Validated cleaning processes maintenance

Facilities and Equipment System This includes (1) buildings and facilities along with maintenance (2) equipment IQ, QQ, calibration, maintenance, cleaning, and validation of cleaning processes and (3) utilities such as HVAC, compressed gases, steam, and water systems. 

The garments used by the workers should be made of synthetic fabrics that minimize contamination risks. Operators should be trained for their work and also for the maintenance of clean conditions and hygiene. Cleaning is a key factor in the maintenance of good conditions and reduces or eliminates potential contaminants that can affect the product. Contaminants can have various sources live particles, inert particles (dusts, glass, file dust, lubricants, etc.) or cross-contamination when different processes or products share the same clean area. To avoid problems, the cleaning procedures should be written and approved, validated, and executed by trained operators. 

This chapter concentrates on the SCADA system and, in particular, its software component. Plant equipment will need process validation, and field instrumentation will require basic qualification such as materials in contact, sterilization and cleaning (if necessary), calibration, and maintenance. 

As will be shown in the following sections 6.2.1, 6.2.2, and 6.2.3 all the main types of processes and techniques of size enlargement by agglomeration (Chapter 5) are being used in the pharmaceutical industry. Characteristic design features are based on what has been discussed above. The equipment is typically small, built from stainless steel, and can be cleaned easily inside and out to avoid cross-contamination. In addition, more and more installations are executed with a physical separation between the (dirty) drives and other mechanical parts that require technical maintenance and the containments that process the charge. Sophisticated control and recording devices are a common part of all systems, in part to satisfy the requirements of process validation. 

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