Industry sector: Manufacture of basic pharmaceutical products (NAF Code 2008: 2110Z)
Company activity: Manufacture of active pharmaceutical ingredients and products for the pharmaceutical industry
Company type: International
Year of company creation: 1994
Contact(s): Industrialisation & Purchasing Departments
Company context
A subsidiary of a global leader, our client offers a comprehensive range of services for pharmaceutical innovators. The company provides its expertise to develop and optimise manufacturing processes for active pharmaceutical ingredients and products intended for the pharmaceutical industry. For example, the company manufactures products used in medicines for diabetes, cancer or depression. For more than 30 years, our client has built proven expertise in API process development and scale-up.
Filtration challenge
Our client was looking to address two issues related to the filtration of its products within its active ingredient manufacturing processes:
- Resolve technical issues observed with the use of certain filter cartridges not compatible with organic solvents (presence of extractables, deformation of the cartridges, mass loss);
- Reduce the filter inventory in order to simplify procurement and stock management.
Pemflow filtration solution
As pharmaceutical products are concerned, two steps are required to validate new filter media within a Change Control procedure:
- Sampling of filter cartridges in order to carry out validation trials on the filtration process and ensure technical, quality and regulatory compliance of the filters;
- Providing all documentation relating to the cartridges for the Quality Assurance department (technical data sheet, validation guide, certificates of conformity).
Good to know
For all our filtration cartridges, we can provide F4P files to facilitate Change Control procedures.
These documents summarise our product specifications by comparing them with the existing ones.
Once these two steps had been completed and validated by our client, we proposed two types of cartridges meeting the specifications and constraints required by the filtration processes.
Organic solvent filtration under thermal constraints
Faced with chemical compatibility issues, the industrialisation department was looking for an alternative to the existing “hybrid” cartridges (media & hardware made from two different materials); the objective being to select media and hardware offering the highest chemical inertness while covering the widest possible solvent spectrum, including operational thermal constraints (up to 65 °C, or even 80 °C).
We proposed a cartridge specifically developed for APIs and validated with most organic solvents commonly used in fine chemicals (Acetone, Acetonitrile, Diethyl Ether, DMAC, DMF, DMSO, Hexane, MIBK, MTBE, THF, Toluene, Xylene).
Good to know
PFA, or perfluoroalkoxy, is a fluoropolymer with properties similar to PTFE. Thanks to its excellent heat resistance, it can be used over a wide temperature range from –220 °C up to 260 °C. It also offers excellent chemical resistance, comparable to PTFE.
Features & benefits
- Fully fluoropolymer construction
- Naturally hydrophobic PTFE membrane and PFA hardware
- Thermal bonding process eliminates adhesives and ensures minimal extractables
- Full traceability of each cartridge
- Consistent and reliable performance
- Filtration rating from 0.05 µm to 10 µm
- Comprehensive validation guide available
The cartridges have been specifically designed for use with corrosive gases and aggressive liquids. The naturally hydrophobic PTFE membrane and PFA hardware represent a highly relevant technical choice for applications requiring excellent chemical compatibility, high reliability and consistently high-quality filtrate.
Aqueous-based solvent filtration
For aqueous-based solvent filtration, we selected high-performance, absolute-rated cartridges offering high retention capacity together with very low pressure drop, resulting from strict control of fibre matrix manufacturing.
Expert advice
For API filtration applications, we recommend that the end caps of filter cartridges be reinforced with glass fibre in order to ensure good thermal resistance and broad chemical compatibility.
Features & benefits
- Filter media: Polypropylene
- End caps: Polypropylene, glass fibre reinforced
- Gaskets: FEP/Silicone
- Filtration efficiency
- Lengths: from 5″ to 60″
- Sterilisation & sanitisation: Steam 121 °C for 60 min (240 cycles), 135 °C for 30 min (8 cycles) – Hot water: 90 °C for 30 min
- Full traceability by batch number
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