Medical packaging must offer complete protection to the product during transportation, so that it can be guaranteed that the product will arrive to the end consumers. With this in mind, there are a series of medical device packaging requirements that you should be aware of, in addition to specific regulations that must be complied with. 

 

Types of medical packaging materials

Based on the special characteristics of medical packaging there are different materials that can offer optimized and safe packages. 

 

Medical grade paper

Nowadays, it offers great benefits and improvements in relation to previous versions. While it is true that the paper is made out of fibers and can compromise the sterility of the goods, the problem has been solved by coating this material with a polymer (such as latex). 

This solution is successfully implemented in bags and caps, and does not sacrifice the porosity required by steam or ethylene oxide (EtO) sterilization. Likewise, the polymers prevent subsequent contamination by denying the microorganisms of surface ways inside.

 

Tyvek ® 

Tyvek ® is sold as an alternative to medical grade paper. It is based on a polymer (HDPE), composed by long, woven randomly oriented strands combined into a sheet through heat and pressure. 

The random composition of these pressed strands results in a porous material that protects the goods against microorganisms. Unlike paper, Tyvek contains no fibers, which means that it does not require additional treatments. Moreover, it is more resistant to tears and punctures than medical device packaging made out of medical grade paper. 

 

Aluminum

Aluminum provides a light, oxygen and moisture barrier that is highly useful in medical device packaging design, particularly in those that contain pharmaceutical and biological products. 

However, this materials has a number of particularities that must be considered. If the aluminum will act as a sheet barrier, heat sealing will be required. In addition, this material is vulnerable to chemical hazards and flex cracking, which makes it necessary to sandwich it between protective layers. Lastly, its proneness to puncture means that medical packaging manufacturers must determine the right width so as to protect the load.

 

Plastic

Most widespread plastics include LLDPE, PP, PET, HIPS and vinyl, in addition to other patented formulas. Plastics can be useful as films (in flexible structures) or as sheets (for semi-rigid or rigid structures). 

Its advantages include the variety of aesthetics that they offer, in addition to the many functions that they can fulfill. Moreover, plastics are compatible with non-porous sterilization methods, and can be combined with paper and Tyvek in case that porous sterilization is required. 

 

Adhesives and coatings

In this case there is the challenge of offering a balance between the strength of the bond and the ease of opening. Should this fail, a heat sealing or poor peeling (which leads to the presence of particles) can compromise the product. 

 

Regulations that medical device packaging must comply with

A series of international protocols and regulations provide criteria for medical device packaging validation. This being the case, medical device testing involves thorough simulations of the motions, forces, conditions and sequences present in transportation environments that might endanger medical packing. 

 

ISTA 3A

This protocol applies under a number of circumstances, including different routes, types of vehicles and handling of exposures. It is used for packaged products up to and including 150 pounds, and analyzes how a package withstands vibrations, shocks and varying atmospheric conditions that may pose a risk. 

 

ISTA 3B

This procedure implies simulation tests on packaged products that are transported by truck. In this case, risk factors such as shocks (rotational drop, free fall, tumbling, impact, forklift handling), vertical vibrations and atmospheric conditions are analyzed. 

 

ISTA 3E

This is a general simulation test for unitized loads that contain one or more products of the same packaged products (generally on a pallet or platform) secured as a single load. In other words, in the ISTA E3 test, product and package are considered to be a single unit. 

This protocol evaluates the stability of the load, the performance of the medical packaging to shock and vibrations, and other types of hazards including pressure, humidity and unusual handling. 

 

Tips for the testing and design of medical device packaging

It is vital for medicines to be protected and for them to be packaged in containers that meet applicable regulations. 

Medical device packaging must protect the goods from any hazardous external influence that might alter the properties of the product (such as humidity, light, oxygen and temperature variations), as well as the chances of biological contamination. Likewise, medical packaging must include the right information to identify the product. 

Things that must be considered in relation to medical device packaging validation include choosing a package that has no adverse effect on the product, and vice-versa. 

In addition, these results must remain throughout the entire expected lifecycle of the product. Given the relationship between the quality of a pharmaceutical product and the quality of its packaging, packaging materials and systems must be subject to the same quality requirements of the pharmaceutical products themselves. 

The advantages of a medical device packaging design include: 

  • Reducing the time from product to market.
  • Generate trust in the launch of the product.
  • Reduce product damages and shrinkage.
  • Balance distribution costs.
  • Improve the market share thanks to an increase in customer satisfaction.

 

Are you looking for the best method to validate and test medical packaging?

Get in touch with us and we will advise you on the machines that are best suited to your medical packaging testing and validation project.

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