Pharma manufacturing products: News in brief
Re-launched Morphologi G3 tackles FPM
Malvern Instruments has revamped its Morphologi G3 automated particle characterisation system to enable fully automated detection, enumeration and size classification of foreign particulate matter (FPM) collected on a filter.
By providing an alternative to manual light microscopy analysis of FPM on filters Malvern claims it can accelerate characterisation and remove any operator subjectivity.
The technology provides information about each individual particle, allowing for users to investigate and troubleshooting the source of contamination.
Morphologi G3 measures FPM as small as 2µm and categorises them into size brackets. FPM can typically include glass, transparent synthetic fibres, stainless steel, rubber, aluminium, and plastic particles.
Regulations regarding FPM have been implemented by the US Pharmacopeia (USP) and US Food and Drug Administration (FDA) to minimise the risk of contamination.
Controlling particulate contamination of materials is particularly important when manufacturing drugs delivered via injection or inhalation.
New temperature logger from Caen
Caen RFID has released a new temperature logger semipassive tag to monitor the refrigeration of products during transportation and storage.
Easy2Log is semi-passive UHF tag that can be used to monitor temperature in a pallet or case, allowing for a localised temperature recording.
The product is available with either a three or five year battery life and Caen claims it is the most cost-effective temperature monitoring system.
Finesse launches new biomanufacturing software
Finesse Solutions has released version 3.4 of its TruBio bioreactor control software, which can automate a wide variety of bioreactors, from 1L bench tops up to 1000L production single-use vessels.
TruBio 3.4 software is optimised for DeltaV version 9.3 from Emerson Process Management and is designed to be useable by users with no prior DeltaV programming knowledge.
Finesse claims to have made improvements to the user interface, vessel configuration management and on-line parameter updates and added new features relating to data management.
High-speed vial filling from Bausch
Bausch Advanced Technology Group has launched two new high-speed machines for the filling, stoppering and crimping of vials.
The Type 550 machine is for the aseptic filling and stoppering of vials and the Type 551 is for crimping.
Both machines can be used in conjunction or Type 550 can be operated as a stand-alone unit. The machines can handle up to 600 vials per minutes and are compliant with current good manufacturing practices (cGMP).
