Compliance and safety are paramount to every pharmaceutical business, but the focus for the FM team is especially important. Mike Knapp explains.
The recognition that working with volatile components or in an unstable environment means that the FM teams need to think not only about the health and safety aspects, but also how to incorporate adequate warnings and flags as they operate and maintain research and manufacturing facilities.
Recent figures from Deloitte show that returns on R&D spend are falling: the largest drug companies are seeing a return of just over 3% on their research spend. When you consider that the average cost to bring a drug to market has increased by 30%, pharmaceutical firms are facing a huge challenge.
For the FM team, whether in-house or outsource provider, technological advances may provide the answer. The emerging technologies around artificial intelligence and automation offer significant opportunities within a digitised supply chain.
A wider strategy Investing in new technology should not be seen in isolation. Those leading pharmaceutical industries that are looking to achieve a competitive advantage through technology are looking at integrating technology into a business transformation programme where they address operating models, production processes and supply chain. The facilities team needs to be closely aligned to this work to ensure the technology is complying with health and safety needs, particularly when working in hazardous environments.
One key area for the FM director to consider is Enterprise Asset Management. There are a number of asset management systems, including Oracle, IBM Maximo and SAP, that are used by pharmaceutical and chemical organisations.
The advances in technology mean that combining artificial intelligence (through predictive analytics) and automation within an asset management system can provide a real competitive advantage for these companies. The predictive analytics, or machine-based learning, could provide a health and safety revolution particularly for those organisations using toxic and flammable materials, for example where complex chemical reactions are carried out with significant energy release. By calculating the interaction scenarios between volatile components, it is possible to create a warning system that forecasts issues before they occur.
Being able to work in an explosive environment requires specialist technology to allow an integrated asset management system to function effectively. Many systems do not have adequately robust mobile solutions that allow seamless integration into the main asset management system. This results in a reliance on paper-based processes or off-line mobile solutions that duplicate effort and time.
Having a mobile system that allows engineers and technicians to maintain production lines in a volatile environment has a number of benefits. As well as improving efficiency (through the removal of duplicated entry), it improves health and safety standards. Mobile systems such as Fingertip are now designed to operate in explosive environments, so that engineers can report and work in real-time.
This means that an organisation can have one database rather than a separate asset management system and computerised ATEX system [referring to the EU explosive atmosphere directive]. For the business this means there is only one central database, allowing all reporting and information interrogation to be automated. It also means that the business can be more efficient in replenishing stock, calibrating systems and carrying out planned maintenance.
One company that has seen the value of investing in technology to create a competitive advantage and improve product quality, as well as demonstrating its commitment to health and safety is Guerbet, a major global player in the medical imaging industry. Guerbet Ireland ULC are investing in Fingertip as part of a major upgrade to their existing IBM Maximo system. The upgraded system will deliver Maximo 7.6 with mobile and paperless functionality. Guerbet’s new system will also feature the very latest Fingertip functionality of calibration.
The calibration data will be captured at the instrument on the mobile device and uploaded in real-time to the site’s Maximo database. Meanwhile, the calibration electronic certificate is generated in real-time within the Maximo database while the technician proceeds on to the next instrument.
“What sets Fingertip Calibration apart from any existing calibration system is that it is fully integrated into Maximo. This is a key product differentiator,” explained Brian Doyle, Managing Director Hazardous Risk Solutions, who is leading the development of Guerbet’s Maximo system and project managing the implementation of Maximo 7.6 and the deployment of Fingertip. “One of the key attributes of any asset maintenance management system is all asset related information must be stored within one database. This data must be accurate, secure, up to date in real-time and be available to everyone charged with managing asset integrity and controlling maintenance costs.
“To effectively manage and report on asset performance, it is essential that information is stored in one single easily accessible database. Unfortunately, too often we see companies who have ended up with multiple databases. They have ATEX compliance information, calibration program data and routine maintenance data spread across different independent systems. It makes planning resources and managing costs far more complicated and leads to major inefficiencies,” Doyle said.
Technology becomes reality Advances in technology mean the opportunities for FM are now a reality. Organisations are able to more effectively deal with health, safety and compliance as well as the more complex issues of financial constraints or ageing plant in declining areas, maintaining sufficient process safety competence as skilled workers are lost and the impacts of moving from production to storage.
Regardless of which system is used, though, having an asset management system for the FM team that has a fully integrated mobile solution is key to ensuring that the company is able to address these issues and to gain a competitive advantage in the marketplace.
Mike Knapp is Director at Peacock Engineering Limited.