Insitec Dry for pharmaceutical processes
PAT solution for real-time particle size analysis of pharmaceuticals.
Engineered to withstand the rigors of the process environment, Insitec Dry for pharmaceutical industry applications provides a robust, proven PAT solution for measuring particles in the size range 0.1 to 2500µm. Insitec Dry laser diffraction analyzers can be configured to suit practically every dry particulate process, delivering real-time monitoring and control 24/7, with options for:
- Dust zoned hazardous environments.
- Gas or dust zoned hazardous environments.
- Mobile application.
Insitec Dry particle size analyzers for pharmaceutical applications deliver fully automated real-time - or manual at-line - size measurement of particulates. They offer proven performance for the monitoring and control of processes such as milling and spray drying, from development through to commercial manufacture. Representative sampling is ensured by tailoring process interfaces to meet unique custom needs. Insitec Dry systems comply with the strict hygiene standards and regulatory controls that apply in the pharmaceutical industry. Every Insitec Dry system offers:
- Base model hardware manufactured to cGMP standards and compatible with CIP/SIP requirements to meet specific manufacturing specifications.
- Easy-to-use software and fully automated operation to minimize training requirements and release operator time.
- Simple integration with existing control platforms to simplify development of automated control protocols.
- High reliability of >95% with little downtime, minimal maintenance and maximum ROI.
All Insitec installations are tailored to the unique requirements of the application. They range from simple at-line, manually-fed systems to fully automated, validated on-line solutions for continuous monitoring and multivariate control. Malvern Panalytical works in partnership with its customers, providing expertise, hardware and software, where and when it’s needed. This solutions developed provide information that drives intelligent process development and secures reliable consistent commercial manufacture.
Factors for success
The success of process analysis depends on detailed consideration of three critical components:
- The process interface.
- Sample measurement.
- Data presentation and use.
The process interface
Insitec systems are items of process equipment and operate within the plant environment. Getting the interface between the instrument and the plant right is essential for long-term, trouble-free operation.
Malvern Panalytical has proven technology for almost every conceivable dry process application, strategies that ensure that representative samples are automatically and consistently delivered to the measurement zone, in an appropriately dispersed state and at a suitable concentration for analysis. Measurement in an appropriately dispersed state ensures access to relevant data whether it is agglomerates or primary particle size that is of interest.
Insitec at-line systems run alongside the process and have a manual interface. For automated continuous operation the Insitec is installed in the process line or on an associated sampling loop.
Insitec Voyager Pharma is a mobile unit that can operate in either configuration. With polished connections, and an easy to clean build, this system offers excellent flexibility when applying PAT within the pilot plant environment for design space scoping and DoE.
Well-designed on-line process interfaces:
- Deliver sample that is representative of the bulk.
- Run reliably with minimal maintenance without disrupting the process.
- Recycle analyzed material to minimize waste.
Insitec systems use the technique of laser diffraction to rapidly measure particle size. When applied to dry systems, complete particle size distributions are measured in less than one second, giving instantaneous monitoring. Even processes with fast dynamics can be tracked effectively.
Insitec systems directly measure the process stream. In some processes particle loading or concentration may vary during routine operation. This presents a challenge for many particle measurement systems and can have a detrimental effect on reported particle size. However the patented multiple scattering algorithms associated with all Insitec systems ensure that reported changes in particle size are always reliable and real. These algorithms mathematically correct for the concentration-dependent effect of the source light interacting with not one, but several, particles before reaching the detectors. Measurements are therefore robustly independent of sample concentration.
Insitec produces reliable, timely and complete data, reporting full particle size distributions. These data provide a secure foundation for better process control whether that control is manual or automated.
Data presentation and use
Insitec systems can be integrated within the process plant. They can be operated as stand-alone units or from a centralized control room. Measurement results drive routine decision making during development and in manufacture. Powerful software packages make integration and data interpretation straightforward.
Malvern Link II software provides the functionality required to integrate an Insitec within an existing control system and to automate process control. It allows operation of the analyzer from either a dedicated PC or from existing control mimics. Importantly Malvern Link II is not confined only to Insitec integration. This software also eases integration with other instrument types, simplifying multivariate control.
RTSizer software presents the measurement data in a clear and accessible way. Results reporting can be tailored to industry and customer norms to improve information flow. Insitec data are used to:
- Improve process understanding.
- Accelerate and improve process development.
- Deliver instant upset detection.
- Support comprehensive process optimization.
- Automate process control.
- Improve product consistency.
- Keep records for batch traceability and quality assurance purposes.
Because complete particle size distributions are reported, monitoring and control can be based on whichever size fraction is of interest: the fines, the 3 to 30 micron fraction, the amount of material over 200 microns, for example.
- Measurement type:
- Particle size
- Measurement range:
- 0.1 to 2500µm
- Measurement principle:
- Laser diffraction
- Optical models:
- Mie theory
- ±2% on Dv(50) reported using the verification reticle
- Enclosure rating:
- Operating platforms:
- 10 bar (g)
- RTSizer (for instrument control) Malvern Link II (for system automation and data link)
- Maximum distance from instrument to PC:
- 500m (up to 2 km using fiber optics)
- 10°C – 70°C
- 35% - 80% (non-condensing)