For healthcare and diagnostic product manufacturers, who supply point-of-care medical devices, it is absolutely vital that the seal integrity of the packaging is tested to ensure that it is fit for purpose as devices cannot be used if there are any visible signs of damage to the packaging such as tears or holes.
Point-of-care seal integrity testing tends to be a process that most healthcare and diagnostic product manufacturers outsource to specialist companies, however bringing this process in-house can actually provide a number of benefits:
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- Greater Control and Accountability – By carrying out the seal integrity testing in-house manufacturers can have greater control and understanding of their processes, they are able to use the test data to implement improvements and continuously monitor the effectiveness of these improvements.
- Turnaround Time – If the seal integrity testing is outsourced, it can take a matter of weeks to get the results, compared to a matter of minutes, if the seal integrity testing is carried out in-house. This means that it is possible to identify potential issues in production quickly, allowing corrective action to be taken almost immediately.
- Cost Savings – Outsourcing the process can be very expensive and it is a cost that is unnecessary if all of the seal integrity testing can be done in-house, meaning that there is an opportunity for substantial cost savings to be made.
Healthcare and diagnostic product manufacturers can easily bring the process in-house and realise these benefits by implementing a single piece of Dynascan seal integrity testing equipment from LIMAB UK (LeakVIEW, MediBLUE, or MediTEST).
To ensure an easy transition from outsourced to in-house, LIMAB UK have a designated product specialist, who can discuss any application requirements, to ensure that the most appropriate piece of equipment is implemented. The equipment can be fully installed and full training can be provided resulting in an IQOQ qualification. Once in use, full support and aftersales service are available, as well as annual calibrations to ensure the equipment is working correctly.
The seal integrity testing methods and standards that LIMAB UK are able to offer and comply with are:
ASTM F1886/F1886M-16 | Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
ASTM F2054/F2054M-13(2020) | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurisation Within Restraining Plates |
ASTM F1140/F1140M-13(2020)e1 | Standard Test Methods for Internal Pressurisation Failure Resistance of Unrestrained Packages |
ASTM F88/F88M-09 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
EN 868-5 | Packaging for Terminally Sterilised Medical Devices – Part 5: Sealable Pouches and Reels of Porous Materials and Plastic Film Construction |
ASTM D3078-02(2021)e1 | Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
ASTM F2096-11(2019) | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurisation (Bubble Test) |
One company that is already realising the benefits and are advocates of in-house seal integrity testing is Summit Medical Group,
Summit Medical Group is an innovator in global healthcare, they have been assisting clinicians, physicians, and hospitals in developing quality medical products for better patient outcomes since 1984. Focusing on surgical, sports medicine, and infection control products, they employ over 100 industry pioneers worldwide and distribute to over 40 countries.
Testimonial
Karthik Nair, New Product Introduction Lead at Summit Medical Group said:
“We contacted LIMAB UK as part of bringing packaging integrity testing in-house so as to have a better understanding of packaging materials and also to comply with new MDR guidelines. We spoke to the product specialist at LIMAB UK and he was able to develop a bespoke system specific to our requirements. The main advantage that we have found is how quickly we get the results. In the past it took a while to get the result back from the testing company, now we can get a result in a matter of minutes. This means we can identify quality issues almost immediately, meaning less wasted time and resources.”
If you are a healthcare or diagnostic product manufacturer and you would like to discuss the potential benefits of bringing your seal integrity testing in-house, please get in touch with our product specialist.