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Pharm Tech
June 2016
Volume 40, No. 6
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| FOCUS |

Building a Better Self-Injection Solution

Adeline Siew, PhD

Experts discuss the key considerations in the development of an autoinjector.
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| PEER-REVIEWED RESEARCH |

Qualifying Personnel to Visually Inspect Cleaned Equipment Part II: Small vs. Large Group Training

Richard J. Forsyth

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
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| FACILITY DESIGN|

Deciding When To Use Modular Construction

Eric Bohn

Different types of modular systems have advantages and disadvantages.
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| SINGLE-USE SYSTEMS |

Integrating Single-Use Systems in Pharma Manufacturing

Susan Haigney

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.
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| FEATURES |

Indian Pharma Is Committed to the Future, Says Biocon Managing Director

Agnes Shanley

Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.
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Improving Pharma Systems with Process Analytical Technology

Susan Haigney

Pharmaceutical Technology spoke with Melissa Topp, director of Global Marketing at ICONICS, about the latest in process analytical technology (PAT).
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| FORMULATION |

Customizing HPMC to Minimize Drug Variability

Divya Tewari, Thomas Durig

The authors evaluated the performance and robustness of controlled-release tablets made with HPMC blends of unimodal and bimodal molecular weight distribution.
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| API SYNTHESIS & MANUFACTURING|

Steps Closer to the Adoption of Continuous Processing

Cynthia A. Challener

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.
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| TROUBLESHOOTING |

Examining Blow-Fill-Seal Technology for Aseptic Processes

Caroline Hroncich

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.
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| STATISTICAL SOLUTIONS |

Demonstrating a State of Control

Christopher Burgess

Do you have acceptable control of your instruments and analytical procedures?
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| REGULATORY WATCH |

Modern Manufacturing Comes of Age

Jill Wechsler

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.
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| OUTSOURCING OUTLOOK |

Watch Out for the Hangover

Jim Miller

Acquisition binges often lead to hangovers; here's what to watch out for.
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| VIEWPOINT |

PAT: “Gateway Drug” to the 21st Century for the Pharma Industry

Emil W. Ciurczak

Process analytical technology paved the way for continuous manufacturing.
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| ASK THE EXPERT |

Make Data Integrity Integral to CGMP Training

Susan J. Schniepp

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.
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| FROM THE EDITOR |

Industry Moves Closer to Continuous Manufacturing

Rita C. Peters

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.
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| PRODUCT SPOTLIGHT |

Acoustic Separator Streamlines Clarifications

The Cadence Acoustic Separator (CAS) from Pall Life Sciences enables the purification of bioprocesses fluids without the use of primary depth filters or centrifuges.
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Sensors Allow for Bluetooth Connectivity

The ArcAir communication package from Hamilton Company enables Bluetooth 4.0 wireless connectivity in all environments.
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Dropper Eliminates Need for Isolation and Insertion

The MD-Dropper Cap from HealthStar is a new dropper bottle technology for blow-fill-seal (BFS) technology.
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Washdown Duty Ribbon Blenders

Washdown duty ribbon blenders from Ross, Charles & Son can be used to mix dry blends such as grains, powders, pellets, and flakes.
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| Webcasts |

Engineering the Mechanical Properties of Amorphous Spray-Dried Dispersions

On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
Sponsored by Capsugel


Understanding Water Activity to Ensure Microbial Safety and Product Stability

On Demand
In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed.
Sponsored by Aqua Lab by Decagon


more webcasts
 

| Events |

MES 2016

August 10-11, 2016

PDA/FDA Joint Regulatory Conference

September 12-14, 2016

ISPE Annual Meeting

September 18-21, 2016


more events
 
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