Overview
Insitec Spray particle size analyzers for pharmaceutical applications deliver fully automated real-time - or manual at-line - size measurement of sprays and aerosols. They are used to monitor and control processes such as spray drying and granulation, from development through to commercial manufacture, with process interfaces being tailored to individual needs to ensure representative sampling. Insitec Spray systems comply with the pharmaceutical industry’s strict hygiene standards and regulatory controls, offering:
- 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.
- Validation and 21 CFR Part 11 compliance.
How it works
Overview
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. The 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 a wide range of spray applications. Insitec Spray at-line systems run alongside the process and have a manual interface. For automated continuous operation the Insitec is installed in the process. The Insitec Spray has flexible configuration options that make the transmitter and detector easy to position around the spray or aerosol with minimal engineering. Specified with an easy-to-clean build, all pharmaceutical systems offer high performance when applying PAT within the pilot plant environment for design space scoping and DoE, or for process monitoring and control at a commercial scale.
Sample Measurement
Insitec systems use the technique of laser diffraction to rapidly measure
particle size
. Working with spray systems, complete particle size distributions are measured in less than a second, giving instantaneous monitoring. Even fine temporal fluctuations in spray patterns can be tracked effectively.
Insitec Spray directly measures the spray or aerosol. Such materials may have very high particle concentrations and can present a challenge for many particle measurement systems. However the patented multiple scattering algorithms associated with all Insitec systems 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. The result is reliable particle size information even for the most concentrated of sprays and aerosols.
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.
Specification
System
| Measurement type | Particle size |
|---|---|
| Measurement range | 0.1 to 2500µm |
| Measurement principle | Laser diffraction |
| Optical models | Mie theory |
| Accuracy | ±2% on Dv(50) reported using the verification reticle |
General
| Power | 100/240V |
|---|---|
| Enclosure rating | IP65 |
| Operating platforms | 10 bar (g) |
| Software | 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) |
Operating environment
| Temperature | 10°C – 70°C |
|---|---|
| Humidity | 35% - 80% (non-condensing) |