TOC analysis in pure water as it should be according to USP and EP.

TOC is one of the most important quality parameters when it comes to pure water (PW) and injection water (WFI). Internationally harmonized standards demand fast and accurate online analysis of the water stream. The ever-increasing developments in the digitization of (production) processes are also embraced by the various pharmacopoeias. Hence the buzzword "PHARMA 4.0" by analogy with INDUSTRY 4.0. Data integrity is a major concern in this.

ALCOA+

The basis of the legal framework is the well-known CFR21 part 11. ALCOA and ALCOA+ are the framework within which these regulations must be worked out. Pharmaceutical manufacturing companies further transpose this into their own SOPs (Standard Operating Procedure).

RecordLoc

Pharmaceutical companies have invested a lot of money to bring their process control systems and data acquisition into compliance with international regulations such as CFR 21 part 11, and they obviously want to continue using those systems. And right they are! Hence TOC analyzers via a connection to an (industrial) PC, with an Audit Trail app such as RecordLOC , the Ensuring data integrity. A not insignificant plus point here is that through the same system conductivity or ozone (O3) and TOC analyzer can be connected simultaneously and thus all the most important analyses are and remain ALCOA+ compliant.

The TOC analyzer

In a PW or WFI water stream, you want the Knowing TOC at all times, without delay. Taking a sample every 6 minutes and then analyzing it, even though it is fully automatic, is not going to work. For such an important quality measurement, you need a actual online analyzer needed that measures the water as it flows through it. After all, what can't happen between sampling?

For a fast response time, it is also important that the analysis is carried out as close to the water flow as possible. The control panel and data processing can easily be placed a little further away, e.g. in a technical room. It only becomes really interesting if this allows you to connect other sensors such as conductivity or ozone (O3) to the same system.

Read the full blog post and find out how to easily comply with increasingly stringent regulations with a "future-proof" TOC analyzer.