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October 2011  
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Steps for Reducing Glass Delamination
Recent recalls have contributed to the pharmaceutical industry's heightened awareness of glass delamination (i.e., the formation of glass flakes in a vial), which could affect drug quality and patient safety. To confront this growing problem effectively, drugmakers must understand its causes.

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In The Mixer

Isolated Robotics: The Future of Aseptic Operations
The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

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>>Coming Soon: For more information about glass delamination, see Ron Iacocca’s article in the November “Analytical Technology” supplement to Pharmaceutical Technology.

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Voice your opinion in our annual Employment Survey, covering job satisfaction, salaries, and more.

 
Troubleshooting Editor's Picks

Scaling Up a Tableting Process

When I run a small production batch of a particular formulation with the same tablet press used to develop it, I get compressibility and disintegration issues. What am I doing wrong?


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Editor's Pick product

Editor's Pick product

The CXS dry vacuum pump range from Edwards incorporates tapered, variable-pitch screw technology that enables gradual compression along the length of the rotor.
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Editor's Pick product

Moyno’s Moyno 1000 close-coupled positive-displacement pump is designed to provide more versatility and performance advantages than other types of positive-displacement pumps.
Read More at PharmTech.com
 
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. www.chemsultants.com/markets/medical-pharmaceutical.aspx
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ASSMANN'S LARGE DOUBLE-WALL TANKS
Double-wall tanks prevent chemical spills without lined concrete containment, featuring a primary inner tank and secondary locked-on outer tank. Constructed of high-density crosslink or linear polyethylene with tanks from 150 to 6,550 US gallons. Assmann linear polyethylene and crosslink tanks are certified by NSF to NSF/ANSI Standard 61. Wall thickness conforms to ASTM D-1998 standards for liquid containment. Also has ISO 9001:2008 certification.
Assmann Corporation of America
www.assmann-usa.com/Double_Wall_Tanks.htm

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TopLine Process Equipment Company

Top-Flo® 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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W.S.Tyler

Custom Metallic Filtration Products for Prototypes and Small Runs

W. S. Tyler specializes in design, service, consultation and fabrication of custom metallic filters for prototyping and small production needs. These products are constructed in stainless steel, Hastelloy, and other metallic filter mesh and/or metal sintered laminates. They allow migration-free filtration from 1 to 200 micron. The filter grade woven wire cloth is available in several twill designs to meet specific filtration application requirements.
Pharmaceutical applications include pressure and vacuum filters, filter candles, Nutsche filters, CIP filters, and fluidized bed dryers.
W.S. Tyler
www.wstyler.com/html/engineered_prod.html

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Product Announcements
  • The Courtoy MODUL P tablet press from GEA Pharma Systems was specifically designed for pilot operations and to satisfy the increased demand for flexibility and product containment when working with potent compounds.
  • Meissner’s FlexFill assembly provides a convenient way to aseptically transfer bottled cell culture media, sera, reagents, supplements, buffers, and microcarriers to a bioreactor.
  • Oseco’s FAS and PRO+ rupture discs are designed to offer exceptionally low frictional flow loss.
  • Sartorius Stedim Biotech’s Sartobind STIC PA (primary amine) anion-exchange membrane binds contaminants at high conductivities under high-salt conditions at levels as high as 20 mS/cm.
  • Thermo Fisher Scientific offers the Thermo Scientific TraceGOLD gas chromatography (GC) column with SafeGuard, which combines an analytical GC column with a built-in guard column.


Calendar of Events
  • Oct. 26–27: From Training to Learning: Improving GMP Performance (Raleigh, NC). This workshop seeks to cover the best way to convey GMP knowledge to staff efficiently, accurately, and effectively.
  • Oct. 26–28: Second Joint DIA–EMA Statistics Workshop (London). The European Medicines Agency and its statistical experts, as well as renowned statisticians from industry and academia, will contribute to this workshop and share their expertise.
  • Oct. 31–Nov. 2: BIO-Europe 2011 (Dusseldorf). BIO-Europe brings together international decision makers from the biotechnology, pharmaceutical, and financial sectors, offering networking opportunities, workshop and panel participation, a high-profile exhibition, and private, prescheduled one-to-one meetings.
  • Nov. 2–4: The Pharma Congress (Washington, DC). This event will focus on pharmaceutical regulatory and compliance topics and provide a forum for sharing best practices.
  • Nov. 3: Effective Facility Management, Operations and Maintenance in a Regulated Environment (webinar). This class will describe the mechanics of a sound maintenance program from a quality perspective, including the major issues that are typically emphasized during regulatory audits.



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