Laser diffraction-based particle size analyser, designed from the outset to meet the specific needs of the pharmaceutical industry, gets updated software
The Malvern Instruments Spraytec laser diffraction-based particle size analyser was designed from the outset to meet the specific needs of the pharmaceutical industry, and the latest version 5.4 software enables users to meet FDA requirements for 21 CFR Part 11 compliance.
21 CFR Part 11 applies safeguards to electronic records and the use of electronic signatures.
Key features offered by Malvern's compliant software include more rigorous authority checks, and safeguards against unauthorised access and use of the system.
Unauthorised deletion and modification of records is prevented.
Where a user is authorised to modify a record, a duplicate is generated and it is this that is edited.
An audit trail records the name of the editor, the reason for the change and the date and time the change was effected.
The original record is never deleted and the modified record points back to it.
The use of electronic signatures is also supported by the use of Adobe Acrobat PDF writer.
Malvern Instruments also supports the user's validation process with IQ/OQ specifications and certificates.
Malvern's Spraytec is a laser diffraction based analyser designed to meet the challenges of droplet size measurement in sprays.
A range of options makes it especially suitable for a variety of pharmaceutical applications.
The recent introduction of an inhalation cell enables the rapid characterisation of materials from drug delivery devices such as metered dose inhalers (MDIs), dry powder inhalers (DPIs) and nebulisers.
A modular system, the inhalation cell can be interfaced with standard respiratory testing equipment.
This allows measurements to be carried out under the same conditions that are used for other respirable drug measurements.
Simultaneous laser diffraction and Cascade impactor measurements can also be made.
