Training and Equipment
A strong training program that qualifies staff on major process steps, with annual reviews, can be critical in reducing failures. “Successful training includes explanation of the task, successful performance of the task under the trainer’s supervision, successful performance of the task under limited supervision, and a verbal or written test assessing the trainee’s understanding of the task,” Larson states.
Purchasing the right equipment may seem obvious, but according to Larson, “in my experience there have been too many failures because a company did not invest in the correct equipment because it was spooked by the cost. This has been true for everything from large systems all the way down to process hoses.”
According to Colleen Dodson, process engineer at Biogen Idec, batch failures create a significant amount of additional work “ to insure that equipment and transfer lines have been cleaned of the contaminant once it has been identified.”
To combat the costs associated with batch failures she recommends implementing steam-in-place and clean-in-place initiatives, “early on in the purification process, where contamination would probably lead to disposal of the whole batch versus just a portion. Existing processes should be retrofitted with these capabilities if contamination becomes an issue.”
Dodson adds that guaranteeing that processes are automated at all feasible points can help reduce operator errors as well. In addition to automation, “ensuring that batch records are well written and streamlined, so as to not have too much unnecessary information will also reduce operator error.”
This analysis of batch-failure rates quantifies where failures are occurring. With an overall industry failure rate of around 7%, finding better solutions can be a financially responsible activity. Risk-management programs, good training, biting the bullet, and investing in the right equipment upfront, and automating as much as possible can help reduce failures.
When they do occur, initiatives including SIP, CIP, and streamlined records can moderate the effects. The 5th Annual report indicated some secondary reasons for batch failures such as equipment failure and failure to meet product specifications. These may be more difficult to manage, but with proper processes and the right equipment such errors can be minimized.