Improper handling of bags is a significant contributor to leaks in single-use systems (SUS). It regularly causes significant, often unreported, failure modes (e.g. tearing and punctures) that cause product, supply, product variability and end-user operability problems.
The cost per leak – including investigations, lost time and product losses – ranges from thousands to many millions of dollars.
Unfortunately, formal training methods and practices vary and are influenced by the bag supplier and the design integrity of single-use (SU) assemblies. Also, there is no standard for handling and deploying SUS, and there are different definitions of defects and failure modes.
Reducing the risk of improper handling
This is about to change with the publication of BioPhorum’s SUS bag assembly leakage and defect toolkit, which gives users a set of tools to respond to problems and materials to include in their communications and operator training.
“This toolkit will help build a solid foundation across the industry to better understand how SU assemblies should be handled to reduce avoidable damage and issues, and how to communicate and investigate root causes when such issues do occur,” said Joanna Tong, Senior Technical Manager at Genentech. “It will reduce the learning curve for new sites and employees that are entering the SU space and allow them to avoid some of those hard-learned lessons that many of us have already encountered.”
The toolkit will help reduce product losses, investigations, manufacturing disruptions and the number of leaks. It equips industry with tools to help standardize the vocabulary around SUS anatomy and processes and expand its understanding of SUS abnormalities.
“We hope that the industry uses these documents to collaborate between end-users and suppliers for a successful SU implementation,” said Trishna Ray-Chaudhuri, Principal Technical Manager at Genentech.
The package of toolkit deliverables includes:
- SUS bag assembly anatomy – provides SU components with commonly used names and descriptions
- SUS visual observation library – clearly defined and aligned SU terminology to help investigation communication, accuracy of information and trending of defects
- SU event response checklist – to ensure key information is consistently recorded and communicated internally and with suppliers
- SU leak root cause analysis guidance –a list of questions specific to the use and handling of SU materials that provide guidance for investigations
- Guidance for developing effective bag handling training – training on SUS handling/deployment for manufacturing operators to minimize ‘user error’.
“For end-users, we can expect to see a reduction in process risk due to bag issues caused by improper procedures and handling,” said Joseph Chartier, North America Manager – Applications Specialists at Sartorius. “From vendors, we should see a reduction in formalized, registered complaints. Altogether, this should promote better collaborations, reduced risk, and savings of time and money.”
Bayer case study
The work was driven by research at Bayer and a case study that found that over 10 years, around 80% of SUS bag leaks were within the control of the biomanufacturer not the supplier, and were mainly caused by how operators handled bags.
Bayer employed a strategy to tackle leakage and related investigations, which reduced the number of SUS component leaks from 40% to 0.04% over several years. This was achieved mostly through improved operator handling and eliminating other internal root causes.
“Not only can the toolkit help end-users investigate and prevent leaks from happening,” said Patti Leazott, Technical Consultant, Mobius Disposable Solutions at Merck, “but it should also help suppliers to reduce the number of complaints and the costs associated with them – a true win-win situation.”