Medical Device Tray Sealers, Indexing Sealers, Tooling and Thermoformers
Standard Dynamic Data per stroke:
Access & Data Logging per event:
Standard Atlas Vac units have for years included dynamic output data (time, temp, psi, time/date, and recipe #) for output to PCL5 capable label printers as a means to capture and document unique package sealing data on each sealing stroke.
For 2016, with Class II UDI package labeling requirements and audit trail needs in mind, Atlas Vac has taken the next step to include data logging of not only the dynamic cycle data but also logging of Operator ID’s & PW, sign-ins, PW changes, UDI, recipe changes, alarms, odometer reading, etc all on a new standard 10” color touch screen. (click here)
With our newest OIT color screens, scanning in lot codes and UDI information becomes easy and accurate. This data is included in the audit trail database generated and can be transmitted to a label printer. All without a PC and its inherent issues.
Easy to validate, outputs in human readable copy, protected data, retained record until uploaded, complete audit trail of sealing functions, audit trail of authorized personnel access, PW authority level access control, sealer data can be matched to individual device as input through UDI scan.
What is interesting, this capability can be retrofitted to many existing standard Atlas Vac units in the field as a means to enhance and extend capital equipment life.
Backwards compatible retrofit for extending your equipment life (click here).
First....no PC is used. Therefore none of the OS updates and related software/firmware reliability issues. All our units are industrial PLC based.
When was a specific UDI packaged and under what exact parameters? By what operator? Now you know!
Was the correct tool nest fixture loaded on the sealer shuttle? Did it match the recipe? Now you know!
Can you track data from each stroke of the sealer? Absolutely.
Can you scan data from a lot paperwork or label set and record during setup? Yes!
What Engineer signed-on to edit the existing recipe parameters? When? Now you know!
Can the Operator scan in the UDI, DI and/or PI information? Even partial values for a match? Yes!
When did someone with the Calibration PW sign in to update the calibration settings? Now you know!
When was the last cycle alarm? What parameter violated? What was the cycle count reading? Now you know!
Did each seal cycle have readings within the set parameters? Now you know!
Can you download this data for an audit trail? Yes!
Not only do you know, you can prove it! (click here for more)
Access to data can be obtained via selected protocols. The first decision is to connect via an Ethernet cable to your internal network or wirelessly to a local internal wireless router? Once your Atlas Vac sealer is connected, the HMI can be viewed remotely from a supervisor’s station, and retrieve the data files for analysis via FTP. When something is not right, your Atlas Vac sealer can immediately notify someone via email, or by text message.
If you want your Atlas Vac sealer to remain off your network, or your wifi, you can always retrieve your data manually via an USB data Drive via the standard Graceport on each machine.
Remote Support – When you contact Atlas Vac for support, sending us your Sealing or Dynamic Data, Audit and Alarms logs will assist us with valuable insight and enable us to get you back on track quickly.
Security Access Levels - Security is always a key factor. In our previous models we provide just two higher users that related to key functions. Within the programming of our new 10” color HMI is a fully functional security system. We provide you with four levels: Operator, Supervisor/Engineer, Calibration and Administrator.
The "Operator" level is for production people using the machines each day. Each person that uses a machine should have a unique user ID so that their individual information will appear in the Stoke Data file, and the Audit Trail data file. In previous years, Operators were not normally required to sign-on but with need for audit traceability, the Operator can be now included in the output data.
The "Supervisors/Engineers" will still higher level access for adding, changing, and deleting recipes. This level has been standard for many years.
The "Calibration" level will have unique access to the system channels for calibration per Atlas Vac procedures. This Calibration level has been a standard feature for many years.
As an "Administrator", you can access the integrated Security program. You will be able to add, edit and delete people and assign them to their levels (operator, supervisor/engineer, calibration).
The key to producing a quality product package is a perfect process and to replicate that process over and over again. Yet, how do you prove the process is within the boundaries you have set? Atlas Vac sealers have always provided process alarms within the PLC program to prevent discrepant packages outside the validated parameters. Can detailed historical data be provided? As always the details are in the data. We provide three data sets. They are: “Sealing Dynamic Data”, “Audit Trail”, and “Alarm History”.
Within the Sealing Dynamic Data file is information captured at the time of the sealing. This includes all key recipe parameters, User ID sign-in (optional), Lot # entered, tool nest ID, UDI, date, time, odometer reading, as well as the actual dwell time, temperature and pressure. If you wish to maintain productivity by using multicavity tool nests, yes, you can track individual items to each tool cavity. Traditionally, much of this output has been available on Atlas Vac sealers in PCL5 format to drive label printing. In 2017, this UDI packaging information (as scanned) is placed in a CSV file that can be extracted via USB Data Drive or FTP (File Transfer Protocol) and evaluated in Excel, or Microsoft’s new Power Business Intelligent for advanced analytics analysis. This information is available for printing of dynamic data on formatted UDI labeling.
Within the Audit Trail file is the key human factors. Who, what, when factors. Which person, did what, when. Items such as recipe creation, recipe loading and deletes, what individual parameters within a recipe were changed. All calibration information is captured and changes are recorded. This information is placed a CSV file that can be extracted via USB Data Drive or FTP (File Transfer Protocol) for secure storage and/or evaluated in Excel.
Alarm File information has been available on screen for several years. What we do with this information is a key factor to process repeatability. Along with the alarm description message, is the date and time, and the users name (if they are logged in). Each alarm is recorded into a CSV file for analysis. This information can be upload, via USB Data Drive or FTP. An exciting new feature available is the immediate notification via email or text message (separate SMS charges apply).
With the installation of our new 10" color touch screen, many of our existing standard Atlas Vac tray sealers can be upgraded to include the newest features for UDI input, Bar Code scanning, Data Logging, Access and Connectivity. Upgrading your capital equipment at a fraction of new may be the solution needed.
Each of these data and access features are now standard factory installed with our 10" color touch screen and are available for retrofit.
A retrofit is typically executed without changes to the PLC program therefore making validation simpler as the only change involves the input/readout device...your screen.
Retrofit to select existing sealers (s/n verification required) can be accomplished. Contact us with your s/n.
Better process replication, tighter controls and immediate notification when something is not right. Backwards compatibility too. This is the Atlas Vac way of doing business.
Data Acquisition & Logging as well as barcode scanning and touch screen inputs accomplished without a troublesome PC and its related software updates and validation issues.
For over three decades, Atlas Vac Machine has been providing industry leading standalone medical tray sealers. Over the past four years, a comprehensive program has been implemented to provide our clients extensive data from each press sealing cycle to ensure proven quality and quantitative analysis. In addition to the seal cycle conditions, the standard data set also includes all recipe edits, sign-on events, alarm events all tied to date code and odometer readings.
By listening carefully to our customers and their individual needs, the goal for our Enterprise Integration Solution (EIS) has been to create a simplified interface between complex corporate Enterprise Resource and Planning (ERP) software and our standard pneumatic or All Electric tray sealers.
John Abraham, President of Atlas Vac Machines states, “This is a deciding moment for our industry. Currently medical tray sealers sit outside of the corporate ERP systems, and there is very little data being generated to prove the quality of the medical device tray sealing event. With stricter FDA requirements being implemented, our EIS is able to ensure that each tray sealing data set is captured and now able to be reported back to the network servers for analysis.”
This bi-directional solution also allows ERP systems to create a simple crafted file with recipes and instructions for our machines. Controlling temperature, pressure and sealing time and other vital information that can be customized to each customer’s individual system needs.
In return, at a predetermined moment determined by each client’s needs, an audit trail, sealing data, and alarm logs are transfer back to the network server for analysis.
With customer support in mind for validated Atlas Vac equipment currently in use, EIS can be added to many existing Atlas Vac sealers using a retrofit kit without changes to the original industrial grade PLC code in use.