Standard Test Method for Determining Integrity of Seals for
Medical Packaging by Visual Inspection
Seal attributes can be directly linked to many variables in process parameters, equipment, or material, as well as the environment (room temperature and relative humidity). Visual seal characteristics and defects can provide 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 a 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 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:
- Size of channel
- Degree of contrast from sealed and unsealed areas
- Amount and type of adhesive between the two package layers
- Reflecting light angle
- Types of materials used
- Use of magnification
ASTM F1886 procedure is comprised of the following:
- ASTM F1886 is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
- Inspection of the seal should be performed at a distance of 30 to 45 cm (12 to 18 in.).
- Completeness and uniformity of the entire seal area of the package must be inspected.
- Any part of the seal where channels appear across entire seal width must be identified and recorded.
- Record the number and location of channels identified on each package.