F1886/f1886m (version 25)

1.1 This document provides a method for a non-destructive visual evaluation of peelable seals, non-peelable seals, and materials of packaging. This method can be used to test the visual integrity for multiple types of bags/pouches or trays.

1.2 This document is divided into two parts:

1.2.1 Part 1—Inspection of seals.

1.2.1.1 This section covers the determination of channels in the package seal. It is the responsibility of the user to define the relevant size of defect that can be detected during method validation. This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed.

1.2.2 Part 2—Inspection of materials surfaces.

1.2.2.1 This section covers the identification of the presence of suspected integrity defects in the primary packaging materials that may impact the intended package integrity. It is the responsibility of the user to define the relevant size of defect that may be detected during method validation. Ref. TMV Guide F3263. This test method is applicable to packaging where the surface may be appropriately inspected. This test method is also applicable to opaque and transparent packaging material surfaces.

1.3 This method when applied to primary packaging is used to assess if there are actual defects based on the inter-laboratory study (ILS) that penetrate fully through the surface material or across the seal.

Note 1: Where observations are noted during visual inspection, these observations should be treated as indications that there could be an issue present. Further testing may be required to confirm whether or not the observation is classified as an integrity breach. See Appendix X1 and Appendix X2 for additional information.

1.4 The values stated in either SI units, or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.