Sterility Assurance

• Thermal Validation
• Microbial
• Sterilization

Kaye Validator AVS Advanced Validation System

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.

Kaye ValProbe® RT Real-Time Data Loggers

Each real-time data logger has a storage capacity of 100,000 data points per sensor to ensure extensive data storage and backup. The flexible real-time data logger is equipped with a 1m/40-inch long, flexible, Teflon™-coated sensor cable and a stainless-steel tip to protect the RTD sensor. The operating temperature range of the logger extends from -85°C to +140°C.

1. Temperature Logger – Rigid
2. Temperature Logger – Bendable Single and Dual Sensor Logger
   i. Single
   ii. Dual
   iii. 5-Sensor Logger
3. Flexible Temperature Sensor Logger
   i. Single
   ii. Dual
   iii. 5-Sensor Logger
4. Freeze Dryer Logger
5. Humidity and Temperature Logger
6. Pressure and Temperature Logger
7. CO2 Logger

 d) ValProbe® RM (Real‑Time Monitoring)

Kaye LTR-150 Dry Block and Liquid Bath

The LTR-150 is a multi-purpose temperature calibrator specifically designed to address the capacity and flexibility needs for thermal validation used for applications ranging from -30°C to 150 °C such as:

• Autoclave
• Steam-in-Place
• Freezer/ Fridge
• Incubators

 b) Temperature Reference Standard

KAYE IRTD 400 – Temperature Standard Probe

The IRTD is a high accuracy traceable Temperature Standard probe used as part of the Kaye Validation systems for Calibrating Temperature Sensors. During calibration/ verification, sensors are compared against the IRTD and offsets are automatically calculated and stored. The broad temperature ranges from Ultra Low Temperature (-196°C) to High Temperature (+420°C), enables it to be used in virtually all temperature validation applications.

MiniCapt® Mobile Microbial Air Sampler

• 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

MiniCapt® Remote Microbial Air Sampler

• 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 Microbial Surface Detection Kit

• Optimize Time
• Automatic Reading
• High Sterility Assurance Level Guarantee
• Able to detect organism within a sample, bringing the sampling sensitivity to a new level

BioCapt® Microbial Impactor

• Stainless steel
• Protects petri dish from unintnetional contamination Vacuum draws air down over media for sample collection

BioLaz® Real-Time Microbial Monitor

• 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

Fedegari FVA/A1 Series

These sterilizers have been specifically designed and developed to meet the most rigorous application requirements in analytical and microbiology laboratories, research institutes, pharmaceutical and food industries as well as medical and hospital sectors.

• Validated operating software DCS PLUS 10 for total control of functional parameters
• Reduced operating costs thanks to optimized consumption and faster and more efficient processes
• Sanitary diaphragm valve in AISI 316 L stainless steel with pneumatical actuator for maximum reliability and tightness
• Patented lid seal with compressed air system
• Wide front door with safety lock for total and immediate access to the technical area
• Perfectly airtight, safe and extremely easy to maintain
• Vertical positioning of filters avoiding frequent rupture

Fedegari FVG Series

The FVG Series vertical steam sterilizers with built-in generator and air compressor are suitable for the sterilization in many different laboratory sectors.

• Exclusive horizontal swiveling lid with pneumatic gasket “rotate-n-seal”
• Built-in 316L stainless steel electric steam generator with automatic water feed pump
• Heat recovering system for water preheating to steam generator
• Dual sensor system, by pressure and temperature for double regulation and control of sterilization process

Fedegari FVS Series

The FVS series are suitable for standard sterilization in the laboratory field.

• Validated operating software TSC 09 microprocessor
• Built-in AISI 304 stainless steel recovery tank for steam condensates
• Exclusive swing-top opening lid with pneumatic gasket, quick closing and safety interlocks
• Portable type autoclave with 2 castors
• Microprocessor control system with graphic color LCD display
• Vertical positioning of filters avoiding frequent rupture

Fedegari FOB Series 

It has been specifically designed and developed to meet the most stringent application requirements in analytical and microbiology laboratories, research institutes, the pharmaceutical and food industries, and in the medical and hospital sector.

• Validated operating software DCS PLUS 10 for total control of functional parameters
• Reduction in operating costs thanks to optimized consumption and better performance thanks to faster and more efficient processes
• Massive pressure vessels, pneumatic valves and hydraulic components made of high corrosion resistant 316 L sanitary stainless steel, sanitary grade
• Easy access to technical area for regular maintenance and emergency
• Unique opening/closing door system with patented pneumatic gasket seal
• Single or double hinged doors
• Vertical positioning of filters avoiding frequent rupture

Fedegari FOB4 Series

The use of first-class quality materials specially developed for the pharma industry guarantees the highest safety standards and consumption savings. These sterilizers have been specially designed with ergonomically features to easily handle the sterilization of large volumes.

• Validated operating software DCS PLUS 10 for total control of functional parameters
• Shortest batch times and optimum drying
• High efficient pre- heating/drying system guaranteed by the AISI 316 L stainless steel plate heat exchanger
• Full accessibility to technical area for easy maintenance
• Single or double vertical automatic sliding doors
• Display on loading and unloading sides
• Vertical positioning of filters avoiding frequent rupture

Fedegari FOB5 Series

FOB5 series floor cabinet steam sterilizers combine high-performance with the most advanced process technology. The use of first-class quality materials specially developed for the pharma industry guarantees the highest safety standards and consumption savings. These sterilizers have been specially designed with ergonomically features to easily handle the sterilization of large volumes.

• Thema4lab process controller engineered and prevalidated by Fedegari according to GAMP 5
• Shortest batch times and optimum drying
• High efficient pre -heating/drying system guaranteed by the AISI 316 L stainless steel plate heat exchanger
• Full accessibility to technical area (frontal and lateral) for easy maintenance
• Single or double vertical automatic sliding doors
• Display on loading and unloading sides
• Vertical positioning of filters avoiding frequent rupture