US Pharmacopeia (USP) 1079 evaluates the storage and handling of pharmaceuticals. This guideline is designed to help ensure that pharmaceuticals remain safe, effective, and stable throughout their shelf life. Protection from storage and handling includes from the time they are manufactured until they are used by patients.
USP 1079 covers a range of topics related to pharmaceutical storage and handling. This including environmental conditions, container/closure systems, labeling, and facility design. The USP guideline provides specific recommendations for each of these areas.
This packaging standard provides recommendations for temperature, humidity, and lighting levels in storage areas. Specific temperature ranges for different types of pharmaceuticals are provided by the manufacturer.
More specifically, temperature ranges are based on their stability and the recommended storage conditions. For example, refrigerated pharmaceuticals must be stored at a temperature of 2 – 8°C, while room temperature pharmaceuticals must be stored at 20 – 25°C.
USP 1079 package testing addresses the types of containers and closure systems that should be used for different types of pharmaceuticals. Containers are based on their stability and compatibility with the container/closure system.
For example, light-sensitive pharmaceuticals should be stored in opaque containers to prevent exposure to light, which can degrade the quality of the drug.
Additionally, the USP 1079 testing guideline provides requirements for labeling pharmaceuticals. This contains information that must be included on the label, such as the drug name, strength, dosage form, and expiration date. This information is critical for ensuring that pharmaceuticals are used safely and effectively.
USP 1079 also provides guidance on facility design for pharmaceutical storage and handling. This includes the layout of storage areas, the types of materials that should be used for shelving and storage units, and the types of equipment that should be used for temperature and humidity control.
Expert US Pharmacopeia 1079 Package Testing Facility
Keystone Compliance is recognized as an industry leader in pharmaceutical package testing. We can test packages ranging in sizes of small vials and boxes to multiple oversized pallets. Our temperature and humidity capabilities are limitless. In addition to having a wide operating range from low to high temperature, we also offer thermal shock testing.
Contact us to receive a quote on your next pharmaceutical test program to USP 1079.