Blow-fill-seal Technology Advances in Aseptic Filling Applications
New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.
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Advances in Real-Time Bioreactor Sampling
The Modular Automated Sampling Technology platform takes online samples from bioreactors and transfers them directly to analytical devices.
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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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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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Vaisala
Vaisala Mapping Kit: The Quickest Route to Environmental Validation
Reliable data from stable sensors eliminates the need to re-run studies, open deviation investigations, and spend extra time reporting. Simply download the software, place the loggers, and begin your study.
- Compact, rugged loggers are easy to place
- 10-year data logger lifespan
- Fast, simple setup
- 21 CFR Part 11 compliant reporting
- Comprehensive IQ/OQ
 Learn more
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Savillex
The PurillexTM range of fluoropolymer bottles from Savillex Corporation is designed specifically for single-use application in the biopharmaceutical downstream process, including storage of API. Manufactured in a clean room for optimal cleanliness, Purillex bottles feature a GL45 closure with a high performance seal. Bottles are available in PFA or FEP, with sizes ranging from 50 mL to 2L. A comprehensive extractables data set is available to support qualification.  www.savillex.com
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Videojet
The Videojet 8610 utilizes a revolutionary, purpose-built cartridge designed to use MEK fluids. You can now bring the simplicity of thermal ink jet to applications that require printing of crisp, repeatable codes on foils, films, plastics and coated stocks. Ideally suited for applications in pharmaceuticals, the 8610 combines high-resolution printing of customer-facing and supply chain information with incredibly simple operation.  Read more
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- Meissner's Saltus M200 is a 200-L single-use mixing system for powder–liquid and liquid–liquid mixing.
- The Allegro STR 200 single-use stirred-tank bioreactor from Pall can be used for production-scale applications in working volumes between 60 and 200 L.
- The FlexSafe scalable range of single-use bags from Sartorius Stedim Biotech is designed for single-use bioprocessing at all stages of drug manufacture, from process development to production, both upstream and downstream.
- The AQ Pro from E Instruments is a compact, handheld unit for real-time datalogging of indoor air quality.
- The GFD laboratory nutsche filter–dryer from Powder Systems Limited (PSL), originally in glass, is now available in metal to allow higher pressures.
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- Jul. 29–31: IVT's Facility Design, Innovation, and Qualification conference (Philadelphia, PA) will bring together industry professionals to discuss the future of bio/pharmaceutical manufacturing facility design.
- Aug. 14–15: MES 2014: Manufacturing Excellence—Implement, Deploy, Integrate, and Maintain MES (Philadelphia, PA) will address manufacturing execution systems efforts in regulated environments.
- Aug. 19–21: Cleaning Validation and Critical Cleaning Processes (San Diego, CA) provides practical information and approaches to effectively implement critical cleaning processes and validation.
- Sept. 8–10: At the 2014 PDA/FDA Joint Regulatory Conference, (Washington, DC) FDA speakers provide updates on global regulatory efforts, and industry professionals present case studies on how they employ global strategies in their daily processes.
- Oct. 1–2: Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing Facilities (Bethesda, MD) will cover the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy micro-organisms.
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