News

With its new service offerings, Honeywell is helping customers in FDA-regulated industries address the three-fold challenge of expediting time-to-market, improving operational efficiency and ensuring regulatory compliance. "There is more emphasis than ever today on the environment within which critical-to-quality processes for pharmaceuticals, biotechnology products and medical devices take place," said Ulf Henriksson, President, Honeywell ACS Service. "Conditions such as temperature, humidity, pressure, air particulate levels, human access to certain areas and other factors must be monitored, safely archived and easily retrieved in case of an FDA audit. Honeywell's service expertise and regulatory knowledge, coupled with EBI R300, provides the critical framework."

To ensure this new validation framework meets industry needs, Henriksson says, EBI R300 was developed in collaboration with leading pharmaceutical and medical device manufacturers and endorsed by a top-tier provider of advanced systems and validation services for pharmaceutical manufacturers.
The electronic record and electronic signature capabilities of EBI R300 will help customers fully comply with all relevant FDA guidelines, including those specified in Title 21 Code of Federal Regulations (21 CFR Part 11).
These new guidelines allow manufacturers to replace most paper-based systems for monitoring and documenting adherence to current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) with electronic equivalents.

The Honeywell solution automatically monitors and archives information - including original point values - about environmental factors such as temperature, pressure, humidity and access in research, production and storage areas. When an employee initiates changes in a validated environment, he or she can add notes to the system to explain the reasons for the change. Authorized employees can sign-off on these actions using electronic signatures that comply with 21 CFR Part 11 standards. In addition, all stored information is easily retrieved for historical and reporting purposes.
"Our best-in-class validation framework for environmental control can be expanded into process control to create a true, one-vendor control-and-compliance solution for FDA-regulated manufacturers," said Mr. Henriksson.
For customers, this "one-stop shop" approach translates into lower training costs, increased administrative efficiency, lower operational risk and improved productivity. Commenting on this one-vendor approach, John Blanchard, Principal Analyst, ARC Advisory Group said: "As more and more companies are challenged by limited resources, rapidly expanding technology and commercial, off-the-shelf components, there is a drive toward standardization and a reduction in the number of suppliers and different systems. In pharmaceuticals, this is reflected in a trend toward a single system for both process and environmental control in order to reduce the cost and time to validation, as well as reduce the cost of system training and maintenance."
Mr. Henriksson cited the experience of a top pharmaceutical manufacturer that is currently using Honeywell as its standard platform for HVAC, as well as to monitor research equipment. The company's scientists use data extracted from EBI to submit environmental conditions reports to the FDA with their research findings, reducing manual labor and ensuring cGMP and cGLP compliance.
Honeywell has been providing process and environmental control technology and expertise to health and life science companies for more than 30 years and has more customers in pharmaceutical manufacturing and biotechnology than any other control technology supplier. The company's services and systems are in use at more than 225 pharmaceutical, biotechnology and medical products sites worldwide. Honeywell will begin delivering services based on EBI R300 in July 2003.