Sterile operations

Fixed thermocouples shall be located at key sterilizer positions, as justified by the sterilizer operation and control characteristics (i.e., at exhaust or vent line, in recirculation heating medium line, next to controller sensor, as applicable). 

Sterilizer engineering drawings Sterilizer operation procedure Sterilizer sanitization procedure Sterilizer maintenance procedures Sterilizer specification utilization list Distribution thermocouple location diagrams Temperature sensing unit location diagram (continuous sterilizers) Sterilizer process log sheets... 

All distribution runs shall be performed, monitored, and documented in accordance with the respective sterilizer operating procedure. 

Process validation Inspection of the establishment to determine compliance with cGMP requirements and adherence to application requirements is a Field responsibility. CDER may request data to support validation of sterile processing operations for example, environmental monitoring, equipment validation, sterile fill validation, and associated sterile operations. 

Among the techniques discussed, moist heat is the most economical and efficient for the general sterilization requirements of fermentation. Therefore, the following four sections describe cell death kinetics and sterilization operations utilizing moist heat. 

Determine the del factor that pertains to this sterilization operation. The del factor, V, is the natural logarithm of the ratio of no, the original number of bacteria present, to n, the number allowed to remain. Thus,... 

Housekeeping An important component of environmental control are the housekeeping activities utilized to clean the facility external to the controlled environments. Aseptic operations utilize a series of protective environments to protect the sterile field. Controls on the surrounding unclassified areas are an important part of the overall control scheme for sterile manufacturing. These unclassified areas support sterile operations in a variety of ways, and it is important to conduct activities therein that assist in the environmental control. Routine housekeeping, periodic sanitization, and even occasional environmental monitoring may be appropriate to... 

The vacuum test ensures that the sterilization operation does not adversely affect the waterproof status of the freeze dryer. 

Of 16 hospital sterilization operators who had been exposed to ethylene oxide and underwent medical and ocular examinations, 14 had lens opacities and 12 had abnormal contrast vision (an abnormality that is nonspecific to cataracts but which often supports the diagnosis) (16). 

D. Batch plants are easier to clean and maintain sterile operation. 

Issues Sterile operation, narrow particle size distribution (PSD) small mean particle size (20 microns) The final step in a multistep synthesis of imipenem, an injectable antibiotic, is a sterile recrystallization. 

The large crystals that appear in the crystallizer cannot be removed and would cause failure of the dissolution time and PSD specifications. Milling and screening cannot be utilized to break or separate the large crystals because of the realistic restrictions of sterile operation. 

The purpose of this book is to provide a generic format for a Master Validation Plan, also often called a Validation Master Plan (VMP), using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. The intent is to show basic format and samples of contents for all the sections of the plan, because it provides a road map for validation to establish FDA requirements master validation procedures, validation programmes, execution protocols, and resources planning and scheduling. 

Air filtration with ceramic filter, spring loaded, steam sterilizable Peristaltic pumps for low delivery capacity and sterile operation O-ring packings for piping and reactor parts... 

Sterile operation may be unnecessary because rumen conditions select for a very specialized mixed population. 

Many other liquid characteristics must be considered by the designer of an evaporator. Some of these are specific heat, heat of concentration, freezing point, gas liberation on boiling, toxicity, explosion hazards, radioactivity, and necessity for sterile operation. Because of the variation in liquor properties, many different evaporator designs have been developed. The choice for any specific problem depends primarily on the characteristics of the liquid. 

If more than one product is to be sterilized at the same time in the same sterilizer, process validation should be completed for each combination. The lot size in many manufacturing operations is tailored" to sterilizer capacity, and in such instances it should not be difficult to avoid mixed loads. This may be more difficult for contract sterilization operations. Ethylene oxide sterilization con-tractSi should address the validation of mixed loads or prohibit them. Both routes have cost implications. 

Direct methods of measuring gas concentration include gas chromatography and infrared spectroscopy. Both methods are dependent upon small samples, and the problems of drawing these samples should not be underestimated. The location of multiple sample pons should be such that a representative sample of a hopefully homogeneous gas mixture is obtainable. With most sterilizers operating at positive pressures, it is not usually necessary to have any special means of withdrawing the gas, but it is essential to have sample lines heated and insulated to avoid condensation of gas and water between the sterilizer and the analytical instrument. 

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