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Maintaining Proper Sterile Storage Conditions 101 - What Factors Affect Shelf Life in Sterile Processing?

/ By Ian LoperSeptember 26, 2022

Manufacturers sterilize tools and supplies to make them safe for clinical use. And t0 maintain their sterility, they assign sterilized tools shelf lives to estimate their effectiveness—provided they are packaged properly and stored in sterile instrument storage.

Providing an expiry for sterilized supplies is a safety measure that manufacturers take towards infection prevention and disease control.

By using sterilized supplies within their shelf lives, keeping them in proper storage, and strictly following handling and distribution protocols of sterilized supplies, you can prioritize patient safety by mitigating the risks of contamination and preventing the spread of disease.

Facts About Shelf Life

Sterilized tools are vulnerable to contamination from the moment they are sterilized up to the moment they are used.

To determine whether they are safe to use, the Sterilization Packaging Manufacturers Council instruct manufacturers to simulate the process of aging and assign an expiry to the sterilized tools they make.

Though having shelf lives makes the use and storage of sterilized items much easier, manufacturers should carefully test the aging process on each new item they plan to release. Not only will this improve the accuracy of the shelf lives they put out, but it also helps determine the type of packaging material needed to protect the sterilized instruments.

Factors that Affect Shelf Life of Sterile Products

Though manufacturers determine shelf life through aging, it is not the only factor that affects the shelf life of sterile products. The shelf life indicated on the product labels is only valid under certain conditions.

Learn about them below to know how to maximize the shelf life of sterilized products.

Storage Area

Sterilized items need specific storage conditions to maintain their shelf lives. Therefore, familiarizing themselves with the requirements to maintain the integrity of their respective packaging is an absolute must.

Ideally, store sterilized items in enclosed storage units to prevent them from getting wet or gathering dust. Also, maintain a temperature between 18ºC and 23ºC and relative humidity between 30% and 60%. If the storage unit is dusty, store the sterilized items in containers.

Shelf Life Practice

From the moment items are sterilized, they already begin aging. Therefore, one can observe two practices to maximize shelf life.

The first practice is first in, first out. This refers to the use of sterilized products that were sterilized first because they are assumed to have aged the longest, and therefore, should be the first to be disposed of.

Another practice observes event-related shelf life. This means that whichever item experiences damage or has the integrity of its packaging compromised should first be disposed of, regardless of its shelf life.

The Packaging Condition

After sterilization, items are carefully packaged to remain sterile. Hence, any damage to the packaging, such as water or oil marks, rips, or lots of wrinkles, are signs of compromised packaging. This means you should not use the sterilized item and send it for another round of sterilization.

Damaged packaging can happen anytime during handling and storage, especially when there is over-handling. To prevent damaged packaging, manufacturers include handling and storage protocols that should be strictly followed.

Sterilizing Best Practices

Sterilized items go through a long process between sterilization and use. To maintain their shelf life and ensure the safety of their usage in healthcare, one must observe the following best practices.

Verify the Sterilization Cycle

Make sure an item underwent an approved sterilization process, in order for them to be suitable for healthcare use.

To do this, check for biological and chemical indicators on products. Only use sterilized items with three consecutive cycles of negative biological indicators and chemical indicators with a correct endpoint response

Separate Physical Facilities

Sterilization involves facilities for decontamination, packaging, and sterilization and storage.

The decontamination area should be separate from the rest, with its own airflow, preventing contamination of clean and sterile items. Meanwhile, the packaging area should be clean, though not sterilized.

Lastly, the sterilization and storage areas should be limited access only, with controlled temperature and humidity. Its floors and walls should withstand disinfectants, and its walls and ceiling should not shed.

Clean Items Before Sterilization

Prior to sterilization, clean items to remove any foreign material which may hinder effective sterilization. This can be done by presoaking or pre-rinsing tools or by putting them through mechanical cleaning machines.

Additionally, whoever is overseeing the cleaning process should be wearing gloves, face masks, and eye goggles or face shields.

Package Items According to Medical Industry Standards

Before packaging items, ensure that hinged items are opened, attachments are disassembled unless otherwise instructed by the manufacturer, concave items are positioned for water draining, and heavy items are not placed over other items to prevent damage.

Then, select packaging materials that will allow the penetration of the disinfecting agent while also maintaining the shelf life of the sterile item afterward. Some packaging materials typically used include paper, cloth, plastic, and paper or plastic peel packages.

Load to Allow Full Sterilization

When sterilizing instruments, arrange items in a way that allows the sterilizing agent to reach all their surfaces before loading them into a sterilizer. Place perforated trays parallel to the shelf and non-perforated containers on the edge.

Loosely, place small medical devices loosely in wire baskets. And put peel packs in perforated racks.

Store Properly

After sterilization, assign shelf lives to items. Then, put the items in a dry, enclosed, and spacious storage unit with controlled temperature and humidity to help them remain sterile.

The storage unit itself should be of a cleanable material that does not shed. Moreover, the storage unit should be at least 8 inches to 10 inches from the floor, at least 5 inches from the ceiling, at least 18 inches from a sprinkler head, and at least 2 inches from any outside walls.

Only Get the Best Sterile Instrument Storage from Distribution Systems International

No matter how well you sterilize your instruments, you are wasting all your efforts when they are not stored under sterile conditions.

Distribution Systems International understands the challenges of handling and storing sterile instruments, and we're here to help you with our custom sterile instrument storage solutions.

Our storage specialists work with healthcare facilities in over 50 states in the country, so you can rely on our knowledge when it comes to helping optimize your instrument and supply storage for improved productivity and operations.To schedule a consultation with one of our experts and receive a free no-obligation price quote, fill out our online form or contact us at 800-393-6090 at Distribution Systems International today!

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