By Matt Migliore
|RFID reader/writer technology is being touted for pharmaceutical process tracking. The RFID-based system identifies each device by its serial number for reference in a database. The reader/writer logs and tracks ongoing wear-related events, such as the number of cleaning cycles and dates performed (CIP, SIP, autoclave) and the number of batches of material processed. Photo courtesy of AdvantaPure.|
With demand for hose and tube products on the rise in many high-purity industries, there is a trend toward more quality and accountability in the manufacturing process for such technologies. To this end, many manufacturers in the hose and tube space are expending a lot of time and effort to improve the quality of their production processes. For example, NewAge Industries (www.newageindustries.com), a manufacturer and fabricator of flexible tubing and hose and a private-label reseller of fittings and clamps, has outfitted its production process with in-line, laser-based monitoring equipment to help ensure its products are being manufactured to the quality required by the end-user. This type of quality monitoring is particularly important for critical industries, such as semiconductor, pharmaceutical, and nuclear.
Though quality and accountability is a pressing issue for hose and tube manufacturers, cost, as always, is also a concern. So while high-quality product is in high demand, it is being demanded at a low price point. As such, John Stover, director of product management for NewAge Industries, says materials like thermoplastic elastomers (TPE) are gaining notoriety. “TPE doesn’t have a lot of the negatives commonly associated with products like PVC, and it isn’t as costly as higher-end materials like silicone,” he says. Likewise, Stover says new PVC-based compounds are coming to market, some of which are being touted as silicone replacements. Although, he says it remains to be seen whether these materials offer the same application stability as silicone.
Jack L. Wisdom, president of Fluortubing USA (www.fluortubingusa.com) and a board member for the NAHAD (National Association for Hose and Accessories Distribution, www.nahad.org), says a trend toward new resins and processing methods in the hose and tube segment is also opening the door for plastic products such as PEEK (polyetheretherketones), which are gaining prominence in highly specialized applications where rubber and common plastics have shown some problematic shortcomings.
The Disposables Trend
With many analysts predicting continued momentum for disposable processing technology in the pharmaceutical and biopharm industries, hose and tube manufacturers are well positioned to make significant inroads in these areas. Traditionally, pharma manufacturing applications have employed stainless-steel components and CIP/SIP (clean-in-place/steam-in-place) processes to ensure the purity of the operating environment. With disposables, components are used just once and discarded, eliminating much of the time, effort, and cost involved with cleaning and purifying stainless-steel systems. For hose and tube manufacturers, a move toward disposables is advantageous, as it will drive demand for thermoplastic and elastomer tubing sets and components.
One area of the disposables market that remains unsettled involves regulatory and validation requirements. Today the proof of cleaning and sterilizing processing equipment is the purview of the end-product manufacturer. With disposables, however, the responsibility for cleaned and sterilized equipment validation is not as well defined. There is debate between the end-product manufacturers and the disposable component manufacturers on who should be responsible for validating the cleaning and sterilization of the disposable components. The end-product manufacturers want the supplied components to be supplied as validated, cleaned, and sterilized, while the disposable manufacturers feel that validation should remain the realm of the end-product manufacturer.
Stover believes that moving the burden of validation from the end-product manufacturer to the equipment supplier would be difficult, as many applications use components of different manufacture in the disposable system. Also, he believes the end-product manufacturers are more suited to validate the cleanliness of disposables since they already have the processes in place from their experience with stainless-steel process systems. “They’re more set up to do that because they have all the documented procedures and test equipment already in place,” says Stover. “We don’t.” To move the burden of validation over to the equipment suppliers’ end, Stover says there would have to be new guidelines for cleanliness, sterilization, and how to prove cleanliness and sterilization.
Currently, ASME-BPE (www.asme.org/communities/technical/bpe) and BPSA-SPI (www.bpsalliance.org) committees are working to define best practices for dealing with issues of how to assemble disposables to assure the cleanliness and purity of the system. Some of the regulatory and validation issues currently under consideration include chemistry (i.e., extractables, leechables, and biological compatibility), container robustness, integrity, and sterility chemistry.
Regardless of the ongoing debate over validation, Stover is ultimately confident in the future of disposable technology. “There’s no doubt that the use of disposables will be the trend of the future,” he says. “There have already been many studies done by many end-product manufacturers proving the cost of using disposable systems easily justifies their use over traditional re-usable systems and the processes used to prepare, clean, and sterilize them for the next process batch.”
Hose & Tube Selection
Proper hose and tubing selection is critical to minimize risk potential. Improper selection could cause contamination of important and expensive product batch. Even worse would be the potential for catastrophic failure in applications that could cause injury or fatality.
When attempting to identify the appropriate hose and/or tube for a given application, Stover recommends users ask themselves a few questions during their specification process. For example:
• What level of quality/purity does your application require?
• What operating conditions will the hose or tubing be exposed to?
• How do you ensure that your process is employed day in and day out (traceability)?
The more information made available about the application, the less chance of the wrong hose or tube being recommended.
To ensure successful application of hose and tube technology, Fluortubing USA’s Wisdom believes end-users would benefit tremendously if hose and tubing distributors were to write specifications for their product lines based on the new NAHAD Hose Assembly Guidelines program. “This information is designed for hose distributors, fabricators, and hose manufacturers, but the end-users will gain the most from the program,” says Wisdom. “Where else can you get data on the correct method for testing hoses, or how to correctly install them, or when they should be replaced?”
Going forward, hose and tube manufacturers figure to continue to experiment with chemistries in the hope of identifying lower cost solutions to critical applications. “Manufacturers are looking for ways to build traditionally expensive products cheaper,” says Stover. Also, Stover sees a trend toward more flexible hoses. For instance, he says fluropolymer hose users are looking for solutions that are more flexible and pliable to replace what has traditionally been a particularly rigid solution.
One new technology NewAge Industries is investing a significant amount of time and effort in is RFID (radio-frequency identification). Under its AdvantaPure (www.advantapure.com) sanitary product line, NewAge is offering an RFID-based solution for tracking equipment through various stages of the manufacturing process. The technology, which is being marketed primarily to the pharmaceutical industry, provides a method for manufacturers to electronically track process equipment use, materials handled, cleaning, and other relevant points of information. The system, originally branded HoseTRACK and tailored for hose and tubing products and related components, has recently been expanded to cover process equipment in general under the brand name Process Equipment Tracking (PET).
to Stover, process information in the pharmaceutical industry is typically tracked manually in hand-written logbooks. He says, while the pharmaceutical industry is already using RFID to track drugs to prevent counterfeiting, among other things, the industry is rather attached to its logbooks for tracking the manufacturing process. Still, Stover says electronic process tracking is slowly gaining a foothold.
With NewAge’s PET technology, RFID tags are placed on process equipment so they can electronically record information about the use of a given piece of equipment. The tag supports read-write capability and can be communicated with via a handheld device. The information stored on the tag is downloadable into a database to provide an audit trail for validation.
With hard-copy “logbook” tracking of process equipment, Stover says documentation is often dispersed throughout a facility, which can make it hard to gather all documentation in a timely manner. Further, he says there are often different logbooks and buildings for equipment use, cleaning, and storage. “When you’re trying to track down all of these logbooks, it can become a bit of a burden,” says Stover.
At this point, Stover says most of the business for PET is coming to NewAge after manufacturers are cited by the Food and Drug Administration (FDA, www.fda.gov) for compliance issues with their validation processes. By upgrading their process from the logbook to RFID, manufacturers have a lot more flexibility and accountability in their equipment tracking process. “Because the data is electronic, you can do a lot of things that makes it easily retrievable and easily viewable,” says Stover. This not only helps the manufacturer make the process easier and more coherent, but also ensures the FDA has the validation data it needs.
While Stover believes it’s only a matter of time until electronic tracking gains widespread acceptance in the pharmaceutical industry, he acknowledges it’s an uphill battle to convince pharmaceutical manufacturers to move away from the trusted logbook. He says, “If they’ve had no issues with regard to tracking, they’re going to look at [PET] and say ‘that’s really neat, but we don’t need it.’”
Matt Migliore is the editor of Flow Control magazine. He can be reached at firstname.lastname@example.org.