Environmental monitoring goes real time

07/01/2002

Future lab management systems could play key role in CFR Part 11 compliance

By Mark A. DeSorbo

FORT WASHINGTON, PA-If the game telephone taught us anything as kids, it's that the story is continually muddled each time it is whispered into another ear.

The same phenomenon may happen if environmental monitoring data is recorded manually; which, in turn, could be problematic if a compliance officer from the U.S. Food and Drug Administration (FDA) should arrive at the door for an inspection of a pharmaceutical or food processing company.

While paper and pens may be the preferred choice for recording environmental data, this economical method is a definite no-no in pharmaceutical and biotechnology cleanrooms, according to current good manufacturing practices (cGMPs), namely the Code of Federal Regulations (CFR) Part 11, which requires electronic records and signatures for environmental monitoring results.

"The problem with the paper-based solution is that you get transcription errors and, in some cases, you would also have a different person entering the data. That's an audit trail problem," says Steven Melick, president of The Sycamore Group, a firm specializing in network and e-commerce infrastructures. "The issues we are trying to resolve are to allow [cleanroom personnel] to re cord the results in real time, using computers to organize the production activities."

Melick, along with Jay Seagren, director of business development, say Sycamore's Laboratory Informa tion Management Systems (LIMS) aims to do just that.

LIMS, Seagren explains, works by directly integrating information with such wireless devices as personal digital assistants (PDAs) so that cleanroom personnel are immediately notified when particle counts exceed allowable limits, tests are invalid or data is missing. Real-time communication eliminates redundant data entry time and reduces the need for subsequent testing while ensuring data integrity and increasing productivity, he says.

"This is a combination of off-the-shelf products and integration services," says Melick. "What we're really offering to companies is a way to auto mate their business process without custom processes. We are not introducing new hardware or software that is proprietary or a product that companies will be making investments on year after year."

According to the company, LIMS, which is still under testing, aims to ensure Part 11 compliance, with data entry by the technician performing the analysis being logged directly into the system. The system also has the capability of providing real-time data validation, increased efficiency as well as 100 percent system availability to technicians.

Melick and Seagren say LIMS can be configured to the pharmaceutical, semiconductor, microelectronics and food product industries.

The idea, Seagren says, was conceived when The Sycamore Group started "a relationship" with a nearby pharmaceutical company, specializing in vaccine production within ISO Class 5, 6 and 7 cleanrooms.

Technicians monitoring production and packaging environments there, he explained, were recording results manually with paper and pens, which was creating productivity as well as cGMP compliance concerns.

"We were discussing some of their automation concerns in their environmental monitoring area, and we spent a fair amount of time determining how we could develop the software to create process efficiency and ensure compliance with cGMP regulations for validation," Seagren says.

LIMS, which allows technicians to assign limits for test volume and achievements, is deployed much like a local area network (LAN), yet is easier to install because a copper cable infrastructure is not needed.

Depending on the size of the facility and any complexities of the integration, Melick and Seagren say companies can expect to pay a minimum of $200,000 for installation.

"This is not a monstrosity, but the cost-savings warrants an investment of this size," Melick adds. "Return on investment within three years is 20 percent, and that does not include cost avoidance from possible FDA fines."