Tag: Contamination Control

Conduct Label Migration Studies for Samples in Contact with Printed Packaging

Understanding the Tip: What is label or ink migration in packaging: Label migration refers to the transfer of chemicals—particularly inks, adhesives, and coatings—from printed packaging materials into the pharmaceutical product. This is a concern when the product is stored in direct contact with printed surfaces, such as blisters, pouches, or sachets without internal barriers. Migrated…

Stability Study Tips

Include Microbial Limits Testing in Stability Studies Where Applicable

Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable microorganisms in pharmaceutical products. For certain dosage forms, these tests are critical to ensuring the product remains microbiologically safe throughout its shelf life. Such testing is particularly important for non-sterile…

Stability Study Tips