Responsible Care is the global chemical industry’s environmental, health and safety (EHS) initiative for driving continuous improvement in performance. This article looks at how the pharmaceutical industry can tackle EHS issues with the support of innovative technologies.
by Jens Feddern
The pharmaceutical and biotechnology industries invest more money in research and development than any other sector worldwide, according to the latest EU study . Developing a single new agent takes an average of 12 to 15 years, and the costs frequently exceed $800 million. Moreover, the success rates are extremely low, for only one product out of more than 10,000 promising candidates makes it to the approval stage. Despite these challenges, the pharmaceutical industry continues to invest more and more money in research and development.
In Europe, over 100,000 people employed in the pharmaceutical and biotechnology industries have taken on the mission to find agents to fight current and future diseases, mitigate pain and improve quality of life. Will the real heroes of the 21st century be working in the pharmaceutical industry? This may well be so if we consider the many diseases against which we must battle today and in the future, including cancer, SARS, avian flu, AIDS and MSE. Pharma does indeed have an important – perhaps even the greatest – impact on human survival.
Does the current public image of the pharmaceutical industry reflect its important role? Not really, if we are to believe the image study conducted by Ipsos in the United States, the world’s largest pharmaceutical market, in April 2007 . According to this study, pharmaceuticals lag behind other industries in the imaging ranking at 9th place. Sixty percent of the over 1,000 respondents felt that pharmaceutical companies do not adequately live up to their social and environmental responsibility.
Do good and talk about it: this is the essence of the approach taken by the Responsible Care programme, a global initiative of the chemical industry aimed at continuously improving on environmental impact, health and safety.
Responsible Care is the global chemical industry’s environmental, health and safety (EHS) initiative to drive continuous improvement in performance. It achieves this objective by meeting, and even going beyond legislative and regulatory compliance, and by adopting cooperative and voluntary initiatives with government and other stakeholders. Responsible Care is both an ethic and a commitment that seeks to build confidence and trust in an industry that is essential for improving living standards and the quality of life. The Responsible Care Global Charter arose from an examination of chemical industry practices and performance that have evolved since the mid-1980s, and was shaped by considering the recommendations of independent stakeholders from around the world. The Charter goes beyond the original elements of Responsible Care since its inception in 1985. It also focusses on new and important challenges facing the chemical industry and global society, including the growing public dialogue over sustainable development, public health issues related to the use of chemical products, the need for greater industry transparency, and the opportunity to achieve greater harmonisation and consistency among the national Responsible Care programmes currently implemented. The International Council of Chemical Associations (ICCA), through Responsible Care, will continue to undertake actions consistent with the environmental principles of the United Nations Global Compact .
Health & safety
Health and safety in the pharmaceutical industry broadly covers three areas. One challenge is to continuously maintain the safety of pharmaceutical products. This is why the industry is strictly regulated. Siemens offers a wide range of services for the entire solution spectrum in order to validate production processes, build infrastructure and IT infrastructure, and continuously maintain product quality.
Safety also extends to the environmental hazards that can arise in a lab or in production equipment. In manufacturing vaccines, for example, the building infrastructure must meet very strict standards in order reliably to prevent even minuscule amounts of pathogens from escaping. The recent example of foot-and-mouth disease in England clearly shows how the unintentional release of contaminated water from a lab can affect an entire continent.
In addition, safety encompasses the staff who work in labs and production processes, and are constantly facing the potential danger of coming into contact with toxic substances. Siemens fume hood systems, for example, provide reliable protection for employees. Chemical reactions and the substances used in cleaning pose an additional risk: both can present an increased risk of explosion. With a unique portfolio of solutions for explosion protection applications, Siemens ensures that both production equipment and the building infrastructure operate safely.
Protecting the environment is not optional, it is essential. Responsible Care breaks this requirement down into three areas: waste reduction, emissions into the air and
emissions into water.
Waste reduction is a major challenge, since there can be no quality compromises in production. Only products that fully meet all quality criteria are delivered to the end customer. The processes needed can be extremely complex, and one challenge – especially in biotechnology – is to ensure that results can be reproduced reliably. Eighty to ninety percent productivity is considered to be very successful, which means that 10% to 20% of the products (a value of US $50 billion for the entire industry) must be disposed of as hazardous waste. In a project in Ireland involving the SIPAT solution, Siemens cut quality costs by 13% and helped reduce waste production by 3.5%, which represents a value of €1.8 million.
Vaccine production is largely based on the use of chicken eggs. Every year, the residue of millions of eggs accumulates and up to now has had to be disposed of at great cost. Siemens has developed a patented solution for transforming this waste into flammable gases, which can then be used for environmentally-friendly energy generation.
The pharmaceutical industry may not be known for its dirty smokestacks, but avoiding emissions into the air nevertheless remains a major challenge. A wide range of chemical substances must be removed from the exhaust air of different production processes. With an extensive process analysis portfolio, Siemens solutions not only monitor the successful prevention of emissions, but the company’s broad process know-how helps to successfully optimise combustion processes, among other things.
In addition to air pollution, avoiding emissions in water is an absolute necessity for safe and sustainable operations in the pharmaceutical industry. As a leading supplier of water treatment technology, Siemens has optimised the water treatment systems of countless installations without the use of chemical substances, for example using the patented CEDI electrode-ionisation system.
Use of resources
The Earth has a limited supply of natural resources. This is becoming painfully clear through the rising cost of energy and water. We need to be aware of our resource usage not only strictly for cost reasons, but more importantly because of the impact on the environment in which we live.
Energy consumption today is said to be directly related to the release of CO2 into the atmosphere. In addition to ever rising energy costs, all companies are obliged to substantially lower their greenhouse gas emissions. If we take a look at the energy balance of the pharmaceutical industry, we see that around 65% of the energy consumed is used for heating, ventilation and air conditioning . Ninety percent of this is used for the labs and clean rooms in the production environments; very little is used for air conditioning the executive floors. The purpose of climate control systems is to protect products and staff from all types of contamination. No compromise is tolerated in terms of safety or product quality. However, in a toxicology research centre of a leading German pharmaceutical company, Siemens still managed to cut annual energy costs by over €600,000 and lower the associated CO2 emissions of more than 5,000 tons per year.
Water is the largest component of a pharmaceutical product. Thus water is subject to special purity requirements, and microbiological contamination can occur very quickly if care is not taken. For this reason, conventional water treatment plants run in constant circulation mode. This greatly reduces the danger of contamination, but traditionally this also requires the continuous treatment of much more water than is actually needed. Using the patented S3 technology from Siemens, water is treated only when it is actually needed, which substantially reduces both water consumption and energy demand. As a result, the consumption of highly purified water was reduced by more than 60 million litres per year in a pharmaceutical project in the United States. As part of an ongoing series in "Process News", Siemens will report regularly on the specific solutions and expertise that the company uses to support its customers in all areas of the Responsible Care programme, along with the successes achieved.
1. The 2007 EU Industrial R&D Investment Scoreboard. European Commission,
2. Annabel Evans. Pharmaceutical companies need to raise awareness of their social investments to improve industry’s image. Ipsos 2007; April 11.
3. Responsible Care Global Charter, www. Responsible-care.org
4. Berkeley Labs: Energy Efficiency Improvement and Cost Saving Opportunities for the Pharmaceutical Industry, September 2005.
Global Sector Head,
Life Sciences Market Manager
Siemens Pharma Switzerland