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. Ensure Performance of Your Sterile Filters with Integrity Testing


Ensure Performance of Your Sterile Filters with Integrity Testing

Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility. Where sterility will be claimed, regulatory agencies worldwide require that the sterilizing-grade filter(s) be integrity tested to ensure filter performance is verified prior to and after filter use.
Therefore, successful filter integrity tests are a critical link between your filter validation and current processing.

Solution

Learn more about designing a robust integrity test operation to ensure reliable filter integrity tests.

2. Selecting the Right Filter for Your Process


Selecting the Right Filter for Your Process

Selecting the right filter for your process is a key component of many operations. This step is vital to minimizing microbial contamination and ensuring product safety and integrity. Selecting the right filter can significantly impact operational efficiency and cost. Understanding the different criteria for filter selection helps narrow the options and streamlines product selection. There are many options available for today’s manufacturers, and filter selection should be based on filter compatibility, retention requirements, fluid stream characteristics, filter format and scale-up needs.

Solution

Let us help you find the right filters to meet your sterile filtration requirements. Our Sterile Filtration Product Selection Guide simplifies selection of the right filter for any stage of your process.

3. Assure Sterile Drug Product with Your Small Volume Parenteral (SVP) Process


Assure Sterile Drug Product with Your Small Volume Parenteral (SVP) Process

Filtration of liquids through sterilizing grade filters is a common method for removing microorganisms from SVPs, especially those that are heat-sensitive. Final filtration with a 0.22 µm filter is the last unit operation in the process and is a critical step for successful manufacturing of a parenteral drug formulation.

Solution

Regulatory requirements and industry best practice help assure this critical process step is effective. Additionally, a comprehensive validation strategy provides the scientific evidence to confirm that process conditions and filters are robust and to defend these decisions to regulatory authorities. Learn more about the use of sterilizing grade filters for removal of microorganisms and critical guidelines for incorporating this step late into the manufacturing process to ensure sterility.

4. Minimize Risk of Contamination Through Quality by Design


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.

5. Define Validation and Qualification Strategies


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.