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The evolution of sophisticated monitoring systems has been accelerated because of stringent EU legislation surrounding the pharmaceutical industry and the escalating demand for preventative maintenance techniques. This article gives an overview of the benefits of implementing these systems in pharmaceutical manufacturing.
The pharmaceutical industry has changed its approach to manufacturing over recent years, moving away from large production facilities to smaller, more flexible areas that can switch from one product to another. This diversity is coupled with a growing scrutiny and control of manufacturing processes by regulatory bodies.
As a result, plant managers in the pharmaceutical industry have an increasingly complex role to play, often having to manage production machine maintenance, oversee building maintenance, produce validation programmes and compile environmental monitoring reports
The need for increased monitoring and control has prompted the development in remote systems to replace standard, local monitoring through on-site systems. Manual inspection of elements, such as temperature, humidity and pressure levels in buildings or laboratories can never be entirely reliable as it is open to human error, individual judgment and the potential for minor mistakes. Local monitoring requires time intensive labour when delivered 24 hours, 7 days a week.
In addition to providing a solution to manpower savings and increasing efficiency, a remote monitoring system can provide significant benefits in the area of preventative maintenance. If expensive pieces of machinery are out of action for any length of time they can lose significant amounts of revenue. One piece of recent research found that one in eight respondents put their annual loss of production because of equipment downtime at over ‚360000 — much of which could have been avoided by using an early warning system.1
Internet-based remote monitoring devices commonly work by being integrated within or installed close to critical assets and equipment, and collecting data on asset and environmental conditions such as temperature and humidity, power outages, water and motion levels. This information is gathered through analogue or digital inputs and transmitted over the Internet via general packet radio service (GPRS), Ethernet or a telephone line at regular intervals to a central server.
Figure 1 Remote monitoring allows real-time data on laboratory status, issues and alerts over wireless connection to email, SMS and Internet-enabled PCs.
On installation the user sets operational parameters on their PC to cover the assets and equipment to be monitored. For example, on a building's air handling unit (AHU), the optimum operative levels are set. Should the temperature level fluctuate outside the pre-determined/desired limits set by the users, the remote monitoring system detects these deviations and acts as an early warning device sending accurate, detailed information about the fluctuations and requesting action to be taken.
Alert notifications can be sent via a short messaging service (SMS) such as text messaging and/or email to named multiple users, such as plant managers, lab staff or security guards, as soon as a fault occurs. This enables personnel to respond promptly and on many occasions, even in advance of a hazard occurring or before the equipment actually fails. Precise status information allows appropriate response actions to be taken more rapidly and effectively. Accessed via a bespoke web page through the Internet, users can access reports and take remedial action by remotely changing any of the settings on their unit and downloading this information to the device.
In the event of power failure, remote systems can also trigger back-up power sources, such as intelligent battery charging, safe battery cut-off or support for solar power — preventing serious materials loss or damage.
Remote monitoring systems are relatively inexpensive to install depending on the specification. There are many opportunities to apply the technology in laboratories, analytical and testing equipment, culture environments, blood banks, and tissue storage facilities. There are distinct advantages in a remote system as, not only does it allow users to view the live status of one or multiple sites from a remote location, but its 24/7 presence helps to:
Pharmaceutical labs handle fragile and in many cases irreplaceable materials, such as proteins, which have taken years of research and trials to cultivate. It is therefore somewhat surprising that the majority of pharmaceutical organizations spend very little on maintenance and monitoring systems that could prevent a terminal failure of equipment. Less than a third of companies invest the majority of their total maintenance budget in this type of preventative action.
But it is not just the time and energy savings that benefits the pharmaceutical sector. Second-generation remote monitoring systems have the ability to acquire data, analyse trends, and provide overview reports of efficiencies and failures.
For those companies that have to demonstrate regulatory compliance to the US Food and Drug Administration (FDA) 21 CFR Part 11, robust records must be kept on all aspects of production and maintenance. 21 CFR Part 820 requires proof of good manufacturing practice (GMP), demonstrating in-depth monitoring and tracking of all the stages of the production process.
Modern systems can provide continuous electronic data collection and logging, with this information and data being automatically sent to a secure web page for historic logging and reporting. Plant managers can view valuable management and asset information of equipment, associated wastage, energy and asset inefficiencies and costs through any Internet connection via easy-to-read graphs and tables.
Off-site engineers and analysts are able to view lab environments in real-time from any location, just by logging on to the Internet. Multiple plants can be compared and contrasted on-screen. Data acquired can then be used to analyse trends in conditions, efficiency, energy usage and wastage — historic records can be provided.
As the systems and equipment used in the manufacture of medicines are highly regulated, there is a need for validation at every stage. High standards of health and safety are required. Rules and guidelines issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission requirements (Directive 91/356/EEC) are exact in the demand for documented evidence of compliance in a number of areas, premises and equipment: production and analysis, documentation, quality control and complaints and product recall.
Efficient remote systems can produce bespoke reports on all the above with the ability to accurately detail deviations and how and when they were responded to and by whom, criteria which has to be lodged to meet the regulations governing the industry.
The life cycle of a drug can be monitored at every stage from research and development to storage.
Research, development and manufacturing. As new drugs go through the research and development process, large volumes of information must be created, managed and filed with regulatory bodies. The information must be stored for significant periods of time. The regulatory agency is required to perform source data verification, check and verify the data collected and manage the data query process.
In a paper system, this is all done on-site with the agency representative seeing the information for the first time and allowing very little preparation to be done in advance.
Queries raised often cannot be resolved during the visit because of time restrictions. Using real-time monitoring of data collected electronically in a web-based system allows issues to be resolved quickly and with relative ease.
Indeed many queries would already have been resolved prior to the agency visit as web-based systems automatically check and request clarification on inconsistent, illogical or missing data. Therefore, in Internet-enabled clinical trials, monitoring is one of the key areas in which the largest time savings and cost savings benefits can be achieved.
However a word of caution about 'web-enabled' systems (which have a unique IP address for each unit); it is more difficult to compare and contrast multiple units, as each page has to be viewed individually. Remote monitoring systems which collect data electonically and send data to a central server, are more effective for compare and contrast activities.
Also, with 'web-enabled' products, if more than a few users are logged in to view information, the unit could potentially crash because of memory capacity shortage, a factor that is eradicated with systems utilising a central server and access via the Internet for information viewing.
Supply chain. A remote system can provide assistance with efficient supply chain/transportation/logistics of chemicals from site to site or to the end user with provable history for each batch. By adding a global positioning system (GPS) modules to a remote monitoring system, it can assist in identification of individual transportation by route.
Storage. To combat the inefficient process of personnel requiring access to archive rooms to take atmospheric readings at specified intervals, a remote monitoring system will do this automatically, sending alerts if the temperature or conditions of a critical asset falls outside predetermined levels/criteria. For remote control, the system can be pre-programmed to turn assets on/off as and when required. This can also be done via the web page.
Infrastructure. Continuous monitoring can be incorporated to analyse the effectiveness and efficiency of equipment such as air conditioning units, creating automatic reports on ambient temperatures to promote ongoing records demonstrating that equipment and buildings are operating within legislative ranges. 24/7 remote monitoring of heating and ventilation systems for example, can help avoid outbreaks of airborne diseases such as legionnaires disease, caused by faulty/damaged equipment.
Monitoring and recording of temperature is an essential part of legislation and by generating reports and recording remedial actions in the case of equipment failure or human error, authorities can have proof of the required level of due diligence in any prospective complaint procedure.
In terms of choice, there are a number of systems in the marketplace with varying specification and installation costs. The most recent models incorporate wireless technology features in the devices. The introduction of wireless capabilities through radio telemetry has altered the monitoring and control industry forever.
Major benefits of this development are the provision of lower installation costs, more efficient and versatile positioning of plants and the greater ease of repair and maintenance. Products using Bluetooth, Zigbee and other wireless protocol are also seeing increasing demand.
Remote systems, which communicate via wireless installation over GPRS, have no requirement to be linked into the ethernet system. They are completely remote from the existing IT infrastructure, which should be welcomed by the IT departments of many companies who are averse to the connection to a 'foreign body' and may have concerns about the additional network traffic.
In addition, systems that communicate via GPRS have an 'always on' approach to asset management. Data can be transferred at high speeds via the mobile Global System for Mobile Communications (GSM) network and coupled with the readily available high-speed broadband Internet access used by the majority home and business users, communications between sites and the office can be more easily accessible and faster.
Additional features to look for are the flexibility of alarm notification routes such as auto-dial out and e-mail. The number of dial outs available on the system should also be considered in line with requirements.
Potential purchasers should also research the data logging and historical record facilities of the equipment as well as the scaleability of the system — can it grow to meet your needs without having to purchase additional units? Does the device come with all necessary software and peripherals? Some devices use costly PC software, which have restrictive licences.
Key advantages to installing a remote monitoring system — the basic cost advantages of preventative maintenance of equipment and systems, reduced labour costs from managing and monitoring remotely and lowering infrastructure expenses. Another huge advantage of a remote monitoring system is that users can view live status of one or multiple sites from a remote location and acquire data, analyse trends and provide overview reports of efficiencies and failures of each asset. This data is critical for helping to meet increasingly stringent regulations and legislations from the EU, FDA and MHRA. However, one of the most significant benefits of all is more simple — peace of mind.
Alan Wilkinson is managing director of T-mac Technologies, UK.
1. Computer-based Maintenance and Management Software, Global Enterprise Asset Management Survey, Intentia, Stockholm (2004).