Filtration Solutions for Pharmaceutical Formulation and Sterile Filling

Cartridges and single-use capsules scale for lab use, process development and production arena

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New! Endotoxin Filters

Introducing the newest additions to our bacteria removal product suite - the GPC and PPC filters. These PES membrane filters are positively charged to retain gram-negative bacterial cell debris.

 

Remove particles, bacteria, mycoplasma and endotoxins from upstream to downstream.

Typical Process Steps for Drug Formulation and Filling and Location of Proper Filters (4)

Your process risk assessment will determine acceptable levels of bioburden throughout formulation and filling. The diagram above represents a generic situation. Bioburden control and sterilizing filters are chosen based on risk analysis and requirements.

Clarification & Prefiltration

Clarifying and prefiltering drug substances and excipients to microbials and unwanted particles lightens the contamination load so the next filter can perform more efficiently. In pharmaceutical processing, where sterile product is critical and final filters carry the greatest cost, prefilters will do the bulk of filtration in order to extend the life of the sterilizing filters.

Made from CPF's proprietary high capacity PES membrane, BCWPS Filters excel in protecting downstream filters. With its low binding characteristics, BCWPS filters are used for the clarification and prefiltration of products with high proteins and preservatives. Membrane based prefilters, such as the BCWPS offer greater retention than a depth filter.

With its high flow rates and particle removal capability, our PGD Prefilters are made with pleated fiberglass depth media and have a high contaminant holding capacity.  PPD Prefilters, constructed with pleated polypropylene depth media, are a great choice for retention of fine particles and have broad chemical compatibility for use in a variety of applications.  When dealing with fluids that have high solids content or contamination, CPF's HLP Prefilters, constructed with high-loft pleated polypropylene depth media, combine superior filtration capacity with exacting retention of fine particles.

Applications

  • SVPs and LVPs
  • Excipients
  • Drug substances
  • Intermediates
  • Fill & Finish
Sterilizing & Bioburden Reduction

From formulation to final fill and finish, Critical Process Filtration delivers high quality bioburden control and sterilizing filters made from Polyethersulfone (PES) membrane in both a cartridge or single use capsule device.

BPS Filters are made with PES membrane, available in single and dual layer configurations. They are designed to reduce bioburden contamination and are utilized in products with high proteins and preservatives that can adsorb to media. 

Our PPS Filters consist of a double layer of PES for the most critical applications and have low binding characteristics for filtering ingredients with preservatives and protein solutions that can adsorb to media. For increased capacity when filtering liquids with high particle loads, HPPS Filters provide a dual layer PES membrane configuration - an integrated prefilter layer with an asymmetric PES final filter. This 2-in-1, prefilter and sterilizing model is a good solution for combining multiple filtrations into a single step.

If endotoxin removal is necessary, the PPC Filter sterilizes and is positively charged to remove gram-negative bacteria debris. 

Protecting tank contents and the process environment

CPF's PTR filters can prevent environmental and process gas sources of bacteria and contaminants. These hydrophobic sterilizing filters are made with Polytetrafluoroethylene (PTFE) membrane to capture microbials as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators in the surrounding work space.

Filtration solutions for producing point-of-use, WFI and bulk water.

 

Pharmaceutical Water Filtration

Validation of Sterilizing Filters

Critical Process Filtration Validation Services Whether you are starting a new process or making changes to an existing one, our technical experts provide validation services to assure consistent performance and regulatory compliance.

It's no secret that validating processes is a major undertaking. That's why Critical Process Filtration's technical experts partner with you to help manage the extensive testing and documentation needed to meet your requirements.

 

Validation Testing for Specific Applications

The validation process begins by collaborating with your team to determine a testing plan that clearly defines your filtration performance targets and steps to be taken. 

Some pharmaceutical intermediates and ingredients may affect the performance of a filter. Validation tests are conducted by Critical Process to determine if the filter will perform as required under the "worse case" operating conditions. Testing includes:

  • Material compatibility
  • Extractables and leachables studies
  • Bacteria viability/challenge/retention studies in process fluid 
  • Establish fluid-based integrity test specifications
  • Other customer specified requirements
Connect with an Applications Engineer about validating your filters.

 

Quality Assurance and Standards

Critical Process Filtration filters are designed for use in cGMP compliant processes. Our state-of-the-art manufacturing facility and quality-management system both meet ISO 9001:2015 standards. Each operation from assembly and test to cleaning, drying, and packaging is done in appropriately rated clean rooms, and each filter is assigned a lot code to ensure the traceability of manufacturing data and materials. A sophisticated MRP system collects and processes real-time data from manufacturing centers and inspection points. 

USP Biosafety and FDA Compliance

The materials used to construct pharmaceutical-grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. Critical Process Filtration filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72, for non-fiber-releasing filters. The levels of bacterial endotoxins in aqueous extracts from pharmaceutical-grade filters are below current USP limits as specified for water for injection.