To meet the increasing patient need for LVP, more complex packaging systems are required to be designed and further qualified to house different solutions. The high maximum daily dose of the multi-components of the packaging system present challenges when evaluating extractables and leachables (E&L). Controlling E&L levels in LVP is vital for the safety, quality, and efficacy of the finished product. Leveraging existing regulations (Pharmacopeial and food compliance) and effective collaboration with the suppliers of the raw materials will provide the required knowledge to design accurate E&L assessments. E&L testing of LVP dictates a low detection limit due to the long LVP treatment duration and high volumes. Thus, impurities with ppb levels such as Nitrosamines trigger great analytical challenges. Approaching LVP based on E&L risk assessment at an early stage of the product’s life cycle, namely material selection, will allow the E&L strategy to succeed in ensuring patient safety and product compliance.
This presentation was recorded on March 24 and is part of a series.