Filtration is a key part of various medical procedures where it is critical to maintain a sterile field that is free of bacteria and contaminants. When sourcing a supplier of IV and medical filters, you may find the following tips helpful.
By: Joyce Laird and Yvonne Klöpping
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Filtration manufacturers with a solid research background often can offer a wealth of innovative products.
(Photo courtesy GVS)
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Filtration is a key part of various medical procedures where it is critical to maintain a sterile field that is free of bacteria and contaminants. When sourcing a supplier of IV and medical filters, you may find the following tips helpful.
Focus on Filtration Quality
Rather than rigidly specifying a filter configuration, customers are best served by simply specifying the flow and quality requirements and letting the supplier select the appropriate filter, says Rafael Simon, Managing Director at Alpha Plan (Radeberg, Germany). “To achieve consistent quality, you have to [test against] a worst-case scenario involving influent fluid quality,” stresses Simon.
Confirm Appropriate Certifications
“A reputable and reliable supplier should have time-tested quality systems in place that enable the production of IV filters with exceptional lot-to-lot consistency and reproducibility,” says Ricardo L. Alfonso, Vice President, Business Development, Pall Life Sciences OEM (Ann Arbor, Michigan, USA). “Check for all applicable certifications,” he advises. These may include US FDA registration and compliance with QSR 21 CFR Part 820, ISO 9001:2000 and ISO 13485, CE marking requirements, CMDAS certification for Canada, and JPAL certification for Japan.
Demand Adaptability
Since each filtration application requires specific flow, rejection and material compatibility requirements, it is important to find a supplier that can offer filters that precisely match your needs, notes Simon. “While a number of off-the-shelf filters are available, you should partner with a manufacturer that can customise a filter for your specific needs to achieve superior performance,” he says.
John Leahey, Director of Medical Products at Filtertek Inc. (Hebron, Illinois, USA) notes that it is wise to partner with a supplier who is able to provide you with more than just filters. “Drug-delivery systems using IV filters host a number of other components, including check valves, needle-free access devices and so forth. By choosing a supplier that can offer the entire family of IV components, you can minimise your vendor base and work with a single point of contact,” he says. “Also, look for a supplier that is adaptable and open to modifying the product to meet your specific requirements,” he adds. “Often, a standard product is a good start to a superior system, but what if you want your product to be highly specialised? Will the supplier invest the time and be capable of engineering something just for you?”
“The best manufacturers maintain a rapid response team of engineers capable of making fast design modifications,” says Alfonso, adding that “expertise in integrating filter media, housing design and connector configurations allows them to customise products to your application quickly and effectively.”
Reward Innovation
Look for an IV filter manufacturer that offers a wide selection of filtration, separation and purification materials. This can minimise development time lines and costs. It also indicates a tradition of long-term research into new products.
Guido Amadesi, Marketing Manager at GVS Filter Technology (Zola Predosa, Italy), says that a company with a history of continual research in IV filters will also provide a wealth of innovative products. “A good example are filters that are able to retain endotoxins, an important target of the biotech and pharmaceutical industries,” he says. “A unique double-face design is another technology that offers the same effective filtration area as others in a package half the size,” Amadesi explains.
Consider Logistics
Manufacturers of IV and other medical filters that offer the security and convenience of global manufacturing and service networks are value-added resources that can significantly reduce the total cost of acquisition.
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