In my 15-plus years at KOSA Filter, I've seen the challenges biopharma and pharma engineers face ensuring sterility, validation, and cleanability in their fluid-handling systems. The liquid filtration line, encompassing sanitary filter housings, cartridges, and membrane systems, plays a critical role in maintaining product quality and process integrity. Let me walk you through the key factors we consider when designing and manufacturing these components.
Material Selection for Compliance and Performance
We primarily use 316L stainless steel for our filter housings and other wetted components. This material complies with ASME BPE 2019 and 3-A Sanitary Standard 2022, ensuring it meets the stringent requirements of the pharmaceutical and biopharma industries. The low carbon content of 316L minimizes carbide precipitation, which is crucial for preventing corrosion and maintaining product purity.
For our membranes and filter media, we use materials like PVDF, PTFE, and PES, each chosen for their specific advantages in terms of chemical resistance, temperature tolerance, and filtration efficiency. All our materials are validated for low extractables, typically <1 ppb, which is essential for ensuring product safety and compliance with FDA 21 CFR and cGMP guidelines.
Designing for Sterility and Integrity
Our filter housings are designed with sterility and integrity in mind. We use welded constructions to eliminate crevices and ensure cleanability. All product contact surfaces are electropolished to a 15-25 Ra finish, enhancing cleanability and reducing the risk of product contamination.
Our sterilizing-grade filtration systems are designed to achieve >99.9% recovery of product, minimizing yield loss. We offer a range of pore sizes, from 0.2 µm absolute-rated to 5 µm nominal-rated, to meet the specific needs of your process.
Validation and Certificates
We understand that validation is a significant concern for our customers. That's why we provide comprehensive documentation to support your validation efforts. This includes certification of welds, materials, and surface finishes, as well as extractable validation data.
Our filter housings and cartridges are designed to facilitate CIP/SIP processes, with dedicated cleaning and sterilization ports. We also offer a range of steam and chemical compatibility options to ensure our products can withstand your specific cleaning and sterilization regimes.
Customization and Flexibility
We recognize that one size does not fit all in the biopharma and pharma industries. That's why we offer a high degree of customization for our liquid filtration products. Here are some areas where we can tailor our products to your needs:
- Custom port sizes and configurations
- Custom filter media and pore sizes
- Custom surface finishes and materials
- Custom sterilization and cleaning options
For instance, a contract development and manufacturing organization (CDMO) working on a novel biologic faced challenges with their existing filtration system. The system's design allowed for product hold-up, leading to batch-to-batch contamination. We worked with them to design a custom filtration system with dedicated cleaning paths and improved product drainage, resolving their contamination issues and improving their overall yield.
Comparing Key Specifications
Here's a quick comparison of some key specifications for our standard and custom filter housings:
| Specification | Standard Housing | Custom Housing |
|---|---|---|
| Material | 316L Stainless Steel | 316L, Alloy 2205, Hastelloy, etc. |
| Surface Finish | Electropolished, 15-25 Ra | Electropolished, 15-25 Ra, or custom |
| Port Sizes | Standard sizes (e.g., 1", 2") | Custom sizes and configurations |
| Sterilization Options | Steam, Chemical | Steam, Chemical, Gamma, etc. |
Engineering Support and Collaboration
Our application engineers are always ready to discuss your specific application and help you select the right filtration solution. We can provide engineering support for system design, validation, and troubleshooting, ensuring your filtration system works as intended.
We also offer on-site training and support to help your team understand our products and their operation. Our goal is not just to sell you a filtration system but to ensure it integrates smoothly into your process and meets your production needs.
I invite you to reach out to our application engineering team to discuss how our liquid filtration products can support your specific needs. We're always eager to explore new challenges and find innovative solutions.
Related product silos: LIQUID FILTRATION, DUST FILTRATION, CONTROLVALVE, HEAT EXCHANGER.