When a British-Swedish drug firm wanted to upgrade its manufacturing facility, it had no hesitation in choosing Vaisala. The company explains how its environmental monitoring system has improved the production process and made regulatory compliance easier at AstraZeneca's Södertälje plant.
AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines. Its prime focus is the treatment of cancer, as well as cardiovascular, metabolic, and respiratory diseases.
They are one of only a handful of companies to span the entire life cycle of a drug, from research and development, to manufacturing and supply. AstraZeneca's plant in Södertälje, Sweden is one of the largest tablet manufacturing facilities in the world, employing more than 3,200 people.
In 2013, with the goal of increasing the plant's operational efficiency, AstraZeneca decided to automate the facility's environmental monitoring system. The project team carefully evaluated several options. Project manager Mats Andersson said, "We made a careful evaluation of various systems.Vaisala was one of the candidates as we had long experience with their monitoring instruments. We were quite sure their system would fit our needs, and our thorough evaluation proved it was so."
Three key considerations in choosing the monitoring system were the reliability of the measurements, the flexibility of monitoring options, and the possibility to expand and modify the system according to requirements.
"The Vaisala continuous monitoring system is easily scalable without extra costs, increases our efficiency with its remote reading abilities and ease of use, and the measurements are very accurate," says Andersson.
"Having used Vaisala's measurement instruments for several years in the AstraZeneca facilities in Sweden, we trusted their quality."
The system's viewLinc monitoring software was easy to install and use. Since installation, the Södertälje facility has added several more monitoring points to its network of sensors. The system collects data on temperature, humidity and differential pressure.
The monitoring software's flexible reporting capabilities help AstraZeneca continue to meet stringent regulatory requirements by providing complete records in a format that is compliant with 21 CFR Part 11 and Annex 11.
With reports automatically sent by email, or easily generated as necessary, system users can quickly demonstrate compliance to regulators.
The automation of monitoring in the Södertälje facility has resulted in a massive reduction in labour, enabling staff to focus on vital work areas like production, validation, quality assurance and control.
As an added benefit of the monitoring system installation, the Vaisala sensors and software were also used to perform an extensive humidity and temperature mapping study of the environments that required qualification. The data from these studies provided accurate and detailed information on conditions, allowing AstraZeneca to better understand its controlled environments.