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Featured Whitepaper: Vaisala
Thermistors and Thermocouples: Matching the Tool to the Task in Thermal Validation
Sponsored By: Vaisala
This peer-reviewed paper (published in the Journal of Validation Technology) focuses on two sensors used in thermal mapping: thermocouples and thermistors, and describes advantages and disadvantages of both, describing why thermistor-equipped data loggers can be used to perform mapping studies in GxP-compliant environments.
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larkin.
Sponsored By: KIMBERLY-CLARK Corp
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Process Analytical Technology as Key Enabler of QbD
Authors: David W. Humphrey / Dr. Brandye Smith-Goettler
Sponsored By: Siemens AG
The Food and Drug Administration (FDA) has championed one initiative, known as Quality by Design (QbD), with the goal of improving productivity and reducing manufacturing costs. Process analytical technology (PAT) is an enabling technology for QbD. Siemens offers a comprehensive, well-integrated solution for process analytical technology (PAT) called SIPAT. |
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How in-line sensors are affecting the pharmaceutical process and validation
Author: Dr. Jorg Pochert
Sponsored By: Hamilton Company
Pharmaceutical Technology conducted an interview with Dr. Jorg Pochert, on a discussion about intelligent vs. in-line sensors. In pharmaceutical processes, in-line sensors generally offer a real-time view of the relevant parameters. In-line sensors make sure processing is done under validated conditions at all times, to obtain the expected product. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, Ph.D.; James C. DiNunzio, Ph.D.
Sponsored By: Leistritz
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Author: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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Automated Audit Management Best Practices
Author: KR Karu
Sponsored By: Sparta Systems, Inc.
In response to recent high-profile product safety issues, the quantity and breadth of internal audits and external audits of suppliers and outsourcing partners have increased significantly. With stepped up audits, inefficient, manual, siloed processes are now causing significant problems, including: poor communications and scheduling; inefficient use of auditor and auditee resources; inconsistent audit output; lack of visibility and oversight into trends; and difficulty in ensuring appropriate follow-up on corrective and preventive actions (CAPAs). All these issues can have an adverse impact on operational effectiveness and product quality. |
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Don't Overlook Pharmaceutical Supply Chain Quality Provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA)
Author: Janeen Skutnik, NSF-DBA, part of NSF Health Sciences
Sponsored By: NSF-DBA (USA) LLC
The Food and Drug Administration Safety and Innovation Act (FDASIA) is a remarkably broad law with far-reaching implications for the pharmaceutical industry. Several provisions of the law focus on ensuring safety and quality in the increasingly global pharmaceutical supply chain. Learn more…. |
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Coating heat-sensitive products at ambient temperatures
Author: Roquette.
See how LYCOAT® / ReadiLYCOAT® can be applied to your heat-sensitive ingredients or dosage forms at the same time as keeping the coating process short and providing an inert coating of perfect quality. And that’s not all….. |
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Analysis of Multi-Component Engineered Particles for Inhalation
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper discusses using Raman Chemical Imaging as method for spatially resolved, chemically-specific analysis of particles that contain multiple active ingredients in order to verify the composition of the particles, which is critical for process optimization, and regulatory requirements. Reviews method used for determining the ratio of drug components. |
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