Webinar - The Environmental Case for Single-Use Systems

Understanding the Environmental Impact of Single-Use vs. Stainless Steel

01:12–04:55

The webinar begins by examining an important challenge in pharmaceutical and biopharmaceutical manufacturing: environmental impact is not always represented by what is easiest to see.

Plastic waste from single-use systems is highly visible, while the water, steam, energy and infrastructure required to clean reusable stainless steel equipment are much less obvious. However, these operational requirements can contribute significantly to the overall environmental footprint of a manufacturing process.

A complete life cycle perspective considers not only how equipment is manufactured and disposed of, but also all the resources required to operate, clean, sterilize and validate it throughout its working life.

Key takeaway: Comparing single-use and stainless steel systems requires looking beyond visible waste and considering the full environmental impact of manufacturing operations.

Life Cycle Assessment of Single-Use and Stainless Steel Systems

05:02–06:48

The webinar examines a cradle-to-grave Life Cycle Assessment (LCA) comparing a full single-use process train with a fixed stainless steel process train across a 10-batch manufacturing campaign.

The analysis evaluates manufacturing, routine operation and end-of-life impacts at working volumes of 100, 500 and 2,000 liters. Importantly, the stainless steel model includes Clean-in-Place (CIP) requirements between batches.

The study followed the ISO 14040 and ISO 14044 standards for life cycle assessment and underwent third-party critical review, providing a structured framework for comparing the environmental performance of both approaches.

Key takeaway: A full life cycle assessment provides a more complete comparison by accounting for manufacturing, operation, cleaning and end-of-life impacts.

Environmental Benefits of Single-Use Technologies

06:55–09:35

Across the full life cycle evaluated in the study, single-use technology showed a 34% lower global warming potential and a 32% lower cumulative energy demand compared with stainless steel.

During day-to-day operation, the difference increased to approximately 38% for both measures, highlighting the importance of what happens between production batches.

The analysis also evaluated 18 environmental impact categories, considering factors extending beyond carbon emissions to areas such as water depletion, resource use, human health and ecosystem impacts. Single-use systems produced lower impacts across all 18 categories evaluated.

Sensitivity testing was also conducted by changing assumptions including equipment life, transportation distances, fuel mix and recycling rates. According to the webinar, single-use remained the lower-impact option across the scenarios tested.

Key takeaway: The environmental advantage identified for single-use systems extended beyond carbon emissions and remained consistent across multiple environmental indicators and operating assumptions.

Why Cleaning Drives the Stainless Steel Footprint

09:41–11:19

A significant portion of the environmental footprint associated with stainless steel comes from the infrastructure and resources required to clean and sterilize equipment between batches.

Approximately 38–40% of the global warming potential and energy demand identified in the analysis came from supporting systems such as CIP and SIP equipment, process water, clean steam, buffer and media preparation, HVAC and other facility infrastructure.

Cleaning also introduces operational considerations. Equipment must be cleaned, sterilized, tested and released before it can return to production. Failed cleaning validation can require some or all of this process to be repeated, consuming additional water, chemicals, energy and production time.

The webinar cites assessments indicating that equipment downtime can represent around 30% of manufacturing time in some facilities.

Key takeaway: Much of the environmental and operational burden of reusable equipment occurs between batches rather than during production itself.

Reducing Water Consumption Through Single-Use Systems

11:25–13:26

Water consumption represents another major difference between the two manufacturing approaches.

The webinar discusses a peer-reviewed model involving a 500-liter antibody manufacturing process. While both stainless steel and single-use configurations required the same process water, the stainless steel system required substantial additional water and steam for cleaning and sterilization.

Within the modeled stainless steel process, approximately 68% of total water use was associated with cleaning and sterilization. A single cleaning cycle for a 500-liter vessel could require around 1,000 liters of purified water.

Water consumption can also have secondary environmental impacts because water must be produced, purified, heated and eventually treated or disposed of. When potent compounds are involved, some contaminated wash water may require treatment as hazardous waste.

Key takeaway: Eliminating or reducing equipment cleaning can address water consumption at its source while also reducing the energy and infrastructure associated with producing and treating high-purity water.

Putting Single-Use Plastic Waste into Perspective

13:33–15:03

Single-use systems do create plastic waste, and the webinar emphasizes that this impact should not be ignored. However, life cycle assessment places that waste within the context of the entire manufacturing process.

In the assessment presented, producing, sterilizing and transporting single-use components represented less than 5% of total global warming potential. End-of-life disposal contributed less than 1%, even under a conservative scenario assuming hazardous waste incineration without material recovery.

By comparison, the recurring water, steam and energy used to clean reusable stainless steel equipment represented a substantially larger part of the environmental burden.

Key takeaway: Plastic waste remains an important consideration, but evaluating environmental performance requires comparing it against the complete resource requirements of reusable alternatives.

Applying Single-Use Technology to Powder Handling

15:10–16:19

The environmental principles discussed in the LCA can also be applied directly to pharmaceutical powder handling.

Reusable product-contact equipment such as stainless steel IBCs, vessels and rigid isolators must typically move through a repeated cycle of use, cleaning, validation and release.

Flexible containment changes this process by allowing the product-contact path to be removed and replaced. Solutions such as flexible IBCs and single-use isolators can therefore reduce or eliminate cleaning and cleaning validation requirements for those components.

Beyond resource consumption, this approach can help reduce changeover time, water use and the risk of production delays associated with failed cleaning validation.

Key takeaway: Single-use powder handling solutions can simplify the traditional clean, validate and release cycle by replacing product-contact components instead of repeatedly washing them.

The Business Case for Flexible IBCs

16:29–18:09

The webinar then moves from environmental considerations to the financial implications of reducing cleaning requirements.

An ILC Dover comparison evaluates stainless steel IBCs against flexible single-use DoverPac® systems for a process requiring five IBC units per batch across six batches annually.

The example estimates approximately $650,000 in initial capital requirements for the stainless steel approach compared with approximately $108,000 for the flexible IBC route.

The difference extends beyond container costs. Stainless steel systems can require washing equipment, utilities, dedicated floor space and supporting infrastructure, while flexible systems can reduce or avoid some of these requirements.

Key takeaway: Evaluating total cost of ownership rather than container price alone can reveal significant differences in capital and infrastructure requirements.

Case Study: Reducing Hazardous Waste and Downtime

18:18–21:22

A customer example demonstrates how these principles can translate into pharmaceutical manufacturing operations.

An antibody-drug conjugate manufacturer was using fixed stainless steel isolators to handle cytotoxic materials during sampling and material preparation. Cleaning between batches generated hazardous wastewater and required significant equipment downtime.

ILC Dover developed a customized single-use isolator maintaining the required containment performance while eliminating approximately 200 liters of hazardous wastewater per batch.

According to the webinar, batch-to-batch downtime associated with cleaning and QC release was reduced from approximately one week to less than half a shift.

The example also illustrates how recurring cleaning and validation expenses can accumulate as production volumes increase, particularly when additional batches require additional cleaning cycles.

Key takeaway: Removing cleaning and validation steps can create environmental benefits while simultaneously improving production availability and reducing operating costs.

Facility, Infrastructure and Operational Benefits

21:28–23:23

Moving to closed single-use systems can influence more than individual pieces of equipment. It can affect facility design, HVAC requirements, production schedules, water infrastructure and the amount of capital needed to support manufacturing.

Reduced dependence on equipment cleaning can lower demand for processed water and the fixed infrastructure required to generate and distribute it. Closed systems may also support manufacturing strategies that reduce the footprint of highly classified processing areas.

The webinar cites published analyses reporting potential capital savings of up to 75% and operating savings of up to 25% in relevant applications, although the presenters stress that individual workflows should be evaluated independently.

Before choosing between stainless steel and single-use technology, manufacturers are encouraged to consider water consumption, cleaning infrastructure, floor space, HVAC requirements, cleaning validation risks and which product-contact components could potentially be replaced rather than washed.

Key takeaway: The business case for single-use technology extends beyond equipment purchasing to facility infrastructure, production capacity, cleaning validation and total cost of ownership.

Single-Use Solutions Across Pharma and Biopharma

23:29–25:49

The webinar highlights how single-use technologies can be incorporated across pharmaceutical and biopharmaceutical workflows.

Applications include sampling, repacking, reactor charging, drying, milling and pack-off within API and oral solid dose manufacturing. In biopharmaceutical applications, single-use solutions can support raw material sampling, weigh-and-dispense operations and media preparation.

Solutions discussed include EZ BioPac® systems for media and buffer preparation, DoverPac® flexible IBCs for powder handling and containment, continuous liners for contained discharge and pack-off, and drum liners and stability bags for transportation and storage.

By making more product-contact components disposable, these technologies can help eliminate washing requirements and the associated water use, cleaning validation and wastewater generation.

Key takeaway: Single-use technology can address multiple product-contact steps throughout pharmaceutical and biopharmaceutical manufacturing rather than functioning as a single isolated solution.

Flexible Single-Use Isolators for High-Containment Applications

25:58–27:15

Single-use isolators extend flexible containment into operations requiring high levels of operator and product protection.

The webinar discusses systems capable of nanogram-level containment, with configurations that can be adapted to different processes, production environments and space constraints.

ILC Dover's portfolio includes SOLO® ADC isolators for antibody-drug conjugate and high-potency API applications, SOLOLAB® and SOLOFLEX® systems for different manufacturing scales, and SOLOPURE® solutions for aseptic containment.

Their flexible design can also support faster changeovers, easier modification and smaller equipment footprints compared with fixed containment infrastructure.

Key takeaway: Flexible isolators combine single-use product-contact components with adaptable containment to support potent and aseptic pharmaceutical processes.

Evaluating the Full Life Cycle of Your Manufacturing Process

27:15–29:08

The central message of the webinar is that the choice between single-use technology and stainless steel should not be reduced to a simple comparison between plastic and metal.

Instead, manufacturers should evaluate what each system requires throughout its complete operating life, including energy, water, steam, cleaning systems, validation, facility space, labor, downtime and waste disposal.

Understanding these less-visible operational requirements can help manufacturers identify opportunities where single-use technology can improve both sustainability and manufacturing efficiency.

Key takeaway: The most meaningful comparison is not simply single-use versus stainless steel, but the total environmental and operational burden required to keep each system running.

Q&A: Practical Considerations for Adopting Single-Use

29:18–37:54

The Q&A explores several practical questions surrounding life cycle assessment and the adoption of single-use technologies.

The presenters explain that the LCA uses a cradle-to-grave system boundary encompassing material production, manufacturing, transportation, operation and end-of-life treatment across the same 10-batch campaign.

They also acknowledge that single-use technology is not appropriate for every application. Material compatibility must be evaluated carefully, particularly where chemicals or vapors could interact with film materials, and manufacturers need to manage the supply and inventory of consumable components.

For organizations beginning their transition toward single-use manufacturing, the presenters recommend identifying process steps involving frequent cleaning, connections and disconnections, open product handling or elevated containment risk. These areas can provide logical opportunities for an initial trial.

Key takeaway: Single-use adoption should be application-specific, with material compatibility, process risk, cleaning frequency and containment requirements determining where the technology offers the greatest value.

The environmental case for single-use systems goes beyond reducing visible waste. A complete life cycle perspective considers the water, energy, steam, cleaning, validation and infrastructure required to keep manufacturing processes running.

By reducing or eliminating recurring cleaning cycles, single-use technologies can help pharmaceutical and biopharmaceutical manufacturers lower resource consumption, reduce downtime and simplify operations, while potentially reducing capital and operating costs.

Final takeaway: The real question is not simply plastic or stainless steel, but what each system requires across its full operating life.