Equipment Processing Report by PharmTech logo
April 2011  
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Production Lines

Are Drugmakers Using Yesterday’s Quality Strategies?
To find out how well industry is applying QbD, and what benefits the approach can bring, Equipment and Processing Report talked to Moheb M. Nasr, director of FDA’s Office of New Drug Quality Assessment.

Read More at PharmTech.com

In The Mixer

Best Practices for Digital Photomicrography of Pharmaceutical Contaminants
The implementation of digital photomicrography has expanded the capabilities of microanalysis for quality control. But if used incorrectly, the technique can hurt more than help.

Read More at PharmTech.com

>>Coming Soon: To learn about emerging methods for manufacturing inhalable drug particles, look for the special report in the May issue of Pharmaceutical Technology.

 
Troubleshooting Editor's Picks

A Nitrogen-Filled Isolator?

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?


Read More at PharmTech.com

Editor's Pick product

Editor's Pick product

The ACS Valves Aero-Flow series of rotary feeders is designed to convey pharmaceutical ingredients efficiently.
Read More at PharmTech.com
Editor's Pick product

L.B. Bohle’s BTS high-speed cone mill has a new impeller design intended to help manufacturers increase throughput by more than 50% on low-density materials, compared with traditional mills.
Read More at PharmTech.com
 
Showcase (Sponsored)

Biocontainer "Standards Guide"@ www.meissner.com
Meissner's repository of ready-to-use single-use TepoFlex® biocontainer assembly designs can be downloaded from Meissner.com.  These "standards" can be purchased for 3-4 week delivery, or used as the basis to streamline the design process for customized assemblies.  Configurations include 2D end-ported, 2D face-ported and 3D configurations.
http://www.meissner.com/products/onetouch/tepoflex.asp

Editor's Pick product
 

Bosch
Click to learn more about the most advanced capsule filling systems available.

Editor's Pick product
 

RoTab T R & D Tablet Press
The portable RoTab T offers precise scale-up to free up production machines from trials. The cGMP design enables easy validation for the production of small tablet batches and pre-clinical studies.

  • automatic tablet weight regulation via filling depth
  • seamless RPM adjustment for die table and Optifiller
  • servo-driven compression roll stations
  • optional servo-driven tablet hardness adjustment
  • automatic punch lubrication with adjustable intervals
http://www.fette-compacting.com/next
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
Editor's Pick product
   
Ropack
Ropack’s 15,000-square-foot Class 100000 dedicated facility delivers low relative humidity (20%), controlled residual oxygen in a temperature-controlled environment. Equipment handles initial R&D; manages stability programs; creates marketing samples; performs scale-up; manufactures commercial production. It delivers high-speed, accurate fill weight performance to 1000 stickpacks/minute and the cartoner packagesup to 100/minute.
http://www.ropack.com/en/service/primary-packaging/stick-pack
Editor's Pick product
   

Sanitary Feeder is Designed for Pharmaceutical Processes
PureFeed® AP-300 feeders are designed specifically for pharmaceutical processes to feed a variety of materials such as Magnesium Stearate, Lactose, Calcium Carbonate, and Acetaminophen.  Quick and easy disassembly along with a disposable EPDM feed hopper simplify cleaning and maintenance.  Feed rates from 0.5 to 150 Kg/hr. are achievable.  Call 1-800-558-0184 to schedule a demonstration of the feeder.
http://www.accuratefeeders.com/pharmfeeders.html

Editor's Pick product
   

Introducing the NEW Masterflex® L/S® Precision Variable-Speed Console Drive
Featuring a digital display that ensures accuracy and repeatability in fluid metering applications. Offers precise speed control and digital display of rpm to confirm speed setting at a glance. A reversible motor enables users to purge tubing before or after pumping; LED indicators confirm motor direction. Call 800-323-4340 or visit ColeParmer.com/8419.
www.coleparmer.com

Editor's Pick product
   
Top Line E-360word Diaphragm Valve Actuator
Process lines stays sealed to atmosphere - eliminates production contamination thus reducing costly product loss, delays & costs incurred restarting the system, and limits the need for system revalidation.
http://www.toplineonline.com

Editor's Pick product
   
W.S. Tyler Offers Traceable Laboratory Services
W.S. Tyler offers a full range of Laboratory Services, including Test Sieve Certification and Recertification. All laboratory services are directly traceable to NIST.
W.S. Tyler’s Certification and Recertification processes ensure that all Test Sieves comply with current ASTM E-11 standards. Test Sieves can be certified to INSPECTION GRADE or CALIBRATION GRADE Specifications. Test Sieves are serialized and supplied with very detailed documents, including standard deviation and specific statistical information on opening sizes and wire diameters, as they relate to known standards.
W.S. Tyler
http://www.wstyler.com/html/lab_services.html

Editor's Pick product
   
Spirax Sarco
Spirax Sarco Presents a Solution for the Prevention of Reverse Flow and Cross Contamination.
http://www.spiraxsarco.com/us/about/news-article.asp?news_id=48

Editor's Pick product

Product Announcements
  • David Round’s Lab-Lift all-stainless steel strap hoist is specifically engineered for demanding pharmaceutical manufacturing use.
  • GE Healthcare PreDictor RoboColumn units are miniaturized chromatographic columns prepacked with GE Healthcare BioProcess chromatography media to enable high-throughput process development.
  • The UltimaPro from GEA Pharma Systems allows the contained processing of highly potent active ingredients, including mixing, granulation and drying, in a single machine.
  • National Bulk Equipment’s sanitary tote dumper was designed specifically for pharmaceutical processing and includes clean-in-place features.
  • Pall’s Kleenpak sterile disconnector is designed for maintaining sterile integrity in process fluids' path before and after tube separation.


Calendar of Events
  • Apr. 26–28: IVT’s 12th Annual Computer and Software Validation (Philadelphia). This event showcases the validation process for computer systems and software. In this create-your-own conference format, participants build their own event to suit their specific validation needs.
  • May 2–5: The Fifth International Pharmaceutical Compliance Congress (Istanbul). The International Pharmaceutical Congress will bring together senior global compliance and ethics professionals and legal counsel from the European Union, Central and Eastern Europe, the Middle East, and Africa to share experiences and best practices.
  • May 12–18: Interpack (Düsseldorf). Interpack 2011 will show entire value-creation chains from the production and refinement of packaging products and packaging materials to quality assurance and consumer protection.
  • May 17: Cleanrooms—Standards and Technology (Edinburgh). This concentrated course will help attendees keep up to date with essential standards and best practices for cleanrooms intended for life-science applications.
  • May 17–19: Cleaning Validation (Bethesda, MD). This course will provide attendees with a complete, hands-on cleaning-validation education program covering automated and manual cleaning.



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Editorial: email Erik Greb
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