The Role of Bioburden in the Contamination-Control Plan
A company’s contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.
>>Coming Soon: For a look at the changing definition of real-time release testing, and an analysis of its practicality, see the February issue of Pharmaceutical Technology.
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Disconnect sterile single-use systems in seconds, anywhere, with Kleenpak™ sterile disconnectors from Pall Life Sciences
Simple to operate and rigorously validated, so you can be sure the disconnected systems remain closed and sterile every time - even outside a controlled air environment. For more information visit  www.pall.com/allegro or email allegro@pall.com.
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OPTIMA GROUP pharma
Meeting highest requirements of the pharmaceutical sector See the Inova SV125 fully automatic filling and closing machine for nested disposable syringes in the Optima Group Booth at this year's Pack Expo International Show, Booth N-4606. Format range up to 50ml with an output of 10,000 syringes per hour is achievable with the 5-lane model. Stop by Booth N-4606 at Pack Expo to view the machine first hand.  Read more...
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Low Feed Rate Feeder is Designed for Pharmaceutical Metering Applications
The PureFeed® DP-4 is a highly innovative gravimetric feeder that can accurately meter dry pharmaceutical powders at feed rates as low as 20 grams per hour.
A speed controlled, inert ceramic feed disc is at the heart of the DP-4 feeder. The disc precisely rotates, discharging tiny amounts of material, continuously and pulsation free over the feeder’s 20 to 2,000 gram feed rate range
Schenck AccuRate
746 E. Milwaukee Street
Whitewater, WI 53190
Phone: 800-558-0184
Fax: 262-473-4384
Web site link:  http://www.accuratefeeders.com/pharmfeeders.html
Contact Person: Mike Karas
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Top Line Process Equip Company
The “NEW” state-of-the-art Top Line diaphragm valve actuator combines exceptionally convenient features with full engineering support to provide you with a TOTAL automation solution. There’s currently no actuator in the sanitary market that can match the outstanding features and benefits of this actuator. You can maintain and change the function of the actuator head without opening the sterile pipeline. The actuator is “The ONLY one of its kind!”  www.toplineonline.com
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- The Quick-Clean Series of rotary airlock valves from ACS Valves is designed to aid in regulatory standard and practice compliance, reduce cleaning and sanitizing time, and simplify inspection.
- Banner Engineering’s QS30AFF400 foreground suppression sensor uses advanced linear imager technology to provide a sensing solution for applications including part-in-place detection and package detection on conveyors.
- PROFIBUS PA is now available on Emerson Process Management’s Rosemount 3051 family of products, including 3051CF flowmeters.
- National Bulk Equipment’s polycarbonate-encased bulk bag unloader is designed for highly contaminant-sensitive process areas handling bulk materials known to generate combustible dusts.
- Performix’s xMES Suite was developed to leverage core master data from an enterprise resource planning system and provide a batch-management solution.
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- Jan. 26–27: Social Media in the Pharmaceutical Industry (London). SMi's 2011 conference on social media in the pharmaceutical industry aims to address the current concerns of the industry about using social media, while allowing delegates to explore the best methods for entering this interactive environment and using it successfully to reach their goals.
- Jan. 27–28: Process Validation for Drugs and Biologics (King of Prussia, PA). This course will provide practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable, and supportable informed decisions.
- Feb. 8: Cleanrooms—Standards and Technology (London). This concentrated course will provide the attendee an opportunity to become up to date with essential standards and best practices for cleanrooms intended for life-science applications.
- Feb. 8–10: HuLST Expo (Cologne). HuLST Expo encompasses four life-science manufacturing test fairs. The event is exclusively focused on testing and product evaluation, from early-stage research and development preproduction testing to certification and approval, and on all aspects of in-line quality-assurance testing and inspection.
- Feb. 9–11: QA–QC Strategy for Biologics and Biopharmaceuticals (King of Prussia, PA). This course will highlight the challenges and pressures facing QA–QC employees in today’s biologic and biopharmaceutical environment. Sessions will demonstrate the strategic importance and value generated by QA–QC through its involvement in the control of the manufacturing process, and in the testing and release of these products.
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| PharmTech Poll: FDA Recalls |
FDA recently was granted the authority to issue recalls for food products. Should the agency have this power for pharmaceuticals as well? |
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