Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity). Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. Visual seal defects will often be the initial indication of heat sealing process variation. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing.
ASTM F1886 testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package. ASTM F1886 covers the determination of channels in the package seal down to a width of 75 μm (0.003 in.) with a 60 – 100 % probability.
The ability to visually detect channel defects in package seals is highly reliant on:
ASTM F1886 procedure is comprised of the following: