The IMD-A system requires no reagents and
minimal human operator involvement, so it is particularly well-suited
for rigorous environmental monitoring applications where time, cost, and
cleanliness are of greatest concern.
contain metabolites or chemical compounds such as NADH, riboflavin, and
dipicolinic acid (DPA). When excited by a certain wavelength of light,
these compounds emit an intrinsic fluorescence signal that serves as a
marker for biological content of the sample.
When a particle enters the IMD-A system’s interrogation zone, it intersects the beam of a single laser light source.
scattering of the laser light determines the size of each individual
particle. At the same time, the presence or absence of intrinsic
fluorescence determines whether the particle is biologic or inert.
- Real-time operation
- Measures particle size and biologic status simultaneously
- Immediate results without staining or reagents
- Continuous monitoring, or by specified sample volume
- Visual status indicator
- Built-in system self test
- USP<1223> compliant
- 21CFR Part 11 compliant
- ISO21501-4 compliance to most specifications*
- Stainless steel enclosure
- Sanitary flange for easy removal and re-installation
- Flexible communications interface for networking
- Standard met : USP<1223> Validation of alternative mircobiological method,s EP 5.1.6 Alternative methods for control of microbiological quality, Manufacture in accordance with ISO 13485.
The IMD-A system is supplied with PharmaMaster software.
The system’s sophisticated PharmaMaster software offers different levels of functionality based on user need and authority. For environmental control, the software features graphic displays that visually communicate custom-defined limits of particle contamination. A green light indicates that operation is safely within defined limits, yellow warns that an Alert level has been exceeded, and red indicates that an Action level has been exceeded. Alert and Action levels can trigger alarms, if desired.
User-Defined Alert Protocols:
PharmaMaster software enables users to create a library of alert protocols with sensitivity levels to match different applications and environments.
Results Displayed by Particle Size:
With PharmaMaster software (as shown in the display at right), users can view independently controlled line graphs to display results for all particles greater than 0.5 μm, all particles larger than 5.0 μm, and all biologic particles. An alarm alerts managers when a user-defined level is exceeded.
With the PharmaMaster software, users can choose to review biologic particles in six data bins, from 0.5 μm to >10 μm.
Two Operational Modes for Application Flexibility:
The PharmaMaster software offers both a continuous detection mode and a point sample mode for a sampling a specified volume or time duration, allowing users to determine the method of environmental sampling that best fits their application.