In regulated industries like the pharmaceutical industry, conditions need to be monitored accurately and traceably. An automated solution saves time, money and effort.
Few industries are as strictly regulated as the pharmaceutical industry. The rigorous regulations aim to ensure the medications we use are safe and effective.
To this end, pharmaceuticals are manufactured, packaged and stored in strictly controlled conditions. These conditions must be continuously monitored and alarmed to allow firms to address possible problems quickly. When necessary, a manufacturer must be able to trace production batches and prove to authorities that the conditions present during production, packaging and storage were within product specifications.
These requirements are one facet of Good Manufacturing Practice, and are followed by pharmaceutical manufacturers around the world.
Peace of mind from automation
How environmental monitoring is implemented is up to the manufacturer. An employee can check measuring devices at regular intervals and manually record the data, or a comprehensive monitoring system can be set up, providing real-time information automatically from the measurement devices.
The automated solution is not only more reliable, it’s faster than an employee walking to each monitoring device, possibly taking hours to make a round. Additionally, staff may be interrupted during device checking, or forget to log the results.
”In the long term, automated systems save money,” says Life Science Expert Piritta Maunu from Vaisala, a manufacturer of measurement and monitoring solutions.
”Even though the initial investment may be high, the system makes the process efficient and better protects sensitive product. Plus, if conditions change, an alarm is sent immediately so the situation can be addressed before the conditions exceed the threshold limits of that product or process.”
In an automated monitoring system the data loggers are placed in different locations of an area. The loggers can measure temperature, relative humidity, carbon dioxide, pressure or other parameters. They send the measurement information to a server, which stores the data.
Should conditions suddenly change, or if pre-set limits are exceeded, an alarm is sent to the personnel responsible via text message or e-mail.
Then staff can quickly see what conditions have changed, and when necessary, fix the problem before damage is done.
”For the user, an automatic monitoring system means security, as they know for sure that the information stored electronically will not disappear,” notes Piritta Maunu from Vaisala.
For example, Vaisala data loggers are battery powered, which ensure the data is immune to power outages. Different levels of alerts contribute to the system’s safety. The system will send a communication alarm if it loses connection, or if someone is trying to tamper with the recorded information saved in the data logger memory, or on the server.
If a computerized system is wanted for conditions monitoring, there are regulations that define what types of systems can be used. For example, in the EU, the use of computerized systems in pharmaceutical manufacturing is laid down in Eudralex Volume 4 – “Guidelines for good manufacturing practices for medicinal products for human and veterinary use, Annex 11: Computerized Systems.”
Transport chain included
Since 2013, regulatory focus has included the transportation of drugs, in addition to their manufacture.
The European Union’s guidelines on the Good Distribution Practice (GDP) of pharmaceuticals requires that all parties in the supply chain be responsible for maintaining drug products within their specified temperature ranges. The new regulation has increased monitoring needs during transportation and intermediate storage.
As with all automated systems, continuous monitoring devices develop constantly. According to Piritta Maunu, a new Vaisala viewLinc monitoring system will be available in 2017. The new system will transfer data wirelessly from the temperature and humidity data loggers to the monitoring system through discrete, proprietary network access points.
The data loggers and access points comprise Vaisala’s proprietary VaiNet wireless protocol. With VaiNet, recorded data is transmitted over distances exceeding 100 meters; which is exceptionally far when compared to a Wi-Fi sensor network.
VaiNet uses sub-GHz frequencies that enable superior signal strength that penetrates concrete walls, metal structures such as shelving, and heavy-duty equipment. The system also does not interfere with other existing Wi-Fi networks, leaving them free of the added load of the monitoring data loggers.
”The new VaiNet wireless technology is for customers who want to monitor their warehouses without adding any extensive cabling or adding new power outlets. “A wireless solution is particularly well suited for companies in the pharmaceutical transport chain,” says Maunu.
The best solution for your environment
Automated monitoring systems can be used to monitor conditions in a wide variety of applications such as museums, data centers, fridges and freezers, aircraft manufacturing and even nuclear power plants – anywhere where the conditions must be controlled and monitored.
There are many different kinds of monitoring solutions. To find the best one for your environment, a little homework is required. There are several considerations when purchasing a system. Firms usually begin by defining their system requirements in a User Requirements Specifications document. This document will answer at least these questions:
- How large is the area to be monitored and how many measurement points are needed? If there are few measurement points and they are relatively close to each other, manual checks may be sufficient. Even then, the value of the products in that space needs to be low, so that a product loss from human error in the manual monitoring process will not incur large costs. If there are many measurement points, or they widely distributed, an automated monitoring system with networked sensors may prove cost effective due to the time and effort saved and added security provided.
- Are the measurement points in a space where cabling is difficult to place, or where cables may be destroyed by foot traffic or equipment? If so, a wireless system is the preferred system.
- How far will the wireless signal have to travel? What are the signal barriers, such as metal shelves, liquids or thick walls? Many wireless solutions require signal amplifiers or repeaters to ensure the data is not lost, however, this added equipment adds a layer of complexity to the system. This can not only add costs, but also make network maintenance awkward.
- Who are the system users? Are they experienced IT staff, or laboratory, or warehouse personnel? Do you need remote access to the system through a browser interface? Or, is the system administration all in one location? What information and reports do the users need to get out of the system?
- How easy is it to expand the system when necessary?
AstraZeneca wanted to tighten its monitoring
To ensure its products are protected during manufacturing, packaging, and storage, Swedish-British pharmaceutical company AstraZeneca maintains strict control over environmental parameters.
In 2013, the company decided to acquire a new monitoring solution for its Södertälje plant. The key considerations for the new monitoring system were the reliability of the measurements, different monitoring options, and the possibility to extend the system according to their needs.
Project Manager Mats Andersson was responsible for the selection and installation project of the system. “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.”
Expansions without any help
The phased project was kicked off in 2014. In the first phase, Vaisala installed and validated their part of the project within one week. After that, AstraZeneca continued with their own validation and other preparations.
In the next phases of the installation project, AstraZeneca added a lot of instruments to the system themselves.
“In a vast facility such as Södertälje, it’s a big benefit that we can add, and especially validate, new instruments by ourselves and expand the system with new and even existing instruments. We have done many extensions since the start of the project,” Andersson says.
After the initial installation for a group of super users, AstraZeneca extended access to the system to other factory personnel. Vaisala’s monitoring system provides permission-based access from any PC on AstraZeneca’s existing network, and the license allows for an unlimited increase of both data loggers and users to the system.
With Vaisala viewLinc monitoring system, AstraZeneca collects information on temperature, humidity, and differential pressure in the production facility.
This information is being used to safeguard product quality. Since the system also fulfills regulatory requirements, AstraZeneca can easily demonstrate their compliance to regulators. Reports are compliant with FDA 21 CFR Part 11, including an audit trail and several graphing and reporting options
“With no need to check the monitoring points manually, we can further increase the efficiency of our operation,” says Mikael Ruda, Associate Director for Maintenance at the Södertälje plant.
Pharmaceutical company AstraZeneca adheres to cGMP (Current Good Manufacturing Practices) and strives to meet or exceed all requirements that ensure purity, safety, and efficacy, from manufacture to final distribution.
AstraZeneca wanted to further improve their monitoring capabilities, for example, by automating the checking of measurement points at its Södertälje plant, which is one of the largest tablet manufacturing facilities in the world.
Conditions need to be monitored to be able to address possible problems quickly.
New regulation has increased monitoring needs during transportation and in intermediate storage.