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Featured Whitepaper: Surety LLC
Not all ELN IP Protection Controls are Equal – What You Should Know as You Go Electronic
A Technology Comparative of “Digital Notarization” Solutions
Sponsored By: Surety, LLC
Using an electronic lab notebook (ELN) or planning to move to one? More laboratories and R&D-centric organizations are changing from paper-based to electronic workflows to remain competitive…and why not? From initial conceptualization through product development and production, ELNs and other lab informatics systems are efficient and effective for what they are designed to do.
The problem is, though, they lack certain defensibilities, particularly long-term, independent protection of the integrity and authenticity of your scientific intellectual property. So how can you ensure the safety and your ownership of your IP in a legal or regulatory dispute?
Many R&D organizations have turned to digital signatures and digital timestamping as solutions for IP protection. But not all are equal. You should be aware of the differences.
This new whitepaper from IP Protection Leader, Surety, examines four of the most common digital protection controls for research-based IP, providing a comprehensive “graded” evaluation of each, and painting a portrait of the bioscience community's various options for neutralizing potential patent and other “ownership” litigation.
Get FREE whitepaper now |
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Monitoring Systems: Sorting out Wireless
Sponsored By: Vaisala
Monitoring systems for temperature, humidity and other parameters can be complex, involving hundreds of sensors in a variety of applications. One of the most important decisions in selecting or adding to a monitoring system is choosing the connectivity method that will allow the sensors to speak to a central processing unit. Decisions on connectivity are dependent upon several factors, including: data integrity requirements for regulatory purposes, logistical concerns such as access points for transmitters, and existing network infrastructures. In this article, we describe the most common wireless methods of connecting sensors to a monitoring system and offer eight considerations for selecting a method best suited to the application. |
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AQUEOUS CRITICAL CLEANING: APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Authors: Malcolm McLaughlin, Theresa Dowds
Sponsored By: Alconox
This Guide to Critical Cleaning places a concise overview of our half-century of experience at your fingertips. From tablet presses to mixing tanks, Alconox detergents handle tough critical cleaning jobs—like removing insoluble coatings residues. The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. |
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Hot Melt Extrusion (HME) - nano-scale compounding developments
Author: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of API’s/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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Humidity measurement in cleanrooms: The devil is in the details
Sponsored By: Vaisala
Systems used for measuring and monitoring RH play a small role in the overall picture of controlling cleanroom conditions, but problems inherent in humidity sensing can cause significant headaches for cleanroom operators. This article describes some observations and insights that are relevant to anyone in the cleanroom community who has struggled with humidity issues. |
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ROTRONIC's New Technology Reduces Calibration Time
Author: Greg Gowaski
Sponsored By: Rotronic Instrument Corp
Maintaining the accuracy of your humidity and temperature instruments requires periodic calibration. Calibration of these instruments can be a costly and time-consuming venture. ROTRONIC’s new AIRCHIP 3000 Digital technology greatly reduces calibration time and cost by eliminating one full calibration cycle. |
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Provide Precise, Seamless Liquid Filling
Author: Gregg E. Johnson, Thermo Fisher Scientific, Fluid Handling, Barrington, IL, USA.
Sponsored By: Thermo Fluid Handling
Sterile liquid flow is paramount in pharmaceutical and bioprocessing applications, which is why Thermo Scientific Masterflex peristaltic pumps are highly-suited for these demanding processes. |
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Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ, Inc
With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization. |
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How to Avoid (and Respond to) FDA 483s
Sponsored By: Vaisala
The following article shows excerpts from some common observations in Form 483 Letters. After the excerpts, we outline 10 best practices of a 483 response including links to further resources. Then we discuss different methods of monitoring, alarming and reporting critical parameters like temperature and humidity in FDA-regulated environments and how to avoid deviations from cGMP in your regulated environments. |
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Establishing Target Fill Counts
Author: Troy Fugate
Sponsored By: Compliance Insight Inc.
How do you determine acceptable tolerances for the in-process fill counts of tablets and capsules. |
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Risk-based Manufacture of Pharmaceutical Products: A guide to Risk MaPP approaches and experience
Author: Kim Ray
Sponsored By: OSO BioPharmaceuticals Manufacturing
A discussion of how Oso BioPharmaceuticals has successfully implemented a scientific, risk-based approach to handling hazardous compounds, how it has impacted their clients, and the reaction of regulatory bodies. OsoBio will share how implementation of this approach has affected its business as well as its clients. |
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Topical Dermatological Formulation Development – "Things You Should Know"
Sponsored By: Dow Pharmaceutical Sciences (Sterile Unit)
There are important issues to consider as you contemplate development of a topical dermatological product. You may already have experience with oral or parenteral products, but there are challenges and issues which are unique to development of topical formulations. |
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An Introduction to Pharmaceutical Forensics
Author: David Exline
Sponsored By: Gateway Analytical
Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles, and addresses quality issues such nonconformance and deviation investigations, contaminant identification and source determination. This whitepaper provides an introduction to this approach and a case study example of particulate examination. |
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Donate Your Surplus Lab Equipment
Sponsored By: EquipNet, Inc.
Have you considered donating your surplus laboratory equipment? The scientific community thrives on the open exchange of ideas and information. This eBook will help you design and run a successful equipment donation program. You will learn the best practices that have enabled leading organizations to create successful equipment donation programs that allow them to do well, while doing good. |
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Evaporative Light Scattering Detectors (ELSD) technology in R&D, QC, manufacturing, method's development or product support labs all over the world (Part 1)
Author: Tim Reyburn, C.E.O.
Sponsored By: Ticoscen Inc.
This white paper’s purpose is to provide general support to end users utilizing Evaporative Light Scattering Detectors (ELSD) in R&D, QC, manufacturing, method’s development or product support labs all over the world. Additionally, this paper puts into plain language what’s going on (in general) in the ELSD market as a whole in regards to the current ELSD platforms that are available. More specific insights, analysis and recommendations can be had by reaching out to Ticoscen. Ticoscen remains the only ELSD support services company specializing in ELSD repair, calibration, sales, training and application support for over 17 years now. |
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8 Steps to Validating/Mapping a Chamber
Sponsored By: Vaisala
Periodic mapping of conditions within environmental chambers such as refrigerators, freezers, RH chambers, or cGMP compliant warehouses is critical for compliance with FDA regulations. This application note recommends methods and key considerations to ensure that you fulfill the requirements for thermal validation projects. These are broad guidelines and for the sake of simplicity we refer to probes, sensors, data loggers interchangeably within this article. |
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THE CASE FOR UPGRADING EXISTING HPLC ASSAYS TO UPLC
Author: Eric Hill
Sponsored By: Impact Analytical
UPLC, ultra pressure liquid chromatography, is the successor technology to HPLC techniques and assays that have been widely used since the 1970s. UPLC has emerged from the laboratory over the past few years and moved to the bench top. It offers similar analytic capabilities as the more familiar HPLC, but operates at much higher pressures. This increased, or ultra, pressure provides the advantages of improved resolution, shorter run times, fewer consumables, and similar advances to separation science and those who depend on it to analyze and characterize vital compounds. |
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