Page 1640 - Flipbook_SolidDesignSoutheast2020
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Containment levels customer validated
               down to less than 1 microgram/m3
               on an 8-hour TWA basis.
               Nanogram containment levels
               achieved using DoverPac ®  and
               secondary containment
                           solvent contact resistance
 dOVeRPaC ®    s s  Materials:  ArmorFlex ®  104 has no halogenated
 COntinUOUs lineR systeM The answer to final pack off containment  armorflex 104  compounds and is safe for incineration.
          ®
 s
 s
 the doverPac ®  continuous liner system provides the advantage of replacing packs without breaking   Â Products pass incendivity testing  ChEMICAL   RESISTAnCE
 containment, unlike using inflatable heads or having operators shuffle tube stock. standard continuous   Â Designed and manufactured using only   acetone   Very good
        FDA & EU compliant materials
 liner pack contains 150 feet of film material and fills up to 30, 185-liter drums. the system is avail-  Â Quality & reliability verified through 100% acceptance testing
 able in 50, 100 and 150-foot length packs. salient features include:  acetonitrile   excellent
   cfr conformance  usp conformance  anisole   Very good
 n  Prepackaged liners save operators’ time  21  CFR  177.1520  conforms to UsP 24 <661> for bUffering   Butyl acetate   excellent
   21  CFR  178.3130  caPacity, heavy metals, non-volatile resi-
 n  Individual packing maximizes in-plant cleanliness  21  CFR  182.90  dUes, residUe on ignition, thermal analy-  cyclohexane   Very good
 n   cGMP benefits over open drum filling  sis, and ir (id identity). Passes UsP class vi (7   cyclohexane/ethyl acetate (50/50)    Very good
 n   Replace packs without breaking containment  day imPlant) testing  Dichloromethane   Fair
 n   Clean in place (CIP) interface incorporated  physical property data  Diethylether   Very good
 n   Anti-static FDA and EU compliant materials  Dimethylacetamide   Very good
 n   Eliminates cross contamination concerns  PROPeRty   test MetHOd   ResUlts  Dimethylformamide   Very good
 n   Interface hardware works with DoverPac ®  or continuous liner system (saves capital cost)  Puncture resistance   FeD stD 191-5120   11 lbf  ethanol   excellent
 n   Operates in Ex environment  ethyl acetate   excellent
    tear strength   astM D 624-91 Die c   470 ppi (min.)
                           hcl (37.4%)   Very good
                           heptane   excellent
    tensile strength   astM D 412-97   5500 psi (min.)
                           hMDs      Fair
                           Koh (50%)   excellent
 step-by-step   elongation   astM D 412-97   490% (min.)
 usage process             Methanol   Very good
 of our                    Mineral oil   Very good
 Continuous liner  european norm data  naoh (50%)   excellent
    en nUMbeR   test   ResUlts  n-methylpiperazine   excellent
                           n-methypyrrolidone   excellent
 versatile hardware   continuous liner pack   sleeve is pulled into drum   unique doverpac ®    next sleeve is   en 388: 1994   Protection against
 easily mounts to   is installed  and filled  crimping system is used to   pulled into drum  reagent (3a) alcohol   Very good
 vessel discharge port  separate filled drum     Mechanical risKs
                           tetrahydrofuran   Very good
    en 420: 1994,   DeterMination oF   Pass   toluene   Fair
 dOVeRPaC ®                2-methoxyethanol   excellent
 ®
 dOVeRPaC  sf for Split Butterfly Valve Powder Transfer Applications
 s
 s
 this system replaces the rigid polybottle for split butterfly valve powder   the   P RO duc T   Fe AT u R e S
 transfer applications. doverPac ®  sf utilizes our flexible Containment technology,   doverPac  ®  *Values shown were achieved in   flexible
 which has been widely adopted by the pharmaceutical industry.  customer validation studies  dOVeRPaC ®  COntinUOUs lineR  enClOsURes  dOVeRPaC sf
      family        1µg/m3           same as
 n  10 and 25-liter volume  Containment Validated *  nanogram levels with  10µg/m3  1µg/m3  valve selected
                   secondary containment
 n  Reduced storage space compared to bottles     100% inspected  X   X   X   X
 n  Eliminates cleaning and validation requirements
             100% inflation tested  X      X   X
 n  Visual verification of product discharge
             integral sampling
 n  Unique conical neck ensures complete product transfer     Capability  X      X
 n  Restrained model accommodates .49 Bar pressure exertions     X   X   X   X
 n  Flexible design allows operators to manipulate sidewalls   Offloading Capability
     to increase product flow     Charging Capability  X      X   X
 n  99.95% API recovery  Model DP2116  Model DP2118
                 cGMP  X   X    X     X
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