Medical and Pharmaceutical...Autoclave validation Cold storage Incubators Medicine Refrigerators/Freezers Laboratories Tecnosoft offers a wide range of different temperature and pressure

1H O W D O Y O U M E A S U R E Q U A L I T Y ?

Medical and PharmaceuticalAutoclave Data Logging Solutions

Sterilization & Validation

2 H O W D O Y O U M E A S U R E Q U A L I T Y ?

Our history

Tecnosoft, founded in 1989, is an Italian research and development company of technical-scientific software, data acquisition systems and solutions for many differ-ent fields. We develop projects on demand and have also our own line of data logging systems for temperature, humidity and pressure monitoring in the pharmaceutical, medical, healthcare and food & beverage fields.

Tecnosoft has a long time collaboration with Ortho Clinical Diagnostics and Becton Dickinson in the medical industry. We developed a vast knowledge of the issues involving medical aspects designing data collecting and analysis solutions in various sectors, from rare antibodies identifi-cation to cold chain monitoring to sterilization validation. In all these years Tecnosoft has developed important skills in understanding the Customer’s requirements and transfer them into the project’s specifics and the devel-opment of the system, keeping itself up to date on new available technologies providing always advanced solu-tions.

Tecnosoft is not a mere hardware manufacturer but a complete solution provider which includes dedi-cated software for specific applications in differ-ent fields, that will answer to regulations’ require-ments and being user friendly to the final operator. Thanks to our flexibility and constant update we can un-derstand rapidly customers needs and translate them in new systems or continuous updates of existing solutions, along with the possibility of customizations for the dif-ferent users.

Our sales and technical team can advise the cus-tomer in selecting the right product for each application, as well as provide after sales support. Since 2002 Tecnosoft has implemented a certified qual-ity system based on the ISO 9001:2000 and then on the 9001:2008 regulation and it is currently updating it to the new ISO 9001:2015.

WE DESIGN AND DEVELOP BRAND NEW SOLUTIONS

ISO 17665

ISO 13060

ISO 15883

UNI EN 285

FDA 21 CFR Part 11

GAMP5

Sterilization of health care products and routine control of a sterilizationprocess for medical devices

Small steam sterilizers - Manufacturers

Washer disinfectors - General requirements, terms and definitions and tests

Sterilization - Steam sterilizers - Large sterilizers

US FDA regulations

Guidelines for good automated manufacturing practice

Pharmaceutical Field


Washer-disinfectors

Steam Sterilizers

Medicine Refrigerators/Freezers

Laboratories

Autoclave mapping and validation

Blood plasma sample monitoring

Steam Sterilizers

Autoclave validation

Cold storage

Incubators

Medicine Refrigerators/Freezers

Laboratories

Tecnosoft offers a wide range of different temperature and pressure data log-gers for sterilization and validation in pharmaceutical, medical field. Our 316 L stainless steel and fully-submersible devices can be placed directly inside the autoclave during the sterilization cycle.

Application Fields for Sterilization and Validation

Medical Field

Compliance & StandardsTecnosoft systems are compliant with the relevant standards and guidelines:

Extreme Vacuum

Bendable Probe Ø 3 mm

Bendable Probe Ø 3 mm


High temperature and pressure data loggers for Sterilization & ValidationTecnosoft provides accurate high temperature & pressure data loggers. Most models are available with different types of probe and are provided with a certificate traceable to a national reference. The batteries are user replaceable.

S-MicroW L

Probe Length: 50 mm or on demandRange: -40°C ÷ +140°C

Flexible Probe Ø 3 mm

Probe Length:20/50/100/150 mm or on demandRange: -40°C ÷ +140°Ccalibrable up to 250°C

Rigid Probe Ø 3 mm

Probe Length: 50 mm or on demandRange: -40°C ÷ +140°Ccalibrable up to 250°C

Probe Length:20/100 mm or on demandRange: -80°C ÷ +140°C

Ultra Freeze Ø 3 mm

Dimensions: 39 h X 20 Ø (mm) / Accuracy: ± 0,1°C (± 0,05°C upon request) / Resolution: 0,01°C / Memory: 20.224 / Battery: +10.000.000 acquisitions @25°C

S-MicroW XL




Rigid Probe Ø 3 mm




Dimensions: 64 h X 20 Ø (mm) / Accuracy: ± 0,1°C (± 0,05°C upon request) / Resolution: 0,01°C / Memory: 20.224 / Battery: +17.000.000 acquisitions @25°C

S-Disk J




Rigid Probe Ø 3 mm Bendable Probe Ø 3 mm




Dimensions: 29,5 h X 35 Ø (mm) / Accuracy: ± 0,1°C (± 0,05°C upon request) / Resolution: 0,01°C / Memory: 54.528 / Battery: +8.000.000 acquisitions @25°C

PressureDisk

Temperature operative range: 0°C ÷ +140°CPressure range: 0 bar ÷ 5 bar absolute

Pressure

Probe Length: 20 l X Ø 3 mmTemperature range: -40°C ÷ +140°CPressure range: 0 bar ÷ 5 bar absolute

Pressure & Temperature

Temperature operative range: 0°C ÷ +80°CPressure range: 0 bar ÷ 1 bar absolute

Dimensions: 43,22 h X 35 Ø (mm) / Temperature accuracy: ± 0,1°C / Temperature resolution: 0,02°C / Pressure resolution: 2 mbar Pressure accuracy: ± 15 mbar / Memory: 27.264 / Battery: +6.000.000 acquisitions @25°C


Tecnosoft standard validation kit includes:

Fittings & Accessories




Validation Kit & AccessoriesFor temperature and pressure control we provide also complete validation kit to validate, map and monitor various thermal processes. This validation kit can be cus-tom configured with any combination of termperature and pressure data loggers and is supplied in an elegant case with all the required accessories and software.

DiskInterface HSComputer USB reading base for downloadingdata and programming all models of hightemperature & pressure data loggers.

Heat Protections

There are several fastening systems available for placing loggers and inserting sensors into any variety of packaging material. Having devices of different shapes and size, with the flexible or semi rigid probe we provide several solutions of fastening.

Heat protections for applications above 140°C, available for S-MicroW L & S-MicroW XL models. The heat protection extends the operating temperature range of the data logger, allowing it to be exposed to higher temperatures up to 250°C for a certain time.

Universal multibayMultiple reading base allows to connect up to 5 data loggers to be programmed and downloaded simultaneously.

- High Temperature Data Lggers with Calibration Certificates- Pressure Data Loggers with Calibration Certificates- Single or multiple logger Reader Station for data downloading and programming- TS Manager Software, FDA 21 CFR Part 11 regulations compliant


TS ManagerValidation Software for autoclaves, compatible with FDA 21 CFR Part 11 regulations.

Operating System Requirements: Windows XP, Vista, 7, 8, 10 (32, 64 bit)

The TS Manager is an advanced val-idation software developed accord-ing to 21 CFR Part 11 and GAMP guidelines.The software enables the user to collect, display and analyse valida-tion data from all Teconosoft high temperature, pressure and humid-ity devices and has all features and all reports needed for validators of autoclaves, incubators in the healthcare & medical industry.

The intuitive interface of software puts in your hands a powerful tool but very easy to use. Create yourdatabase of Customers and Instru-ments to validate, create validation profiles to analyse the processes, start your loggers and then down-load them and check all data col-lected. The IQ/OQ protocols are also available from Tecnosoft.

• Data in the devices not editable• Data in software not editable• Access for each user through a login and password• Client/server setup and shared database• Multi-user access• Multi-level users, with different functions for each level• Customers and validated Instruments database for vali-

dators activity• Logbook: recording, not editable, of all carried out opera-

tions• Data analysis through pre-set or customizable param-

eters• Possibility of pre and post mission comments• Vasualization in graph, with zoom, and table• Multi graph analysis

• Graph divided into Sections with analysis and statis-tics for each section

• Synchronized data table with statistics for each acquisition: maximum, minimum, average, maximum-minimum, maximum-average, average-minimum

• Theoretical temperature calculation based on pres-sure in saturated steam environment

• Customizable parameters: acquisition step, mission duration, analysis type (lethality with Z and reference temperature values setting, Overkilling for validation)

• Print of customizable reports• Data and reports export in HTML and XLS (MS Excel)

format• Calculated parameters: Lethality (F0, PU, A0 etc.)• Languages: Italian, English, German

Software Features


Process Analysis

Setup Loggers

Data Analysis

Printed Report

Starting a monitoring mission is quick and simple: put the logger on the DiskInterface HS already connected via USB and just press Start. The software will automatically recognize the type of logger connected and will show its status. Proceed and choose the profile to use to analyse your data. Profiles are set of parameters such as acquisition rate, start delay, kind of analysis (F0, Overkilling, PU etc.). Here you can assign also the Customer and Instrument you are going to validate (autoclave, washer-disinfector etc.). In the next step the logger will be programmed and you can assign also the use you are currently making of it (validation, test,production control etc.).

TS Manager offers several tools to analyse your data. A complete HTML report is displayed with all the details from your process: type of analy-sis, result, logger used, operator who programmed and downloaded it, all data acquired. The Graph has zoom feature, vertical and horizontal markers to set points for analysis both on temperature and pressure (you can define a part of graph to analyse and calculate span between max and min, time span etc.). You can also customize the grid of thegraph easily. The Data tab allows for a quick reading of all the data, sta-tistics such as max, min and average and the profile analysis with the result according to expected values. You can also export data to Excel or other format file.

TS Manager lets you print complete reports of your processes, with header image of your com-pany and all the useful data to track the mission. You can choose to print graph, data table. Re-ports are printed according to regulations and can be signed on each page by the validator or the operator. Multi graph reports can be created thanks to the Group function: select all the mis-sions you want to include in a new group and TS Manager will show all curves and data into a single graph and table. Sections can be gener-ated to highlight different phases of the process and analysis are made on each section. Finding a mission is extremely easy thanks to a large set of filters. Quickly scroll through all the data ac-quired (date, time, temperature and pressure, eventually), look at the mission’s statistics, like number of acquisitions, duration, maximum, minimum and average values for temperature and pressure. Export all the data, not only the acquisitions, but also all mission’s details, to an Excel file. Analyse the data acquired using the chosen profile or select other profiles from the drop-down list. Add comments: create custom comments and load them automatically, to save time and create quick reports.


TECNOSOFT SRLVia Luigi Galvani, 4

20068 Peschiera Borromeo (MI) - ITALYTel: +39 02 2692 2888 - Fax: +39 02 2692 2875

Web: http://www.tecnosoft.eu Email: [email protected]

For technical assistance call

+39 199422456

@Tecnosoft.loggers Tecnosoftsrl @tecnosoft_srl Tecnosoft srl

Documents

Medical and Pharmaceutical...Autoclave validation Cold storage Incubators Medicine Refrigerators/Freezers Laboratories Tecnosoft offers a wide range of different temperature and pressure