Medeva Pharmaceuticals PA, Inc. - Executive Summary |
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Medeva Pharmaceuticals PA, Inc. (Medeva) is committed to providing and maintaining environmentally sound work conditions with proper engineering controls, equipment, procedures and training to prevent or minimize the impact of unintentional releases of hazardous materials. Medeva has implemented and maintains written accidental release prevention programs intended to reduce the possibility of a hazardous release and to mitigate any release from the facility. These accidental release prevention programs are comprised of administrative and engineering controls dedicated to the facility process. Administrative controls incorporate detailed, process specific standard operating procedures which include start-up, normal operations, temporary operations, safe operating parameters, consequences of deviations, hazard information, special safety precautions, emergency operations and emergency shutdown. Medeva provides extensive training and certification for all employees involved in process operations. Additional administrative controls include the following written programs: Spill Prevention Plan, On-Site Emergency Response Plan, Hazardous Materials Off-Site Response Plan, coordinated with the Northampton County Emergency Management Agency, (LEPC), as well as, Hazard Communication and Process Safety Management of Highly Hazardous Chemicals (PSM) programs. These programs provide employees and responders with detailed instructions and information governing hazardous materials and emergency responses at the facility. Medeva provides initial and refresher training, drills where applicable, and confirmation of understanding relative to these written programs for all affected employees. Engineering controls include dedicated, hard piped material transfer systems, automatic fail-closed and redundant valves, overpressure burst disk protection with audible alarms, emergency stop systems, high and low level detection equipment with alarms and dedicated process vent and emerg ency air pollution control equipment. Routine inspections, preventative maintenance and equipment replacement are also conducted for facility processes. Medeva is located at 3950 Schelden Circle in the Lehigh Valley Industrial Park IV. The Industrial Park is located in the City of Bethlehem, Pennsylvania, in Hanover Township, Northampton County. The exterior grounds of the facility consist of paved parking and driveway areas surrounded by lawn and landscaping. Properties immediately surrounding the facility include another Medeva facility (currently inactive) to the North, Ondra Huyett Associates to the West, and Prestige Gift Box Systems, Corp. to the East. The South side of the property is bounded by a vacant lot. The facility site consists of 3.96 acres occupied by two buildings. One, a single story 26,500 square foot building consisting of offices, manufacturing area, packaging area, laboratory, warehouse and maintenance with an attached, walled, 9,000 square foot concrete utility pad. The utility pad houses the facility refrigeration equipment, raw material storage and air pollution control equipment. The second is a detached, single story, 600 square foot building used for storing flammable liquid raw materials. There are no threshold quantities of flammable liquid materials stored or used anywhere at the facility. Both Medeva buildings are protected by supervised automatic sprinkler systems, emergency alarm pull stations which mobilize fire, police and Medeva facility responders when activated, and security alarms to alert police of unauthorized entry. Medeva currently manufactures and packages two inhalation anesthetic pharmaceutical products, Isoflurane, USP and Enflurane, USP. The facility stores and uses two raw material chemicals in the manufacture of these products above the threshold levels set forth in 40 CFR, Table 1 to Part 68.130. Chlorine (CAS No. 7782-50-5) is received, stored and used in one ton cylinders for reaction steps in the manufacture of the anesthetic products. The facility limits the number of one ton cylinders of chlorine on site to between two and six based upon production levels. These one ton cylinders are received on an as needed basis. Only one chlorine cylinder a time is handled at the facility, and only one cylinder is in use at a time. Anhydrous Hydrofluoric acid (HF) (CAS No. 7664-39-3) is also received, stored and used in one ton cylinders for a reaction step in the manufacture of one of the products. The facility limits the number of one ton cylinders of HF on site to one or two based upon production levels. HF is also received on an as needed basis. No more than one cylinder of HF is handled at the facility at any time, and no more than one HF cylinder is in use at a time. Medeva has reviewed potential releases of these materials as a worst case scenario and also a more realistic alternative scenario using EPA's RMP*Comp program. While a catastrophic chemical release is highly u nlikely due to the engineering and administrative controls is use, the results of this review determined that a scenario involving a release of HF would be the worst case release due to the greater distance HF would travel downwind than chlorine. As the facility never has more than one ton cylinder of HF in use at a time, the release scenario was based on the loss of an entire cylinder, or approximately 1,300 pounds of HF. The release was modeled after a catastrophic failure of the cylinder valve. Under the worst case weather scenario conditions, determined by EPA's RMP*Comp, the release of 1,300 pounds of HF from the facility would travel downwind for 1.8 miles. This 1.8 miles represents the estimated toxic endpoint, or distance the HF might travel before dispersing enough to no longer pose a hazard to the public. A more realistic release, developed as an alternative scenario, indicates an estimated downwind toxic endpoint of 0.6 miles for a catastrophic failure of the cylinder valve. An alternative release for a catastrophic failure of a ton cylinder of chlorine was also reviewed and found to have a toxic endpoint of 0.4 miles. The potential alternative releases described are believed to pose little, if any effect to the public as the facility maintains excellent engineering and administrative controls relative to these processes. Additionally, Medeva is located within an industrial park with limited residential areas within the ranges indicated for alternative releases. Medeva maintains and adheres to specific, detailed handling and use insructions for operating processes which use these hazardous materials. These instructions provide general accidental release prevention through both technological and management policies. Key elements of the prevention program include limiting the quantities and use of these materials, inspection and leak testing prior to use, equipment maintenance, automatic and redundant valves, emergency stops and alarm systems. The facility also maintains special equipment for managing ton cylinder emergencies. Hazard assessments and risk analysis were conducted for the facility as it is subject to and compliant with OSHA's PSM rule relative to these hazardous materials. Additional assessments were conducted for the facility Spill Prevention Plan and Emergency Response Plan. These assessments aid the facility in identifying potentitals for accidental releases and recommendations or corrective actions necessary to further reduce this potential. During the five year period, 1994 through 1999, the facility experienced on accidental release of approximately ten pounds of chlorine. This release occurred on May 24, 1995 and was managed and stopped on-site by facility personnel with no off-site consequences. One employee was taken to the hospital as a precautionary measure, examined and released with no adverse health effects. The facility conducted an accident investigation, and as a result modified operati ng procedures and equipment involved in this process. There have been no subsequent accidental releases of any materials. Medeva has implemented and maintains two emergency response programs. The Facility Emergency Response Plan is an on-site plan designed to aid in the management of a facility emergency. The plan contains detailed information, employee responsibility and actions required, lines of authority and emergency contact information. This plan sets specific guidelines for a variety of emergency contigencies and is rehearsed through unannounced drills. As a part of this plan, the facility emergency alarm system automatically notifies police and fire personnel to respond when activated. As a planning facility, Medeva also maintains a Hazardous Materials Off Site Response Plan with the Northampton County Emergency Management Agency and Hanover Township Volunteer Fire Company # 1. This plan coordinates the efforts, identifies lines of authority and provides contact informa tion for off site responders during a hazardous materials emergency. As part of Medeva's ongoing commitment, improvements in safety are a continuing process. Medeva encourages employee participation amd recommendations for procedural, process and administrative improvements. These recommendations are reviewed, revised if applicable, and implemented where a positive safety benefit analysis exists. The facility is also currently improving the existing preventative maintenance and management of change programs. Other goals for increasing safety include air pollution control equipment upgrades and process equipment improvements. |