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December 2011  
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Production Lines

Moving from a Reactive to a Systemic Approach to Manage Risk
Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements.

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In The Mixer

Equipment Design and Appropriate Procedures Improve Cleaning
To ensure that sterilization and cleaning are efficient and safe, it is not enough to develop the appropriate procedures. Selecting the right manufacturing equipment further improves cost efficiency, as well as patient safety.

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>>Coming Soon:For a roundtable discussion of multilayer tablets between Natoli, IMA, and the Elizabeth Companies, see the January issue of Pharmaceutical Technology.

Troubleshooting Editor's Picks

Increasing Dwell Time without Decreasing Output

We have several tablet formulations that are dwell-sensitive—they require more time under compression than other formulations. Given increasing demand, we do not have the luxury of slowing the tablet presses down in an effort to increase that dwell time. How can we maximize dwell time and maintain or increase output in our tablet presses?


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Editor's Pick product

Editor's Pick product

Banner Engineering has added the Q26 Series photoelectric sensor to its line of clear-object detection sensors.
Read More at PharmTech.com
Editor's Pick product

The E-Z Tec DSP pharmaceutical gravity-fed metal detector from Eriez incorporates an adjustable sensing head.
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Showcase (Sponsored)
Fette Compacting America Inc

Fette Compacting now offers the FE55, a tablet press that delivers unprecedented levels of productivity, flexibility and availability.  The FE55 is clad in easily-detachable, FDA-certified high-performance polymer panels and offers 360-degree access. The FE55 has the ability to produce single- and double-layer tablets and direct pressing – the only machine of its compact size to offer all three capabilities. Click here for more info.
Editor's Pick product
 
Chemsultants International

Providing Consulting, Product Development, and Testing of Adhesives and Specialty Coatings for the Pharmaceutical Industry..
http://www.chemsultants.com/markets/medical-pharmaceutical.aspx
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TopLine Process Equipment Company

Top-Flo® SV2 sample valves are specifically engineered to be the finest in the industry and incorporate many features and benefits not found on other sampling valves. Top-Flo® SV2 sampling valves come standard with minimal internal deadleg area designed into each valve, keeping hold up volume to a minimum for accurate samples every time. Right angle or In-Line models available from stock in sizes 1/2'' to 6'' in a variety of inlet/outlet connections. www.toplineonline.com

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Product Announcements
  • ATMI’s Integrity Xpansion bioreactor systems are designed to enable large-scale, cell-based manufacturing.
  • Bosch Packaging Technology’s fully integrated Pharmaceutical Melt Extrusion and Calendering Line is designed to enable a continuous production process for pharmaceutical substances.
  • Meissner’s CS/CL capsule filters can be selected with connection options, including sanitary flange, hosebarb, and male and female fittings.
  • Moyno's Metering Pump now includes enhanced pumping elements and integral variable frequency drive–motor controls that expand the scope of metering applications.
  • Thermo Fisher Scientific’s line of Thermo Scientific Nalgene 0.1-µm polyethersulfone filters now includes a 1-L unit for vacuum filtration of cell-culture media.


Calendar of Events
  • Jan. 9–13: PepTalk 2012 (San Diego). This conference includes scientific programming centered around protein-based therapeutics. The four distinct protein pipelines examine formulation, purification, biotherapeutics, and expression.
  • Jan. 17: Fast and Effective Cell Culture Media Development Using Design of Experiments (webinar). This course provides practical advice for the application of design of experiments (DOE) as a tool in culture media development. DOE offers the ability to effectively develop culture media in few experiments.
  • Jan. 18–19: European Prefilled Syringes (London). This conference will provide an opportunity for debate about key challenges currently facing the parenteral market. The forum will look at various areas, including device development and the design concept, secondary packaging and quality assurance, and technological and regulatory updates.
  • Jan. 19–20: Latin America: Regulatory Compliance Requirements for Life-Science Products (San Francisco). This two-day course on Latin American regulatory compliance requirements will cover topics ranging from preclinical and clinical requirements through product registration, amendments, and renewals for pharmaceuticals, biologics, medical devices, and combination products.
  • Jan. 25–26: Enhancing Drug Bioavailability and Solubility (Boston). This event will bring together leading formulation experts to share and discuss emerging drug bioavailability and solubility-enhancement strategies to assist attendees in maximizing the time-to-market on drug-development pipelines.

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Editorial: email Erik Greb
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