| SUPPLY CHAIN |

Synchronizing Anticounterfeiting Efforts

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.
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Decoding Serialization Regulations

The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
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| FACILITY DESIGN |

Facility Design Issues for Single-Use Processes

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.
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| EQUIPMENT AND OPERATIONS |

New and Updated Laboratory Equipment Optimize Efficiency

The past several months have seen new product releases and updates made to already available laboratory equipment.
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| PEER-REVIEWED RESEARCH |

A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic Solution

In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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| OUTSOURCING REVIEW |

Update on Continuous Bioprocessing: From the Industry’s Perception to Reality

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.
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| EU REGULATORY WATCH |

EMA Faces Brexit Challenges

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.
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| API SYNTHESIS & MANUFACTURING |

Accessing Cannabinoids Using Biocatalysis

Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.
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| STATISTICAL SOLUTIONS |

Do You Listen to What Your Data are Telling You?

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
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| ASK THE EXPERT |

Ensure Quality in a Contract Test Laboratory

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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| PRODUCT SPOTLIGHT |

Sterilizer Uses Pulsed Light Technology

The Robotic Pulsed Light Sterilizer (RPLS1) from Steriline uses pulsed light technology for ready-to-use nest sterilization and can sterilize tubs of syringes, vials, and cartridges.
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Planetary Dispersers with PLC Recipe Controls

The Ross PowerMix Planetary Dispersers with PLC Recipe Controls from Ross, Charles & Son deliver batch-to-batch consistency in the mixing of high-solids, high-viscosity applications.
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Paperless Recorder Shortens Sampling Intervals

The SMARTDAC+ GX series panel-mount type paperless recorder from Yokogawa Electric Corporation comes with new functions, including sampling intervals as short as one millisecond and the control and monitoring of up to 20 loops.
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Control Box Connects Lab Sensors and Pumps

The Easy Control Box from Mettler Toledo connects any lab sensor and pump to make real-time measurement and controlled dosing available to non-experts.
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