A chain is only as strong as its weakest link. No matter where this adage is applied – sports, logistics, economies, even families – the idea is that even a small or overlooked facet can compromise the larger collective.
This rings especially true for aseptic processing of fragile biological products in highly controlled current good manufacturing practice (cGMP) environments. You’ve worked long and hard to develop your sample, carefully documenting details along the way. Yet, when it comes to sample workflows performed in a biosafety cabinet (BSC), can you supply relevant written process controls and document appropriate aseptic processing protection for the duration of the activity? Or, do you take your BSC performance for granted until an alert signals a problem or recertification is required?
Without complete BSC data and documentation, a weak link of non-compliance exists that can threaten project timelines, costs, and objectives. This non-compliance may occur because although cGMP requirements protect sample integrity and ensure consistency in the overall process, conventional BSCs lack the capability to adequately document process control and protection measures.
For example, when airflow velocities decline due to the accumulation of captured particles in the high-efficiency particulate air (HEPA) filter, operators are alerted that remedial action is required. No documentation is available to support when the decline started, the extent to which it may have impacted sample safety and quality since the last documented BSC certification, or even the operator’s response to the alert.
Alternatively, the Thermo Scientific™ Herasafe™ 2030i BSC – CTS Series represents a strong link in the aseptic processing chain. A critical difference between this electronically monitored BSC and conventional BSCs is the addition of advanced data collection capabilities to support cGMP requirements. Meticulous electronic monitoring and documentation of ongoing BSC activities, trends, and performance are tracked through three main types of BSC data:
- Performance indication – includes environmental elements that are particularly relevant during aseptic processing of biological products such as air cleanliness, the cabinet’s front edge air barrier flow, velocity data or estimates of motor information, and status changes
- Usage indication – offers a record of operator actions like window position and on/off status of fans, lights, and internal receptacles to support consistency over time
- Lifespan performance indicators – provide a long-term BSC health assessment from motor information to light hours of use to reduce the risk of unplanned downtime.
Electronically monitored BSCs are better positioned than their conventional counterparts to align with cGMP regulations. In addition to preventing issues that could impact safety and quality and simplifying the compliance process, electronically monitored BSCs like the Herasafe 2030i BSC-CTS Series provide a strong link in the aseptic processing chain.
Replace other potential weak links in your chain with Thermo Scientific’s Forma™ Steri-Cult™ CO2 Incubators – CTS Series, Sorvall™ X4 R Pro Centrifuges – CTS Series, CryoMed™ Controlled-Rate Freezers – CTS Series*