The robust ShockWatch product portfolio includes temperature, tilt, impact, vibration, and humidity detection systems. ShockWatch also provides complete cold chain services to not only monitor facilities, vehicles, and cargo, but also provides cold chain analysis and compliance support for customers. Services include 24/7 real-time monitoring, regulatory compliance gap analysis, packaging design and testing, shipping studies, temperature mapping, and transport qualification (IQ, OQ, PQ) and validation studies. Visit shockwatch.com to learn more or request a free consult.
By Sunil Gupta, Founder, www.SASSavvy.com and Senior SAS/CDISC Consultant, Gupta Programming
With Internet technology being more global, sophisticated, and secure, pharmaceutical companies need to adapt to grow and ride the cost-conscious trend just to survive. Cloud-based tools, such as wikis, offer a paradigm shift in project management, FDA compliance requirements, and job aids for mentoring new employees. With centralized systems, validation issue trails can be tracked for QA and FDA auditing purposes.
By Paul Miller, Vice President and General Manager of Nilfisk CFM
In developing a comprehensive and effective cleaning program, pharmaceutical plants should understand the importance of choosing the correct vacuum for their application — this machinery represents a critical component in helping to minimize or avoid certain risks. A superior vacuum not only maximizes production efficiencies by enhancing the performance and lifespan of critical manufacturing equipment and safeguarding product quality, it also protects the safety and health of employees.
By Jeff Clark, 7P™ Solutions
Over the past several months I have written a couple of articles focused on the pharmaceutical time and temperature supply chain. While some may have found the opinions to be a bit strong as they related to the lack of proper training within the industry, I believe I received more “behind the scenes” agreement than not. The fact of the matter is, any of us involved in this important supply chain must understand not only the regulations that touch our individual businesses, but we must also understand the product which we have been given responsibility to manage and ensure patient safety!
By Michael Gotz, QuickSTAT
In the previous blog post, “Infectious Biologicals Category A and B – Classification Guidelines,” I provided definitions of Infectious Biologicals Category A and B and some basic guidelines on how to classify your shipments. These definitions are clear and helpful when you know that your shipment contains pathogens. In that case, it is either on the list for Category A, or if it is not, then it is classified as Category B.
By Adrian Possumato, Global Director of Healthcare Packaging, Multisorb Technologies
As the healthcare market continues to grow and evolve, sorbent (desiccant, oxygen absorber, hydrocarbon adsorbent) manufacturers are faced with developing new sorbent formats that will allow placement flexibility while continuing to positively impact the drug or device stability profile.
By Kevin Zarnick, Pharmaceutical Sales Manager, Thermo Fisher Scientific
The U.S. Food and Drug Administration (FDA) issued the Prescription Drug Marketing Act of 1987 (PDMA), which was then modified by the Prescription Drug Amendments of 1992. Included was Section 503(e)(1)(A), which establishes the pedigree requirement for prescription drugs.
By Peter Bouza, Micromeritics Instrument Corporation
Particle analysis plays a key role in the pharmaceutical industry — in both product efficacy and manufacturing. Particle size can impact the dissolution rate of an excipient or active pharmaceutical ingredient (API), and can impact formulation or tableting of a drug.
By Ivo Backx, Manager of Business and Project Development for the Pharmaceutical Industry, Siemens
Ivo Backx points out that integration of all process automation architectures is essential if continuous manufacturing is to be rolled out successfully. Equipment manufacturers sometimes focus on only one aspect of the process. They might, for example, have a solution for continuous coating or for tablet pressing, but they don't design it in a way that integrates with the equipment that precedes it and the one that comes next in the line.
New Release! The ISPE PQLI Guide: Part 4 — Process Performance and Product Quality Monitoring serves as practical how-to guidance with examples of technical and scientific methodology for adopting a process performance and product quality monitoring system (PPPQMS) in line with the expectations of ICH Q10, Pharmaceutical Quality System. Learn more.
By Gregory Krueger, Kevin Epting, Priyanka Gupta, and Roger Alsop, Sartorius Stedim Biotech
Sartobind® Pico and Sartobind® Nano are laboratory-scale membranes, and due to their small size and high throughput they are perfect for use on automated chromatography systems.