Malvern Instruments Inc.

Westborough, MA, United States

Malvern Instruments Inc.

Westborough, MA, United States
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Patent
Malvern Instruments Inc. | Date: 2017-03-22

An isothermal titration micro calorimetry (ITC) system (300), comprising: a microcalorimeter (20), an automatic pipette assembly (30), a pipette translation unit (310) and a wash station.. The microcalorimeter (20) has a sample cell (50) and a reference cell (40), the sample cell (50) accessible via a sample cell stem (180) and the reference cell accessible via a reference cell stem (170). The automatic pipette assembly (30) comprise a syringe (200) with a titration needle (210) arranged to be inserted into the sample cell (50) for supplying titrant and a fill port (500) at an upper section of the syringe (200), providing fluidic contact with the syringe cavity when the plunger (230) is positioned above the fill port (500). The pipette assembly (30) also comprises an activator (220) for driving a plunger (230) in the syringe (200). The pipette translation unit (310) comprises a pipette arm (380) that is supported for rotation about an axis (A), supports the pipette assembly (30) at its other end and is further arranged to move the pipette assembly vertically. The pipette translation unit (310) is arranged to place the pipette assembly (30) in position for titration, washing and filling operations. The wash station is for the titrant needle (210).


Newey-Keane L.,Malvern Instruments Inc.
BioPharm International | Year: 2016

The author reviews some of the techniques that can yield valuable information on protein stability during characterization studies. A key emphasis is the data delivered by alternative techniques, the enhanced information produced when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow. © 2016 Advanstar Communications Inc.


Behara S.R.B.,Monash Institute of Pharmaceutical Sciences | Larson I.,Monash Institute of Pharmaceutical Sciences | Kippax P.,Malvern Instruments Inc. | Stewart P.,Monash Institute of Pharmaceutical Sciences | Morton D.A.V.,Monash Institute of Pharmaceutical Sciences
European Journal of Pharmaceutical Sciences | Year: 2012

Purpose: The purpose of this study was to assess the effectiveness of three commercial capsule-based dry powder passive inhalers [Rotahaler® (RH), Monodose Inhaler® (MI) and Handihaler® (HH)] in de-agglomerating salbutamol sulphate (SS) and micronized lactose (LH300) powders and their sensitivity to air flow rate changes and air flow resistance. Methods: Aerosolisation was assessed in real-time using a laser diffraction method: this approach was possible as only single-component formulations were tested. Volume percent of the aerosolised particles with diameter less than 5.4 μm at air flow rates from 30 to 180 l min -1 was obtained with the RH, MI and HH and provided a parameter, relative de-agglomeration (RD), as a measure of de-agglomeration. The pressure drops across the device at various flow rates were obtained from a differential pressure meter. Results: The relationship between RD of SS and LH300 and air flow rate appeared substantially different between the devices. It was surprisingly found that in some cases RD dropped at the highest air flows: this indicates a device specific maxima in RD occurs, and this may in part be attributed to changes in capsule motion. It is proposed that this relationship between RD and pressure drop provides a patient focussed simple way to assess RD performance. This assessment indicated that MI was the most efficient relative de-agglomerator at lower pressure drops, while HH increases its effectiveness at higher pressure drops. Conclusion: The approach of measuring RD as a function of pressure drop revealed instructive variations in the aerosolisation performances of different devices. This new approach helps compare device performances with different powders, and hence improve optimisation and consistency of performance. © 2012 Elsevier B.V. All rights reserved.


Denigris J.,Malvern Instruments Inc.
Advances in Powder Metallurgy and Particulate Materials - Proceedings of the 2015 International Conference on Powder Metallurgy and Particulate Materials, PowderMet 2015 | Year: 2015

Gas Atomization, typically used for high quality spherical particles required for applications such as Metal Injection Molding (MIM), has process variables that alter the resulting PSD of the powder. However, off-line lab testing reduces the response time of that control, and hence quality and yield suffer. OnLine systems, using the proven technique of Laser Diffraction, can report full particle size distributions (ie. D10, D50, D90) automatically, 24/7 and can enhance the knowledge of process performance for both technicians and management. From batch- to batch quality to process development of gas atomization pressure settings, variables can be controlled with continuous real time data. Optimization trials can also be monitored, so real knowledge of the process performance can be learned without sacrificing additional production run time, which can be costly. Monitoring PSD in real time can result in new product offerings, tighter quality specifications, increased yield and ultimately lower cost of manufacturing.


Rawle A.F.,Malvern Instruments Inc.
Procedia Engineering | Year: 2015

Like most things in life one gets out what one puts in and this is no truer than in modern instrumental particle size distribution techniques. The mantra of 'garbage in = garbage out' is meant to convey that the apparently complicated laser diffraction, dynamic light scattering, and electron microscopy techniques measure faithfully what they are given, but what they are given may not be representative of the entire product or material on which significant economic decisions will be made. Tiny samples down to pg in size on electron microscopes are somehow meant to be able to generate information on what may be many tonnes of heterogeneous sample. The bad news is that distribution and heterogeneity imply that statistical methods must be employed in order to obtain accurate and reproducible information. The good news is that representative sampling is amenable to simple statistical evaluation and 2 major predictions can be made:Based on a required or specified precision or standard error (SE), the point at the top end of the distribution to be specified to this degree of precision, and the density of the sample, then a simple prediction of the minimum mass, required to meet this required level of precision, can be calculatedSimilarly, if the mass utilized in the particle size distribution determination is known and the point in the distribution to be specified (plus the density of the sample again), then we can calculate a theoretical best achievable precision based solely on the heterogeneity of the sample This paper will illustrate the 2 points above with practical examples. © 2015 The Authors.


Rawle A.F.,Malvern Instruments Inc.
Procedia Engineering | Year: 2015

This paper deals the determination of the particle size distribution of a material nominally (and inadequately) described as "0 - 10 silica". First, we will outline the routes to obtaining a stable set of light scattering data via wet and dry laser diffraction determination. These stable data are a prerequisite for the deconvolution to a particle size distribution. Second, we will focus on the importance of using the correct optical constants (real and imaginary parts of the refractive index) in order that the derived particle size distribution is correctly stated. In particular this robustness study will show how incorrect optical properties can influence the form (shape) of the derived distribution, plus assignation of key points in the distribution (in particular, x10). Certain supplementary information is essential in confirming the correct optical propertiesDensity via helium gas pycnometryX-ray diffraction (XRD) for polymorph confirmationBecke lines for bracketing the real part of the refractive indexVolume concentration experiment for measurement of the imaginary/absorptive part of the refractive index In this manner we can then be confident of a stated particle size distribution and an awareness of the factors that can significantly affect this derived distribution. © 2015 The Authors.


Zhou C.,Aurora Pharmaceutical | Qi W.,Malvern Instruments Inc. | Lewis E.N.,Malvern Instruments Inc. | Carpenter J.F.,Aurora Pharmaceutical
Analytical Biochemistry | Year: 2015

A Raman spectrometer and dynamic light scattering system were combined in a single platform (Raman-DLS) to provide concomitant higher order structural and hydrodynamic size data for therapeutic proteins at high concentration. As model therapeutic proteins, we studied human serum albumin (HSA) and intravenous immunoglobulin (IVIG). HSA concentration and temperature interval during heating did not affect the onset temperatures for conformation perturbation or aggregation. The impact of pH on thermal stability of HSA was tested at pHs 3, 5, and 8. Stability was the greatest at pH 8, but distinct unfolding and aggregation behaviors were observed at the different pHs. HSA structural transitions and aggregation kinetics were also studied in real time during isothermal incubations at pH 7. In a forced oxidation study, it was found that hydrogen peroxide (H2O2) treatment reduced the thermal stability of HSA. Finally, the structure and thermal stability of IVIG were studied, and a comprehensive characterization of heating-induced structural perturbations and aggregation was obtained. In conclusion, by providing comprehensive data on protein tertiary and secondary structures and hydrodynamic size during real-time heating or isothermal incubation experiments, the Raman-DLS system offers unique physical insights into the properties of high-concentration protein samples. © 2014 The Authors. Published by Elsevier Inc.


Patent
Malvern Instruments Inc. | Date: 2014-02-20

A viscometer, comprising: a source of fluid pressure, a tube, an array of optical detectors, an acquisition driver circuit and viscosity computation logic. The tube has an inside volume that is hydraulically responsive to the source of fluid pressure. The array of optical detectors is positioned along a length of the first tube with a plurality of its detectors optically responsive to the inside volume of the first tube and including an image data output. The acquisition driver circuit is responsive to the image data output of the first array to acquire a series of successive images of the inside volume of the first tube. The viscosity computation logic is responsive to the acquisition driver circuit and operative to compute the viscosity of a fluid flowing along the first tube from the series of images of the inside volume of the first tube.


Trademark
Malvern Instruments Inc. | Date: 2016-03-08

Scientific and laboratory instruments and software for the analysis of the concentration, molecular weight, size and structure of molecules and particles; scientific and laboratory instruments and software for the analysis of the viscosity of liquids, suspensions and solutions.


Trademark
Malvern Instruments Inc. | Date: 2016-01-12

Scientific instruments, namely, calorimeters; computer software for the collection, analysis and presentation of scientific data gathered by calorimeters.

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