eShop
Sign in
English
Major pharmacopoeias (e.g., ChP, USP, EP, JP) have strict requirements for sterile finished products like injectables, ophthalmic preparations, covering sterility tests, sterilization validation, package integrity, and microbial limits. So, how does that work when you've got delicate drug compounds that can't be exposed to heat or chemical sterilization?
That's where the PES filter step in.
In the pharmaceutical industry, sterile filtration is one of the final and most critical stages before final packaging. The PES(polyethersulfone) filter works a lot in making sure everything is free from bacteria without damaging the medicine itself.
In this article, we’ll explain how PES filters work, why pharma companies prefer them as their number one option, and why Cobetter is a brand worth considering. Wondering how sterile products remain clean? This is your solution.
What Is a PES Filter and How Is It Used?
Let's first get into what a PES filter is before we go further.
PES stands for polyethersulfone, a high-performance thermoplastic polymer that's commonly used to make filtration membranes. The membranes have tiny pores—small enough to block bacteria and microorganisms, but still let liquids pass through.
Because PES is hydrophilic, it is great for filtering liquids. That makes it perfect for biological solutions, cell cultures, buffers, and water-based processes in pharmaceutical manufacturing.
What makes PES a preferred option in certain applications? Let's find out.
Why Sterile Filtration is Important to Pharma Manufacturing
All injectable drug products must be sterile. That's not just a best practice—it is the law of major Pharmacopoeia. Whatever is injected into the body, whether it is a vaccine, insulin, or intravenous fluid, must be free from bacteria and other contaminants.
And how is that achieved?
One common method is heat sterilization, but that can only be used with heat-stable products. The majority of modern therapies, especially biologics and cell-based treatments, are heat-sensitive. That is where filtration comes into play.
Sterile filtration removes bacteria and microorganisms without using heat or harsh chemicals. It is quick, reliable, and gentle on the sensitive products.
To meet FDA and EU regulations, pharmaceutical companies need filters that are qualified and validated. These qualities make PES filters a reliable choice for sterile filtration.
Now that we’ve covered why sterile filtration is essential, let's discuss why pharmaceutical manufacturers are turning to PES filters as their preferred choice.
Benefits of Using PES Filter Membranes in Pharmaceutical Companies
PES membranes have several advantages that make them great fit for pharmaceutical applications. Here are some of the most important ones.
High Flow Rates for Faster Processing
One major benefit of PES filter is their high flow rate due to its asymmetric structure and uniform porosity. This helps speed up production, which really matters in large-scale filtration.
Low protein binding for sensitive drugs
Protein-based drugs—such as insulin, monoclonal antibodies, and growth factors—are especially sensitive to filtration. These molecules are often unstable and tend to bind to certain kinds of filter membranes, reducing the end drug concentration.
PES membranes feature very low-protein binding and are ideal for the filtration of protein-based drugs.
Certified for Safety and Compliance
Regulatory agencies like the FDA, EMA, and USP have stringent requirements for the use of sterilizing-grade filters in pharmaceutical manufacturing, covering validation, pore size (must be ≤0.22 μm), integrity testing, bioburden control, and process applicability.
Cobetter's PES filters go through rigorous testing, integrity validation, and are supported with complete documentation to help pharmaceutical companies stay audit-ready at all times.
So, we’ve covered the benefits, what makes Cobetter stand out?
What Sets Cobetter PES Filters Apart From Others
There are plenty of filter options out there. Some of them have been in the industry for decades. But Cobetter has also established a reputation in the field—and for good reason.
Innovative Membrane Technolgoy
With over 20 years of membrane technology, Cobetter’s PES membrane has patented asymmetric structure which make it the most choices where high flow rate filtration is required.
Tested for Performance and Reliability
Comprehensive Extractables Study Report compliant with USP <665>/BPOG Guidelines. With 14 years of dedicated validation experience, we have successfully delivered:
- 1,500+ clients across the pharmaceutical industry
- 13,000+ validation cases
- 30,000+ validation reports
Reducing Cost Without Sacrificing Compromising Quality
Cobetter provides reliable performance with low cost, allowing businesses to scale up without compromising on quality. When factor in performance, pricing, and solid technical support, Cobetter becomes a strong alternative to other brands.
Technical Support When You Need It
Choosing the right PES filter isn’t always simple. Cobetter’s technical team can help you find the right format, pore size, and material compatibility for your specific process. We work with startups, global manufacturers, and everyone in between.
Conclusion
At Cobetter, we’re here to help you find the right filter that fits your needs. Whether you're launching a new drug or scaling up an existing line, our team is ready to support you every step of the way.
Have questions about sterile filtration or choosing the right filter? We’d be happy to help. Just send us an email at [email protected].
Commonly Asked QuestionS
1. What is a PES filter?
A PES filter is made of polyethersulfone membrane used to filter bacteria and particles from liquids in pharmaceutical and biotech processed.
2. Is the PES filter well-suited to sterile filtration?
Yes. PES (polyethersulfone) membranes are widely used in sterile filtration due to their unique material properties and design advantages. PES membrane features asymmetric structure and uniform pore sizes, and high bacteria retention efficiency.
3. What pore size is used for sterile filtration?
Sterile filtration typically uses a 0.2 or 0.22 micron pore size. These are small enough to remove most bacteria.
4. Can PES filters be sterilized?
Yes. PES filters can be sterilized using steam (autoclaving) or gamma radiation—both standard methods in pharmaceutical manufacturing.
5. What are common applications of PES filters in pharma?
PES filters can be used in both upstream and downstream bioprocessing, for applications like buffer and media filtration, prefiltration for column and TFF protection, and final sterile filtration.
6. In what ways are PES filters distinct from other membranes like PVDF or Nylon?
PES membranes are known for their high flow rates and low protein binding, making them ideal for high-throughput and protein-sensitive applications.
7. Are Cobetter PES filters certified?
Yes. Cobetter’s filters are qualified to meet industry standards and come with full validation reports and traceable quality control documents.
8. How do I choose the right PES filter for my application?
It depends on your solution and process. Cobetter provides technical guidance to help you select the right format, pore size, and membrane type for your needs.
