Scientific Papers
Study a selection of White Papers covering a variety of topics, supplied by Industry Associations, Pharmaceutical Businesses and other pharma experts, to benefit the wider pharmaceutical industry.
If you would like to supply a paper for this page, please contact melsands@step-exhibitions.com
Genotoxic Impurities – A QC Laboratory Perspective
Much has been written on manufacturer’s responsibilities to identify potential sources of genotoxic impurities and perform testing, there is not the same level covering the subject of laboratory testing…
TOC combined with Headspace GC in Cleaning Validations
Total Organic Carbon (TOC) analysis is commonly used in Cleaning Validations. What happens when an OOS results is obtained? Butterworth outline their approach to such a situation…
galeneIQ™ The bulk filler-binder that makes medicine taste better.
Chemlink
Isomalt is disaccharide alcohol derived from natural beet sucrose. It can be used in a wide-range of solid dosage forms such as direct-compression tablets, chewables, effervescents, powder sachets and high-boiled lozenges…
L-HPC (Low-Substituted Hydroxypropyl Cellulose) to formulate solid dosage forms with good stability.
L-HPC is a dual functional excipient which has disintegrant properties binder capabilities and also has good but also a binder due to its excellent compressibility. The key benefit is that…
Dry Granulation – A material sparing method.
Medelpharm
In this paper Bruno Villa, General Manager at Medelpharm, explains benefits of dry granulation and principles of hybrid modeling with a STYL’One Evolution tableting press…
Product Datasheets Do Not Tell The Whole Story
PCT
A comparison of Mass Flow Meters from various manufacturers based upon their published data. As this data relates to only calibration conditions further experimentation was undertaken to identify actual performance…
Back-Flow Contamination Of Flow Control Devices : Experimental Assessment Of Impact Upon Accuracy
Mass Flow Controllers are an essential control unit within Bioreactors where fragile cells depend on proper flow of oxygen for metabolism and carbon dioxide for pH control. Unfortunately, in the…
Higher Specifications Simplify System Design
PCT
The high turn-down (10,000 : 1) of Alicat Mass Flow Controllers allow the systems engineer to simplify the design, reduce the number of instruments required and reduce costs…
Content uniformity of pharmaceutical solid dosage forms using Vis-NIR spectroscopy examplified on cefixime tablets
This Application Note demonstrates different application possibilities of Metrohm Vis-NIR analysers for the determination of content uniformity parameters in pharmaceutical products such as tablets. This unique analytical technique enables significant…
Following the progress of pharmaceutical mixing studies using near-infrared spectroscopy
Metrohm
Well-mixed active substances for medications are indispensable in the pharmaceutical industry. This applies not only to the pharmaceutical active ingredient but also for lubricants, binding agents, explosives, oxidants and dyes….
Metrohm
Near-infrared spectroscopy for monitoring a single-pot granulator
Metrohm
This Application Note describes the utilization possibilities of a new sensor design that permits, in combination with an NIRS XDS Process Analyser, the determination of solvent residues in a High-Shear…
Investing in Automated Visual Inspection and Sorting Machines: Costs, Risks and Performance Evaluation
Nowadays pharmaceutical companies are increasingly investing into automated visual inspection and sorting machines in order to replace subjective and manual sorting. Apart from the fact that the technology itself sometimes…
EU GMP Annex 1: The New Draft and the Implications for Sterile Products Manufacturing
RSSL
EU GMP Annex 1 is the primary document governing the manufacture, control and release of sterile pharmaceutical products (both terminally sterilised and aseptically filled medicines). The Annex will shortly undergo…
NSF
Can You Take The Hits and Bounce Back Stronger?
NSF
In this white paper, Martin Lush discusses three useful steps that can help companies thrive when the going gets tough…
NSF
Struggling Day to Day? Here Is Your Survival Tool Kit
NSF
In an effort to help inexperienced industry professionals, NSF International’s Martin Lush contacted 30 high caliber pharma veterans asked them: “What single piece of advice would you give the young…
EU GMP Annex 1: The New Draft and the Implications for Sterile Products Manufacturing
PCT
BPE-2016 standards are often applied to mass flow meters and controllers regardless of their position relative to the sterile boundary. 316L stainless steel can be used for elements in the…
Alicat Mass Flow Controllers’ Resistance to Backpressure Contamination
PCT
Mass Flow Controllers are an essential control unit within Bioreactors where fragile cells depend on proper flow of oxygen for metabolism and carbon dioxide for pH control. Unfortunately, in the…
Simplified Gas Line Configuration for Bioreactors and Bioprocess Systems
The high turn-down (10,000 : 1) of Alicat Mass Flow Controllers allow the systems engineer to simplify the design, reduce the number of instruments required and reduce costs…
Analysis of Temperature and Pressure Conditions on Flow Measurement
A comparison of Mass Flow Meters from various manufacturers based upon their published data. As this data relates to only calibration conditions further experimentation was undertaken to identify actual performance during more normal, day-to-day conditions…
Conical Milling: How to effectively scale-up from lab to pilot to production
In many pharmaceutical processes, what works in the lab doesn’t always scale-up seamlessly into production; this is true in conical milling. Larger batches, different process conditions, and varying material characteristics…
Evaluating the Rheological Properties of Hyaluronic Acid Hydrogels for Dermal Filler Applications
Hyaluronic acid (HA) is a naturally occurring polysaccharide frequently used as a functional ingredient in many topical and subcutaneous anti-ageing treatments such as dermal fillers, which exploit the polymer’s unique…
Characterizing Opthalmic Viscosurgical Devices (OVDs) Using a Rotational Rheometer
NETZSCH
Ophthalmic Viscosurgical Devices (OVDs) are viscoelastic solutions or gels used to protect the corneal endothelium from mechanical trauma and to maintain intraocular space during eye surgery. They usually contain one…
A best practice approach to handling waste powder from OSD manufacturing
Hanningfield
The loss of active pharmaceutical ingredients (APIs) during oral solid dosage (OSD) production is inevitable. Managing material loss is vital for reasons of safety, regulatory compliance, and cost. This white…
