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April 2012  
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Production Lines

Achieving Containment in High-Potency Manufacturing
The growing use of high-potency APIs is leading to changes in how the pharmaceutical industry looks at containment.

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In The Mixer

Blow-Fill-Seal Technology Meets Challenges of Sterile Packaging
Using blow-fill-seal technology to form and fill a plastic container in a continuous process addresses sterile packaging issues such as package defects, contamination, and process validation.

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>>Coming Soon: For an article on using closed-vial technology in aseptic filling, see the Bioprocessing and Sterile Manufacturing Supplement to the May issue of Pharmaceutical Technology.

Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.

 
Troubleshooting Editor's Picks

Maintaining Continuity when Networks Fail

My network failed and I had to scrap my batch because my historian did not collect the required data. How do I upgrade the reliability of my network to maintain data continuity if my network fails again?


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Editor's Pick product

Editor's Pick product

The AdvantaTube sealer and sterile welder from AdvantaPure seal and weld TPE tubing for single-use fluid transfer systems.
Read More at PharmTech.com
Editor's Pick product

Fitzpatrick introduces the Contained Chilsonator System for roll compaction of powders.
Read More at PharmTech.com
 
Showcase (Sponsored)
Assmann Corporation of America

ASSMANN LINEAR POLYETHYLENE AND CROSSLINK TANKS ARE NSF CERTIFIED
Assmann linear polyethylene tanks are certified by NSF to NSF/ANSI Standard 61: Drinking Water System Components – Health Effects. The Certification is for multiple potable water contact materials up to 140°F. Assmann’s High-density crosslink resin tanks also have NSF 61 Certification and are Certified for chemical storage and are suitable for a variety of chemicals.
Assmann Corporation of America, 300 N. Taylor Road, Garrett, IN 46738. Phone: 888-357-3181. FAX: 888-826-5329 (TANK-FAX). Website: www.assmann-usa.com. E-mail: info@assmann-usa.com
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W.S.Tyler

W.S. TYLER® to Distribute New Age Hosokawa ALPINE Air Jet Sieve® e200 LS

W.S. Tyler® is the exclusive distributor in North America for the Hosokawa ALPINE Air Jet Sieve® e200 LS.
ALPINE developed the process of air jet sieving over 50 years ago. It is a most efficient process that uses air flow as the only force that moves the material being analyzed.
The standard unit is available with a choice of three different software packages, from quick individual analysis to special traceability analysis, such as for pharmaceuticals.
A special Sieve Adapter is provided that permits the use of other ASTM Standard, ISO Standard, and traditional Air Jet Sieves.
W.S. Tyler offers set-up and training and a limited 12-month warranty on the Hosokawa ALPINE Air Jet Sieve® e200 LS.
W.S. Tyler
http://www.wstyler.com/html/test_sieves.html
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Bosch

Bosch Packaging Technology will be demonstrating the latest in syringe filling technology in their booth at Interphex. The fully equipped line includes a Bag Opener, Tub Opener, and Filling system for nested syringes. The line also has the Combi filling system capable of running a variety of dosing options on the same machine. Click to preview the system.
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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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Eriez Magnetics

ProGrade® Magnetic Separators
Simply the strongest magnetic separators available, Eriez' ProGrade® permanent magnets outperform competitors removing even weakly magnetic fine contaminants. Available in grate, plate, tube and trap assemblies for both liquid and dry applications. Many items are stocked for next-day shipment. For more information, go to Eriez' website.
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Ropack

Visit Booth 1166 at Interphex to learn more about Ropack's recent launch of stick-pack production in a $9 million, 15,000-square-foot dedicated suite. This state-of-the-industry facility is ideal for all humidity- and temperature-sensitive solid dose products. Ropack provides contract packaging into blister, stick-pack, bottle and pouch;, powder blending and encapsulation; and in-country clinical trial distribution management. Contact: paul.dupont@ropack.com.http://www.ropack.com
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Natoli

Interactive Tablet Compression Accessories Catalog.
Are you tired of jumping through hoops to get price quotes? You can now browse products online and quickly request quotes anytime, anywhere. Simply flip through the pages of the digital catalog, click on an item to add it to your "Quote Cart", and checkout when you're ready – it's that easy. Get started now!
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OBK Technology's

Large or small, OBK Water can provide cost effective solutions to your water system needs. These include: Preparation of User Requirement Specification (URS) and Design Specification (DS); Full System Design to required product standards; Factory (FAT) and Site Acceptance Test (SAT); Full System Installation; System Start-up and Commissioning. We also cover full validation (IQ, OQ, development and execution and PQ and SOP development), training and maintenance support. http://www.obkltd.com
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Go Industry-Dovebid

Auction of a Complete 400,000 sq. ft. Pharmaceutical Manufacturing & Packaging Facility
On May 9 & 10, 2012, GoIndustry DoveBid will be conducting a Live & Webcast Auction of a Complete 400,000 sq. ft. Pharmaceutical Manufacturing & Packaging Facility in Humacao, Puerto Rico, due to a plant closing.
To preview the auction or find out more, please visit http://www.go-dove.com/event-16423
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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.
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Product Announcements

Calendar of Events
  • April 24–25: ExcipientFest Americas (San Juan, Puerto Rico). This event features technical talks on excipient technology, new drug applications, and regulatory issues.
  • May 1–3: INTERPHEX 2012 (New York, NY). This premier exhibition for pharmaceutical manufacturing features the latest in automation systems, instruments, controls, processing, packaging, contracting products and services, and everything you need to run a laboratory or production facility.
  • May 3–5: 3rd Pharma Bangladesh International Expo (Dhaka, Bangladesh). This expo features pharmaceutical raw materials, active ingredients, processing machinery, packaging machinery, equipment, and related services.
  • June 11–13: IVT's GMP Week (San Diego, CA) addresses industry's top GMP regulatory concerns and provides valuable information regarding how to implement risk-based approaches for compliance.
  • June 20–21: Extruder manufacturer Leistritz hosts the 7th annual Pharmaceutical Extrusion Seminar, which features basic extrusion theory and hands-on demonstrations, as well as pharmaceutical industry speakers.
PharmTech Poll: Analytical equipment

What would you identify as the most significant advance in analytical instrumentation and methods development during the past 5-10 years?

Vote Now!
 
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