  » 

10 

6.5 

5.7 

R  &  H  IRN-150 

oc 

4.J 

OC 

L.*J 

10 

1.0 

2.8 

UNIT  DESIGN  CHARACTERISTICS 
Large  unit 

Solicited  Goals:  Adaptable  to  higher  flow  rate  RO  pump/filter 

combination 

Flow  Rate:  200-300  ml/min 

Capacity:  1  g  of  NaCl 

Source  Water:  10  mg/ml  TD5 

Dimensions:  Within  23  x  20  x  8  centimeters 

Design  Characteristics 
Exterior  dimensions 

Height:  5.5  inches/  14.0  centimeters 

Diameter:  1.75  inches/  4.45  centimeters 

Bed  volume:  150  ml 

Separatory  Matrix 

Composition:  100  g  Rohm  &  Haas;  IRN-150,  Nuclear  Grade, 

Mixed-Bed  Exchangers 

Connections:  Inlet  and  Outlet  female  Leur-lock  connectors 

Housing  Materials:  Polycarbonate 

Matrix  Restraints:  Combinations  of  Cellulose,  Polypropylene, 
Polyethylene,  and  Nylon 

Functional  capability 
Weld  strength: 

Working  Capacity:  6.6  grams  of  NaCl  (at  285  ml/min) 

Efficacy  in  altered  orientation 

Small  Unit 

Sol icited  Goals: 

Flew  Rate: 

Capacity: 

Source  Water: 

Dimensions: 


18 


20  25  ml/min 
1  g  of  NaCl 
10  mg/ml  TDS 

Within  23  x  20  x  8  centimeters 


Design  Characteristics 
Exterior  dimensions 

Height:  2.0  inches/  5.1  centimeters 

Dianeter:  1.0  inches/  2.5  centimeters 

Bed  volume:  6.6  ml 

Separatory  Matrix 

Composition:  12.5  g  Rohm  &  Haas;  IRN-150, 

Nuclear  Grade,  Mixed-Bed  Exchangers 
Connections:  Inlet  and  Outlet  female  Leur-lock  connec¬ 

tors 

Housing  Materials:  Polycarbonate 

Matrix  Restraints:  Combinations  of  Cellulose,  Polypropylene, 

Polyethylene,  and  Nylon 

Functional  Capabilities 
Weld  strength: 

Working  Capacity:  1.0  grams  of  NaCl  (at  125  ml/min) 

Efficacy  in  altered  orientation 

The  following  factors  are  all  interrelated  in  a  very  complex  manner  and 
have  a  particularly  significant  effect  on  small  Ion  Excnange  systems. 

5.  ESTIMATES  OF  TECHNICAL  FEASIBILITY 

Mass  production  is  quite  feasible  based  upon: 

1.  Completion  of  two  fully  functional  prototype  designs, 

2.  Demonstrated  capabilities  which  exceed  the  specified  goals  for 

capacity  of  Sodium  Chloride  in  solution  and  functional  requirements, 
and 

3.  Completion  of  proposed  device  housing  designs,  including: 

a.  Injection  molded  cylinder  similar  to  the  prototype 

1. )  Radial  fins  in  place  of  multi-layered  mesh  to  support  the 

frits  and  improve  fluid  collection. 

2. )  Either  male  or  female  Leur-lock  connection  to  ASMI  stand¬ 

ards 

b.  Injection  molded  top 

1. )  Fluid  collection  chamber  with  minimal  space 

2. )  Female  Leur-lock  connection  to  ASMI  standards 

The  following  areas  could  be  improved  further  in  massed  produced  devices: 

1.  Obtaining  smaller  mesh  resin  particles.  Easily  solved  with  more  com¬ 

plete  regeneration  of  existing  smaller  mesh  resins.  There  is  a  ten¬ 
dency  for  some  non- uniformity  of  flow  in  prototype  device  with  the 
largest  particle  sizes. 

2.  The  relative  density  of  counterions  imrobi 1 ized  to  individual  resin 

particles  varies  significantly  enough  to  constitute  a  potential 
problem,  if  the  water  source  contains  increased  concentrations  of 
dissolved  salts.  The  localized  attachment  of  ions  can  induce  local¬ 
ized  changes  in  the  separatory  bed,  i.e.  formation  of  pockets  of 
compacted  resins.  This  was  observed  only  when  the  source  water  TD 
concentration  was  1  gram/ liter  or  greater. 


13 


3.  Obtaining  frits  of  FDA  approved  materials  capable  of  with  standing 
autoclaving  for  sterilization. 


20 


Figure  1  .  Flow  Through  A  Tradational  Column 

Conventional  Open  Column 


Face  of  Fluid  Phase 
within  the  device  is 
retarded  at  the 
periphery 


21 


Sepratech  Column 


Figure  2 .  Sepratech  Flow  Design 


Face  of  Fluid  Phase 


Difference 


7K 


Cone 


Traditional  Column 
Sepratech  DctIc« 


/ 


^ t 


— ■ 

ihhhhh! 


»»*»##»««i******-**#***#*#** 

V V.V.V.V.V.VAV'V.V.V/ 


Y  y  y  y  y  y  y 


minium 


Figure  3  .  Bed  Vol 


Compens 


Frit 

Expansion 


Ours 


Traditional 


Bed 

Compacted 


r? 


Head  Space 
Formation 


Channel 

Formation 


Figure  4.  Variability  of  Orientation 

Additional 


Versatility  of  Orientation 


Ours 


Result 

-  Decreased  Capacity 

-  No  Uniformity  of 

Flow 

-  No  Separation 

of  Peaks 


Figure  5.  Prototype  Housing  Desgin 


Q, 


(3)