News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts. WEEKLY
Attendees and exhibitors seemed happy to return to Philadelphia for the annual INTERPHEX trade show Mar. 26–28, 2008, after
a three-year run in New York City. Traffic in the aisles was steady, and exhibitors reported high-quality leads.
Attendees looking for packaging innovations found something in every aisle. All facets of packaging were represented, from
the beginning to the end of the line. Special emphasis was placed on sterile filling, barrier materials, quality control,
and anticounterfeiting measures. Although the California e-pedigree deadline was postponed from Jan. 1, 2009, to Jan. 1, 2011
immediately before the show opened, pedigree solutions were also well represented and will be discussed in detail in August's
Packaging Forum.
Sterile filling
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Integrating closure treatment with an isolator-equipped filling system simplifies delivery of sterile stoppers to the sterile
filling line. After stoppers are treated, an elevator lifts the closed vessel in place to dock it with the isolator. A rapid
transfer port ensures a sterile connection. Programmable logic control and an identifying chip hard-wired in the vessel track
stoppers to ensure they are ready for use and are correct for the product. The lift, which is constructed entirely of stainless
steel and specially sealed, is cleanroom compatible and handles 30–300-L vessels (stopper processing, vessels, transfer station,
and "Atec Lifting Device," Atec Pharmatechnik, Sörup, Germany).
Low energy electron-beam (e-beam) technology used in the food industry for surface decontamination also can sterilize the
outside of syringe tubs before they enter an isolator. The e-beam system eliminates the use of hydrogen-peroxide vapor, links
directly to the isolator, and handles as many as six tubs per minute. Three such systems have been installed, one each in
Switzerland, Italy, and the United States ("E-Beam Tunnel," Metall+Plastic, Radolfzell-Stahringen, Germany).
The "Stericlean TX60" cleanroom robot from Stäubli withstands hydrogen-peroxide vapor sterilization.
Operators working through glove ports can be the limiting factor on sterile filling lines. Sanofi-Aventis (Paris) has boosted
line productivity 100% by installing a six-axis robot on a syringe-filling line at its vaccine plant in Le Trait, France.
The robot also reduces operator exposure to toxic products and repetitive-motion injuries. The ISO Cleanroom Class 4 (Class
10 under US Federal Standard 209E) robot features a smooth surface coating, lip seals at joints, internal lines and connections,
and a round, smooth base. It also withstands hydrogen-peroxide vapor sterilization ("Stericlean TX60" robot, Stäubli, Duncan, SC).
Because cleaning packaging lines is time-consuming and companies must protect operators from exposure to toxic chemicals,
interest is growing in disposable product-contact parts. Commonly used on the processing side in the biotechnology industry,
disposable product-contact parts on vial-, ampul-, and syringe-filling lines can eliminate hours of cleaning and validation
work while increasing line flexibility and uptime. A single-use product path also cuts changeover time and utility and cleaning-agent
consumption while minimizing wastewater generation, cross-contamination, and the capital investment in stainless steel parts.
The "Prevas Disposable Dosing System" from Bosch Packaging Technology.
The first prevalidated, preassembled, and gamma-sterilized system consists of positive-displacement rolling diaphragm pumps,
needles, and other product-contact parts. The system meets US Pharmacopeia standards. Accompanying documentation certifies
sterility, extractables and leachables levels, and the shelf life of the product-contact parts, which come double-bagged and
ready to install with sterile plug-and-use connections. Used parts are generally incinerated ("Prevas Disposable Dosing System,"
Bosch Packaging Technology, Minneapolis, MN).
