Importance of ultrapure Type 1+ Water for the Development of Generic Medicines

The need to guarantee delivery of ultrapure type 1+ water reliably and consistently is ever increasing as new analytical techniques and applications evolve with lower detection limits. Research and development laboratories require a constant source of high purity water to ensure the accuracy of results in their workflow.

Background

The customer is one of the largest generics companies in the world and an important subsidiary of a leading multinational healthcare company, developing high-quality and affordable pharmaceuticals. The European-based Development Center is focussed on creating high-quality and affordable pharmaceuticals, and in the last two decades, has grown steadily and is responsible for a quarter of global development activities.

Ultrapure Water is a Key Component in Research and Development

The customer uses large volumes of ultrapure water in their research and development laboratories to develop and carry out analytical techniques for the drugs they produce. Before the mobile phase of analysis, sample preparation is conducted, this is one of the most water-intensive processes is the study of dissolution. Tablets are dissolved in a solution similar to that found in the human stomach, using at least 1.5 liters of ultrapure water for each sample.

Analytical tests using HPLC and LCMS are then conducted at varying levels of dissolution to study the effect on the drug. Buffers containing a
mixture of ultrapure water and other components, such as Acetonitrile or Methanol, are used in this mobile phase, during which the laboratory runs 100 HPLC systems for eight hours per day placing a large demand on ultrapure water. Finally, water is also used for less critical tasks such as glassware and bench washing.
The Head of Analytical Development commented: “We rely on multiple highly sensitive analytical techniques, so we need to ensure that the quality of water is never interrupted. There was some concern that our existing systems could not guarantee this, possibly even compromising our results”

Guaranteed Water Purity is a Mandatory Requirement

The availability of optimal purity water with a quality of 18.2 MΩ.cm resistivity is a mandatory requirement for the Development Center, in-line with Standard Operating Procedure and Pharmacopoeia Standards. This strict requirement ensures clean data without compromise. The laboratory uses high-end analytical techniques such as ICP-MS, HPLC, GC-MS and other critical applications used in research work. These techniques measure elements in solution at trace levels in the ppb or ppt range and therefore rely on high purity water free from ionic impurities and with a Total Organic Carbon (TOC) value of < 5 ppb.
Prior to the arrival of PURELAB® Chorus, the laboratory was using ultrapure point-of-use polisher systems that rely on a single deionization pack to provide water. There was a risk that trace levels of weak ions could enter the workflow affecting the accuracy of results.

PureSure® Guarantees Optimal Purity and Avoids Downtime

The introduction of the fully validated PURELAB Chorus 1 Analytical Research model fitted with a Halo Flexible dispenser allows the scientists to conveniently dispense water into any size container and receive real-time feedback relating to inorganic water purity and TOC. The PureSure system design incorporates two deionization packs and a quality sensor between them. This ensures that any trace levels of inorganic impurity that may escape the first pack are removed by the second pack. The two purity sensors give an early indication of when the first pack is reaching capacity by providing a non-invasive visual alarm. PureSure provides confidence to the customer that they are receiving the highest quality of water at all times, and that deionization packs can be changed without interrupting vital work time.

“PURELAB Chorus is suited to our work because its design focuses on delivering the optimal purity, defined as a requirement of our SOP, while providing an easy to use interface. We know that we will always be getting the purity of water that is essential to our applications”.

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