Environment Filling

Extensive process simulation (broth fill) results for BFS effectively demonstrate that high levels of sterility confidence can be obtained with a properly configured and validated machine. However, in order to maintain high levels of sterility assurance, it is important that levels of microbial contamination are controlled within the filling environment. 

All finished products are tested for sterility in a controlled-access clean room environment in a laminar flow hood, which provides no greater level of a microbial challenge than that encountered in the fill environment. The testing environment consists of a gowning room and sterility test suite that meets the same air quality standards as the hlling suite. 

The acid hydrolysis of silicates and carbonates that arises from the dissociation of CO2 in solution is known as carbonation (Equations (4) and (5)). Carbonation only occurs in a restricted number of subglacial environments, because ingress of atmospheric gases to these water-filled environments is restricted. It largely occurs in the major arterial channels at low flow, particularly near the terminus, and at the bottom of crevasses and moulins that reach the bed. Sediment is flushed rapidly from these environments, and there is little time for the formation of secondary weathering... 

The closures of BFS containers are formed within the automated process by the head mold set which closes around the top of the severed section of parison following filling. The integrity of the container and closure is generally tested by a manual or automated method of leak detection performed outside of the filling environment following removal of excess plastic (deflashing) from the filled product units. 

The medium or media selected are capable of growing a wide spectrum of microorganisms, including those that would be expected to be found in the filling environment... 

From a surgical perspective, reconstitution or replacement of the connective tissue layers is critical—in the CNS to maintain the fluid-filled environment, and in the PNS to maintain nerve continuity and facilitate regrowth. Similarly, due to relatively small operative spaces and sensitivity of both the CNS and PNS to direct mechanical compression, surgical hemostasis is of paramount importance. In both connective tissue repair and surgical hemostasis, FCM-derived products play a pivotal role. 

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