In late January, close to 400 process analyzer professionals gathered in Phoenix for the 17th International Forum on Process Analytical Chemistry (IFPAC/2003). For reasons internal and external to the analyzer community, this is shaping up to be a watershed year.
Included were representatives of major end-user companies from the petroleum, chemical, pharmaceutical, food processing, and other industries, vendor representatives (instrument manufacturers, components-supplies-services firms), academic practitioners including the two key National Science Foundation-sponsored research centers (CPAC and MCEC), representatives from key national labs (Battelle PNL, Los Alamos, Sandia, Oak Ridge, Argonne) and a range of federal government agencies (FDA, EPA, Army, Air Force, USDA).
This annual meeting, along with ISA Analysis Div.s annual symposium (Calgary April 28-30) and the Pittcon Conference & Exhibit (March 9-14), is "required reading" for those charged with staying on the leading edge of process analytical technology.
Three themes highlighted the conclave:
* Process analytical technology (PAT) is receiving strong regulatory backing from FDA (CONTROL--July 02, p74).
* Modular, standardized analyzer sample systems (NeSSI) are now in their second generation (CONTROL,Aug. 01, p158 & May 02, p74).
* Online and portable analyzers are being applied to homeland security concerns (CONTROL,Feb. 03, p76).
Ajaz Hussain, deputy director of the Center for Drug Evaluation and Research within FDA, presented a regulators perspective on the potential advantages of widespread use of PAT in pharmaceuticals manufacturing. Among his key points: Quality cannot be tested into pharmaceutical products, it results from a quality-oriented process design; and without specific on-stream analytical measurements, final product quality is neither predictable nor controllable in real-time.
While the present empirical approach to current good manufacturing practice (cGMP) results in a generally adequate level of pharmaceutical product quality, it is an inefficient process marked by post-production testing and rejection (or even recalling) of products showing unacceptable quality. FDAs long-term goal is to move toward a science-based approach to cGMP enabling the high-tech pharmaceutical R&D environment to be emulated in the pharmaceutical manufacturing sector.
In encouraging a science and risk-based approach to pharmaceuticals manufacturing, FDA is designing regulatory incentives that include a "research exemption" to allow for continuous improvement without fear of being labeled non-compliant. Pharmaceutical cGMPs for the 21st century will incorporate up-to-date concepts of risk management and scientific insight to promote, not discourage, innovation, to ensure that submission review and inspection are coordinated and synergistic, and to provide for the consistent and effective utilization of resources.
NeSSI Generation 2 moves from 4-20 mA analog signal transmission with explosion-proof or purged packaging toward serial digital data transmission and intrinsically safe (IS) packaging. Under the leadership of Ulrich Bonne of Honeywells Sensing & Control unit (CPAC is providing umbrella leadership to forestall anti-trust problems), a NeSSI subcommittee is formulating a Dept. of Energy grant proposal to allow field testing to demonstrate the feasibility of the concept and expedite the availability NeSSI-compliant components.
DoEs interest is in a standardized approach to a cross-industry measurement problem that promises significant improvements in industrial energy efficiency. A dozen process industry firms have committed to testing NeSSI hardware and sharing their application experience. Four suppliers of sample system hardware are currently on board. Additional participants are being sought.
The overall project is valued at about $2 million, with DoEs funds ($1 million) providing the hardware for 15-20 NeSSI applications, matched by end users technical manpower costs for design, operation and evaluation.
Analytical specialists representing the Dept. of Defense and the U.S. Army held half-day sessions on biological warfare agent detection and chemical warfare agent detection. For chemical agent detection, first responders are being provided with litmus paper that changes color depending upon the specific chemical sensed.
Four mobile laboratories with lightweight (35 lbs.) GC-MS analyzers are being tested. Ultimately, every state is expected to have a mobile unit and a response team.
Days at IFPAC start early, and evening workshops start at 7:30 p.m. and run into the night. Concurrent technical sessions present agonizing choices in many instances, motivating many companies to send multiple delegates. IFPAC/2003 did not disappoint.
Terrence K. McMahon
McMahon Technology Associates
135 Fort Lee Road
Leonia, NJ 07605