Integrated processing parameters

To realize a process integrated quality control the conception shown in fig. 2 was followed. The casting process which is influenced by process parameters like thermal economy, alloy composition or black wash will be pursued with particulary to the problematic nature adjusted sensoring systems. On basic factors orientated sensoring systems like microfocus radioscopy, and tomography will be employed and correlated with sensoring systems which can be applicated under industrial conditions. 

If improvements should be achieved by an automation of the inspection process this requires a control of the process parameters of the whole equipment by an integrated "intelligent" system and not by displays still being controlled by the human inspector. This integrated control-system ensures that the inspection conditions are at the highest reproduction level. 

To operate the MPI or LPI equipment at stable and reprodncable inspection conditions modern units are equipped with a monitoring and control system called "Quality Assurance Package" (termed QAP). The QAP System is ba.sed on an industrial PC with a bus system and field sensors. It ensures that process parameters important for the reproducability of the MPI or LPI are controlled an held between defined limits by a central computer system. It can be adapted to any old system, as well as integrated into new systems. 

This paper describes work on equipment and instrumentation aimed at a computer-assisted lab-scale resin prep, facility. The approach has been to focus on hardware modules which could be developed and used incrementally on route to system integration. Thus, a primary split of process parameters was made into heat transfer and temperature control, and mass transfer and agitation. In the first of these the paper reports work on a range of temperature measurement, indicators and control units. On the mass transfer side most attention has been on liquid delivery systems with a little work on stirrer drives. Following a general analysis of different pump types the paper describes a programmable micro-computer multi-pump unit and gives results of its use. 

Allow the tank to achieve steady-state operation in the absence of control (Kc = 0). Use the resulting process reaction curve to estimate combined proportional and integral control parameters. Then use the obtained steady-state values as the initial values for a following sequence of runs. 

The OUR versus time curves for the two wastewater samples constitute the analytical basis to determine the components and the relevant process parameters of the wastewater (cf. procedures number 1 to 3). The mathematical description of the processes in the water phase, Table 7.1, is particularly integrated in procedure 3. The description of the reaeration requires that actual sewer and flow characteristics be available (cf. Section 4.4). 

Data Integrity To demonstrate that records are valid and trustworthy. A record is a combination of raw data and the metadata (processing parameters plus other related information necessary to reconstruct the records) ... 

Development studies, summarized within a distinct report on the physiochemical aspects, drug substance attributes, and finished product characteristics, become critical parts of the validation package. Such data is also valuable for future integration into a manufacturing operation. This includes the scientific rationale for formulating and bulk-handling procedures, lyophilization processing parameters, finished product analysis, and stability requirements. 

How the integrity of quality-related critical process parameters and data will be maintained throughout design, development, and acceptance testing and within the system in its operational use... 

For packages incorporating heat seal adhesives, the attributes of integrity have a direct relationship with the process parameters, process equipment, and packaging materials. Visual inspections are very suitable for production in-process controls of quality assurance. 

In modern freeze-drying systems, the filter integrity test is carried out automatically. All the relevant process parameters are documented by the control system of the unit. The important thing is to make sure that after every integrity test, the filter and the entire piping system are perfectly dry. This is effected by means of the installed liquid ring pump. 

---