Validating your Labelling Systems
Validating your Labelling Systems
Validation is used a lot in the pharmaceutical and food production industries. If you need to validate your labelling system but don’t know where to start? Start here…
- What is meant by validating your labelling systems?
- Do you need to validate your labelling system?
- Writing up a functional requirements specification (what do you want your labelling system to do)
- What hardware, consumables and software do you need in order to test?
- Designing an operational qualification (OQ) protocol.
- What evidence do you need?
- What needs to be validated – the data populating the label and the sources of data.
Validation is used a lot in the pharmaceutical and food production industries.
What is Validating a Labelling System?
In a nutshell, validating a labelling system is how you evidence that your label printing process produces the same quality of printed labels every time.
You need to know what it is expected to do, write out all the steps and conditions involved – documenting all the settings – and test that it does as you say it will.
Your label printing process must be consistent – you can’t have inconsistently unreadable labels.
We work with international clients both remotely and in person on validation projects. Contact us for help with your project.
Do You Need to Validate Your Labelling System?
Not everything in a manufacturing process needs to be validated. High-risk parts of your manufacturing process, that carry a high risk to consumer safety, should be prioritised over low-risk processes.
Using risk management tools, we can define a list of critical quality attributes (CQA) that describe a pharmaceutical or food production process.
Elements of a labelling system can have a critical effect on products. The wrong use-by date, the wrong product name or incorrect allergy information could have potentially fatal consequences for consumers.
Because of the potential harm mislabelling can cause, you do need to validate your labelling systems.
How to Validate Your Labelling System
Let’s start with deciding what outcomes you are looking for.
A clear unambiguous specification of the labels you need. This is known as Functional Requirements Specification (FRS).
This might include:
- Barcode using the correct symbology (code 128, Datamatrix) and is readable
- Barcode includes all the correct information
- The text is large enough to read and remains legible for the life of the product – i.e. if it’s exposed to chemicals or heat
- Dosage information is clear and correct
- The label adhesive sticks for the life of the product
- The data is correct on each label (i.e. the correct batch code)
- The printer is able to print labels of the required size range
- An audit trail of what’s been printed and by whom
- Permissions for different people to create, edit and approve labels
- Must be able to incorporate variable data such as lot number, expiration date, serial numbers & randomised numbers in the label design
- Must be able to read data from CSV files, databases & spreadsheets
- Must be able to alter data within the software without the need to make changes outside the system & re-import
Put Together Your Labelling System
Normally, you spend time in process design – building a prototype production system.
Luckily with labelling, the design process is relatively quick, as the options for label design software and printers are limited.
Once you know what you want – draw up a specification of the hardware, software and consumables you need.
You will need an installation qualification (IQ) document – a checklist of items to ensure everything is installed to specification.
If you need help, contact us to put together an IQ for you.
An example of this might be
- Zebra desktop ZD421 printer
- BarTender Label Design Software – Enterprise Edition
- CSV data file
- 75mm x 50mm Cryogenic labels made in a factory with BRC A accreditation on rolls of 500 delivered on a 38mm core.
- Wax resin thermal ribbons – 74m x 89mm.
Using these components you’re able to begin testing your labels.
Draw Up Your Operational Qualification Protocol
Now you know what your labelling system needs to do, and you have assembled your labelling equipment, it’s time to draw up the tasks (known as a protocol) that will test what your system does and what it needs to do.
For example –
- Load printer with thermal ribbons.
Load printer with Zebra 2300 black wax thermal ribbon. Close the print head. Wait for the printer to calibrate. Feed through five additional labels to ensure the ribbon isn’t wrinkled.
Adjustments must be made to the printer printhead temperature (darkness) and speed settings in the software to ensure the label print quality is acceptable.
You will need different labels and ribbon combinations to test to ensure the best results. Contact us for samples for your testing.
Approving Your Validation
Validation is normally designed by a production or labelling specialist.
The protocols are then checked over by a quality assurance (QA) specialist.
The last part of the validation process is the operational qualification – OQ.
The document is then signed off by the author and a QA specialist.
What Evidence do You Need?
Samples of printed labels.
Getting Help with Your Validation
So you know you need to validate your labelling system for your food or pharmaceutical operation and are ready to get started.
We’ve installed dozens of labelling systems for clients, large and small, around the world.
If you want help with your validation and want to save time, contact us for help and advice.
Visit our contact us page and get in touch.
Useful Links
https://en.wikipedia.org/wiki/Computerized_system_validation
Updated 14 Sept 2024
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