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Lyophilizers







Lives International is a leading manufacturer of cGMP validation systems used for mapping of environmental chambers. We supply pharmaceutical and biotech industries with the most advanced technology in thermal validation and thermal mapping and with the latest software developments.


We offer both thermocouple based systems and wireless dataloggers. Our hardware is FDA compliant as well as our software, generating complete automated reports, close loop calibration and FDA 21 CFR Part 11 compliant
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HEADQUARTERS


North America:
USA

99, Pine Hill Rd
Nashua, NH 03063
Ph: +1 603-821-1898
Fax: +1 603-821-1888


Canada
1819, Rene-Levesque West Bd,
Montreal H3H 2P5
Ph: +1 514-281-0197
Fax: +1 514-289-9594


Europe:
France

3, rue Jules Guesde
92300 Levallois Perret
Ph: +33 142 708 589
Fax: +33 142 708 744


Romania
Str Lucian Blaga nr. 1
300001 Timisoara
Ph / Fax: +40 356 174249

Lyophilizers (Freeze Dryers)
 

Lyophilization is a complex process of removing water from the product through sublimation at low temperature & vacuum. The equipment (often called freeze dryers) is a very difficult type of chamber to thermally map. A freeze dryer has many shelves that are closely spaced together to hold product. Accurately measuring the shelf temperature during the process cycle can be quite challenging particularly if using thermocouples.

Installation of thermocouples into a freeze dryer is very time intensive. Thermocouples must be threaded into the chamber through the vacuum line using a special flange assembly ( see Accessories). The tip of each thermocouple must be carefully “strapped’ or taped onto multiple positions of each shelf. If not done properly, the shelf temperature measurements will not be accurately mapped. Vacuum leaks and broken thermocouples are common problems which can add significantly to equipment downtime.

Using a thermocouple based system (i.e. XpertVal System) for this application should be considered only if seeing “live data” is absolutely necessary. For example, the freeze dryer is new and has never been qualified.  In this case, seeing “live data” may be advantageous to allow for mechanical adjustments or to determine product load configurations.

The better alternative is to use wireless dataloggers that are designed to handle this application. The Lives XpertLog System of wireless dataloggers are ideally suited for mapping freeze dryers. Each datalogger has an 18 inch extended RTD sensor.  A copper cap is provided that slips onto the bottom portion of each datalogger. The copper cap has a groove so that the RTD sensor can be flush mounted. The datalogger can then be placed on any shelf location with the RTD thermally insulated to the shelf temperature. (see picture above). 

In summary, the Lives XpertLog System of wireless dataloggers can save substantial hours of labor and equipment downtime for this application. (see chart). Also, periodic verifications of the process conditions can be easily done without disruption to operations.

 
 
Lyophilizers (Freeze Dryers)
 

Lyophilizers (Freeze Dryers)


Thermocouples versus XpertLog Wireless Dataloggers

 
Thermocouples versus Wireless Dataloggers (Freeze Dryer - 60 points)
 

Time Saved Using Wireless Dataloggers =  17 Hours


   
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