Tough Quality Demands at Boehringer Ingelheim microParts
Having a cold is a nuisance: Your nose is running, your throat hurts, and your ears ache from pressure, in other words, your whole body feels miserable. Going to a drugstore and picking up a remedy can be a great relief. But remedies that bring relief are dependent on years of research and development. Only after an elaborate approval procedure does the medication become available to patients on the national and international market.
Such processes are also part of the daily routine of production development at Boehringer Ingelheim microParts GmbH. Boehringer Ingelheim microParts, a technology company located in Dortmund, as a developer and producer of so called microstructure technology, has focused on the area of medicinal technologies since the mid-1990s. In cooperation with other well-known providers of health technology, Boehringer Ingelheim microParts 300 employees are developing innovations in vaporizer technology, micro fluidity, and micro optics.
Many cure and application possibilities available on the health market are based on microstructure technology, as evidenced by Respimat® Soft Inhaler, available on the European market since early 2004. At the behest of Boehringer Ingelheim, a pharmaceutical company active worldwide, Boehringer Ingelheim microParts developed a medicinal vaporizer/inhaler, utilizing a precise jet dispenser structure, which treats respiratory tract ailments and allows for a steady and, at the same time, propellant-free diffraction of a precise dosage of medication. The inhaler allows the patient to receive a soft, slow medicated mist with a high percentage of fine droplets which is easy to inhale. Operating the device is effortless and comfortable.
Since treatment of the patient is the most important aspect of any medical innovation the technology inherent in this ground-breaking inhaler often remains unknown to the average consumer. Similarly, the market for microstructure technology has remained a virtually unknown field, although we encounter innovations produced and developed in this area on an almost daily basis. When the Boehringer Ingelheim microParts corporation began working on its first projects, these projects were aimed at a market that didn’t exist yet as such. Only after developing a new micro jet, did the company begin to focus on the health market, which has become an area where Boehringer Ingelheim microParts presents new developments and products based on its own and customer-specific research.
Major expansion projects that increased Boehringer Ingelheim microParts production area to approximately 17,600 square meters, soon to be increases by 30,000 more square meters, as well as the annual proliferation in profits and employee base by 30 percent, affirm the company’s successful trajectory.
In order to reach the highest standards in development, planning, and deployment and validation of certain machines and processes, including serial productions of micro systems in cleanroom spaces, Boehringer Ingelheim microParts, provider of miniature products, acts completely independent and insists upon retaining the highest possible quality standards:
“In order to become a successful provider for products aimed at the health market, it is essential to set high standards for quality and stick to them,” explains Dr. Stefan Kreuzberger, manager in charge of marketing and sales. “Someone could claim that we produce more paper than products, but the demands of the health market are very high – and with good right! – and they guide all of our actions.”
Dr. Kreuzberger, the communication expert at Boehringer Ingelheim microParts as well as Dirk Burstedde, supervisor for gauge management and CAQ administrator agree that validated processes as well as 100% documenting and retracing make up a vital part of the Westphalian company’s capacities. In order to maintain quality criteria, and in response to attaining certification satisfying DIN ISO 9001 and DIN ISO 13485, Boehringer Ingelheim microParts decided to employ CAQ AG Factory Systems software for quality control. “What began in 1995 with a single module for gauge management has since been expanded into a complete Compact.Net server-based system with unlimited licenses to satisfy the high quality demands of Boehringer Ingelheim microParts”, explains the gauge management supervisor.
Employing a software system with unlimited licenses makes good sense at Boehringer Ingelheim microParts. With 190 registered users and over 110 workstations, the company has a specialist operating in every department to attend to the quality control system. Every specialist can instruct his employees independently as to system possibilities and specifications. Boehringer Ingelheim microParts decided to employ CAQ AG software because of its cost efficiency, an aspect that many CAQ AG customers value. Boehringer Ingelheim microParts compared the possibilities and conditions of the Rheinböllen company with those of other providers. After extensive research Boehringer Ingelheim microParts decided to choose the provider with the best service and price-performance ratio, CAQ AG software. This decision dates back to 1995, and no one has regretted it to date.
“The software has been expanded by several functions last year which we employ and use extensively”, affirms quality specialist Burstedde. “For example, when we realized in 2002 that our Access database potential was fully exhausted, we were able to switch easily to a SQL-based server solution through a simply “switch change”. I am not sure whether other software developers support such a switch as well.”
Data and values acquired at the Dortmund company are impressive. To date, Compact.Net and the expansion modules PMM.Net and QAM.Net control over 1,300 gauges, 220 audits, and nearly 10,000 inspection orders. This makes it necessary to employ the software efficiently and utilize its potential fully. In order to possess the latest innovations in technology and the appropriate know-how to use them, the quality team at Boehringer Ingelheim microParts participates regularly in training sessions.
As part of TSP (Top Service Pack) the Hunsrück software company frequently offers free training, continuous software updates, a dedicated service hotline, and service at the customer location. In this way, experts at Boehringer Ingelheim microParts can create their own configurations and special forms as well as integrate them effortlessly into the existing system. Ergo, it has become clear that Compact.Net will remain the right choice and part of the future growth at Boehringer Ingelheim microParts.