The pharmacopoeia requires the testing of four parameters for pharmaceutical water: conductivity TOC、 Endotoxins and microorganismsControlling these four parameters can ensure the purity of water used in all fields of pharmaceuticals. Recently, some technologies have been developed to better support and simplify the release of pharmaceutical production water, and to increase the adoption rate of PAT to improve efficiency. For example, real-time release testing (RTRT) for TOC and conductivity, microfluidic technology for bacterial endotoxin testing (BET), and rapid microbiological methods (RMMs) for microbiological testing can all be used to streamline QC laboratory processes and reduce human interference related to water quality testing. By adopting lean laboratory practices/PAT, pharmaceutical companies can benefit from improved process efficiency, faster product launch, reduced workload for analysts, and greater sustainability, while maintaining data reliability and compliance.

If you are looking for practical steps to streamline the pharmaceutical water testing process, you need to consider all aspects of testing, such as sample handling, instrument capabilities, data review, process, and sustainability. Based on current available technologies, lean laboratories can adopt laboratory testing, sideline testing, or online testing, each with its own advantages and disadvantages.

The disadvantage of laboratory sample testing is that it may introduce pollutants, delay the release of production water, and conditional release may bring risks. Alternative methods for laboratory testing include sideline testing and online testing. If properly validated, online detection can be used for real-time release detection（RTRT）Real time release of production water is achieved through the use of validated online recording instruments. RTRT maintains aclosed-loop systemEnsure the integrity of the process and samples by eliminating human factors. As you can imagine, transitioning from laboratory testing to on-site and online testing can reduce the labor and consumables required for pharmaceutical water testing. In the long run, time and money can be saved and efficiency can be optimized with fewer resources and materials.

The commonly used method is to use it in the laboratorytoc analyzerPerform TOC and conductivity measurements with conductivity probes. This requires separating samples from different usage points for analysis in the laboratory. The process of separating samples, transferring them to the laboratory, and analyzing them is not only labor-intensive and costly, but also introduces pollutants, leading to false or out of specification (OOS) test results. In order to reduce routine sampling and analysis of conductivity and TOC, many end users are transitioning to RTRT.

For conductivity and TOC analysis, there are three situations where online instruments can be used: (1) for process/pharmacopoeia monitoring; (2) Used for process control and understanding; (3) Used for pharmacopoeia monitoring, release, process control, and understanding. RTRT involves the use of online instruments in all three scenarios and allows real-time monitoring and release of pharmaceutical grade water for production. This requires additional verification to fundamentally increase confidence in using online instruments in these three situations.

How to streamlineEndotoxin testingLaboratory analysis? So far, in the past 40 yearsLimulus amebocyte lysate (LAL)There is almost no innovation in detection, and most of the current detection still uses time-consuming traditional methods. And now, there are better new methods.Automated analysis using a centripetal microfluidic platform can provide automated detection of endotoxinsSave a lot of time and reduce the chance of errors. With the advancement of this technologySievers Eclipse Lunar Eclipse Bacterial endotoxin TesterThe introduction of endotoxin analysis has achieved automation and meets the requirements of the pharmacopoeia.

Like 96 well plates, microfluidic systems enable you to carry out the same biochemical reactions, butLess manual workloadHigher consistencyLess reagent consumptionPre loaded standard samples and PPC are used to automatically generate standard curves and PPC peaks, saving you a lot of time, reducing pipetting steps, and minimizing the chance of errors.

By introducing microfluidic technology, you can alsoReduce the storage capacity of the refrigeration room and decrease the laboratory footprintEclipse microplates can be stored at room temperature, so there is no need to occupy additional space in a 2-8 ℃ refrigerator. The Eclipse analyzer is smaller and more compact than a 96 well plate reader or robotic system, providing more desktop space. The Eclipse endotoxin testing software also allows setting up client servers, so it canRemote review and signing of endotoxin dataMinimize the need to physically visit the laboratory.

Since agar was used as a growth medium in the late 19th century, the growth and counting of microorganisms have remained largely unchanged. Due to its reliability and accuracy, microbiological testing has always relied on agar plates to quantify microorganisms in pharmaceutical water. Although the use of microplate counting according to pharmacopoeia regulations to determine viable microorganisms is reliable, it is time-consuming and labor-intensive, typically requiring at least two analysts. Microbial detection of ultra pure pharmaceutical water requires several days of propagation and cultivation before it can be read on agar plates. Usually, manual recording of results creates opportunities for data reliability gaps. Due to the time required for accurate plate counting, most pharmaceutical water is at risk when released before microbial results are available.

In order to reduce risks and minimize the time required for microbiological testing,Rapid microbial methodsRMM is on the rise in the microbiology industry. Compared with pharmacopoeia tablet counting,RMM can provide biological results fasterRMM can return results in less than an hour.

Pharmaceutical water testing does not need to be so time-consuming and difficult. With the laboratoryImplementing PAT and moving towards a more streamlined process can optimize and simplify pharmacopoeia testingWithout affecting regulatory requirements. The important transitions to lean laboratories include adopting PAT technology, reducing human factors and error opportunities, and adopting more efficient work methods such as laboratory testing, sideline testing, or online testing. When using appropriate tools and providing effective support, simplifying laboratory processes and shifting towards real-time release testing is easy to achieve, saving you a lot of time and resources.