Pharma Manufacturer Saves $50K and Meets FDA Pressure Monitoring Requirements with Wireless System

FDA Pressure MonitoringCleanrooms assure the quality of products in a range of industries, and key among them is pharmaceutical manufacturing. One large manufacturer of generic active pharmaceutical ingredients (APIs) in India, however, addressed the need to meet FDA regulations regarding cleanroom pressure monitoring.

It’s not difficult to appreciate that manufacturing requirements for APIs are stringent. Since the formulated API is going to be used for treating human diseases, and is often a life-saving drug, the efficacy and quality is of much concern. To achieve this, it is imperative to prevent contamination from cross product, external dust, or other issues. Consequently, facility and environmental controls must be the most exacting and robust. Cleanroom facilities with air handling systems are the only solution.

 Within the manufacturing facility, the filtration, drying, and powder processing areas are of critical importance. The powder processing area is equipped with a dust collector, terminal HEPA, and return air riser to ensure the environment is clean. During filtration, product is isolated and dried into a powder form. This powder is further processed for its’ particle size. A suitable environment in the area for temperature and pressure is maintained in the filtration room and powder processing area so that no contamination can travel in the room. The pressure must be maintained so that in the event of a leak, air travels out of the critical areas to the adjacent room and not vice versa. The recent FDA regulation 21 CFR Part 11 requires digital monitoring of cleanroom pressure with respect to the adjacent room atmosphere and requires an audit trail of these records to address data integrity.

 To meet these demands, the company explored traditional wired system options first and discovered it would result in a huge production loss due to the following:

  • Process shutdown of three weeks to complete civil work
  • Area cleaning after completion of civil activity
  • Re-validation and monitoring of at least seven days for particle control and microbial control
  • Total shutdown for up to a month, which would result in lost production and revenue

 Faced with this dramatic potential loss, the company turned to Emerson wireless experts. Emerson provided a unique and innovative solution for a wireless pressure monitoring system, which not only ensured compliance but eliminated a major shutdown of the clean area.

The Emerson system included 165 wireless Rosemount 2051 differential pressure flow transmitters connected through a WirelessHART® mesh network. These replaced 165 mechanical gauges and provide a full audit trail through network communications.

 Amazingly, the system was a plug and play solution with zero modifications or cabling work required. The installing and commissioning of meters was done in three days. There was no need for re-validation of FDA approvals since no site modifications or cabling was involved. The company estimates that it saved $50,000 and avoided a lengthy production shutdown.

More information on Rosemount 2051 wireless DP transmitters can be found here