New IX Resin In Primary And Secondary Service Solves Quality Problem For Pharmaceutical Manufacturer's DI Water
Now Consistently Meets Below-USP Spec for TOC
The resin regeneration contractor for a major pharmaceuticals manufacturer reports that substitution of a new mixed bed ion exchange (IX) resin in both primary and secondary service has ended recurring out-of-spec episodes for their deionized (DI) water. The resin change has allowed them to consistently meet an especially low total organic carbon (TOC) specification of <50 ppb for their DI water in their process loop. The United States Pharmacopeia (USP) specification for TOC calls for <500 ppb.
"They said they were getting over 250 ppb half the time, which was causing them shortfalls in their production," recalled Dave Weatherill, principal at Regeneration Services in Burlington, ON. "Since we substituted the new resin, they have been consistently far below their 50 ppb spec, and thereby able to move forward with production schedules as planned."
The DI water is analyzed continuously for TOC, utilizing calibrated, certified, and validated methodology. Since the new resin was installed, readings have been consistently below 3 ppb.
Original lake source water drawn by the city passes through 60-micron disposable filters to bring total suspended solids (TSS) down to 5 ppm.
It is then pumped from a storage tank to the primary (working) and secondary (polishing) DI systems, which are set up in series. Each features a tank containing a 3.5 cu. ft. column of the new resin. A third tank, also containing a 3.5 cu.ft. resin column, serves as a standby unit. The ultrapure water is recirculated back to the storage tank at a makeup rate of 10 gal./min. (USGPM).
The new mixed bed resin is manufactured by The Purolite Company of Bala Cynwyd, PA, which develops, manufactures, services and supports an extensive variety of resins for a broad range of industrial applications. This new resin was among the first produced with new machinery in a specially controlled environment.
"The new manufacturing process is designed to reduce leachables to very low levels, and to eliminate microbiological contamination," noted Francis Boodoo, technical director.
"The ability to rinse quickly to resistivity and TOC quality standards are of fundamental importance to the pharmaceutical industries," he continued. "Particle shedding should be at a minimum, while the resins should be free of microbiological problems. We test every batch to ensure it meets our specifications for resistivity and TOC before it is released for distribution."
"For best quality and subsequent performance, warehouse storage and transit times should be kept to a maximum of six months. Product drums should be stored under cool conditions, keeping away from sunlight and keeping the inner bag liners for the drums tightly closed to prevent air intrusion and subsequent product degradation."
Designated UltraClean UCW 3700, it is described as a ready-to-use, 1:1 chemical equivalent that is highly regenerated in the H+ and OH- forms. The cation and anion are gel resins that are polymerized with a styrene-divinylbenzene matrix, and functionalized. The resin beads effectively resist fragmentation that could result in particle release into treated water.
The new mixed bed resin is specially designed to meet key challenges for every regeneration, particularly including proper separation of cation-anion during backwashing, which is critical in preventing cross-contamination of the resin with the wrong regenerant.
Regeneration Services is a partnership of water purification experts offering water system design, service and troubleshooting. It offers consulting services for all types of ion exchange systems, as well as membrane systems.
The company can also provide independent review and validation of water purification equipment performance, and maintains several pilot system columns, with associated controls and reagents, for testing process solutions.
For more information, visit www.purolite.com or www.regenservices.ca
SOURCE: Indumark