[1] Recommended Practices for Selection and Use of Packaging Systems - 1

AORN Journal, Dec, 2000

Steam sterilization parameters can vary according to humidity, altitude, packaging material, package contents, load, position of item within each sterilizer, size of pack, weight of pack, density of pack, and efficacy of the sterilization cycle.

2. Manufacturers of packaging systems should provide materials data relevant to sterilization. Practice settings should follow manufacturers' instructions for each packaging system for steam sterilization.(4)

3. Packaging systems for ethylene oxide (EO) should

* be permeable to EO, moisture, and air;

* permit aeration;

* maintain material compatibility (ie, nondegradable) with the sterilization process; and

* maintain the integrity of the system.

The purpose of packaging systems for EO sterilization is to permit sterilization and aeration of package contents and packaging material, maintain sterility of package contents until opened, and permit delivery of contents without contamination.(5) Woven, nonwoven, peel pouch package, and some rigid container materials are permeable to EO and do not impede rapid aeration of contents. Woven materials, however, absorb a large amount of the relative humidity needed for EO sterilization, which may prevent adequate penetration of EO to all surfaces of the package contents.(6)

4. Packaging systems for hydrogen peroxide plasma sterilization should

* be permeable to the process,

* maintain compatibility (ie, nondegradable, nonabsorptive) with the sterilization process,

* be made of a material recommended by manufacturers and used according to the manufacturers' instructions, and

* maintain the integrity of the system.

The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination.(7) The low temperature plasma sterilization process is affected by altitude and peel pouch packaging material.

5. Manufacturers of low-temperature plasma sterilizers should provide materials data relevant to peel pouch material. Because the absorption of the plasma sterilant (ie, hydrogen peroxide) could have an adverse affect on the effectiveness of the sterilization process and be absorbed by paper peel pouches, it is recommended that peel pouch material be made with polyester/nonwoven polyolefin laminate.(8)

RECOMMENDED PRACTICE III

Packaging materials should be processed to maintain the properties required for sterilization.

1. Packaging materials should be maintained at room temperature (ie, 18 [degrees] C to 22 [degrees] C [64 [degrees] F to 72 [degrees] F]) and at a relative humidity of 35% to 70%. Maintaining room temperature and moisture content of packaging material facilitates steam penetration and prevents superheating during the sterilization process.(9)

2. Woven materials should be laundered between every use for rehydration. Resterilization without laundering may lead to superheating and could be a deterrent to achieving sterilization.(10) Overdrying and/or pressing and storage in areas of low humidity may lead to overheating and sterilization failure. Woven packaging that is adequately hydrated should withstand multiple sterilization processes. For barrier quality wrappers, manufacturers' instructions should be followed for the suggested number of processings.(11)