Industry sector: pharmaceutical industry
Company activity: manufacture of pharmaceutical products (oncology, endocrinology, metabolic diseases…)
Company type: major global group
Company founding period: 17th century
Contact: technical project engineer
Compagny context
The company produces and markets pharmaceutical products and active ingredients for oncology, neurodegenerative diseases, infertility treatment, endocrinology, metabolic and cardiovascular diseases, and dermatology. It also manufactures and handles chemical products in dry form and uses various filtration systems on its production lines.
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filtration challenge
Our customer wanted to protect a centrifuge operating under an inert nitrogen atmosphere for the production of a powder. The liquid to be filtered contained in particular isopropyl alcohol, also known as isopropanol. The filtration system proposed had to meet the following constraints:
- compatibility of the filter media and seals with isopropanol
- supply of two filter housings: one DN25 (flow rate 20 to 25 L/min), the other DN40 (35 to 40 L/min)
- pressure: 1 bar
- temperature: 0 to 40 °C
- viscosity of the fluid to be filtered: 2.3 mPa·s at 20 °C (with a maximum viscosity of 4.5 mPa·s)
The customer also wanted an FDA certificate for the seal material, as well as material and surface roughness certificates.
Pemflow filtration solution
To meet this specification, we proposed the following filtration solution combining:
- 2 stainless-steel 316L single-cartridge filter housings, 20″ code 7, with FDA-certified EPDM seals (ethylene–propylene–diene monomer), one in DN25 and the other in DN40 to meet the required flow rates, and
- 2 filter cartridges fitted with an absolute 0.5 µm pleated depth filter, featuring the following characteristics:
- polypropylene “Melt Blown” filter media compatible with isopropanol
- materials compliant with US FDA Title 21 and USP Class VI requirements for FDA certification
We also provided the customer with the FDA certificate for the EPDM seals as well as a complete documentation pack meeting pharmaceutical production requirements, including:
- a diagram of the system
- installation and operating instructions
- the 316L stainless-steel finish specification for the filter housings and the material certificate
- the certificate of compliance with the Pressure Equipment Directive (PED)
- the hydrostatic test certificate
- the Quality Approval certificate
Three factors were decisive in the company’s choice of Pemflow:
- the fact that the proposed filter cartridges were already used on their site for API and pharmaceutical water filtration,
- the low initial pressure drop of our filter cartridge, lower than that of cartridges offered by other manufacturers,
- the competitive price of the filters.
The filtration solution implemented by Pemflow during the winter shutdowns is now fully operational.
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