PMPN_Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News, November/December 2015

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NEW PRODUCTS November/December 2015 Pharmaceutical & Medical Packaging News • 31 Syringe Manufacturing A company will invest approximately 300 million euros to expand and upgrade its manufacturing facilities over an estimated five-year period. Site expansions will result in addi- tional capacities for drug product manufacturing and logistic services. A central technology element of the planned upgrades will be the implementation of an in-house-made improved restricted access barrier system (RABS) concept that will con- tribute to increased operational excel- lence in aseptic manufacturing. For decades, Vetter has relied on RABS as one of the two distinct technolo- gies available today for its aseptic filling processes, the other being isolators. RABS achieves the steril- ity assurance level (SAL) required by regulatory authorities and allows for rapid product change-over coupled with high safety, the company reports. To better meet future industry trends in quality, safety, and flexibility, a cor- porate project team has evolved this 'Improved RABS concept' by com- bining the advantages of isolator and RABS technology. The core of the approach is a 3-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide. Following a successful pilot project in a selected cleanroom, the company will now implement this decon- tamination concept in all of its clean- rooms within the next years. The company is a contract development and manufacturing organization (CDMO) and a global provider of fill and finish support of aseptically pre- filled syringe systems, cartridges, and vials. Vetter Pharma International GmbH, www. A system has been specifically engi- neered to accurately and quickly measure OTR for a wide range of high-barrier materials and packages. The new OX-TRAN Model 2/22 L is suited for pharmaceutical, medi- cal device, and other applications in need of reducing oxygen permea- tion of packages. Test times can be reduced significantly depending on barrier levels, the company reports, and the system's repeatability specification has been improved 2.5 times over the industry- standard OX-TRAN Model 2/21 L. "By obtain- ing more precise data about oxygen transmis- sion through packaging materials, companies will be better able to pre- dict, and in some cases, extend their product shelf life. The information also will be a useful in helping to manage material costs vs. shelf life expectations," said Karsten Kejlhof, vice president sales and marketing, package testing and permeation, MOCON. The OX-TRAN Model 2/22 L is designed to operate at a lower cost of ownership by eliminating several common maintenance expenses. The install wizard allows for step-by-step user installation and the gas-saver feature automatically reduces con- sumption when the system is idle. In addition, many safety features have been added to increase com- ponent lifetime. Barrier films can be accurately and repeatably measured down to 0.005 cc/m2/day at precise temperature and relative humidity conditions. This is ten times more sensitive than the company's previ- ously introduced Model 2/22 H, the company reports. Automation features include rela- tive humidity (RH), temperature, pressure, flow, and testing. These easily are set via the integrated, intui- tive touch screen, which enables new operators to accurately execute with as little as 10 minutes of training. MOCON, Moisture-Transmission-Rate Testing

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