Whitepapers

Driving towards manufacturing excellence: 10 reasons to adopt on-line particle size analysis

Justifying an investment in on-line analytical instrumentation relies on having confi dence in the technology and being able to make a reliable estimate of the potential gains. With on-line particle size analyzers based on laser diffraction, users routinely report payback times of between six months and a year. Economic advantage fl ows from many sources: reduced waste, manpower, energy, material, plant capacity; better product quality; automated control; and faster process development and optimization. The detailed case for justifi cation is unique to individual plants but the themes are well understood and common to all. The database of case studies demonstrating benefit, across all industry sectors, grows each year. Consultancy services offering mobile particle sizing technology make it easier to understand the potential for each and every plant.

Inform is a series of white papers designed to provide advice on material characterization issues

Spray drying is one unit operation for which particle size is a critical parameter. Figure 3 shows an in-line laser diffraction analyzer measuring the output from a small lab-scale dryer.

The instrument measures the entire product stream, producing data with high statistical signifi cance. Its installation as close as possible to the exit minimizes time delays. A feedback control loop allows manipulation of either atomizer pressure or feed to maintain particle size at a given set point. Increasing feed rate produces coarser particles; increasing atomization pressure has the opposite effect. Figure 4 shows data from the in-line system

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Press Releases

Malvern specialist presents GPC/SEC benefits at Chromatographic Society meeting

28 February 2012: Malvern, UK: A separation technique specialist from Malvern Instruments will speak at the upcoming symposium ‘Chromatographic characterisation and purification techniques for Biopharm’, a meeting with a packed programme of presentations and workshops that will focus on monoclonal antibody-derived drugs. This 2-day event is organised by the Chromatographic Society and will be hosted at the GlaxoSmithKline Medicines Research Centre in Stevenage, UK on 14/15 March 2012. Malvern is also one of the symposium sponsors.

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Georgia Tech researchers apply Malvern Zetasizer Nano in novel way to predict protein aggregation

4 January 2012: Malvern, UK: Researchers at the Georgia Institute of Technology School of Chemical & Biomolecular Engineering (Georgia, US) are using the simple to use technique of dynamic light scattering (DLS) measurements to predict otherwise difficult-to-measure aggregation behaviors in proteins. Using the Zetasizer Nano from Malvern Instruments, the Georgia Tech team measures small volumes of stable protein solutions with low concentrations of different salts. From the results they can infer ion-specific trends in the kinetics of aggregation induced by much higher concentrations of the same salts. Such trends, derived from the analysis of non-aggregating samples, could be confirmed experimentally in rapidly aggregating samples of the same protein

Associate Professor Sven Holger Behrens said, “We use the Malvern Zetasizer DLS option in two ways in our protein studies. The first is a common approach and records the change in hydrodynamic radius [particle size] that occurs as proteins aggregate. Our second, more novel technique, is to look at non-aggregating protein solutions with the same types of salt-ions but much lower salt concentrations. These low salt solutions remain stable for as long as we look at them and we have found that protein interactions in these solutions, visible in DLS as a change in diffusivity [or apparent particle size] with protein concentration, correlate strongly with aggregation stability at much higher concentrations and can therefore predict ion-specific aggregation trends in proteins.”

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Malvern Instruments and Postnova Analytics co-operate to deliver combined solution for characterizing challenging particulate systems

15 February 2012: Malvern, UK: Malvern Instruments (Malvern, UK) and Postnova Analytics (Landsberg/Lech, Germany) have announced that they are co-operating to deliver the combined FFF (Field-Flow Fractionation) and DLS (Dynamic Light Scattering) solutions that today provide critical insight when characterizing a number of challenging particulate systems. Such systems include complex, aggregated, surface-coated and heterogeneous particles, as well as larger polymers, and aggregated, cross-linked, nano-particles and fibrillated proteins.

Used together Malvern’s Zetasizer Nano and Postnova’s FFF systems provide information not accessible by other means, and are highly complementary to Malvern’s Viscotek gel permeation chromatography/size exclusion chromatography (GPC/SEC) range.

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Malvern Instruments commits to extensive program of free educational webinars in 2012

1 March 2012: Malvern, UK: With more than 70 English language webinars scheduled for 2012, plus many presented in multiple languages, Malvern Instruments continues its commitment to the company’s firmly established cultural premise that knowledge sharing has great benefits for all concerned. Now in its 11th year, Malvern’s program of online web seminars includes a wide range of material characterization presentations, appropriate for beginners through to experts from a wide range of industries. Catering to worldwide audiences, live presentations are broadcast across multiple time zones and extend across numerous languages including: English, Spanish, Portuguese, Chinese, Japanese, French and German. Participation is free of charge and registration is straightforward. Simply visit: www.malvern.com/webseminars

Marisa Fraser-Moreira, Malvern’s Marketing Communications Manager for The Americas said, “Malvern’s 2012 web seminar programme offers even more opportunities for shared learning, networking and direct contact with technical experts, than in previous years. Past success has encouraged an ongoing expansion of this service. It is clear from increasing audience numbers and feedback that not only does Malvern benefit from liaising with instrument users, but seminar participants genuinely value the opportunity to learn about new technologies, methodologies and applications

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Smarter particle sizing’ on Malvern booth at Pittcon 2012

6 February 2012: Malvern, UK: Materials characterization company Malvern Instruments focuses on ‘smarter particle sizing’ as the Mastersizer 3000 laser diffraction particle size analyzer makes its Pittcon debut in 2012 (Booth #3641 Pittcon 2012, 11-15 Mar 2012, Orlando, FL).

This small footprint instrument delivers precise high-resolution wet and dry sample measurement from 10 nm to 3.5 mm, with rapid operator-independent measurement enabling increased lab productivity

At the plant, particle size data are used to automatically vary the speed of the classifier used to separate the milled cement into a fine product stream and a coarser recycle. In the past this control loop was driven by data measured in the laboratory using a Mastersizer 2000 laser diffraction particle size analyzer (Malvern Instruments). Now the data come from the on-line Insitec system

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Introducing a new, unique turnkey isolated milling suite at Interphex

30 January 2012: The results of a unique collaboration between four market leading companies serving the powder processing industries will be unveiled on Booth #2443 at Interphex 2012 (1-3 May; New York, USA). This new turnkey isolated milling suite encloses the innovative ARTMiS Automated RealTime Milling System within Powder Systems Ltd's (PSL) containment unit, providing a secure, advanced processing solution for those dealing with highly potent and/or high value materials

This small footprint instrument delivers precise high-resolution wet and dry sample measurement from 10 nm to 3.5 mm, with rapid operator-independent measurement enabling increased lab productivity

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Malvern’s light scattering supports formulation development for Novozymes’ recombinant albumins

29 November 2011, Malvern, UK: Scientists from Malvern Instruments and from biological ingredients and technology developers, Novozymes Biopharma, have successfully completed the first phase of extensive collaborative studies. These have involved the application of Malvern’s light scattering technologies in evaluating the formulation stability of two of Novozymes leading recombinant albumin products – Albucult® and Recombumin® – which are used in the manufacture of human therapeutics.

The teams applied the resolving and detection capabilities of size exclusion chromatography light scattering (SEC-LS) and dynamic light scattering (DLS) offered by Malvern’s Zetasizer Nano system to monitor the stability of these Novozymes products. These results have now been published as a series of application notes that are freely available on the Malvern Instruments website; www.malvern.com/labeng/industry/protein/novozymes.htm

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New article describes PAT for automated pharma mill control

A newly published article, jointly authored by specialists from Malvern Instruments and a major pharmaceutical company, describes the implementation of a Malvern Insitec on-line particle size analyzer on an active pharmaceutical ingredient milling operation at a commercial site. The Insitec was used to transform a stand-alone manual mill into an automated process unit that will integrate into the manufacturing facility. Automation benefits include improved product quality, increased throughput and less waste, and the authors state that this proven solution also opens the route to semi-continuous operation and real-time release, both of which are important long-term goals for operational excellence.

Unlike some process analytical technology (PAT) instruments that are modifications of laboratory solutions, the Insitec laser diffraction particle size analyzer was designed specifically for use in the process environment and is proving valuable for milling operations such as this

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New pharmaceutical interface for Parsum in-line particle sizing probe from Malvern Instruments

The new ‘Pharma option 3: Parsum View’ user interface for the Parsum IPP 70 in-line particle size measurement probe, available from Malvern Instruments, simplifies the system’s use as a PAT (Process Analytical Technology) tool for continuous monitoring of granulation, spray drying and fluidised bed operations, for example. Parsum View is designed specifically to fulfil GMP requirements for pharmaceutical production. It can be supplied alone or in combination with pharma option 1- verification kit for checking measurement accuracy, and 2- material traceability, a unit with highly polished contact surfaces supplied with material traceability documentation.

Together with pharma options 1 and 2, Parsum View simplifies regulatory compliance, streamlining adoption and ongoing use of the IPP 70 within the pharmaceutical sector. It works either in a network (Ethernet) or on a standalone basis to provide the data security and complete audit trail necessary to meet the industry’s need for exemplary record keeping. Key features of the new release include: detailed user access control with flexible user levels; user and password management; and safe storage for measurement values and settings in an SQL-database

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Mastersizer MS3000 – Particle Size Analyzer

Zetasizer Nano–Nanoparticle, colloid and protein Characterization System

Viscotek TDAmax – GPC/SEC System

Malvern Morphologi G3

Insitec – Online Particle Size Analyzer

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