Pharmaceutical Technology EPR Monthly Issue:
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Pharm Tech
June 15, 2016
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PRODUCTION TRENDS

Mitigating Data Integrity Risks

Computerized systems can solve some of the data integrity problems with conventional paper-based systems.
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Take PharmTech's Annual Equipment and Manufacturing Survey

This month, we are collecting your feedback on trends in finished product manufacturing and innovation in pharmaceutical equipment and manufacturing. The results will be shared in August. To share your views, click on the link or copy and paste into your browser: www.surveymonkey.com/r/PharmTechEquipment2016
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Now Online

Natoli Institute Brings Academic Focus to Industrial Pharmacy.
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TROUBLESHOOTING

Examining Blow-Fill-Seal Technology for Aseptic Processes

Experts discuss the types of plastic containers that can be used, temperature considerations, and how to optimize the blow-fill-seal process.
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More Troubleshooting

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EXPERT INTERVIEW

Adam Feinberg, associate professor of Biomedical Engineering at Carnegie Mellon University, discusses challenges in 3D bioprinting.

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Interphex
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PACKAGING

Blister Pack Optimization

Science-based software and testing services expedite the material selection process and ensure blister packs deliver adequate barrier protection for solid-dosage forms without over-packaging.
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More Packaging

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Editor's Picks

Single-Use Tube Assemblies Are Validated and Ready-to-Use

Customized puresu single-use fluid path assemblies from Watson-Marlow Fluid Technology Group incorporate tubing and BioPure components and are supplied ready to use.
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Imaging System Tests Integrity of Blister Packs

PTI’s VeriPac UBV Leak Detection System is a deterministic, non-destructive technology designed specifically for multi-cavity blister packs.
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SPONSOR SHOWCASE

World's Fastest Capsule Filling Machine

Fette Compacting's new FEC40 Capsule Filler produces up to 400,000 capsules/hr – nearly twice that of any other capsule filler. This dramatically elevated output is accomplished in a remarkably small footprint, making machine reconfiguration due to floor space unnecessary. The high performance-to-footprint ratio is due to Fette Compacting's patented Duplex Concept, which utilizes a mirrored capsule filling process and double-sided discharge.
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Natoli Custom Heavy-Duty Toolboxes

Natoli heavy-duty toolboxes contain everything you need to properly set up a tablet press. Each toolbox comes customized with all the necessary tools and accessories for your specific press model. Order by machine type and number of stations. Available for special or modified tablet presses. / Visit natoli.com for more information /

Equipment: Miscellaneous Centrifuges

Rebuilt Heinkel Inverting Filter Centrifuge, Model HF-600.1 stainless steel MOC, has a full mechanical rebuild, all product contact parts have been chemically cleaned, includes a complete Electrical & Control System designed for Class 1 Div. 2. Machine has been fully tested and is ready for quick delivery and start-up. Unit includes (1) year warranty on the mechanical portion (excludes normal wear items).
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Leistritz will host its’ 11th annual Pharmaceutical Extrusion Seminar on June 22-23, 2016 in NJ.
For details or to register see: http://www.alec-usa.com/PES-2016.htm

Note: Leistritz manufactures twin screw extruders and systems for continuous mixing/devolatilization of API's with excipients.


Webcast

Compliance Is Key: Solutions to Decrease the Likelihood of Receiving a Form 483

Thursday, June 23, 2016 at 11:00 am EDT

Compliance to regulations requires in-depth knowledge and adherence to the latest GMP guidelines, and sustaining these guidelines and technical standards in the laboratory environment. Recent FDA inspections have exposed a lack of data integrity, incomplete audit trails, and inadequate procedures as regulators continue to tighten their approach to inspections for drug license holders and contract service organizations. The presentation will include recent 483 excerpts and areas for improvement in basic laboratory controls to prevent data manipulation. One instrument manufacturer's practical solutions to improve data integrity and 21 CFR Part 11 concerns will be discussed.
Sponsored by: Anton Paar USA

more webcasts

EVENTS

MES 2016

Aug. 10–11, 2016 | Philadelphia, PA

IVT's 2nd Annual Data Integrity Validation Conference

Aug. 17–18, 2016 | Cambridge, MA

ISPE Annual Meeting

Sept. 18–21, 2016 | Atlanta, GA

more events

eBOOK

Bioprocessing and Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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