ValSuite Pro Software

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 :-

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 :-

Configuration Data

It is possible to insert the actual picture of the autoclave and shelves. The software shows the Icons for each sensor which has unique id numbers. The sensors with ID numbers could be drag into the corresponding positions in the picture.
As per FDA norms, the validation should be done by keeping the sensors at pre -defined points inside the autoclaves which should be given the autoclave suppliers or should be estimated by the users. Out of all the points, the point which experiences the least temperature value is referred as “cold spot”. It is mandatory that one sensor should be located at the cold spot.
This feature makes the validation more authentic and reliable.

 

Validation Report

The validation report is an open platform. All report modules can be selected or deselected to create a custom designed report. The individual parameter values can be changed to local values using the small arrows or by directly entering new values. The report can be saved as templates.

The definition of the different parameters directly refers to the EN 554 norm, and we have template their coved EN17665/EN554.

 

Below are some typical values.

Sterilization Temperature           Holding Time

121 degree                         15 Minutes

126 degree                         10 Minutes

134 degree                           3 Minutes

143 degree                           1 Minutes

 

Autoclave volume           Equilibrium Time

< 800 litre                            15 Seconds

> 800 litre                            30 Seconds

 

Typical use of Validation Report

 

Qualification of Autoclaves

Heat Distribution studies

Heat Penetration study with saturated steam condition

 

Requirements

The Temperature Sensors must have the same Sample time.

The Saturated Steam Test and the Pressure test require a pressure Sensor with the Same Sample time as the Temperature sensors.

All Selected Sensors must reach the Sterilization Value.

When evaluating, no values higher than the Process Band are allowed. If the user has a value higher than the process band, the holding time will be 0 or a few seconds.

Analyzing the Sterilization process is divided into 4 phases.

 Come Up phase: Starts at a user defined Time Marker and ends when the Holding phase begins.

 Equilibration phase: Starts when the first Sensor reaches Sterilization Temperature and ends when the last Sensor reaches the Sterilization Temperature.

 Holding phase: Starts when Equilibration time finishes and ends when the first sensor is outside the sterilization Band.

 Cooling phase: Starts when the Holding Phase is complete, and ends at a user defined Time Marker.

 Earlier validation reports were prepared as per  EN 554. But now it was simplified to EN 17665

The validation  can be done at 121 or at 134

If 121, then holding time will be 15 minutes

If 134, then holding time will be 3 minutes

As per EN 554, Process time band should have been : +3 above set point

But as per EN 17665, the process band could be +2 deg C above set point or +1 degC  below the set point.

The reason is that, due to some reasons, if any probe falls below the set point just for few seconds during initial come up time,  the process fails as per EN 554.  All the sensor should be above 134.

Holding time – as soon as the last sensor enter the set point and 1st sensor drops down the set point. Means, all the sensors are within the band.

134 – 3 minutes

121 – 15 minutes

Max temp difference – 2

Maximum value – minimum value should be 2 deg C at any point – not in EN 17665.

Max Temp FLactuation for each sensor – not necessary in EN 17655

Max Temp difference for 60 sec – this is applicable only for small loads

Minimum Holding Time :- automatic by temperature ( no time markers)

Come up time : from start to all the probes reaches set point

 

Here you can see the typical Validation Report prepared as per EN 17665 for Autoclave Validation. The software automatically generate the report from the collected database.

 

 

 

 

 

 

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.

Test Setup

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.

Outputting Reports

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.

Maintain Security

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.

 

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?

Saturated Steam test

The Saturated Steam Test checks the maximum deviation between a pressure Sensor and the Temperature Channels converted to a pressure according to the steam table.

 

Air Leak Test

This is to make sure that the autoclaves have the tight vacuum during the  measurement.

The pressure loggers / sensors will be inserted into the autoclave and perform 30 minites logging before connection of feed through.

Next step is to connect the feed through and then again do the same test. This is to make sure that feed through do not lead out the vacuum while connecting.

Then perform the validation.

After the validation, you can perform the third study.

In such cases, the customer should compare all the three studies and make sure that there is no deviation or change in the pressure profile. This guarantee that the autoclave has enough vacuum.

Pressure deviation should be withon 100 mbar at 134 deg C for 1 minute

70 mbars at 121

If Cable systesm, three tests

One before feed through

One with feed through

One after the process

In case of Loggers, only 2 tests are necessary.

The Merging Option in the software helps the processor to verify the three graphs and data easily.

 

 

 

1. Total Validation Report as per EN 17665 and EN 554

The report separately describes:-
Equilibration band,
Process Band,
Difference Band,
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
Minimum Value
Maximum Value
Average Value
Maximum – Minimum
Average – Minimum
Delta
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.

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