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Pharmaceutical & Medical Packaging News, November/December 2014

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21 November/December 2014 Pharmaceutical & Medical Packaging News • pmpnews.com man's terms, they are residues of dead micro-organisms that may induce fever and are dangerous to patients receiving a drug through parenteral administration. Endotoxins are impossible to eliminate from filled containers; thus efforts are generally directed at eliminating endo- toxins during preparation processes, the companies tell PMP News. The NOX FLEX system performs both decontamination and depyrogena- tion in a single-step process. Weiler and Noxilizer believe that such an approach could meet a growing need in pharma- ceuticals. "A growing share of all med- icines are biologics, including proteins and monoclonal antibodies," observes Reed. "BFS technology and the ASEP- TECH Blow-Fill-Seal System STERI- Shroud with NOX FLEX in particular, is well suited for the aseptic processing of biologics, vaccines, and other protein- based materials. These products are particularly sensitive to residual steril- ant in the filling environment. NO₂ has been demonstrated to have a fast aera- tion rate with negligible residuals, making the Noxilizer process ideal for all drug processing." When asked what changes to BFS machinery were made to accommodate the NOX FLEX system, Reed reports that "the STERI-Shroud is a completely new, patent-pending design based on strict processing parameters which incor- porate the NOX FLEX NO₂ process. As a result of these process constraints, the STERI-Shroud is available for new ASEP-TECH BFS systems only." The new decontamination/depyrogenation process is designed to coincide with the normal cycle time of the clean-in-place/ sterilize-in-place process for sterilizing of the product path in the BFS machine. During the decontamination process, the NO₂ is introduced to the sealed shroud and recirculated for the exposure period. "Standard validation processes must be followed to ensure compliance with regu- latory authorities," Reed continues. "The challenge studies that have been con- ducted support the process with a strong scientific basis." The technology could be well timed. "Regulatory agencies continue to focus on improved patient safety and are developing standards to ensure ster- ile, contamination-free products," says Reed. "In particular, regulatory standards state that pharmaceutical manufacturers should be aware of new procedures designed to reduce risk to the product through the use of enhanced technology. One such pro- cedure is the reduction of pyrogens during the decontamination process." Weiler and Noxilizer expect the first ASEP-TECH BFS systems equipped with STERI-Shroud to be delivered in calendar year 2015. For more details, visit www.weilerengineering.com and www.noxilizer.com. 0 Unit-Dose Packaging BFs Vials At Pack Expo International, Bosch Pack- aging Technology launched its enhanced blow-fill-seal (BFS) packaging line, fea- turing the new Sigpack HCUL horizontal fow wrapper. Before being packaged by the fow wrapper, the vials are separated into individual ampoules by the system's vial separation unit located at the infeed of the wrapper or placed as a card direct into the lug chain of the wrapper, a Bosch spokesperson tells PMP News. The line can handle vials in varying thicknesses. Using a Sigpack LDF Delta robot, the pre- formed and flled BFS cards are fed into the fow wrapper, where the unit can her- metically package up to 300 single BFS vials per minute. According to Bosch, the system employs a cross-sealing unit that allows the sealing jaws to close more gently and in a more controlled manner than other fow wrap- pers currently available. The spokesper- son reports that the system's long-dwell sealing feature ensures longer sealing times to produce hermetic packages. It can use either ultrasonic or heat sealing technology, and hybrid machines can employ ultrasonic sealing technology on the lon- gitudinal sealing unit and heat sealing on the cross seam for heat- sensitive products. The modular Sigpack HCUL can also be engineered for modifed atmosphere packaging (MAP). Compared with conven- tional MAP systems, where the gas is inserted by a lance, the gas supply for the RT-MAP and the sensor for measur- ing residual oxygen content are integrat- ed in the longitudinal sealing unit, Bosch reports. This approach allows real-time measurement of residual oxygen content in the package and facilitates the rejection of packages with excessive residual oxygen. A control system manages product alignment, the force applied during vial separation, and information printed on the packaging, such as the bar code. "Authorities such as the FDA increas- ingly demand that vials be packed sepa- rately and not as vial cards, also known as 'unit-dose packaging,' " states Jörg Kleiner, pharmaceutical and medical sales manager for Bosch Packaging Systems AG, a company of Bosch Packaging Technol- ogy, in a news release. "Not only do phar- maceutical manufacturers need to meet these requirements, but at the same time maintain high productivity." More details are available at www. bosch.com.

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