Classical Pharmaceuticals
Small Molecule Manufacturing Expertise

Sterility Assured-Filtration Strategies

It is critical that drug products are free from bacteria and other microorganisms to ensure patient safety. For pharmaceutical products that cannot be terminally sterilized, aseptic filtration is used to meet these requirements. We have the expertise to address filtration process challenges.


1. Minimize Risk of Contamination Through Quality by Design

The selection of an effective and efficient sterilizing grade filter is essential to provide sterility assurance. Understanding filtration systems and components can be a challenge, given the array of different options.

Solution

We design and manufacture filtration system components to provide high assurance of sterility for aseptic processes by applying principles of quality by design (QbD). Our Sterile Filtration Product Selection Guide (PSG) can help you identify the optimum product for your process.

2. Define Validation and Qualification Strategies

Sterilizing filtration must be qualified during early clinical phases to demonstrate the ability to provide a sterile product without adversely affecting its properties. The filter, as critical equipment used for manufacturing a sterile investigational drug, should not contaminate or otherwise react with, add to, or be absorbed by the drug. Understanding the key elements of sterile filtration, validation and regulatory guidance for developmental phase drug products is critical to insuring that the process is properly defined and validated.

Solution

To assess the performance of a filter and thereby ensure the quality of the product, several aspects need to be examined including bacterial retention, chemical compatibility, extractables and adsorption. See how a defined validation strategy helps ensure that processing conditions are optimized and filters are tested to confirm their performance.