FILTERS
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Choose a supplier that offers a range of IV components, suggests John Leahey of Filtertek Inc. That way, you can minimise your vendor base and work with a single point of contact.
(Photo courtesy FILTERTEK) |
Quality Comes First
Quality should apply to more than the end product. John Leahey, Director of Medical Products at Filtertek Inc. (Hebron, IL, USA) says that quality must cover the product, its functionality and the way it was manufactured.
“Ask if the manufacturer employs the latest technological advancements to ensure product quality,” he says. “Is the product manufactured in an environment appropriate for medical products? Does the manufacturer use vision inspection systems and adhere to the latest quality standards? Does the product contain the best combination of materials for your application? For example, all polyethersulphone media is not the same. Does the supplier offer the option of switching material vendors for optimum performance?”
Check the Regulatory Track Record
“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, MI, USA). “Check for all applicable certifications.” 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.
Look for a Resourceful Supplier
Leahey 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, needless 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 who 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,” Alfonso says. “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, 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.”
Consider Logistics
You pour significant time and financial resources into creating and maintaining an effective world-class operation. Why would you do business with suppliers that are not committed to achieving the same goals? Leading 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.
