Issue



A glimpse at Interphex unveilings


06/01/2005







By Angela Godwin

Over 950 exhibitors from around the world gathered together this past April for the Interphex conference and exhibition at the Jacob K. Javits center in New York City.

Walking the floor of the three-day pharmaceutical manufacturing conference, now in its 26th year, it was easy to get lost (both figuratively and literally) in the maze of product demonstrations, chachki giveaways and elaborate booth displays, which ran the gamut from a sample pill-bottling operation to a full-service tiki bar. Still, some vendors chose a more traditional approach to getting out their message, which was, of course, to introduce their new products and promote their old ones. Here are a few of the new-to-market innovations directly applicable to the contamination-control industry.


Figure1: Pall introduced its single-use Mustang?? XT5000 ion exchange membrane capsule for chromatography applications.


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Pall Corporation (East Hills, N.Y.; www.pall.com) held a press conference to introduce five new additions to its product line: the single-use Mustang® XT5000 ion exchange membrane capsule for chromatography applications (see Fig. 1); the Kleenpak™ HT single-use connector, which can aseptically connect two sterile fluid pathways without requiring laminar flow hoods or other equipment; the SUPRAdisc™ HP depth filter, which incorporates two layers of media for greater dirt-holding capacities to improve clarification steps in biological, bioprocess and pharmaceutical filtration applications; a modular tangential flow filtration (TFF) system, which uses disposable components, eliminating the need for cleaning and cleaning validation steps; and finally, new user-friendly software to simplify TFF and chromatography process control, making it easier to make process changes, scale up production, and ensure 21CFR Part 11 compliance.


Figure 2: The Pod platform from Millipore is a disposable filter system designed to increase speed, safety and cost savings in the manufacture of new drugs.
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Millipore Corporation (Billerica, Mass.; www.millipore.com) announced its new Pod platform, a disposable filter system designed to increase speed, safety and cost savings in the manufacture of new drugs (see Fig. 2). The small footprint of this system is a huge advantage, particularly in the pilot facility, and the horizontal arrangement ensures that the filters are being used evenly and uniformly.

Everest VIT (Flanders, N.J.; www.everestvit.com), a leader in remote visual inspection technology, introduced its newly expanded CA-ZOOM Pan-Tilt-Zoom (PTZ) 6.0, a high-powered zoom camera for clean-in-place (CIP) validation inspection of pharmaceutical tanks, vessels and piping systems. The camera is now available with an ultraviolet (UV) light source and lens filter for use in “riboflavin rinse” inspection processes whereby a solution of 0.02 percent riboflavin and water is applied to the internal surfaces of a vessel prior to normal cleaning operations. Because riboflavin fluoresces under UV light, traces of it can be detected with the CA-ZOOM PTZ 6.0, indicating a problem with the cleaning process. Also, because the camera can be placed directly inside the vessel, the need for an individual to enter the space is eliminated, increasing worker safety and decreasing the time it takes to perform an inspection. Everest VIT manufactures videoprobes in a range of sizes, including an ultrasmall model (less than 9 mm in diameter) for similar CIP and high-purity weld inspections.


Figure 3: GE's new Kaye Validator can quickly analayze a swab sample for the presence of API residue and cleaning agents.


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GE Infrastructure Sensing (Billerica, Mass.; www.gesensing.com), provider of process validation and monitoring instrumentation, introduced its Kaye Validator® ITMS, a portable instrument that uses proprietary ion trap mobility spectrometry to quickly analyze a swap sample for the presence of small-molecule API residue and cleaning agents (see Fig. 3).

Rockwell Automation (Milwaukee, Wis.; www.rockwellautomation.com) announced that it has teamed up with IBM Health Care and Life Sciences to deliver manufacturing technology and expertise to enable pharmaceutical companies to identify opportunities to increase efficiency and reduce risk. Rockwell also announced that it will offer OEM-specific Regulatory Compliance Services (RCS) to help life-science customers lower engineering costs, streamline manufacturing processes and speed time-to-market.


Figure 4: Swagelok introduced the GSI series of weir-style valves.
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Swagelok Company (Solon, Ohio; www.swagelok.com) introduced the GSI series of weir-style diaphragm valves, designed and manufactured to meet strict industry requirements and available with Kwik-Clamp and TS series sanitary clamps and tube butt weld end connections (see Fig. 4).

Christ Water Technology (Aesch, Switzerland; www.christwater.com) introduced its Septron SMH 3000 EDI module for high-volume ultrapure water production. Nilfisk-Advance America (Malvern, Pa.; www.nilfisk-advance.com) launched its CFM 08 Series of industrial vacuum cleaners with clog resistant filters and interchangeable attachments. Setra Systems (Boxborough, Mass.; www.setra.com) debuted its Micro-Cal Model 869 Ultra Low Pressure Documenting Calibrator designed for air-handling processes in critical environments. III