Thermal Validation & Mapping Systems LIVES INTERNATIONAL
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1 North American Head Quarters: Lives International Groupe Inc. 1819,Boul Rene-Levesque Ouest, Suite 202 Montreal, PQ H3H 2P5 Tel : Fax : European Head Quarters : Lives International 3, rue Jules Guesde, F Levallois Perret ; France Tel : Fax : lives@lives-international.com Thermal Validation & Mapping Systems LIVES INTERNATIONAL Accuracy & Reliability in Thermal Mapping - Lives International
2 The reference in Thermal Validation and Mapping - 7 years experience in thermal validation systems conception and manufacturing. Thermal Validation System XpertVal - thermocouple based system - data protection (21 CFR part 11). Wireless thermal mapping & validation systems XpertLog - data protection (21 CFR part 11). - Using the most recent technology wireless thermal mapping systems are used by major players in pharmaceutical area - Lives International covers Europe and North America through it s Headquarters and distributors. - Hot Line 24h / 7 - Metrology laboratories for calibration using traceable to COFRAC / NIST equipment - Calibration : European users : accredited calibration laboratory American users : accredited calibration laboratory in PA USA for both XpertVal & XpertLog systems
3 Technical Specifications: Temperature, Pressure & Temperature, Humidity & Temperature XpertLog systems represent the newest technology in wireless data loggers XpertLog is the most reliable data logger for high accuracy measurements. Very rugged systems, XpertLog have been developed for working in unfriendly environment in pharmaceutical industry. Loggers : Temperature Pressure & temperature Humidity & temperature PT-100, 4 wires High accuracy : 0 à 5 bar abs Capacity sensor Specific applications : Range : & accuracy - Temperature -60 to +140 C (continuous) ± 0.1 C -80 to +100 C (continuous) ± 0.1 C 1 : -80 C freezers : continuous -80 C for several days cycles - no thermal shield needed - Pressure - Humidity Extremes: no shield: C (limited time) with shield C C 0 to 5 bar absolute ± 8 mbar 20 to 90 %RH ± 2 %RH 2 : sterilisation tunnels: standard operation at up to 340 C for 15 minutes requires thermal shield and standard cooling zone not appropriate in depyrogenetion ovens (250 C for several hours) Material : Ketron Peek FDA compliant Battery Lithium, user replaceable Leak free IP-68 Data collection interval Memory Internal watch accuracy 1 second to 24 hours data points < 1 second / month USB Docking Station : - High speed communication - Customizable : 4, 8, 12, 20 - Reduced dimensions - Simultaneously programming of unlimited number of loggers Weight 35, 40 or 70 g (battery included) Calibration COFRAC / NIST traceable ITS-90 coefficients included Applications : - Autoclaves - Freezers, Refrigerators - Freeze dryer - Cold rooms - Ovens / Stability chambers - Sterilization tunnels
4 Fixed logger Diameter : 40 mm Height (except sensitive element) : 31 mm Sensitive element : customizable Ref. : DL_Xlog_TR Flexible logger Diameter : 40 mm Height (except sensitive element): 31 mm Cable length : max 50 mm Ref. : DL_Xlog_TF Shelf Contact Device for freeze dryer Ref. : SL_Xlog_TF Humidity and Temperature logger (fixed & flexible) Diameter : 40 mm Height : 72 mm Cable length : max 50 mm Ref : DL_Xlog_HR Ref : DL_Xlog_HF Pressure and Temperature logger Diameter : 40 mm Max height : 67 mm Ref. : DL_Xlog_PF
5 XpertVal was designed for simplifying validation jobs versus the existing validation systems; In compliance with FDA and European regulation, this system uses the most recent technology and the most powerful software enhancements. Reports are generated automatically and data integrity complies with FDA 21 CFR Part 11 Technical Specifications : Regulations - FDA - EN285 - EN NFX FDA 21 CFR part 11 Total system accuracy Number of channels - XpertVal Fl - XpertVal HP Standalone mode Better then 0,20 C (after thermocouples calibration) - close loop calibration 21 channels 60 channels The loggers can be programmed for working with or without computer Advantages : - Reduced dimensions - User friendly software - Automated reports - Automatic calibration Reports - Generated automatically - Customizable Sensors - Thermocouples (T, K, J ) - RTD (PT 100) ma VDC... Memory - XpertVal Fl - XpertVal HP PCMCIA memory card up to 4 Mo internal data points Applications : - Autoclaves - Freeze dryers - Ovens / stability chambers - Freezers / refrigerators - Cold rooms - Sterilization tunnels
6 Temperature blocks & oil bath Lives temperature block : - ATC 156 : -25 to 155 C - ATC 157 : -45 to 155 C - ATC 320 : 30 to 320 C - ATC 650 : 30 to 650 C - ATC 125 : -90 à 125 C Oil bath : to 140 C to 100 C Reference Probe Hart probe : With external display, accuracy C Lives/ Ametek probe : To be connected on the front panel of the block correction coefficients introduced in the block Pressure / Humidity Sensitive pressure surface Clamp connection, 0 to 5 bar absolute. Humidity transducer Capacity 0 to 100 %, accuracy ± 1,5 %RH Accessories - Validation replaceable insert for block - Adapter for autoclaves Fedegari - Leek free feedtrhough - Bundle of thermocouples T, J, K
7 Lives Software: total validation solution, yet user friendly CARACTERISTICS XpertLog & XpertVal Software Advantages Applications - Intuitive and user friendly cut half training time Autoclaves - Secured access, Id of equipment, traceable - Electronic signatures - Close loop Verification / Calibration (several points) automatically - driven by the software - performed by the user - Protected raw data and test reports - Report : - Customized - Generated automatically - Different programming possible for the same cycle - Unlimited number of loggers (XpertLog) - Calculations : user customizable Freeze dryers - Languages : Multilanguage Comply with all Regulations : - EN EN HTM CGMP - 21 CFR part 11 Software validation manual IQ & OQ SOP
8 User friendly interface Loggers programming : Templates configuration : XpertVal & XpertLog
9 XpertVal & XpertLog Test Report Verification Report
10 Trend Report Statistics Report :
11 Distributors : Canada: Lives Groupe International Inc. Ireland : ITL Denmark : Ametek Belgium : Stork Italy : Delta Strumenti Switzerland : Techniserv Romania: Medisol Jordan, Syria: Startech Egypt : MYMSA References : Pfizer - France - Abbott Pfizer Ireland - Genzyme - USA MSD - France - Sanofi Aventis LFB - Merck Santé Organogenesis - USA - Organon Innothera - Septodont Usifroid - GSK Validapto - Canada - Ingerop Serono - France - Serono Suisse Transgene - Biomérieux Lab Assistance - Delpharm Ciba Vision - Axcell Technologies Hydrex - Adour Bio Conseil Sofresid - MCC Trinity Biotech - Ireland - Human Genome - USA Merck Biosterile - USA - Merck MRL - USA Merck Mexico - Hikma - Portugal Hikma -Jordan - Trust Pharma - Algeria Validapro - France - Pierre Fabre Weleda - Weleda Assystem - Confarma - Techniserv - Pharma Frontier - Korea
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