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Instantaneous Microbial Detection

Latest Generation Technology for Industry Professionals

Instant Microbial Detection

With their headquarters in Tucson, Arizona, USA BioVigilant invented instantaneous microbial detection technology to address environmental monitoring needs in the pharmaceutical, biotechnology, healthcare and many other industries. BioVigilant IMD instruments provide continuous, real-time results for monitoring of air and water, determining particle size and biological status simultaneously. Their systems are extensively used thoughout the world by many of the worlds leading organizations.

Unlike other rapid microbial methods, BioVigilant’s optically-based systems require no staining, no reagents, no waiting period, and little human intervention. The company holds 19 patents with an additional 37 applications pending. BioVigilant is a division of Azbil North America, Inc, the North American affiliate of Azbil Corporation which is publicly traded on the Tokyo Stock Exchange.

Flowtech Scientific exclusively represents BioVigilant in Australia and New Zealand and their real-time detection technologies for both AIR and WATER very much compliment the environmental monitoring systems and instruments Flowtech Scientific offers.

IMD-A Series Instantaneous Microbial Detection Systems for Air

IMD-W OWBA Instantaneous Microbial Detection Systems For Water

Why Instantaneous Microbial Detection

IMD-A systems for AIR provide clean room environmental monitoring in real time, instantly detecting microbes so you can act. Advanced optics and signal processing help reduce risk and require no staining, reagents or human intervention. Save time and money by knowing what’s lurking in your environment.

 

Why are more manufacturers choosing Instantaneous Microbial Detection?

  • Better process control
  • Shorter product releases
  • Increased quality assurance
  • Regulators support technology
  • Faster time to results
  • Significant cost savings
  • Real-time results
  • Continuous monitoring
  • No waiting
  • No Reagents
  • Fully Automated
  • Little training needed

Minimize risks with Instantaneous Microbial Detection

  • Quality management tools for the 21st century
  • Enhanced manufacturing agility
  • Continuous improvement and innovation
  • Maintained state of control

21st Century Environment Monitoring

  • Faster remediation
  • Shorter periods to product release
  • Tremendous cost savings

Instantaneous Detection Systems for AIR

BioVigilant’s IMD-A 300 and 350 systems for AIR revolutionize environmental air monitoring for microbial contamination. Continuous, immediate and real-time.

Using proprietary optical technology, the IMD-A system is capable of simultaneously detecting both size and intrinsic fluorescence of airborne particulates-screening for biologic particles as small as 0.5 microns. The system offers a ready means for determining the microbial content of an aerosol sample on a particle-by-particle basis, thereby providing a continuous, real-time analysis of environmental bioburden. This constant monitoring and effective trending deliver knowledge to act, actions that could prevent excursions from leading to the catastrophic loss of a batch. The IMD-A 300 system samples air at 1.15 liters per minute and the IMD-A 350 samples air at 28.3 liters per minute.

Biovigilant for Air

PharmaMaster Software

Featuring PharmaMaster software, the IMD-A system is designed for easy measurement setup, monitoring and analysis. This 21CFR Part-11 compliant software is configurable to a user’s specific measurement requirements for both episodic sampling and continuous monitoring. The system offers a simple, uncomplicated interface suitable for a clean room operator, as well as the measurement flexibility needed by a facility manager. Unique measurement profiles can be customized with specific action and alert parameters for each environmental application. The historical data feature creates a searchable archive of measurement data that permits replay of previous samples, in addition to reporting and exporting of data for in-depth analysis.

Why Instantaneous Microbial Detection

IMD-W instantaneous microbial detection systems for pharmaceutical grade WATERS delivers a new tool for assessing and reacting to bioburden risks in real time.

 

Why are more manufacturers choosing Instantaneous Microbial Detection?

  • Better process control
  • Shorter product releases
  • Increased quality assurance
  • Regulators support technology
  • Faster time to results
  • Significant cost savings
  • Real-time results
  • Continuous monitoring
  • No waiting
  • No Reagents
  • Fully Automated
  • Little training needed

Minimize risks with Instantaneous Microbial Detection

  • Quality management tools for the 21st century
  • Enhanced manufacturing agility
  • Continuous improvement and innovation
  • Maintained state of control

21st Century Environment Monitoring

  • Faster remediation
  • Shorter periods to product release
  • Tremendous cost savings

 Benefits:

  • Improved product quality
  • Better risk management
  • Enhanced process understanding
  • Energy savings
  • Improved resource allocation and labor efficiencies

Features:

  • Real-time results without staining or reagents
  • Detects particles and determines biologic status simultaneously
  • Enhanced interferent discrimination
  • Automated system suitability routine
  • Supports 21 CFR Part 11 compliance
  • 21 CFR Part 11 compliant
  • Integrated touch screen user interface
  • Data may be exported for offline analysis and storage
  • Flexible communications interface for networking; can be controlled externally by common industrial control systems (e.g. SCADA, PLC)

One Method, Many Applications

Purified water has many uses throughout the biologics, pharmaceutical, and medical device industries – from cleaning equipment after manufacturing, to heating and cooling for sterilization and sanitization, to providing the base constituent of life-sustaining therapies. Because of the many uses for highly purified water, there are many ways to use the IMD-W system, an instantaneous microbial detection system for pharmaceutical grade waters.

Flexibility to Meet All of Your Application Needs: On-line, At-line, and In Laboratory

The IMD-W system has been designed specifically with flexibility of use in mind. The system may be used in a laboratory setting for the testing of individual samples, and also can be placed online for continuous monitoring.

Biovigilant IMD-W Water Analyzer Typical Applications

Filling Line Cleaning /Clean-In-Place (CIP)

Typically, the filling line conveyor belt and other ancillary equipment are considered product contact surfaces for the purposes of pharmaceutical, biologic, and medical device manufacturing and, for that reason, need to be as clean as the product itself. Residual API or sugars, for instance, may harbor microbial growth which could compromise sterility in the cleanroom. Therefore, water used for cleaning filling lines, conveyor belts, and other machinery should be rinsed down to bulk purified water levels with zero chemical residuals. The IMD-W system can facilitate the process by determining the water’s microbial count prior to these cleaning processes, either by assessing grab samples from the clean water line, or for CIP processes, through direct online connection.

Pre-treatment and Reverse Osmosis (RO) Effectiveness

Sampling of the purified water generation process, near or at the end of the pretreatment, is performed to confirm water quality inputs into Water-for-Injection (WFI) or Purified Water (PW) generation systems. Here, the IMD-W system can be used to monitor continuously the post-RO filtered water, much as online conductivity and TOC instruments are used. When combined, these data will help paint a picture of the pretreatment water generation process, support the development of schedules for critical system cleaning and sanitization, and lead to a better understanding of the microbial nature of that process throughout water production.

Storage Tank Sampling

Water within storage tanks usually is re-circulated to reduce the chances of microbial adhesion and biofilm formation. Even in these closed systems, changes may occur in not just the microbial quality of the water, but also in the integrity of redundant filters and gaskets. An IMD-W system can be very useful in monitoring these loops on a continuous basis to assure that microbial levels are low or to maintain a constant baseline. Potential contamination from gasket and filter changeouts may be monitored in real time, and the resulting data used to support the decision to bring a water generation system back into production. Finally, continuous monitoring of recirculating storage tanks allows for greater understanding of microbial proliferation in the system being monitored, if any exists. These data can provide a concrete rationale to justify water hold-time recommendations.

Water System Validation

Validation of a purified water system typically is performed upon installation of the line, or when there are modifications to it. Every sample site is sampled, each day, for a period of a month or so during validation. This is a very work-intensive process using traditional methods, requiring those involved to wait each day for updated results from the past several days, and then to make adjustments to the line until counts are right. By using an IMD-W system, this iterative adjustment process can be greatly accelerated as a result of IMD-W’s instantaneous microbial feedback on each water sample collected.

Routine Water Sampling

After water system validation has been completed, it is possible to reduce sampling requirements based upon schemes to monitor Critical Control Points (CCP) or through risk analyses of the validation data. In this situation, an online IMD-W system installed at each CCP can deliver continuous monitoring capability. Generated data can be sent to a central location and monitored remotely, much like data from online conductivity and TOC analyzers are managed. In this way, the IMD-W system can accelerate actions to mitigate risk and reduce investigation costs, driven by data collected in real time while offering a means to enhance process understanding.

Biovigilant Water Analyser

Additional Documents – Air Analysers

Biovigilant 2021 PDA Annual Poster

Additional Documents – Water Analysers

Coming soon