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Equipment Processing Report by PharmTech logo
October 2014
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Production Lines
Evaluating Cross-Contamination Risk of Highly Potent APIs
Manufacturers using highly potent APIs must examine cross-contamination routes and determine acceptable limits.

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Advertisement:
The Vivaspin® Turbo 4 optimized design, the sleek internal profile, ensures maximum process speeds right down to the last few micro liters after > 100 fold concentration. The UV joining technology allows for a smooth joint transition between membrane and plastic housing, allowing the collection of the concentrated sample into the unique pipette-friendly dead stop pocket. Learn more

Now Online - Modularity Creates Flexible Manufacturing Systems: A roundtable discussion on modular bio/pharmaceutical manufacturing systems to enhance flexibility in facility design.


In The Mixer
Using Flow Sensors as Diagnostic Tools
Changes in compressed air consumption are an early indicator of problems that need correction.

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Troubleshooting Editor's Picks

Integrated Systems Hold the Key to Successful Serialization
Packaging machines, coding equipment, inspection and data capture systems, material handling, controls, and software must work together in a serialization system.

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Editor's Pick product

Editor's Pick product

Pharma Technology Inc.'s PharmaSpray external lubrication system delivers a consistent, validatable amount of dry lubricant to enhance tablet press performance.
Read More at PharmTech.com
Editor's Pick product

A horizontal cartoning machine from Bosch Packaging Technology offers a flexible choice of in-feed systems, package formats, and closure options.
Read More at PharmTech.com
 

Showcase (Sponsored)
Tablet Press for Premum Large Batch Production

Fette Compacting America’s FE75 Tablet Press is a double-sided rotary press that can be equipped with up to 115 punch stations to produce more than 1.6 million tablets per hour.  Ideal for the premium production of large batches, the FE75’s four compression rollers feature a special control system for direct compression, enabling the machine to operate with two intermediate pressures. www.fetteamerica.com
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Natoli

Have You Seen the All-New natoli.com?


Natoli’s redesigned website features simpler navigation, online browsing with photos of press parts and accessories, a blog and more. Search our parts catalog by OEM number, manufacturer, or machine. You can also learn more about our two new tablet presses – the RD20 and NP-155. natoli.com
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Leistritz

PES – Pharmaceutical Extrusion Seminar. Leistritz will host the 9th annual Pharmaceutical Extrusion Seminar on June 18-19, 2014.  This “hands-on” seminar starts with the basics and explains why extrusion is an ideal technology to consistent/repeatable dosage forms that comply with the FDA’s Process Analytical Technology (PAT) initiative. Highlights also include cutting-edge extrusion technologies being developed today. For program details see: www.alec-usa.com/PES2014.htm
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Introducing Tool-Less Valve Maintenance

With a revolutionary mount-and-turn design and no tools or torquing required, the Pure-Flo® EnviZion™ valve from ITT Engineered Valves reduces maintenance costs by over 90 percent. The integrated thermal compensation system eliminates the effects of thermal cycling and provides a reliable seal that does not degrade over time. The result? Significantly lower TCO. How much will you save?
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Jet Pulverizer

New ISO 8 Processing Suite for dry powders

Jet Pulverizer Co. has enhanced their cGMP services by building a new ISO 8 (Class 100,000) classified processing suite for micronizing Pharmaceuticals, Nutraceuticals, Cosmetics, and Foodstuffs.  Various processing services are available such as jet milling, hammer milling and screening at cGMP level protocols.  The cGMP level includes enhanced cleaning procedures, cleaning verification, and documentation for strict FDA requirements.  FDA registered and inspected facility
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Sturtevant

The Sanitary Micronizer® by Sturtevant…the first jet mill listed by the USDA for sanitary design and fabrication of milling equipment.

The Sanitary Micronizer® can consistently produce particles to 10 microns or less without heat buildup or contamination. FDA/USDA approved design.  Learn more
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Product Announcements

Calendar of Events
  • Nov. 2–5: Pharma Expo (Chicago, IL), a processing and packaging conference and tradeshow produced by PMMI and ISPE, is co-located with Pack Expo International.
  • Nov. 2–6: At the AAPS National Meeting 2014 (San Diego, CA) scientists can network and attend educational programs.
  • Dec. 1–4: At the PDA Training and Research Institute's 2014 Lyophilization Week (Bethesda, MD), learn about the development of lyophilized products and the validation of lyophilization processes.
  • Jan. 21–23: IVT's Quality Risk Management: Applications to Design, Validation and Automation that Yield Eye-Opening Results (Orlando, FL) will discuss effective risk management and assessment in critical production and laboratory environments.
  • Jan. 25–28: The IFPAC Annual Meeting (Washington, DC) is the 29th International Forum and Exhibition for Process Analytical Technology (Process Analysis & Control).




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