USP 671 — Standard for packaging permeability and moisture resistance
The USP 671 standard (United States Pharmacopeia) establishes requirements for the packaging of pharmaceuticals and medical products, focusing on the permeability and moisture resistance of packaging materials. This standard ensures that packaging meets moisture-protection and moisture-control requirements, which is critical for maintaining product quality and safety.
Primary test methods in USP 671
The USP 671 standard (United States Pharmacopeia) includes several test methods to determine the suitability of packaging materials.
Moisture permeability:
This test evaluates the amount of moisture that penetrates the packaging material and thus measures the packaging’s moisture protection. Relevant standard: ASTM D7709.
Barrier properties:
This test assesses how well the material protects the contents from external influences, such as air and moisture.
Leak-tightness tests:
Leak-tightness is measured to ensure that no moisture or foreign substances can penetrate the packaging.
Application areas of USP 671
Pharmaceutical industry:
Protection of medicines from moisture and other environmental influences.
Medical devices:
Preservation of sterility and quality of medical devices.
Cosmetics:
Prevention of quality degradation due to moisture ingress in sensitive cosmetic products.
USP 671-certified machines
Below are five instruments commonly used:
- With GraviTest the determination of water vapour transmission rates of polymeric films and other sheet materials by gravimetric method becomes mere child’s play.
- The new Automatic Gravimetric WVTR Tester GINTRONIC GraviTest 6250 comes with a 0.01mg balance as a standard feature. The 0.01 mg balance makes WVTR measurements of low perm materials 2-3 times faster than the previous generation systems.
- The same instrument like GINTRONIC GraviTest 6300/6400, but with 10 sample places with 30cm2 / 28,3cm2. Conforms to ASTM E96, JIS L1099 A1+A2 and many others.
- The same instrument like GINTRONIC GraviTest 6300/6400, but also for samples with a thickness up to 50mm.
