Advanced Solution for Independent Digital Maintenance and Qualification of Chromatographic Systems

Don’t let equipment maintenance become a cost trap

Regular maintenance of chromatographic systems is intended to ensure that the instruments operate at optimum efficiency and that the separation of substances meets the highest standards. However, the maintenance of chromatographs means a high financial outlay for many laboratories, as it is usually carried out by the equipment manufacturers. In addition to scheduling agreements, a lot of documents and data have to be exchanged between the user and manufacturer sides - resulting in confusing paperwork and organisational efforts.

AIQ Tool allows laboratories to fully automatically perform maintenance and qualification

In order to make maintenance more cost- and time-efficient, AnaTox GmbH & Co KG has added a new feature to its proven AIQ Tool. The qualification software now also allows a standardised maintenance procedure for all system components, which brings significant cost advantages for equipment maintenance. The software automatically recognises the components of the system and lists the corresponding maintenance steps and associated tests. The guided process subsequently reduces downtimes to a minimum. The condition before and after maintenance is clearly documented and digitally stored. With the AIQ Tool, laboratories see themselves in a position to maintain and qualify their chromatographic environment independently and vendor-independently via a single software.

Chromatographic systems are essential for the work of many manufacturers of pharmaceutical products in quality control and laboratories in areas such as life science and food. It is therefore increasingly important that the equipment operates as efficiently, economically and safely as possible. "Regular maintenance is therefore essential not only as preparation for mandatory qualification, but also to help extend downtime and prevent wear and tear on certain components - downtime is an expensive luxury for laboratories too," said Detlef Wilhelm, Managing Director of AnaTox GmbH & Co KG. However, maintenance is often unnecessarily time-consuming, as manufacturers' technicians are usually sent to the laboratory for this purpose. This is sometimes accompanied by a confusing coordination process in which maintenance lists have to be processed and exchanged in paper form. Long-term and clear documentation is difficult simply because of their number. If, in addition, a component change is necessary, the device cannot be used during this time until a technician has carried out the exchange - here, too, the laboratory is dependent on external specialists. Overall, this results in different high costs for the maintenance processes, most of which could be avoided.

The AIQ (Automatic Instrument Qualification) tool from AnaTox GmbH & Co KG provides a remedy. This is a user-friendly, intuitive qualification software for chromatographs, which has now been extended to include a manufacturer-independent maintenance function. This enables the laboratory to perform independent maintenance, which resolves dependencies, facilitates maintenance and at the same time provides legal certainty. All tests can be performed by the laboratory staff (also with appropriate training by AnaTox) - the commissioning of the equipment manufacturer is no longer necessary.

Software guides users step by step through maintenance

As soon as a user connects to the instrument to be serviced, the software automatically determines the status of the chromatograph and lists the necessary maintenance steps. These are manufacturer-compliant and meet the applicable regulations and guidelines concerning the use of this laboratory equipment. Depending on the type and design of the equipment, the necessary functional tests are then carried out on a module-by-module basis. This may include testing for leaks or pump efficiency, for example, but also heating rates of thermostated ovens or detector performance. Users are guided through the process step by step, the actual test procedure and evaluation is done automatically by the AIQ tool. "The program instructs the user in detail when, for example, a component needs to be cleaned or replaced, and the software automatically stores which steps have been carried out, repeated or skipped," explained Wilhelm, describing how the system works. In the latter two cases, the user can enter why this was necessary in a comment function. "The big advantage is that in the course of maintenance, a complete digital documentation is automatically created, which can be used for later comparison or as preparation for qualification," he continued.

An additional advantage of the maintenance tool is the tracking or reading of the chromatograph wear counters. "This data helps customers track how often the equipment has been used and how heavily certain components have been stressed," Wilhelm said. On the one hand, this makes it possible to quickly determine where wear has already occurred. Likewise, the implemented tests can also be used individually for fault diagnosis. In this way, it is possible to order and stock spare parts in a timely manner and at a lower cost, so that replacement can be carried out quickly without having to wait a long time for a technician. Since the laboratory has complete control over the maintenance process, some costs can be saved, arising when the technician performs the equipment inspection and parts replacement. During AnaTox's training courses, which can also performed remotely, users get an impression of which maintenance steps and part changes they can perform themselves.

2-in-1 solution increases the independence of the laboratory from the manufacturer

The driver concept of the AIQ tool uses the direct control of the connected instrument via network for the data communication. All parameters are continuously monitored and the recorded results - including all raw and metadata - are stored in AIQ's own database so that they cannot be manipulated by external access. In addition, the detailed maintenance report also includes the details of the engineer who performed the maintenance, as well as his certificate, which is stored in the database of the AIQ-Tool software, so that complete traceability of the maintenance is ensured at any time. The corresponding module-specific counters are also updated or reset. This ensures that the subsequent qualification with the AIQ Tool can be successfully performed by the user. The reporting thus contains all relevant information on the status of the system. "With the AIQ Tool, laboratories get a 2-in-1 solution that allows them to perform both maintenance and qualification in a fully automated, legally compliant and user-friendly way, making them less dependent on manufacturers and their technicians for maintenance, component care and testing. Maintenance costs can be reduced enormously as a result," concluded Wilhelm.

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