𝗪𝗵𝗮𝘁 𝗶𝘀 𝘁𝗵𝗲 𝗹𝗶𝗺𝗶𝘁 𝗼𝗳 𝗧𝗢𝗖?

The limit of Total Organic Carbon (TOC) in pharmaceutical water systems, such as Purified Water (PW) and Water for Injection (WFI), is typically set at 500 ppb (parts per billion).

This limit is specified in pharmacopeias like the USP (United States Pharmacopeia) and EP (European Pharmacopeia) to ensure water purity by controlling organic contamination levels.

Total Organic Carbon (TOC) is a measure of the total amount of carbon in organic
compounds present in water.

Set alert and action limits for control failure of TOC results.
Based on yearly trend set alert and action limits.

𝐀𝐥𝐞𝐫𝐭 𝐥𝐢𝐦𝐢𝐭
The alert limit is a threshold that indicates a potential deviation but is not an immediate failure. It acts as an early warning signal that the TOC .
The alert limit is 100 ppb

𝐀𝐜𝐭𝐢𝐨𝐧 𝐥𝐢𝐦𝐢𝐭
The action limit is the point at which a formal investigation or corrective action is required. It indicates a potential or actual failure to meet water quality standards.
The action limit is 250 ppb

𝐏𝐞𝐫𝐦𝐢𝐬𝐬𝐢𝐛𝐥𝐞 𝐥𝐢𝐦𝐢𝐭
This is the maximum allowable TOC level to ensure water purity, established by regulatory
bodies like USP and EP.
The permissible limit is 500 ppb