Medical device packaging not only illustrates eye-catching looking and lucid instructions. Moreover it plays an important role to assure medical devices in a sterile system starting from manufacturing to end-user presentation. Therefore a suitable medical device packaging is strictly required to follow some gold standards. Below regulations are complied and considered:
ASTM D1585 – Guide for Integrity Testing of Porous Medical Packages
ASTM F2097 – Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
EN 868 – Packaging materials and systems for medical devices to be sterilized, General requirements and test methods
ISO 11607 – Packaging for terminally sterilized medical devices
With simulation of customers’ physical applications, there are types of packaging forms to be used in current medical devices’ packagings. We elaborate below suggestive matrix to provide a consideration of your packagings.
What we understand is drape & gown usually are used in procedures or ER. So easily to open is the characteristic of the packaging.
just like Tyvek header bag. Furthermore, anther consideration option is 70g or 80g paper pouch for strong enough packaging.
Due to high volume of usage and low cost orientation, blister packaging machine is adopted for efficient packing. Further consider the sterilization requirement to use breathable materials or not. The product market price is very low and cost sensitive, common packagings are overall plastic bag with vented window or 60g paper pouch. Manually assembling, packing and sealing is necessary.
First we should consider the contents to fit which sterilizations. Then we can decide what kinds of materials to pack. Normally to have high volume throughput and efficiency, blister packaging machines widely used. The roll stock materials of top and bottom webs are film/film, paper and PP/PE, paper and PA/PP, paper and paper. Other option is to use the multilayer aluminium pouches.
Catheter and the related products are classified as the high value medical devices. So as for their packagings, it is highly recommended to present in terms of top web as coated Tyvek or strong coated paper and bottom web as semi-rigid tray or rigid tray. Small portion customers adopt Tyvek/film pouch.
Glove packaging here is indicated to pack the sterile surgical gloves. Thanks to using surgical procedures, the packaging is highly demand. Usually there are inner papers to wrap the gloves and a pouch is the second packaging to pack. Normally two webs of pouch are mainly medical paper with one laminated PP or PE to keep good peeling performance.
Urinary drainage’s space is more square. Usually two-layers packagings are required. Use crepe paper to wrap urinary drainage, then pack into paper pouch or tyvek header bag. Puncture-resistance and good transparency is required in this kind of medical devices.