At PCL, we routinely specify, purchase, install and validate medical pouch sealers of all technologies and brands. These activities are either performed at the client’s manufacturing facility where we roll up our sleeves, get our hands greasy, install the sealer, and then train the local engineering team how to use it. Or we temporarily install sealers in our lab for initial de-bugging and optimization before sending them to our client for permanent installation. We have learned a lot through these experiences and want to share some best practices that may be helpful on your next project.
First, it’s important to put the work in up front and have a well-defined strategy. Use this knowledge to seamlessly receive and setup your sealer, rather than be surprised once it has landed.
- Define the size, weight, and footprint
- Do you need to procure a table or stand, or does the sealer have its own stand?
- Verify utility requirements of the sealer and make sure your connections are ready—electric, air, water- do you need an extra regulator? Shut off valve? Is your capacity sufficient?
- What materials will be sealed?
- Determine which side contains the sealant layer- either the film or the Tyvek- and be aware that the sealant layer needs to face the heated side of the sealing machine for good seals
- Does the pouch vendor have a recommended starting point for time, temperature, pressure settings?
- Be aware that pouches may require dramatically different settings depending on the type of sealer- constant heat, impulse, rotary band
- Have you ordered pouches yet? Don’t want to forget those!
- Establish production layout in advance- use tape on the floor, tables, carts or other physical objects to represent the sealer and other production equipment
- Verify direction of motion, if applicable (e.g. left to right or right to left)
- Interact with the simulated layout – how will product be delivered to the area? How long does it take to load product? Where will sealed pouches be placed?
- Conduct time trials to get a better estimate of cycle time
- How will your production team verify acceptable seals?
- What test methods will be used?
- Are test methods established and validated?
- Read the user manual front to back, cherish it and use it, print a copy for quick reference
- Understand the calibration requirements and schedule service in advance
- Order the spare parts kit and have those items stocked – know what they are and how they fit with a preventive maintenance plan
- What tools will you need to have available? Any special grease or lubrication?
Also take advantage of any opportunities to visit the manufacturer before the sealer ships, such as a factory acceptance test. This is a great opportunity to get hands on experience, identify any last minute issues, create relationships with technical personnel, and even build prototype packaging samples for feasibility testing (e.g. drop & vibration).
Once the sealer lands, refer very strictly to the user manual for initial uncrating and moving into position. Check the sealer for damage. Make the utility connections. Turn on the sealer and run through its basic functions. Verify even and consistent pressure across the entire length of the sealing surface (old fashioned carbon copy paper is great for this- it will highlight any areas with uneven contact, scratches, or gouges).
At this point, you should be well on your way to a successful sealing validation! Sealing validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ). Refer to our guidebook on the Three Pillars of Packaging Validation to learn more, or contact us directly to answer any questions.
Stay tuned next week for how to establish optimum sealing parameters for your new machine!