The sponsor has presented plans to address these impacts to ensure that the proposed project will upon implementation of the specific agreed measures, comply with the environmental and social requirements - the host country laws and regulations and the World Bank/IFC environment and social policies and the environmental, health and safety guidelines. The information about how these potential impacts will be addressed by the sponsor/project is summarized in the paragraphs that follow. Further information is provided in the attached documentation.
Environmental and occupational heath and safety management systems.
Since IFC’s first project with the company, Bosnalijek has established comprehensive environmental and quality management procedures which incorporate European Union Good Manufacturing Practice (GMP) Rules and Guidance for Pharmaceutical Manufacturers. An environmental management system has been established, which has been subject to external audit and received ISO 14001 certification in January 2003.
Three member of Bosnalijek’s Quality and Environmental Management Department have been trained as ISO 14001 lead auditors and a total of twenty employees have been trained as environmental auditors and regularly inspect the company’s operations; these audits are supplemented by annual reviews by an external auditor. Around forty environmental aspects have been defined in the Environmental Management System, and an annual environmental investment budget designed to reduce environmental impacts is agreed with the Company’s senior management.
Bosnalijek does not have a policy, though it does have systems for occupational health and safety management. All employees’ health is monitored, semi-annually for those employees who may have contact with pharmaceutical products, annually for drivers and on a three-year cycle for other employees. Procedures have been developed for potentially hazardous activities such as work in confined spaces or electrical maintenance. Material data safety sheets are held for all substances used, and safe working procedures have been defined for each.
Bosnalijek records and investigates all workplace accidents in accordance with local legal requirements, and where appropriate develops work processes to prevent recurrence. Bosnalijek’s workplace lost time accident frequency is very low. Bosnalijek believes that it understands and manages OHS risks in its operation. Nevertheless, Bosnalijek has not undertaken a systematic risk analysis in the manner in which environmental risks were identified, and some examples were seen of unguarded process machinery. Such an audit will be undertaken by November 2005. Bosnalijek will then implement such corrective actions shown necessary and will seek OHSAS 18001 certification of its OHS management system by December 2006.
Emissions to air.
Emissions to air occur from utility systems and from process extraction systems.
Steam for space and process heating is provided by four gas-fired boilers. Air emissions from these are measured regularly and are well within local and IFC requirements.
All process extraction systems are equipped with HEPA filters as required by GMP, thus controlling potential process releases. Spent filters are treated as hazardous waste (see below).
Waste water treatment and disposal.
Process, kitchen-related and sanitary waste waters are generated, and all are discharged to the municipal collector system. There is no effective municipal sewage treatment. Discharges from Bosnalijek meet current Bosnian limits but exceed IFC guidelines from time to time. Process waste water is generated from production plant washing; its volume and contamination is limited by adoption of ultrasonic precleaning and by running multiple batches of the same product. Bosnalijek is constructing separate process and sanitary waste water drains from its current four production buildings housing the development laboratory, ampoules, solid oral forms and ointments/syrups. These process water drains will be combined with process waste water from the new production building and, after a brief monitoring period to verify design assumptions, the combined process water discharge shall be treated to meet IFC requirements for discharge to surface waters.
Kitchen waste water passes through a grease trap before being combined with other sanitary waste water drains. If Sarajevo’s municipal sewage treatment system is not repaired by summer 2006, then Bosnalijek will install systems to treat its sanitary waste water to meet IFC requirements for discharge to surface waters.
Management of solid wastes.
The solid wastes of concern arising from Bosnalijek’s operations are raw material packaging, and pharmaceutical waste comprising, out of specification product, time-expired pharmaceutical products arising within Bosnalijek of collected by Bosnalijek on behalf of local health services, and other materials such as dust, filters and protective clothing which may have come into contact with pharmaceutical products.
Raw material packaging depends on the product. Antibiotics are delivered in blister packs, while other products are delivered in plastic bag-lined cardboard or plastic drums. These plastic liners and drums are landfilled. Bosnalijek will review disposal of the plastic liners and for each, according to the product it contained, will either document that the liner is suitable for landfill or will redefine it as pharmaceutical waste. Bosnalijek will contact its suppliers to investigate the possibility to return the secondary packaging drums for reuse.
All pharmaceutical waste is weighed and then stored in a locked secure warehouse on site. When volume is sufficient, the waste is transported by a licenced contractor to Germany or Austria for thermal destruction in a licensed incinerator.
Hazardous material storage and management.
Bosnalijek has a dedicated flammable chemicals store, which is kept locked and equipped with a carbon dioxide fire extinguishing system. Flammable materials are stored on a concrete surface, but one which does not have any spill containment. This will be built.
Fuel oil, stored as backup boiler fuel, is stored in an above-ground tank which is surrounded by a secondary containment wall.
