Ellab Validation Solutions – Wireless Dataloggers
Both the E-Val Flex thermocouple system and the TrackSense® Pro wireless data loggers are well suited to the validation of autoclaves. To validate the sterilization process according to the predefined acceptance criteria ValSuite™ Pro software is a valuable tool.
Autoclaves can be used for sterilization of liquids in various containers such as bottles, vials, ampoules, bags, and medical equipment.
In most cases it is necessary to monitor the temperature of the product during sterilization. This could be during batch production and cycle development and validation.For this reason, Ellab offers a wide range of fixtures and fittings.The reproducibility, which is enabled by the fixtures and fittings, makes re-validation much easier and reliable.
Commonly used standards and guidelines for validation of autoclaves are ISO EN 285, ISO EN 17665 and PDA Technical Report No. 1 Validation of Moist Heat Sterilization Processes.
Guidelines state that 11 temperature-measuring points are needed when performing a heat distribution study of an autoclave that is from 1,5 to 2,5 m3. This number is reached by placing one sensor in each of the eight corners in the autoclave, one in the center, one close to the drain, and one next to the autoclave’s temperature sensor.
In addition to achieving minimum and maximum temperatures for set time periods, there are a number of other measurements, which many users find critical. These include the equilibration time, which is the difference between the first sensor achieving temperature and the last. Also, the spread of temperatures during the sterilization period and the deviation of individual temperature sensors over the sterilization period are also considered critical during the validation of autoclaves.
Another critical parameter is the use of saturated steam. In order for the sterilization to be effective the steam has to be saturated, as this transfers the most energy from the steam to the product. To facilitate the validation of this parameter ValSuite™ Pro software includes a saturated steam analysis that correlates temperature and pressure automatically.
To document the validation adequately a diagram must be made that shows all the sensor’s ID numbers related to their exact position in the autoclave. This is easily done in ValSuite™ Pro software by integrating the data session with predefined schematics, pictures and Word documents.
A critical factor when validating autoclaves is the calibration of temperature sensors. It is essential that the user can demonstrate that the sensors were within an acceptable accuracy when they were used. This means calibrating shortly before the validation run (referred to as Pre Calibration) and then checking the accuracy afterwards to ensure that they are still within predefined tolerances (referred to as Post Calibration). Using the automatic calibration feature in ValSuite™ Pro software simplifies the procedure and the software generates a complete calibration report.
ELLAB offer a dedicated package for Autoclave Validation. We have cable based Eval Flex Validation system as well as wireless datalogger validations system packages fully compliant to FDA 21 CFR part 11.
ELLAB TS PRO Wireless Datalogger Package
Ellab TrackSense Pro is a wireless multi-channel data logger unmatched in accuracy, performance and versatility. The flexible system is easily adapted to your requirements and provides an elegant solution to the most demanding validation applications including SIP validation .
The Accuracy of the system is :-
• Temperature: ±0.05°C
• Humidity: ±2%
• Pressure: ±0.25% Full Scale
• Time: ±5 Sec. Per 24 Hours
• Rotation: ±1%
The robust loggers are designed to operate under extreme conditions without ever loosing valuable data. They can tolerate temperatures from -80°C to +150°C and withstand pressures up to 10 Bar fully immersed. The non-volatile memory stores up to 60,000 data points. Recent improvements in battery technology have dramatically improved performance and lifetime even at high temperatures.
The small size and convenience of wireless data loggers make them exceptionally easy to use in countless validation applications.
Each logger has multiple channels for recording data with a memory capacity of up to 60,000 data points. The state of the art technology allows for variable sample rates. A predefined start and stop time can be set and the sample rate can be adjusted within a specific temperature range.
The logger is made of AISI 316 stainless steel and the electronics are sealed in heat and moisture resistant material.
The standard Pro logger is designed with interchangeable sensors and user replaceable batteries
TrackSense® Pro Logger
We suggest TrackSense® Pro loggers for SIP validation applications, which are designed to be accurate and durable in the harshest conditions. All components have been selected and tested to withstand the high temperatures and pressures associated with steam sterilization.
Sky Access Point
The Sky Access Point can be used for the online transmission of the data during validation, which means you can receive the data online in the computer in the same way as using cable based validation systems
The Sky Access Point offers many advantages over standard wireless access points.
The proprietary wireless protocol significantly reduces battery consumption in the radio data logger. All other wireless equipment is rejected by the Sky Access Point, greatly improving transmission success and security.
Upto 128 sensors can be transmitted online into the same computer. The transmission rate is 5, 10 or 60 seconds and the connection to the PC is through Ethernet or USB.
We offer logger with rigid sensors or logger with flexible sensors for this application.
Please refer the below pictures showing how the user could insert the measuring sensors through the Tri clamps and gaskets. The picture shows how our logger with rigid sensor could be used for validation of SIP in pipelines.
ELLAB offers ValSuite Pro Software, which is validated and fully compliant to FDA 21 CFR Part 11. The main features of the ValSuite Pro Software are :-
Detailed Control of Validation Studies
The ValSuite™ software documents and guides you through the complete thermal validation process. The database structure in the software enables complete documentation and procedural control for the operators.
Templates allow detailed test criteria to be pre-set in the software by the assigned administrator. Information on sensor placement, operator, test,vessel, required temperature limits, start and stop time, monitoring interval and specific calculations can all be pre-set and saved. This ensures accurate documentation and correct implementation of required procedures for consistently repeated tests.
Pre-identifying sensor positions greatly reduces setup time and errors. A test setup sheet is an indication where each sensor should be placed. Later during analysis this information is easily displayed and tracked.
Software Data Analysis Features
Data analysis tools greatly reduce the time needed to find critical data. The ability to zoom graphically and display up to 8 tiled windows at once simplifies identifying important data. Multiple calculations such as min/max values, standard deviation, average, deltaT and lethality can be calculated on any block of data displayed. This eliminates the need to export data which improves data security.
ValSuite™ collects and presents validation data from both real-time E-Val Flex and TrackSense® Pro wireless data logging systems. The data from both systems can be presented and analyzed in the same session. The system can run up to 128 channels which can be identified and displayed in different groups such as penetration and distribution. Any grouping or specific channels can be displayed in a separate data block and analyzed.
A complete thermal validation report can be produced with pass/fail criteria, detail on mapping positions, operator and vessel ID, calibration offsets for sensors, full data lists and statistical summaries on the data. ValSuite™ also maintains templates for reports designed to meet specific requirements of tests such as EN17665 (EN554). The templates can be customized to organize the data and perform calculations to your exact criteria. Offering this greatly reduces the time needed for the data analysis process. Reports can be reviewed with the print preview feature and a pdf file document is generated.
ValSuite™ Pro operating software is designed to maintain the highest level of security for compliance with 21 CFR Part 11. The software administrator controls and assigns user ID and access privileges. Any user function can be deactivated which will deny access for specified users. This significantly reduces the risk of mistakes applies tight control of usage by the administrator.
Raw data cannot be changed and user actions are recorded in the audit trail. Any analysis of data such as time markers, limits or comments will be recorded in the audit trail. Analysis reports can be produced with an electronic signature with the ID of the user generating the report. Accessing information from the audit trail is simplified with the ability to search by date, study ID, user ID and vessel ID.
Compliant to FDA Guidelines:
• Raw data is built into a database structure and cannot be modified or erased
• Complete audit trail with easy search engine to find data by date, session, user and module
• User ID and passwords with detailed user access control
• Sensor ID provides complete NIST traceability
• Customized report generator eliminating need to export data
• Specific compliance reports (e.g. EN17665)
• Automated pre and post calibration reports
• Print preview feature with report output in pdf file format
GAMP Guidelines and DS/EN ISO 9001
All documentation for the development of ValSuite™ Pro software is in accordance with the guidelines set out in GAMP. Software package includes appropriate documentation. Ellab’s quality system is compliant with DS/EN ISO 9001.
The following reports could be generated during the validation of your autoclaves / SIPs :-
1. Total Validation Report as per EN 17665 and EN 554
The report separately describes:-
Saturated Steam Analysis,
Lethality calculations etc.
We also offer Validation Report as per your SOP ( if you follow a different procedure other than EN 17665 or EN 554)
2. Limit Report :-
The Limit report is able to analyze the Data in a Session, in a very simple and efficient way. The report sets up a Test scenario for a specific range of the data values, which will give the result of Passed or Failed.
Typical use of Report – Can answer questions like:
Is there at least one sensor that obtained a specific Lethality Value of 15 or higher?
Did all the Sensors measure between 121 and 124 in the Holding time?
Which sensors did not reach the sterilization temperature?
Did all Temperatures fulfill the Saturated Steam condition in the Holding Time?
3. Air Leak Test
This is to make sure that the autoclaves have the tight vacuum during measurements.
The pressure loggers / sensors will be inserted into the autoclave and perform 30 minutes logging before the validation to make sure that the autoclaves maintain proper vacuum during measurement. The same test repeats after the validation. Pressure deviation should be within 13 mbar over a period of 10 minutes with a slashing pressure of 70 mbar according to EN 285.
4. Merging of Data Files
The software could merge different repeat tests files to confirm that there is no deviation in the results. This indicates the genuine and reliability and repeatability of the validation data. You can also reconfirm that your autoclaves are working well and do not require any repair or servicing.
5. Statistics Report
This repot can be used to prove that the process is correct throughout the measurements
The following data can be generated both in graphical and tabular format
Maximum – Minimum
Average – Minimum
Standard Deviation etc.
6. Lethality value ( Fo values )
The Lethality value can be calculated as total process or based on specific band. For example Fo value during holding time, Fo value during cooling time etc. You have the option of selecting different Fo values in the same graph. The D value also can be changed, if your SOP demands for it. The standard D value used is 1 and z value is 10.
7. Time Markers
The Time markers can be used to define and certain process time. For example come up time, equilibration time, holding time, dwell time, cooling time etc. This helps the processor to prepare the data from a certain period.
The above mentioned reports will be generated for your autoclaves, SIPs etc. Similarly we have a different set of reports for your Lyophilizes, DHS, Tunnels, Warehouses etc.
Conclusion : ELLAB offers the perfect validation package for Autoclave Validation applications . The system package include the most accurate loggers and sensors ( accuracy : +/-0.05 deg C), accessories, fittings, fixtures, validation software, calibration lab etc.