Equipment Processing Report by PharmTech logo
May 2012  
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Production Lines

Ongoing Challenges in Continuous Manufacturing
Advances in process analytical technology and in defining lots for release are key for enabling use of continuous processes in solid-dosage manufacturing.

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In The Mixer

Classifying Rouge Aids in Determining Maintenance and Remediation Procedures
Properly identifying and classifying rouge, a form of surface corrosion that comes in many forms, is important in determining whether it may be affecting product quality and whether further actions are necessary.

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>>Coming Soon: For a technical forum on avoiding contamination in aseptic processes, see the June issue of Pharmaceutical Technology.

 
Troubleshooting Editor's Picks

Reducing Wet-Cake Drying

We are using a vacuum oven to dry our wet-cake intermediate. At 120oC, it takes 26 hours on average to dry the material from 80% to 10% moisture. Can we shorten our drying time, possibly by agitating the product to improve heat transfer?


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Editor's Pick product

Editor's Pick product

Koslow Scientific Company's Passi-Flash 3036 portable tester verifies passivation of stainless steel equipment.
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Editor's Pick product

Vaisala's CCL100 Cold Chain Logger records and monitors time and temperature during transportation of perishable products.
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Showcase (Sponsored)
Bosch

Missed Interphex? It’s not too late to take a tour of the Bosch booth. Videos from the show demonstrating the latest in Bosch equipment and services can be found on our blog. See the FXS Syringe Line, The FLT Vial Filler, GKF 702 Capsule Filler Track & Trace, and the Stock Optimization, and E-portal from our Services Group. Click now to take the virtual tour!.
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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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Assmann Corporation of America

MOLDED IN FULL DRAIN OUTLET FROM ASSMANN
Assmann's Full Drain Outlet (FDO) assembly, patent pending, for 2,500 gallon tanks and larger, drains tanks without mechanically installed nozzles and can be utilized where heavy solids or salts may accumulate in the bottom. Assmann linear polyethylene tanks are certified by NSF to NSF/ANSI Standard 61, while high-density crosslink resin tanks have NSF 61 Certification http://www.assmann-usa.com/FDO_Modular_Stand.html
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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
http://www.wstyler.com/html/engineered_prod.html

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Caron

Caron's Photostability Chambers ideal for forced degradation
Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. The 6540 series control light and temperature conditions. The 6545 series precisely control light, temperature and humidity. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. For more information visit, http://www.caronproducts.com/151
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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/air_jet_sieve200ls.html
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Product Announcements
  • Swan Analytical USA's AMI LineTOC is an in-line analyzer that continuously measures total organic carbon in pure and ultrapure water.
  • Colder Products Company added back-to-back body adapters and sanitary inserts to its MPC and MPX quick disconnect product lines.
  • HEMCO Enclosures isolate liquid handling workstations, HPLC equipment, sample weighing, and other automated laboratory processes.
  • Value Plastics new PharmaLok Series of single-use clamps incorporate user-friendly, one-hand operation mechanisms.
  • MG America's AlterNova Capsule Filler AlterNova Capsule Filler accurately doses combination products.

Calendar of Events
  • May 21–23: 2012 AAPS National Biotechnology Conference (San Diego, CA). This conference covers a broad range of biotechnology topics including quality-by-design, manufacturing of biologics, antibody drug conjugates, and vaccine development.
  • 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 18–19: Sterility Assurance for Aseptic Processes and Terminal Sterilization (Chicago, IL). This PDA conference features case studies on quality risk management for aseptic product manufacturing and focuses on manufacturing essentials.
  • 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.
  • June 25–27: IVT's Contamination Control Week (Boston, MA). This conference was formerly called IVT's Aseptic Processing, Cleaning Validation and Environmental Monitoring Conference. This year's conference will address how industry leaders are tackling contamination control challenges.
PharmTech Poll: Significant Changes

Looking forward 10 years from now, what do you think will be the most significant change to drug development and manufacturing?

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