Sterility Assurance

 

Thermal Validation

a) Validator

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Advanced Validation Technology

The Kaye Validator AVS (Advanced Validation System) combines accurate sensor measurements with all GMP requirements for calibration and traceability to national standards, while generating compliant reports and managing the validated assets and validation equipment. The Validator AVS offers improved hardware features, an easy to use data handling concept and an intuitive, user-friendly software interface.

The Kaye Validator® simplifies the entire validation process by reducing setup time, minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports. It comes with a comprehensive 1-year warranty and is supported by fully validated hardware, software and firmware documentation.

 

b) ValProbe

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Ultimate design for Freeze Dryer and Cryo application up to -85C with flat measuring surface to maximize thermal response time and accuracy of measurement. Long battery life at extremely cold conditions.

The new Cryo Logger with the very thin and flexible tip is the perfect datalogger for an extended temperature range from -85°C to +140°C. The Logger provides a single solution for a variety of applications, such as cryogenic chambers, Lyophilizers, ultralow freezers and other deep temperature applications and high temperature applications.

 

c) RF Wireless

The Loggers are designed for operation in warehouses, chambers, fridges and freezers. Loggers have internal RH sensor and either an internal or external temperature sensor. There is an option to read 4/20mA, 0-10v or contact switch inputs.

  • Internal RH Sensor: Range 0-100%RH, Accuracy 2%RH
  • Internal Temperature: Range -20°C to 60°C, Accuracy 0.5°C
  • External Temperature: Range -200°C to 200°C, Accuracy 0.1°C to 0.3°C
  • Battery Life: e.g. 2 years @ 1 min sample rate

The loggers store up to 10,000 samples per sensor permitting the operation as a data logger if RF communication is not possible, e.g. one logger placed in a warehouse exhaust HVAC duct. The logger will resume transmitting data once it is in RF communication with the base station or other logger.

 

Microbial

a) Air Sampler

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  • Glove-compatible touchscreen
  • Intuitive user interface
  • HEPA filter exhaust
  • Remote connection to the BioCapt Microbial Impactor (Single-Use)
  • Autoclavable with a sanitizable enclosure
  • Available in 12 languages

Click here to see product video

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  • Intuitive user interface
  • HEPA filter exhaust
  • Remote connection to the BioCapt Microbial Impactor (Single-Use)
  • Autoclavable with a sanitizable enclosure
  • Available in 12 languages
Surcapt
  • Optimize Time
  • Automatic Reading
  • High Sterility Assurance Level Guarantee
  • Able to detect organism within a sample, bringing the sampling sensitivity to a new level
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  • Stainless steel
  • Protects petri dish from unintnetional contamination Vacuum draws air down over media for sample collection
  • Complies with ISO 14698-1
  • Culture media validated to be
    stored either at room temperature or under refrigeration, with a shelf life of up to nine months
  • Offered in standard culture media of trypticase soy agar (TSA) and sabouraud dextros agar (SDA), as well as client-specific, pre-validated microbiological culture media
  • Compatible with leading active air monitoring systems
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The Compressed Gas Sampling Kit allows effective monitoring of air in compressed gases for the presence of viable microorganisms.

 

b) Real Time Monitoring

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  • Capable of single BioCount detectionrepresentative of one colony-forming unit (CFU)
  • Validated to USP 1223 and EP 5.1.6 requirements
  • Not constrained by physical and biological efficiencies associated with impact air samplers
  • Not constrained by the type and quality of the growth media
  • Real-time, continuous counting free from error sources, including: contamination, mishandling and inaccurate counting
  • Easy to operate
  • Doesn’t require any special handling, training, or logistics
  • Sensor can be connected directly to Particle Measuring System or third-party software
  • Designed for continuous operation