EU Annex 1 Compliant Single Use Aseptic Fill/Finish Isolator


Solo have just upgraded their single use vial fill isolator to be more fully compliant with EU Annex 1  GMP guidelines by adding a pre batch Pressure Decay test functionality. The 2020 design has larger working chambers and increased airflow to deliver a unidirectional airflow vial fill zone meeting the stringent EU Grade A classification. The complete assembly is tested at Solo’s UK facility and any specific fill needles and aseptic filtration parts are added to customise the isolator to the clinical batch requirements. After assembly the isolator is compacted for transit using a specially developed handling skid that stays with the enclosure during the GI sterilisation process.

 

The new design has been designated soloPURE after the extensive GI dosimetry testing carried out in conjunction with our development partners.


What are the benefits of the new soloPURE:

 

  • Grade A aseptic fill isolator ready for batch manufacture in under 1 hour – no VHP cycle required
  • Dual isokinetic probes to monitor particle count in Grade B vial preparation and Grade B vial filling / stoppering chamber
  • Finished vial exit though GI treated heat sealable liner system
  • Exit liner size increased to 45M cassette length
  • All batch contact parts fully disposable

soloPURE is the entry level product in Solo growing aseptic isolator range

For Vial filling  Syringe Filling or Lyophiliser interface contact the team at Solo Containment

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    verso

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    aseptic

    Solo’s aseptic isolators are designed for batch fill finish type applications where complete sterility is required.

    custom

    We can either offer modifications to the core product range or a full bespoke design process.

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