Company activity: Manufacturing of active pharmaceutical ingredients and products for the pharmaceutical industry
Company type: International
Company founding year: 1994
Contact(s): Industrialization & Procurement Services
COMPANY CONTEXT
A subsidiary of a global leader, our client offers a full range of services for pharmaceutical innovators. The company specializes in developing and optimizing manufacturing processes for active pharmaceutical ingredients (APIs) and pharmaceutical products. It produces compounds used in medications for diabetes, cancer, and depression. For over 30 years, our client has demonstrated expertise in the development and scaling of API processes.
FILTRATION ISSUE
Our client aimed to address two key challenges related to filtration in their API production processes:
- Resolving technical issues with certain filter cartridges that were incompatible with organic solvents (presence of extractables, deformation of cartridges, mass loss).
- Reducing the filter inventory to streamline procurement and stock management.
FILTRATION SOLUTION BY PEMFLOW
To meet pharmaceutical requirements, two steps were necessary to validate new filter media under a Change Control procedure:
- Sampling of filter cartridges to conduct validation tests, ensuring compliance with technical, quality, and regulatory requirements.
- Providing all necessary documentation for the Quality Assurance department (technical data sheet, validation guide, certificates of compliance).
Did you know?
For all our filtration cartridges, we can provide F4P data sheets to facilitate Change Control procedures. These documents compare our product specifications with those of existing equipment.
Once these steps were validated, we proposed two types of cartridges meeting the specifications and constraints of filtration processes.
Filtration of organic solvents under thermal constraints
Due to chemical compatibility issues, the industrialization department was seeking an alternative to existing hybrid cartridges (made from two different materials). The goal was to select a media and hardware offering maximum chemical inertia while covering a broad range of solvents, including those subjected to operating temperatures of up to 80°C.
We proposed a cartridge specifically developed for APIs and validated for most organic solvents commonly used in fine chemistry (Acetone, Acetonitrile, Diethyl Ether, DMAC, DMF, DMSO, Hexane, MIBK, MTBE, THF, Toluene, Xylene).
Did you know?
PFA (perfluoroalkoxy) is a fluoropolymer with properties similar to PTFE. It withstands extreme temperatures (-220°C to 260°C) and offers excellent chemical resistance.
Features & benefits:
- 100% fluoropolymer construction
- Hydrophobic PTFE membrane with PFA hardware
- Thermal bonding process eliminates adhesives, ensuring minimal extractables
- Full traceability of each cartridge
- Consistent and reliable performance
- Filtration threshold: 0.05 µm to 10 µm
- Complete validation guide available
Filtration of water-based solvents
For filtration of water-based solvents, we selected high-performance cartridges with absolute-rated filtration, offering high retention capacity and low pressure drop, thanks to strict control over the fiber matrix manufacturing process.
Expert advice
For API filtration applications, we recommend using filter cartridges with glass fiber-reinforced end caps to ensure high thermal resistance and broad chemical compatibility.
Features & benefits:
- Filter media: Polypropylene
- End caps: Polypropylene reinforced with glass fiber
- Seals: FEP/Silicone
- Filtration efficiency
- Available lengths: from 5" to 60"
- Sterilization & sanitization: Steam 121°C (240 cycles), 135°C (8 cycles), Hot water 90°C (30 min)
- Full traceability by batch number
Need to filter organic solvents under specific conditions?
Contact our experts to assess your requirements.
