In relation to pharmaceutical products and medical devices derived from raw materials of animal origin, for which the raw material may contain viruses that are dangerous to human health, the EU has introduced legislation requiring manufacturers of pharmaceutical products or medical devices to demonstrate the ability of purification and manufacturing processes to inactivate or remove viruses [EMA CPMP/BWP/268/95 (biopharmaceutical products) and ISO 22442-3 (medical devices)].

Viral clearance is a measure of the capacity of the dedicated manufacturing process to inactivate or remove viruses. These studies involve viral spiking at intermediate stages in the process and then demonstrating the inactivation or removal of the virus during the subsequent stages.

Viral clearance studies involve:

  • Identification of the process stage involving the inactivation or removal of viruses
  • Verification of the scaled-down process
  • Selection of viruses
  • Verification of the performance of the process stage with viruses

Viruses available for viral clearance study:

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Viruses available for viral clearance study. 

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July 14th, 2021
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We are pleased to invite you to participate in our Advanced HACCP webinar that will be given from July 20th to 23rd.  The price per person is $4,500 + taxes and it will have a 16 hour duration...
June 23rd, 2021
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We have the pleasure to invite you to our next VIP event. It will take place online on June 29th 2021 from 9am to 1pm. The topic is going to be "The importance of a good internal aud...