Drug manufacturers must verify the identity of their incoming raw materials prior to release into the production process. For some, meeting this requirement involves extracting and testing samples from a small fraction of their incoming containers; for others it means testing every single package. Regardless, all find thorough and compliant material identity verification a costly exercise, with costs that span operational, personnel, facility planning, capital equipment, maintenance and consumables. This paper discusses ways to make these processes more efficient and less costly.
The purpose of this paper is to discuss the application of Raman spectroscopy to the unique requirements of raw material testing. In order to do so we will answer the following questions: What is and why perform identity testing? What are the incentives to speed up testing? Should we consider modifying the testing process? How does the Thermo Scientific TruScan handheld Raman instrument perform ID testing? How well does TruScan work for common raw materials? Can this be deployed in a regulated pharmaceutical environment?
Thermo Scientific TruScan is a rugged, handheld system for rapid material verification. On-the-spot results are delivered in seconds with nondestructive point-and shoot sampling through sealed packaging. TruScan reduces the need for quarantine areas and staging of raw materials, while minimizing risk of exposure and contamination. Quickly validated and easily operated, TruScan was designed for use in GLP and cGMP environments and is an approved technology for USP ID testing.
This resource pdf outlines best practices for optimizing pharmaceutical raw material inspection. Highlights include a lean manufacturing progress report, white papers, videos and additional resources on raw material inspection.
For years, drug manufacturers have been caught between two opposing forces supply chain management and supply quality management. The only way to confront these challenges is to create a culture of quality that begins at the top and permeates down through the supply chain. This paper looks at how it can be done.
Cartridge filtration can be a reliable, efficient means of producing bulk pharmaceutical grade water. This detailed paper from 3M illustrates its effective use for some of the most critical applications: the removal of particulates that might contaminate water systems, eliminating Pseudomonades and other microorganisms, reducing endotoxins, and protection of storage tanks during draw-down.
Life Sciences companies are facing shifting business models, expanding generic competition, and an ongoing search for high-growth markets. That's why organizations are seeking ways to increase revenues and maintain profits. The workforce is one resource that can yield significant return with minimal investment. After all, labor is the most controllable expense across Life Sciences manufacturing and R&D. This paper sheds light on how automated workforce management can help gain insight into labor costs, maintain complete audit trails, and shorten development cycles.
A new leaner, more cost-effective approach to track and trace demands new technology. Due to advances in the power of digital signal processors (DSP), imaging sensors and decoding algorithms, traceability applications such as ID code reading, text verification, mark quality assessment, and label inspection can now be accomplished more economically using the latest generation of smart camera vision systems.
Use of Rapid Micro Biosystems' Growth Direct System for BI enumeration speeds time to result through the system's ability to accurately count micro colonies before they become visible to the naked eye, and thus saving up to 50% of the time required to perform a test using standard culture based methods.
This study demonstrates that microbial contaminants in egg white, a model matrix for allantoic fluid, can be rapidly analyzed on the Growth Direct system. Equivalent numbers of colonies were detected by the Growth Direct in 13 hours as were counted via the culture method after 24 hrs: a 50% time savings.
This Technical Brief describes how the Zeta Plus Activated Carbon Cartridge series is evaluated for use in pharmaceutical applications and how the optimal carbon type and media grade are chosen for a given application. In addition, the brief describes how a process is scaled-up in order to determine the requisite Zeta Plus Activated Carbon filter area for manufacturing and production of an active pharmaceutical ingredient.
With cleaning validation the fundamental question is ,"How clean is clean?" With Total Organic Carbon (TOC) instruments and methods, the question is whether to perform validation, verification, or qualification. Part of the question is not necessarily which mode to use, but, "Does the method or instrument 'suit' its purpose?" Given the current confusion regarding the use of TOC for compendial and analytical method purposes, this paper demonstrates what mode (validation, verification, or qualification) of choice should be used for TOC instrumentation or the methodology.
Sample matrices can create analytical obstacles and calibration challenges during routine Total Organic Carbon (TOC) analysis. This paper describes a novel approach to wet chemical oxidation employing both heat and pressure, and present data showing the Sievers InnovOx TOC Analyzer's calibration robustness and long-term stability.
Accuracy is a key consideration in the proper selection of a TOC device. TOC Sensors exhibit significantly less accuracy than TOC Analyzers, but provide the benefit of lower cost, easier operation, faster analysis and a smaller footprint, therefore choosing a TOC Sensor versus a TOC Analyzer is a matter of intended use. This paper outlines this dilemma, and describes how GE's CheckPoint TOC Sensor optimizes the use of TOC Sensors in diagnostics applications.
Surveys of tablet press users reveal that machines with segmented turrets increase output and reduce set-up and cleaning time over conventional presses and previous turret technologies. This paper will discuss survey data from drug manufacturers using the technology and quantify some of the benefits over conventional press technologies.
Drug manufacturers have made significant improvements to their operations using Lean principles, but one area they often overlook in applying Lean is their workforce. As labor pressures increase and margins tighten, savvy manufacturers are leveraging Lean to increase workforce flexibility, reduce wage variability, align labor with demand, and improve their bottom line. This paper, sponsored by Kronos, sheds light on several areas where Lean benefits workforce management.
Mergers & acquisitions are complex ventures that have an alarmingly high failure rate. A primary explanation is that companies do not audit the one true factor that determines organizational success: people. This whitepaper provides practical guidelines to M&A success relative to the workforce. Specifically, you will learn: workforce risks that impact M&A; an approach to quantify workforce value; and an audit philosophy to assess the workforce.