The growing industry trend is to utilize single-use technologies throughout the biopharmaceutical manufacturing process. In the past couple of years, more clients have asked us to assess implementing single-use technologies into both existing and new designs, with many choosing to combine single-use and traditional stainless-steel systems for hybrid production designs.
On a recent project, we were tasked with evaluating whether installing a single-use flow path from a bulk holding vessel to an aseptic filling machine was beneficial versus the traditional stainless-steel approach. After looking at both process and financial impacts of both options, a single-use transfer line was chosen for the lower capital investment and reduced engineering and validation time required.
We have seen significant advancements in single-use technologies in recent years including single-use mixing systems, bioreactors and larger volume capacities. These developments have expanded our opportunities to implement single-use system designs throughout the manufacturing process which can provide clients with many advantages, both process and financial.
Primary Process Benefits of Single-Use Technologies
- Increased flexibility in the manufacturing process
- Production lines can be used for multiple products without the risk of cross contamination
- Reduced risk of contamination from microorganisms and cleaning residue as single-use systems come pre-sterilized and are disposed of after use
- Improved batch turn-around time and production change-over times, increasing facility throughput
- Overall production operation simplification, increasing efficiency and reducing labor
Primary Financial Benefits of Single-Use Systems
- Lower capital investment (equipment and infrastructure)
- Reduced engineering, building, installation, and validation costs and time
- No need for sterilization-in-place (SIP) and cleaning-in-place (CIP), reducing facility utility requirements for water-for injection (WFI), clean steam and chemical additives up to 30%
- Long-term reduced maintenance time and expenses required to maintain the system
While there are costs associated with single-use waste disposal, studies have shown the reduction in the utilities required outweighs cost for disposal. There are also several programs available that recycle single-use waste and turn it into steam, electrical power or other materials. Implementing single-use technologies also requires us to consider new factors in process design.
What You Need to Know Before Implementing Single-Use Technologies
- Biocompatibility of the materials used in all single-use components with products
- Leachable and extractable data must be carefully analyzed to ensure undesirable components from the single-use components do not enter the final product
- Appropriate measures must be implemented to ensure suppliers are meeting sterilization and cleanliness standards
- Adequate warehouse space must be allocated to store single-use systems
- Quality control will be the responsibility of the single-use system supplier, making them a key player in the supply chain
Adriana Svenjak, Process Engineer – Laporte’s New Jersey office