Industry sector: Pharmaceuticals
Company activity: Manufacturing of injectable glass, polypropylene and polyethylene vials and ampoules
Company type: SME
Founded: 1990–2000
Contacts:
- Buyer
- Technical & Safety Manager
- Qualified Pharmacist / Industrial Director
- Utilities Technician
Company context
Filtration is used to produce purified water of a quality suitable for the manufacture of injectable solutions.
Filtration challenge
A high concentration of endotoxins (> 0.25 EU/mL) was detected in the system, with contamination found in both storage tanks (recirculated / filtered at 0.2 µm) and in both purified water loops.
For more information on endotoxin removal, read the article “How to eliminate endotoxins from pharmaceutical-grade water.”
Pemflow filtration solution
The existing membrane cartridges were replaced with FiberFlo™ hollow fibre cartridges —
0.45 µm and 0.2 µm on the filtration stages before UV exposure, and 0.05 µm after.
Particular attention was paid to the filtration flow rate, which directly conditions the endotoxin retention capability of the filter.
To ensure sufficient contact time between the Polyphen membrane and the lipopolysaccharides it must capture via chemical affinity, the flow rate must remain below 500 L/h per 10-inch height.
In addition, the use of membranes with a large exchange surface area — 3 m² versus 1.4 m² for a 20-inch pleated membrane, for example — helped limit pressure drops within the purified water circuit.
The modifications implemented by Pemflow reduced endotoxin concentrations to below 0.25 EU/mL, the maximum acceptable threshold for injectable preparations.
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