Industry sector: Manufacturing of pharmaceutical preparations
Company activity: The company produces pharmaceutical preparations, medicinal-use chemicals, and herbal products. It also manufactures sodium bicarbonate, potassium chloride, and therapeutic clays for both professionals and consumers.
Company type: Independent French pharmaceutical laboratory operating in more than 30 countries
Founding period: 1929
Contacts: Maintenance Manager – Continuous Improvement Engineer
Company context
Our client is an international specialty pharmaceutical group committed to developing new solutions for targeted debilitating diseases and improving patients’ quality of life.
The company’s mission is to innovate in the service of patients throughout their care pathway by providing services tailored to their needs.
During a general presentation of our filtration expertise, the company consulted us regarding an issue involving coarse filtration, subject to the strict requirements and regulations of the pharmaceutical industry.
Filtration challenge
A viscous fluid consisting of a clay suspension in water (the dry matter represents between 25 and 26%) had to be filtered during draw-off from a decanter. This liquid solution is then processed to obtain a powder, considered as the active ingredient of a medicinal-use product.
To avoid malfunction, damage, or production blockage, our client asked us to propose a coarse filtration solution compliant with the standards and regulations applicable to the manufacture of pharmaceutical preparations.
Our client sent us its specifications with the following requirements:
- Cleanable metallic filter with a filtration threshold of 3 mm (3000 µm)
- Maximum draw-off flow rate of 7 m³/h
- Filter housing to be installed INLINE on DN110 piping
- Materials and equipment compliant with US FDA and European EN1935/2004 standards
Notice
EN 1935-2004 standard: European regulation concerning materials and equipment suitable for food contact.
FDA: The Food and Drug Administration (FDA) is the U.S. agency responsible for food and drug safety. Among its missions, it authorizes the marketing of medications within the United States.
Pemflow filtration solution
One of the installation requirements was the ability to install the filter housing inline, so we proposed a truncated-cone basket filter.
This solution meets the client’s constraint of an inline housing while retaining macroscopic contaminants inside the screen in a conventional filtration direction—from the inside to the outside.
Connection to the existing pipework is made via an EN1092-1 flange.
The filter housing is inspected weekly to ensure that no contaminants have been accidentally introduced through the top opening of the decanter. It was therefore essential that maintenance operations be easy for the operators.
We consequently selected an ergonomic quick-opening/closing system using swing bolts and eye nuts.
The filter body is made of 316L stainless steel and mounted on adjustable legs. The inlet and outlet connections are DN100 PN16, fitted with EN1092-1 flanges.
Upon delivery, and in accordance with our client’s requirements, we provided the complete documentation package, including:
- Material certificates
- FDA and EN1935/2004 certificates
Our proposal was selected over a Y-strainer solution.
Two points were particularly valued by our client:
- A larger exchange surface in our solution
- Easier maintenance operations
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