How Medical Device Companies Keep Products Sterile

As the healthcare industry and medical manufacturing have grown, keeping medical devices sterile has also become big business. The growing market for sterility testing of medical devices reflects this. The global market for sterility testing of medical devices and pharmaceutical projects is expanding at a compound annual growth rate of 7.0 percent, putting it on track to reach a value of $1.5 billion by 2025, Transparency Market Research projects.

The growing market for medical device sterility testing illustrates how important hygiene is for medical manufacturers. Here’s a look at some of the policies and procedures that medical manufacturers follow to ensure that devices stay sterile as they’re being produced and delivered to healthcare providers.

Keeping Devices Sterile Through Strategic Materials Selection

Materials used for medical devices must meet strict regulatory standards to ensure their suitability for their intended application. For instance, devices such as medical implants must meet standards codified by the USP-NF. These standards rate the biocompatibility of substances by testing them for qualities such as how toxic they are to humans, how much they irritate tissue and how they react with cell structures.

Other materials are selected based on their physical and chemical properties. For instance, Viton fluorocarbon o-rings have a wide range of temperature resistance, and after exposure to vacuum conditions exhibit minimal susceptibility to outgassing, which is the release of gases stored in a material. Gas release can cause materials to become contaminated, so minimization of this quality is important for keeping medical seals sterile. This makes Viton a good selection for many types of medical seals.

Protecting Devices During the Production Process

Medical manufacturers also must observe best practices to maintain sterility during the production process. A key to maintaining hygiene during production is following cleanroom standards defined by the ISO. Cleanroom environmental factors such as humidity and temperature are carefully maintained to prevent contamination as well as prevent medical device materials from physical or chemical alteration.

To help achieve this, cleanroom walls are constructed from substances that can be cleaned with antiseptics. Air entering the cleanroom is filtered and monitored to verify that particles such as dust do not exceed threshold levels of density. Airlocks, protective gear, and restrictions on which substances can be brought in further help ensure the integrity of cleanrooms.

Staying Sterile During Shipping

Once devices have been produced, manufacturers must take additional steps to keep them safe during shipment. Packaging materials must meet ISO requirements to make sure they are suitable for protecting devices during shipment. Packaging containers must be strong enough to avoid tears and other damage, as well as proof against leaks. Tests are conducted to make sure packages can endure the rigor of shipping conditions. Packages must also include safety labels that meet rigorous standards.

Unpacking procedures are just as important for keeping medical shipments sterile. Medical facilities designate areas for unloading and storing medical devices that require a sterile environment, such as surgical tools. Staff who unload, store and transfer such devices employ safe handling procedures to preserve sterility.

Medical manufacturers take steps throughout the production and shipping processes to keep devices from becoming contaminated. Devices are made from substances carefully selected to ensure sterility. Cleanrooms keep devices from becoming contaminated during production. Packing and storage procedures ensure that devices remain sterile until it’s time for them to be used. These best practices help keep medical devices clean and protect patients from germs, ensuring that their hospital visit is a healthy and safe one.