Operating Procedures batch

Finally, during the qualification of the facility, all systems are tested, calibrated, and cleaned. The mechanical and service infrastructure must be qualified. The operational qualification will involve practice runs. All documentation must be finalized. This includes standard operating procedures, batch records, and equipment logs. 

Process equipment if there is some other method (signs, operating procedures, batch tickets, etc.) that convey the required information to workers. 

The nature of batch operations (unsteady-state), frequently involving manual intervention, creates significant issues pertaining to the design of control systems, design of operating procedures, and the interaction between the... 

Proper design of equipment, procedures and the work environment can greatly reduce the probability of human error. Designing and maintaining operating procedures is a challenge for batch systems because of the multiplicity of procedures for each piece of equipment, and the variety of operations within... 

If operating procedures need to be developed from scratch, this could account for a considerable portion of the pre-startup work. If current, valid standard operating procedures exist, and the toll is only introducing a new set of batch instructions, the task becomes simpler. However, it is recommended that the new batch instructions are reviewed simultaneously with the existing startup, shutdown, normal and emergency operating procedures for the equipment to help ensure potential process deviations are examined and addressed. 

Batch sheet Sometimes called batch instruction. The operating procedure for making a batch product. Primarily focuses on material quantities, as well as instructions for any mixing, reaction, heating, cooling, diying required for the process... 

Crooks, C. A., and Macchietto, S., A combined MILP and logic-based approach to the synthesis of operating procedures for batch plants. Chem. Eng. Commun. 114, 117 (1992). 

A wide variety of designs and operating procedures exist in the chlor-alkali industry. These vary from once-through to recycle operation with the caustic solution, from continuous to batch addition of the caustic make-up as well as in the means of provision of a back-up reservoir of caustic for containment of chlorine-laden pressure relief and emergency shutdown streams. 

Ridelhoover and Seagrave [57] studied the behaviour of these same reactions in a semi-batch reactor. Here, feed is pumped into the reactor while chemical reaction is occurring. After the reactor is filled, the reaction mixture is assumed to remain at constant volume for a period of time the reactor is then emptied to a specified level and the cycle of operation is repeated. In some respects, this can be regarded as providing mixing effects similcir to those obtained with a recycle reactor. Circumstances could be chosen so that the operational procedure could be characterised by two independent parameters the rate coefficients were specified separately. It was found that, with certain combinations of operational variables, it was possible to obtain yields of B higher than those expected from the ideal reactor types. It was necessary to use numerical procedures to solve the equations derived from material balances. 

Level 1 changes consist of site changes within a single facility where the same equipment, standard operating procedures (SOPs), environmental conditions (e.g., temperature and humidity) and controls, and personnel common to both manufacturing sites are used and where no changes are made to the executed batch records, except for administrative information and the location of the facility. 

Change in batch size, up to and including a factor of ten times the size of the pivotal clinical trial/biobatch, where (1) the equipment used to produce the test batch(es) are of the same design and operating principles (2) the batch(es) is manufactured in full compliance with cGMPs and (3) the same standard operating procedures (SOPs) and controls, as well as the same formulation and manufacturing procedures, are used on the test batch(es) and on the full-scale production batch(es). 

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