Pharm Tech's EPR: Quality by design in hot-melt extrusion and lyophilization

July 2012

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Defining Design Space in Hot-melt Extrusion
Continuous manufacturing of amorphous solid dispersions in a twin-screw extruder is well-suited to quality-by-design processes such as defining design space.

Analytical Tools for a Quality-by-Design Approach to Lyophilization
Experts share insights into analytical tools and techniques.

>>Coming Soon: An interview with Bend Research on advances in solubility and formulation in the August issue of Pharmaceutical Technology.

Product Neutralization for Rapid Microbiological Test Methods

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?

Editor's Pick product

Sartorius Stedim Biotech’s Sartopore Platinum sterilizing-grade filter for biopharmaceutical manufacturing improves product yields and filtration performance.

Xevo mass spectrometers from Waters use ion optics technology that increases sensitivity and reduces laboratory downtime.

Dreamfill Inc Dreamfill System offers you fill accuracy,speed,and reliability, while other filling machine do not. Compare the Dreamfill system with other filling machines to see the difference for yourself. Model: TNU 153 ND: Features Fifty(50) gram load settings( Pre-programmable) for your most popular powders, Examples are as follows. Semi-Automatic,TableTop Auger Powder Filling Machine. Fill Accuracy & Weight Control: very high precise SP1 SP 2 system gives optimum fill weight control. We specifically designed the Dreamfill to be compact in size to accommodate smaller footprints-all this while exceeding the performance capabilities of much larger machines Click to preview the product* .

Natoli NEW Tablet Compression Accessories Catalog A brand-new edition of the catalog is now available! Packed with dozens of new products and expert tips, the new catalog is an essential resource for tablet manufacturers. You can browse the interactive online version, download the PDF, or we'll ship you the traditional printed version absolutely free. Get yours now! http://www.natoli.com/AccessoriesCatalog-PT3.aspx

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.

The PreVAS (Pre-Validated, Pre-Assembled, Pre-Sterilized) product line from the partnership between Bosch Packaging Technology and Sartorius Stedim Biotech employs single-use technologies in systems for aseptic filling.
Baumer’s VeriSens vision sensor, developed with GEA Lyophil, identifies problems in automatic freeze-dryer loading and unloading systems.
Airflow Systems’ PCH Series of portable dust collection systems provides source-point collection of airborne contaminants.
The COCAM wt880 camera from Laetus has a narrow design permitting inspection of barcodes in tight spaces in the packaging process.
Service Engineering’s tool-free, feeder-bowl technology is designed for pharmaceutical cleanroom use.

July 23–25: Bio-Process Systems Alliance (BPSA) 2012 International Single-Use Summit (Washington DC) focuses on the opportunities and challenges created by the expanding and emerging markets for single-use technologies.
July 24–25: Pharmaceutical Technology Presents Bio/Pharmaceutical Manufacturing Outsourcing (Philadelphia, PA). Companies can learn the most efficient and productive ways to outsource manufacturing and manage costs during this focused, interactive forum that brings together bio/pharmaceutical executives and contract manufacturing organizations.
Aug 14–15: CBI's 7th Annual Forum on Manufacturing Execution Systems (MES) (Philadelphia, PA) addresses innovative MES efforts within the pharmaceutical, biotech, and medical device industry.
Aug 21–23: CPhI South America (Sau Paulo, Brazil) brings together over 3,500 pharma professionals from around the world to network and find new business opportunities in this growing market.
Aug 23–24: IVT’s Validation and cGMP Compliance Week Canada (Toronto) is a case-study driven event that includes workshops on implementation strategies for validation, quality systems, and aseptic processing.

PharmTech Poll: Energy Efficiency

Has your manufacturing site implemented an energy efficiency plan to reduce carbon footprint?

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