This pharmaceuticals facility is situated in a rural area outside the town of Clayton in North Carolina. The insulin vial filling line was approved by the FDA in 1996 and in 1997 approval was received for the insulin cartridges line as well. Human insulin crystals, produced in Denmark, are formulated and filled into vials and cartridges which are then packaged for distribution. The insulin is supplied primarily to the US market. The total number of employees at year-end was 149.

"Our big challenge is to reduce the pH of our waste water. Apart from that, we really have a very clean process here."
Bill Guthrie, Safety and Environmental Coordinator, Clayton, and a member of Novo Nordisk's International Environmental Network.

Major impacts
Clayton maintains four environmental permits issued with regard to our air emissions, waste water discharges, storm water discharges and hazardous waste generation. The supporting processes designed to ensure the integrity of the insulin account for the impact on the environment. These processes include the production of ultra-pure water for injection and for the cleaning and sterilization of product components, the manufacturing area and equipment.

Breaches of regulatory limit values
During 1997, there were 34 breaches of the pH limit. Untreated waste water was discharged direct to the local municipal treatment plant in 1997. It contained strong detergent with a high pH due to potassium hydroxide. In itself, the high pH is not a problem because the treatment plant raises pH as part of the purification process. Nevertheless, it is a breach of the limit and we have worked closely with the local authorities to monitor and address these excursions. To meet regulatory limits, a waste water neutralization system with a capacity of 70,000 US gallons (265 m³) per day has been built (operational on April 1, 1998). We anticipate that the new system will prevent further excursions.

Environmental focus
The current environmental focus is on achieving 100% regulatory compliance and minimizing our environmental impact.

During 1997, a Waste Minimization Committee was established. The committee steers working groups which are addressing solid waste reduction and recycling, chemical waste reduction, energy efficiency, water reuse and reduction, and the reduction of raw materials.

Opportunities to save resources are being identified and prioritized. We expect to make significant gains in the reduction of hazardous waste and water consumption.

The increase in water consumption in 1997 was due to two factors. The first was an increase in vial production and the initiation of cartridge production. Total production volumes more than doubled. The second was the installation of a new WFI (water for injection) still in early 1997. We are currently focusing on improving the efficiency of the still in order to reduce water consumption.

Clayton data

Franklinton, USA