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Pharmaceutical Technology-04-02-2016
Pharmaceutical Technology
Understanding Measurement Uncertainty in Weighing
April 02, 2016
Troubleshooting
40
4
A program for calibration and routine testing of weighing instruments ensures accurate results.
Blister Pack Optimization
April 02, 2016
Packaging Forum
40
4
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.
Technology Transfer Connections
April 02, 2016
Cover Story
40
4
Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.
Requirements for Product Technology Transfer
April 02, 2016
Ask the Expert
40
4
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.
Ensuring Quality in Solid and Semi-Solid Dosage Forms
April 02, 2016
Features
40
4
Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.
Conjugation Chemistry with Highly Potent Compounds
April 02, 2016
API Synthesis and Manufacturing
40
4
Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.
Failure Mode Effects Analysis for Filter Integrity Testing
April 02, 2016
Features
40
4
Understanding of the risks associated with FMEA is crucial in lot release testing.
More Outsourcing? More Monitoring.
April 02, 2016
From The Editor
40
4
A global API marketplace increases the burden of supply chain monitoring for drug companies.
Shipping: Proactive Risk Management
April 02, 2016
Features
40
4
Technology is making it easier to stop problems before they can affect patients and the bottom line.
Container Selection for Biologic Formulations
April 02, 2016
Formulation
40
4
Choosing the right container and container closure system is crucial for ensuring product quality, safety, and efficacy of a biologic formulation.
Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products
April 02, 2016
Features
40
4
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in Malta
April 02, 2016
Peer-Reviewed Research
40
4
The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
Ruggedness of Visible Residue Limits for Cleaning Validation
April 02, 2016
Peer-Reviewed Research
40
4
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Vaccine Development Faces Urgency and Challenges
April 02, 2016
Regulatory Watch
40
4
Global outbreaks energize vaccine R&D and drive production modernization.
CMC Development is Hot
April 02, 2016
Outsourcing Outlook
40
4
Demand is driving expansion and consolidation of formulation and clinical trial materials services.
Multi-Shaft Mixer for Sanitary Applications
April 02, 2016
Product Spotlight
40
4
Ross VersaMix Multi-Shaft Mixers are designed for sanitary and high-purity applications.
Peristaltic Pumps Optimize Process Security
April 02, 2016
Product Spotlight
40
4
Peristaltic cased pump for upstream and downstream biopharmaceutical applications from Watson Marlow Fluid Technology Group.
Capsule Checkweigher Achieves Highthroughput
April 02, 2016
Product Spotlight
40
4
The Anritsu Capsule Checkweigher from MG America achieves high throughput of up to 230,000 capsules per hour.
Flexi-Caps Protect Against Breakage
April 02, 2016
Product Spotlight
40
4
The Flexi-Cap Protect from Schreiner MediPharm.
FDA Insights on Quality in Solid Dosage Manufacturing
April 02, 2016
Features
40
4
Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.
Pharmaceutical Technology, April 2016 Issue (PDF)
April 02, 2016
Issue PDF
40
4
Click the title above to open the Pharmaceutical Technology April 2016 issue in an interactive PDF format.
SWOT Analysis
April 01, 2016
Peer-Reviewed Research
40
4
A strengths, weaknesses, opportunities, and threats analysis.