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ASTM D4169-05 Revision
The latest revision to the ASTM 4169 standard only differs slightly from 4169-04A and gives much better guidance regarding the use of low pressure high altitude testing.
For example:
On page 9, section 16 (Schedule I – Low pressure (High Altitude) Hazard – this gives Medical Device Manufactures a rationale for not performing this type of testing on porous medical packages.
The new guidance document advises companies (medical / non-medical) on when to utilize the low pressure high altitude procedure, known as ASTM D6653-01 “Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method.”
This methodology helps companies determine what atmospheric effects are relevant to their packaging. This procedure is primarily utilized on non-porous packages (Foil/Foil) / (Poly/Poly). With a packaging system that is non-porous, the medical device manufacturer would want to evaluate what the potential hazards would be by air shipment. When a package can not breathe, it is susceptible to bursting and thus, deems the package non-sterile.
The new ASTM 4169 procedure gives medical device manufactures guidance on when to use the ASTM D6653-01 standard and when not to use it. If the packaging system is porous, there would be very little effect from using it because the package (Tyvek or paper packaging) is able to breath.
For example:
Company A
Single Barrier Foil/Foil Package (Non-Porous Packaging)
ASTM D4169 Recommendations: DC 13 Schedules: A,C,F,I,E,A
Company B
Single Barrier Tyvek/Poly Package (Porous Packaging)
ASTM D4169 Recommendations: DC 13 Schedules: A,C,F,E,A
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