Packaging medical supplies is an intricate affair. Whether to use a tray or pouch to pack your medical device is a decision that depends on both your budget and the sterilization method involved.
The central product in the medical industry is the medical device, which has to be packed safely while at the same time maximizing storage efficiency. To do this effectively, medical supply companies should observe the following packaging basics.
1. Package Design
The most common packaging designs used by medical supply companies are trays and pouches. For instance, pouches feature an attractive design and cost under a dollar apiece. On the other hand, trays feature more aesthetic and pleasant designs. The appropriate design, therefore, depends on the device to be packed and available budget.
If a company is budget-conscious, pouches are highly recommended since they are cheaper to manufacture. Trays, on the other hand, are the better option, but they cost more and take a long time to manufacture.
The materials used to make pouches and trays largely depend on the sterilization method and the features of the medical devices. Delicate devices such as those with sharp features require special packaging materials.
2. Sterilization Methods
Autoclave, ethylene oxide (ETO), gamma, and electron beam (E-beam) are the most popular methods used to sterilize medical devices. For sterilization requirements, use a material that allows the sterilant to easily penetrate the product. It is also important to use material that will not change colour or disintegrate during the sterilization.
For sterilization methods that use gas or steam, it is necessary to choose porous material to allow vapour to pass through. After settling on the type of material to use, perform a trial run to avoid potential problems during the validation phase. Gamma sterilization is highly recommended due to the fact that it is fast and effective.
3. Package Testing
The ISO 11607 stipulates package validation testing for medical services. The validation consists of testing the device for seal integrity, distribution, material integrity and package ageing. Ageing testing has longer lead times of between one to six months depending on the device’s shelf life. It is therefore important to factor this consideration during the planning phase. It is also important to test the package in the state it will be when finished. This implies that package-testing should be done after the product has been sterilized.
4. Validation
The sterile packaging’s validation process involves the product’s shelf life, package integrity, and establishing the level of sterility assurance. The ISO 11607 covers shelf life and package integrity. For sterilization, the method chosen determines the appropriate standard. For instance, E-beam and gamma sterilization use the ISO 11137 standard, which involves setting the sterilization dosage using the sterility assurance level and the product’s bioburden, which refers to the number of bacteria a product attracts during the manufacturing process.
Sterility assurance level (SAL), on the other hand, is based on the offchance that a unit exposed to sterilization would remain non-sterile. The most common SAL has a one-in-a-million probability of being non-sterile. Hospitals require medical devices with SAL of 10-6. There are, however, a few types of biological implants that defy this standard. Besides sterilization validation, for manufacturing processes to produce sterile medical devices, quarterly sterilization audits are necessary.
Most medical companies have great products. The packaging adopted can either enhance the product or grossly undervalue it. Since the packing has to go through a series of validation tests, it is wise to start its development during the product’s development phase. To ensure that your packaging is of the appropriate standard, make sure you’re using the right packaging leak detection equipment.
