As more and more pharmaceutical companies launch into new projects, an even greater amount of pharmaceuticals are secreted into the environment. “Sustainability” has become commonplace in operational discussions; however, companies are still working toward that end.
According to statistics reported by WHO, 15 percent of waste generated by health-care activities is considered to be hazardous: infectious, toxic, or radioactive.
Washington State’s Department of Ecology explains the process of direct disposal of these pharmaceuticals:
If disposed of or excreted to the sewer, pharmaceuticals are sent to wastewater treatment plants that offer primary, secondary or tertiary treatment levels. Regardless of the level of treatment, most conventional wastewater treatment cannot effectively eliminate pharmaceutical compounds.
Landfill leachate can contain trace amounts of pharmaceuticals as well. Often this leachate is sent to the same wastewater treatment systems that receive residential wastewater. Pharmaceuticals have been detected in landfill leachate, so disposal of pharmaceuticals at engineered landfills may merely postpone pollution of surface water and ground water.
. . . Many cities, counties and states are struggling to prevent and remove pharmaceuticals in both wastewater and solid waste.
In August 2015, the EPA (Environmental Protection Agency) issued two proposed hazardous waste regulations:
- Management Standards for Hazardous Waste Pharmaceuticals
- Hazardous Waste Generator Improvements
With the proposed regulation scheduled to take effect at some point in 2016, pharmaceutical waste disposal processes at facilities are going to change.
Amrit Chaudhuri, CEO of Mass Innovation Labs, participated in an exclusive Q&A on pharmaceutical waste management. His edited responses are below.
Q: Could you describe the various wastes that pharmaceutical companies produce on a typical monthly or yearly basis?
Chaudhuri: Typical waste streams would include hazardous waste, regulated medical waste, and non-hazardous waste.
- Examples of hazardous waste would include solvent waste from an HPLC unit or expired hazardous chemicals.
- Examples of regulated medical waste would be material contaminated with biological materials.
- Examples of non-hazardous waste that would be disposed of would be any material that a company wants disposed of through means other than putting directly in the trash. This helps to limit potential liability or exposure of material placed into trash or landfills.
Q: What are some of the key areas (or places in the manufacturing process) that often produce a large amount of waste?
Chaudhuri: Manufacturing areas typically generate a lot of solvent waste or non-hazardous waste. The solvent waste is typically a by-product waste from their process or from sterilization of the manufacturing clean space. The non-hazardous waste coming from manufacturing is often material the QA/QC group has tested and found it doesn’t meet their standard for using within manufacturing. Another area that generates large amounts of waste is a research and development laboratory. The R&D lab is working on methods to prove that their concept is viable and as a result a lot of chemicals are used or expire which would result in waste needing to be disposed of.
Q: At present, how do companies typically dispose of this waste?
Chaudhuri: Companies have traditionally utilized strictly waste disposal companies. Our waste disposal company offers us a consulting team, training department, a waste water service and install department, a facility care team, and an on-site services team. They also assist with permitting, training, on site collection of waste, and decommissioning of labs.
Q: What are some of the regulations in place for the disposal of waste?
Chaudhuri: The EPA set the regulation stage on a federal and state level for defining what is considered hazardous waste and needing to be managed as such. The Department of Transportation then has regulations for managing how waste is handled and labeled and the paperwork that follows with it during transportation. Those are two main agencies with applicable regulations that need to be followed.
Q: Are practices of disposing waste significantly different between countries?
Chaudhuri: Yes. For the most part, it depends on how developed the nation or country is. For instance, a developing nation (third or fourth world nation) has a hard enough time trying to meet the basic needs of humanity, let alone try to set standards for proper disposal of waste. However, with more developed countries) there are regulations in place.
Q: What are some of the impacts we are seeing thus far from the disposal of pharmaceutical waste?
Chaudhuri: The main impact is the dramatic reduction in material that would otherwise be landfilled or incinerated.
Q: What are some of the lab designs and facility setup that may be beneficial in managing pharmaceutical waste?
Chaudhuri: Setting up a facility with a Main Accumulation Area (MAA) for waste that allows for the correct waste containers is the first step. By having the right amount of space in the MAA, it allows for consolidation of waste and fewer shipments which increases the organizations profitability. We took this into consideration when building out our facility and it has helped to reduce waste disposal costs. Designs that can be made within the lab would include identifying what type of collection containers will be needed and then building the lab to accommodate space for those containers. In many cases, labs don’t take these considerations into the design build, adding time and money to the collection process.
Q: What are some of the ways that workflow can be altered to better manage pharmaceutical waste?
Chaudhuri: Creating a culture within the lab where workers understand their impact on profitability and exposure of their company is where companies need to start. The lab worker needs to have a basic understanding of the impact of waste on site. Helping employees understand what should actually be captured as hazardous waste versus regulated medical waste versus solid trash is a key factor in waste management. Often, facilities aren’t characterizing their waste the right way.
Q: What are some of the sustainable practices or alternatives that pharmaceutical companies can utilize to help reduce the waste and its impact on the environment?
Chaudhuri: Finding a waste management company that focuses on the company’s needs rather than being just a disposal company is key. Taking the time to review waste streams to ensure everything being shipped is utilizing the greenest solution is a key component of that partnership. In many cases, exploring simple solutions can lead to large savings. One example is ensuring that staff understands proper protocols, with even something seemly as small as a broken thermometer containing mercury. Proper disposal is crucial, and the exposure to the employee and the organization can be detrimental to business continuity.
Q: In the biotech space, what are some of the new developments involving management of waste disposal?
Chaudhuri: Two innovations for managing waste in a biotech space are the recycling of regulated medical waste and a closed loop solvent system:
- Recycling of regulated medical waste: The standard for years has involved landfilling or incineration of regulated medical waste, which goes against our sustainability goals. Our waste management partner, Triumvirate Environmental, owns a facility permitted to recycle this material. This is helping biotech companies achieve goals that they didn’t believe would otherwise be possible.
- Closed loop solvent connection system: Many clients ask to improve the collection of harmful vapors created with the labs. Our partner worked with a manufacturer to create a closed loop system that contains the vapor, resulting in a clean atmosphere for the lab workers.
Q: Are there any trends that are developing in the disposal of pharmaceutical waste?
- Recycling of regulated medical waste
- Recycling of laboratory and manufacturing plastics
- Closed loop solvent system
- Sustainability and product
Q: What are your recommendations to companies looking to re-think the way they dispose of pharmaceutical waste?
Chaudhuri: Take the time to first understand your processes and develop a strong partnership with your waste management company where you can ask questions. It’s important to consider your role in improving environmental sustainability and profitability.