A Hybrid Approach to Combination Products
Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

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Basic Equipment-Design Concepts to Enable Cleaning in Place: Part II
The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.
>>Coming Soon: For Pharmaceutical Technology's annual global review of Big Pharma's manufacturing strategies, including an analysis of manufacturing investment and rationalization, see the August issue.
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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. |
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Caron's Photostability Chambers ideal for forced degradation
Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. The 6540 series control light and temperature conditions. The 6545 series precisely control light, temperature and humidity. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. For more information visit,
www.caronproducts.com/photostability |
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Top-Flo® SV2 sample valves are specifically engineered to be the finest in the industry and incorporate many features and benefits not found on other sampling valves. Top-Flo® SV2 sampling valves come standard with minimal internal deadleg area designed into each valve, keeping hold up volume to a minimum for accurate samples every time. Right angle or In-Line models available from stock in sizes 1/2'' to 6'' in a variety of inlet/outlet connections. www.toplineonline.com
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The PreVAS family of aseptic single-use dosing systems by Bosch represents a new chapter in dosing system technology. PreVAS is the first completely pre-assembled, and pre-sterilized dosing system available for the clinical and production pharmaceutical and biotech filling market that is supplied with supporting validation documentation.
http://boschpackagingpharmana.wordpress.com/prevas
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GoIndustryDoveBidLive & Webcast Auction July 28, 2011 Mylan Pharmaceuticals
Late Model Pharmaceutical Pilot, Lab/Packaging Equipment Etobicoke, Ontario, Canada
www.go-dove.com/event-15525
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- Bosch Packaging Technology’s GKF 702 capsule-filling machine was designed to produce small batches in the laboratory.
- EMD Millipore has introduced the NovaSeptum 60-mL bottle, the latest addition to its NovaSeptum product line for sterile sampling of pharmaceutical manufacturing processes.
- Emerson Process Management’s Baumann 85000 sanitary pinch valve is designed for low flow rate, low-pressure control of sterile liquids within the biotechnical and pharmaceutical industries.
- The No. 949 cleanroom oven from Grieve can heat vials electrically to 500 °F and is appropriate for Class 100 rooms.
- Silcon Med-X tubing from NewAge Industries is platinum cured for a high degree of purity.
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- July 28–29: Sterilization Procedures: Technology, Equipment, and Validation (Los Angeles). This basic course covers the microbial, scientific, technological, and statistical foundations of sterilization methods. Those who have knowledge of established processing procedures but lack a clear picture of the scientific principles of microbial destruction will benefit from this course.
- Aug. 15–16: Best Practices for Facilities and Utilities Design, Qualification, and Monitoring—Applying the Life-Cycle Concept (Los Angeles). This course will help those in pharmaceutical and biotechnology manufacturing who are responsible for vendor selection and controls, design, construction, installation, verification, and qualification of facilities, utilities, and their associated computerized controls.
- Aug. 22: Ensuring Operational Excellence in Bioprocessing (Boston). Biopharmaceutical firms are currently adopting best practices from other highly competitive industries early in the development process and customizing these approaches to operational excellence. This course will provide an overview of these approaches and how they work, as well as case studies of how these innovations have been applied in bioprocessing and elsewhere.
- Aug. 22–25: The Bioprocessing Summit (Boston). This conference is specially formulated to focus on the most pressing challenges of bioproduction. From cell-line selection and transfection to biopreservation, scale-up, and bioreactor design, this event explores the bioprocesses that continually consume time and resources.
- Aug. 24–26: IVT’s 8th Annual Method Validation (Philadelphia). This three-day course is designed for employees who manage or execute the validation of analytical methods for the quality control of small- and large-molecule pharmaceuticals and biopharmaceuticals.
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