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Whether developing new, ground breaking drugs or generic formulations, both the time and cost associated with pharmaceutical development is significant.
Malvern is focused on providing well designed, innovative analytical instruments, which follow the QbD (Quality by Design) ethos, in the fields of drug discovery, chemical and formulation development and pharmaceutical manufacturing.
Malvern can help with many aspects of QbD implementation; providing measurement technologies which have been designed, developed and tested following QbD principles, providing instruments, software and documentation to facilitate rapid method development, validation and transfer. We understand analytical instrument deployment and on-going support in a regulated environment to help you save time and money in bringing your product to market.
We understand what is involved in the development and manufacture of a drug product and the requirements to measure the Critical Material Attributes and Critical Quality Attributes (CQAs) affecting the Critical Process Parameters (CPP) in the manufacturing process.
Malvern’s value is in the breadth of characterization tools and application understanding that can be used to help accelerate pharmaceutical development. Malvern can implement systems that provide information on several Critical Material Attributes (CMAs) in one analysis, such as particle size, shape, and chemical identity or molecular weight, size and concentration. Whether characterizing the particle size and morphological properties of a novel Active Pharmaceutical Ingredient (API) or the suspension stability or rheological attributes of an New Chemical Entity (NCE), work flow efficiencies can be achieved when common platform technologies are utilized.
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This article explains how a Parsum probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by ...
This online demo is designed to provide you with an introduction to the Mastersizer 3000. You will be able to take a look at the Mastersizer 3000 and it’s accessories via the webcam in our lab, and we will share the Mastersizer 3000 software with you...
In the early history of cryptography and ciphers then invisible inks using silver salts and other chemicals were used. Silver colloids were regularly used and abused in this area. Silver colloids are now finding application (and legislation) as bater...
The properties of polymeric excipients can directly affect the clinical efficacy, safety, and quality of a finished pharmaceutical product and are routinely identified as critical quality attributes (CQAs). This article looks at how gel permeation/si...
Spraytec can measure how the particle size delivered by a dry powder inhaler (DPI) changes as a function of applied air flow rate, providing a deagglomeration profile which can be used to compare the performance of different formulations in a device ...
Silver colloids and invisible ink
(September 2 2015)
Nanoparticle size is an important criterion for our formulations and we routinely measure this with the Zetasizer Nano.
The images from the Morphologi G3 provided compelling evidence that the particles, rather than the sizing method, were a root cause of observed variability.
Reading Scientific Services Ltd
After just four months, the Morphologi G3-ID is already heavily used by researchers and students throughout the university. The automated microscopy and image analysis functions are especially popular and have saved countless hours compared with using manual microscopy techniques.
Southern Cross University
The software really is the shining star of the Mastersizer 3000. It makes it feel radically different from other systems on the market and a really great instrument to use. I especially like the live trends which make it so quick and easy to compare data sets.
NSL Analytical Services
Throughout the research and purchasing process, we assessed at least five to six different systems before selecting the Mastersizer 3000.
We can switch between different product grades around three to nine times faster than when we only had offline Blaine measurements for plant control. This has had a major impact on plant throughput. Here we have found the Insitec essential for the production of high quality products.
Mr Thomas Schuster
The technical support that we’ve received has been a deciding factor in our decision to continue to work with Malvern. Malvern systems also provide the cutting-edge performance and reliability that we need.
Domino Printing Sciences plc
The Morphologi G3-ID has proven straightforward and easy to use and we’ve already been successful in expanding our application of it into areas beyond construction materials.
Dr Ameneh Schneider
Association of the Austrian Cement Industry
The Insitec systems are a trusted and integral part of our plant. Our view is that real-time data is invaluable when it comes to producing slag cements with comparable performance to conventional products.
We use software capabilities, which were originally developed by Malvern for pharmaceutical industry users, to apply and demonstrate the analytical rigor required for certification of our powders.
Dr. Robert Deffley
In a comparative assessment the Morphologi G3 delivered the perfect balance between speed of measurement, image resolution and price.
Insitec is extremely reliable and enables us to provide milling plant for both wet and dry processing that efficiently meets customer goals for premium product quality and low energy consumption.
Malvern came recommended by colleagues in the industry but it was the features of the Mastersizer 3000 itself that sold us on the instrument. We’ve been running for a year now without any reliability issues and with minimal running costs. Most importantly we produce data that can be trusted.
Insitec brings value in three areas. It allows us to quantify differences in grindability, supports the development of an effective processing solution and improves the efficiency of our toll manufacturing, which is often a precursor to customer investment.
All information supplied within is correct at time of publication.
Malvern Instruments pursues a policy of continual improvement due to technical development. We therefore reserve the right to deviate from information, descriptions, and specifications in this publication without notice. Malvern Instruments shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this material.
Malvern and the 'hills' logo, Bohlin, Gemini, Insitec, ISys, Kinexus, Mastersizer, Morphologi, Rosand, SyNIRgi, Viscotek and Zetasizer, are International Trade Marks owned by Malvern Instruments Ltd.