ultraWAVE increase productivity for Pharmaceutical Testing Lab


Neotron

CUSTOMER

NEOTRON is a global provider of analytical and testing services in the food, food ingredients, food packaging, feed production, pharmaceutical and consumer products markets. NEOTRON’s goal is to ensure that its customers’ products and services meet the requirements for quality, safety and performance through its testing services. NEOTRON operates globally, with 30% of its orders coming from outside Italy.
In particular, the NEOTRON Pharmaceutical Analysis Laboratory provides compliant testing for pharmaceutical companies and industries in compliance with good manufacturing practice (GMP).
Their analytical expertise offers a broad portfolio of tests on several matrices, such as APIs, excipients, and primary packaging materials. The lab has been operating in the fields of chemical, biochemical, and microbiological analysis for 30 years, supplying essential technical support for the control and development of new products.

CHALLENGE

They usually analyze about 100 samples per week that require digestion. In the past, they used hot plate digestion, but struggled with incomplete dissolutions and an increased sample load, which severely bottlenecked their work flow. To overcome these issues, they moved to processing their samples using Milestone’s ETHOS 1 closed vessel digestion system.
The ETHOS provided high quality digestions, but their lab still faced throughput issues due to the wide variety of samples they analyze. Due to limitations with rotor-based technology, batches in the ETHOS only consisted of 1 - 2 types of similar samples, thus elongating their sample preparation process.
FROM THE CUSTOMER VOICE
We were able to increase our productivity by 30% in the lab thanks to the ultraWAVE
Dr. Alessandro Lombardi, PQC Manager, NEOTRON Pharma Division
  • Neotron

IMPLEMENTATION of ultraWAVE

“The main reason for equipping ourselves with the ultraWAVE was because of the already large, and still increasing, demand of analyses. We needed a unit capable of handling the expected growth in sample workload due to the upcoming implementation of USP methods <232>/<233>. This led us to seek a microwave digestion system with higher throughput capabilities.” The lab was also attracted to the ultraWAVE due to its ability to digest mixed sample matrices (powders, tablets, liquids, etc.), the ability to use disposable glass vials, and its high temperature and pressure capabilities. In other words, they were drawn to the ultraWAVE’s ability to digest difficult matrices quickly, and to completion.
Although all vials are placed in the reaction chamber together, they are able to achieve good recoveries even for volatile analytes without any indication of cross contamination. Because they run everything from raw materials through API’s to finished products, the flexibility of the ultraWAVE was paramount to them.

ultraWAVE

The ultraWAVE is based on the SRC (Single Reaction Chamber) technology, that achieves extraordinary performance capabilities combining microwave heating with a high-pressure reactor which acts simultaneously as microwave cavity and vessel.
ultraWAVE

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Netron needed an instrument able to provide dependable data integrity: the instrument’s operating software assures full traceability of all operations performed with the system, and is therefore fully compliant with the requirements of 21 CFR Part 11.
Neotron