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Determining Breathable Area Of Sterilisation Package?

For effective EtO sterilisation the packaging material must be breathable to allow the high-humidity EtO gas mixture to infiltrate the package. A partial vacuum is drawn before and after the cycle to facilitate the movement (in and out)of the EtO and moisture vapor.

If the package does not have sufficient permeability, the process will be ineffective.

A packaging that allows a breathable barrier allows sterilant to permeate during the sterilisation process while prohibiting the penetration of microorganisms during handling and storage, after sterilisation. The total package porosity of a sterilisable pouch which is dependent on the gas flow and surface area is a key for sterilisation and aeration phases of ethylene oxide gas sterilisation processes. The cycle and aeration times decrease as the porosity increases. Hence a smaller porous area is ample.

Determination of porous area requires knowledge of some specific characteristics. Breathable surface area, package volume, secondary and tertiary packaging, and peel force are all factors that determine porosity limitations. The worst case average porous area, the volume of the package and the gas exchange rate for each part of the EtO cycle at a minimum is needed for determining the porosity. The end sterilisation testing is also needed to qualify a package design. Product families of worst-case design and cycles are helpful defining the limitation of sterilisation testing, but optimizing the porosity of a package for an EtO cycle is a continuous process.

Packaging Failures: The Largest Source of Sterility Recalls

“Sterility Recalls” is a disturbing issue within the healthcare industry. “The largest source of sterility recalls [80% according to some sources] is packaging failures. Packaging design has to match product complexity.

In the changing landscape of the healthcare industry, one major change is the increase in more complex products including:

i) Combination products, such as the pairing of a delivery device and a pharmaceutical

ii) The growth of kits, and larger products made up of more items connected together whereby reducing the amount of manipulation and handling required by healthcare pros

iii) More microbiologic-centric products like skin tissues.

More complex products mean packaging/sterilization pros must consider more complex material structures, and understand that materials and products are likely to be more sensitive to sterilization.

Another part of the changing healthcare landscape is regulatory compliance. Major Factors Responsible for Packaging Failure Recalls:

• Lack Of Technical Expertise: Technical talent require thorough on-the-job training and expertise. • Not Validated Packaging Processes • Inappropriate Sealing • Supplier Quality Issues • Batch Sizes For Testing: Which may cover the issues such as no. of batches of materials to be used, sterilization stresses to be placed on packaging, etc.

Testing And Packaging Of Product With The Maximum Stress Exposure

It may be useful to test the product in the package, even though testing just the packaging is a simpler, less costly process.

Sterility assurance and packaging professionals need to work together to make sure that the testing performed will provide a safe and effective package.

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