January 20, 2026 Case

API filters for cGMP-compliant pharmaceutical production

API Filters in the Pharmaceutical Industry

Reliable filtration for cGMP-compliant API production

In the production of Active Pharmaceutical Ingredients (APIs), filtration is rarely a secondary consideration.
An incorrect filter selection can result in batch loss, process delays, or non-compliance. For this reason, filtration is a critical element in both chemical and biotechnological API processes.

API production is subject to strict cGMP (current Good Manufacturing Practice) guidelines. This means that filtration solutions must not only perform technically, but also be demonstrably validated, reproducible, and fully traceable.

Van Borselen Filters has supported pharmaceutical manufacturers for decades with reliable, validated filtration solutions for API production.

Experienced partner in API filtration

As one of the most experienced filtration suppliers, Van Borselen Filters has built extensive expertise in filtration for pharmaceutical manufacturing processes.

For decades, we have proudly been the filter supplier to the Dutch production site of a global top-10 pharmaceutical company with API manufacturing operations in Europe. For this customer, our filters are fully validated within the production process.

Through:

  • consistent product quality
  • reliable delivery from stock
  • and technical support by filtration specialists

we have ensured a stable and controlled filtration process for many years in a highly regulated environment.

 

Filtration challenges in API processes: practical experience

In API production, we see that filtration failures are rarely caused by the filter medium itself.
In most cases, the root cause lies in:

  • incorrect filter sizing
  • insufficient or improper prefiltration
  • or a filter that is not optimally integrated into the process

This is why we do not focus solely on the filter, but on the entire process context. This approach makes the difference between a filter that simply “works” and a filtration solution that is structurally reliable.

 International Standards & Validation

Filters used in API production must comply with strict international regulations. The sterile filters supplied by Van Borselen Filters comply with, among others:

  • USP Class VI
  • FDA Title 21 (CFR)
  • EC 1935/2004
  • GMP guidelines

In addition:

  • all filters and components are fully traceable
  • each filter is individually integrity tested
  • production takes place in an ISO Class 8 cleanroom

This makes our filters suitable for critical API applications, where process reliability and compliance are essential.

Filters for API production

  • Filters for steam: PTFE filters, capsule filters, sterile air filters, porous sintered metal filters, and filter housings.
  • Filters for WFI (Water for Injection): PES filters, dual-layer filters, RO membranes, and filter housings.
  • Filters for compressed air: Prefilters, high-performance filters, PTFE filters, and filter housings.
  • Filters for nitrogen (N2): PTFE filters, capsule filters, sterile air filters, and filter housings.
  • Filters for storage tanks (surge tanks): Vent filters, PTFE filters, capsule filters.
  • Filters for crystallizers: Vent filters, PTFE filters, capsule filters.
  • Filters for lyophilization machines (freeze-drying machines): Vent filters, PTFE filters, capsule filters.
  • Filters for spray dryers: Vent filters, PTFE filters, capsule filters, coarse filters, and sterile filters.
  • Aseptic filtration: PES filters, PTFE filters, and capsule filters.
  • Filters for clarifying liquids: PES filters, pleated filters, filter modules, and filter housings (PES/pleated and modules).
  • Prefilters: Pleated filters and filter housings.
  • Machine for separating dry substances: PharmaSep.

Learn more?

Contact us

If you would like to receive any additional or specific information about our product range, or if you would like one of our account managers to visit you, please do not hesitate to contact us.

A filter is suitable for API production when it complies with cGMP guidelines, is validated, fully traceable, and consistently performs within the defined process conditions.

Key standards include USP Class VI, FDA Title 21 (CFR), EC 1935/2004, and GMP guidelines, ensuring product safety and regulatory compliance.

No. The required pore size depends on the process step, the medium, and the risk assessment. Not every API application requires sterile 0.2 µm filtration.

Sterile filtration mechanically removes microorganisms from liquids or gases, while sterilization inactivates microorganisms, for example by heat or steam.
For a more detailed explanation, read our blog on sterile filtration in pharmaceutical processes.

Prefiltration protects the final filter, extends service life, and prevents premature blockage, contributing to process stability and reduced operational risk.

In many cases, yes. This depends on available documentation, material compliance, and integrity testing. Each application is assessed individually.

Yes. A large part of our API filtration range is available from stock, supporting continuity and reliability in pharmaceutical production.

Validated API filtration for critical pharmaceutical processes

Van Borselen Filters supports pharmaceutical manufacturers with validated API filters in accordance with cGMP guidelines. With decades of experience in pharmaceutical filtration, we deliver reliable solutions for liquids, gases, and dry solids, supported by technical expertise and consistent delivery reliability.