Business sector: Hospital activities (NAF Code 2008: 8610Z)
Company activity: Medical center specialized in the treatment of patients with renal failure
Company type: Association
Company creation period: 1985
Contact(s): Responsible Pharmacist / Technical Manager
Company context
The organization is a care center for patients undergoing periodic hemodialysis. Housed within a healthcare facility, the association establishes, organizes, develops, and manages various care units available to patients with renal failure who have reached the dialysis stage. Due to its location within a hospital, the most fragile patients benefit from a large medical team and from care provided in the evening and at night.
Filtration challenge
For all organizations dedicated to providing care to patients with renal failure, the quality of advice and the expertise of the supplier in the medical field in general, and in dialysis filtration processes in particular, are essential.
As part of the renewal of the supply of various filtration consumables, the association wished to entrust the sourcing of filter cartridges to a company with recognized expertise in medical filtration, capable of providing high-quality solutions aligned with their budgetary constraints.
In addition, filter availability, within one week at most, was a key selection criterion.
Pemflow filtration solution
The filtration chain in the dialysis field consists of three types of media, each with a 20-inch length:
- Nominal prefiltration
- Absolute filtration
- Biological-grade water loop return filtration
Prefiltration
Prefiltration is divided into two filtration stages: 5 µm nominal, followed by 10 µm nominal.
Nominal depth filter cartridges fully meet the requirements of this particulate retention stage.
Manufactured with a true density gradient, it offers a large void volume with low pressure drop and excellent dirt-holding capacity. Its structure remains intact even under demanding operating conditions. The cartridge fibers are continuously thermally bonded to the central core.
The materials are compliant with US FDA Title 21 & USP Class VI. They meet the food contact requirements of European Regulation EC 1935/2004.
The product reference is engraved on each cartridge to ensure full traceability by batch number and can be supplied with an individual certificate of conformity.
Note
Nominal efficiency
The term “nominal” is used to define a filter element whose filtration efficiency at the stated rating is on the order of 90.00%.
Absolute filtration (Beta ratio 5000)
This filtration stage aims to remove any carbon fines and protect the reverse osmosis unit. At this level, it is necessary to select a cartridge range with an absolute rating, i.e. a filter element whose filtration efficiency at the stated rating is greater than 99.98%.
Two types of filter media can be implemented:
In the absence of colloids, we install absolute depth cartridges, 100% polypropylene, with an absolute rating of 1 µm.
The cartridge fibers are continuously thermally bonded to the central core to minimize fiber migration. All layers are bonded to ensure a maximum void volume while increasing fiber density, providing true depth filtration.
The construction materials used are FDA & EC 1935/2004 compliant.
All cartridges are manufactured under strict quality control, with a batch number and full traceability of all components.
In the presence of colloids, we propose glass microfiber cartridges.
Expert advice
A colloid is a dispersion of one or more gelatinous and deformable substances suspended in a liquid. Glass microfiber, which is naturally electropositive, is well suited to the retention of colloids (negatively charged), on the one hand. On the other hand, the entanglement of these microfibers (fine and numerous) enables the efficient capture of deformable particles.
In this case, where colloid retention capacity is required, we opt for absolute-rated cartridges.
Biological-grade water loop return filtration
The microbiological quality of fluids used in hemodialysis is fundamental. The objective is to prevent the passage of undesirable bacteria and endotoxins at the water loop return.
In this context, a naturally hydrophilic pleated Polyethersulfone (PES) membrane is the ideal choice for sterilizing filtration, with a microorganism retention efficiency greater than 10¹¹ (bacterial challenge – LRV > 11 at 0.2 µm – Brevundimonas diminuta).
The cartridge range, featuring a biological-grade pleated PES membrane, offers the technical characteristics required to comply with the standards and regulations related to the safety of healthcare delivery.
The thermally bonded construction eliminates adhesives and ensures a minimal level of extractables. The bacterial challenge confirms the sterilizing quality of the membrane (ATCC 19146). In addition, the end caps are reinforced with polypropylene in order to withstand the temperature peak during sterilization (hot water at 90°C for 30 minutes), carried out several times per week.
According to the LAL test methodology, the filters are validated for an endotoxin retention equal to or less than 0.25 EU/mL.
We have entered into a multi-year filter supply contract with this client.
The delivery lead time and availability of the filters are of critical importance when cartridges are installed in care units.
This is why we have set up a dedicated stock of cartridges for this client within our warehouses. This service enables delivery within 24 to 48 hours and secures the client’s day-to-day operations.
Dedicated product storage in our warehouses
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