LYOINREADY® LyoClear Coated Vial

A neutral borosilicate glass tubular coated vial. The interior is coated with a hydrophobic polydimethylsiloxane (PDMS) film, which effectively prevents drug product fogging during the lyophilization process.

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Fogging refers to the phenomenon during the freeze-drying process where the liquid formulation creeps up along the vial wal, it is characterized by a persistent layer of white mist that adheres to the inner surface of the vials post-lyophilization. The presence of white “fogging” can raise concerns with respect to DP manufacturing process control and potential compromise of container closure integrity. During the drug manufacturing process, this may lead to an increased rate of product nonconformity.

Applications

Particularly suitable for all lyophilized preparations sensitive to adsorption loss and with strict appearance requirements, including: monoclonal antibodies, antibody-drug conjugates (ADCs), recombinant proteins, and vaccines (mRNA, viral vectors) ,etc.