Lifecycle Engineering

Intrinsic Safety is a protection technique for safe operation of electronic equipment in hazardous atmospheres. The underlying principle is to ensure that the available electrical and thermal energy in the system is always low enough that ignition of such hazardous atmosphere cannot occur. Note that no single component or circuit is intrinsically safe of itself, but only in the context of an overall and properly designed Intrinsic Safety system.

Within life sciences, similar concepts can be deployed:

Intrinsic Quality is a protection technique for quality operation of manufacturing equipment in GMP environments. The underlying principle is to ensure that hazard thresholds within the system are always low enough that the @risk product or specification cannot be compromised. Note that no single component or ‘circuit’ can be said to exhibit intrinsic quality of itself, but only in the context of an overall and properly designed Intrinsic Quality system.
 

The design of the ‘Biopharma Quality Engineering Data Management’ program in the Avenio engine facilitates the portrayal of plant processes in producing safe, pure and efficacious products. The process streams are supported by plant, facilities and systems whose attributes are all individually risk assessed by virtue of their inclusion based on the principles highlighted in ASTM E2500. However this does not in itself guarantee a low risk process as process steps in themselves are interlinked, often interdependent and subject to both individual and collective risk.

As an example a bioreactor as an entity may be designed and engineered to function in accordance with its associated specifications but may be operated incorrectly or fed by a system that in itself was operated incorrectly etc.

As such the process as an entity must be risk assessed, controlled and reviewed using the quality risk management principles defined in ICH Q9. Avenio therefore becomes a vital tool as a risk communication/mitigation vehicle, when used as a system for maintaining and updating process data supplied by process, plant and quality subject matter experts.