What Is the Significance of USP659 and How Does It Impact Storage and Distribution?

What is USP659 ?

The United States Pharmacopeia (USP) is an independent, not-for-profit organization originated in 1820.

The mandate of this organization is to develop standards for quality, purity, identity, and strength for medicines, food, and health.

What’s the significance of USP659 ?

Temperature conditions are essential to ensure all medications & vaccines’ efficacy, quality, and potency.

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A positive, proactive, and responsible attitude ensures that optimum room temperature within the given framework is maintained.

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All medications with temperature label claims must prove that temperature & climate control provide pure, efficient, and required potency of medications and vaccines.

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Optimum room temperature is maintained in laboratories, pharmacies, and hospitals to maintained medications quality.

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What are Temperature Definitions Outlined by USP659 ?

USP659 outlines specific temperature conditions that ensure quality of medications and vaccines are maintained by optimum room temperature management

USP659 outlines specific temperature conditions, temperature ranges for varied room types are:

Cold : not exceeding 8°C (46°F)

Cool: between 8°C & 15°C (46°F and 56°F)

Warm: between 30°C & 40°C (86°F and 104°F)

Excessive heat: above 40°C (104°F).

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Mean Kinetic Temperature (MTK) expresses the overall effect of temperature fluctuations during the storage or transit of perishable goods.

MTK typically should not exceed 25°C. However, transient spikes up to 40°C are permitted as long as they don’t exceed 24 hours.

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Companies must adhere to the USP659 packaging and storage requirements by labeling every component

Compliance Measures for Packing and Storage

Storerooms should be designed and adapted to ensure good storage conditions

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Pharmacopeia products should be off the floor, suitably spaced to permit cleaning and inspection, and away from heat, light, air, and moisture, which may damage the medicine.

Regular training of staff and personnel is essential to eliminate inefficiencies

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