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  • Publicado : 4 de mayo de 2010
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Validacion Vapor Puro

Los generadores de vapor puro tipo CPS-E son iguales que los CPS pero con calentamiento eléctrico: son diseñados y construidos para producir vapor limpio o puro de acuerdo con las buenas prácticas de fabricación GMP establecidas para la industria farmacéutica por la FDA y la EMEA. Así mismo, las especificaciones técnicas del equipo cumplen completamente con las normativasaplicables: Normativa europea de recipientes a presión (PED), EN 258 (HTM 2010), recomendaciones de la ASME BPE para instalaciones de proceso farmacéutico, marca CE, etc.
The HVAC system
The inspection of the air handling system entailed a visual inspection of the equipment in the
plantroom, measurement of room pressure differentials, checking supply and return grille locations for airflowpatterns, checking qualification documents and drawings. In general the air handling equipment appeared to be in good condition and well maintained. The air handling systems have very basic controls, with no Building Management automated control system. Reliance was largely on maintenance adjustments and re-qualification to ensure adherence to system parameters.
Purified Water (PW) and Water forInjection (WFI) System
The Purified water system and WFI section underwent a cursory inspection following the process through from the raw water input into the system, through to the purified water loop
Pure steam generator:
Pure steam conductivity was checked continuously on-line. Required steam quality should comply with WFI specifications.
Pure steam generator re-qualification was performedannually. The following tests have been performed during the re-qualification:
? Chemical analysis (pH, conductivity and TOC)
? Microbial analysis (Microbial limit test and Bacterial Endotoxins test)
? Non-condensable gases
? Dryness value
? Superheat

Atleast You must qualify the first phase of water system validation and after getting satisfactory results of first phase of water system ,you may conduct PQ of pure steam generator.
Performance Qualification:-
The basic strategy of pure steam generator is to maintain the system under normal operating conditions during which frequent sampling and testing are performed, in order to profile the system. The following tests will therefore be performed once at the use points of pure steam generator. Samples of pure steam will be takeneach day from selected points-of-use over a three consecutive working day schedule. The sites selected will be rotated among all use points so that each point will be tested for pH, conductivity micro-organism, non-condensable gases and Endotoxin during the study.
The performance of each major system component and all user points will be verified during testing. This will be accomplished by samplingthe system for days and performing analyses and microbiological evaluation on these samples.

Test Specification
pH 5.0-7.0
Conductivity < 1.3µS/cm
Micro-organism Absent
Endotoxin 0.25 EU/ml
Non-Condensable gases Non-condensable gases should not exceed 7ml for every 200 ml of condensate collected.

As part of PQ for Pure Steam, we need to do the following tests w.r.t Non-Condensablegases: (Refer EN285 & EN554)

Non-condensible gases
Non-condensible gases result from the water from which the steam is generated. These gases will usually be air, though carbon dioxide may be present, caused by certain water treatment processes, typically water softeners. This is exacerbated by excessive aeration that can exist in many pharmaceutical water treatment plants where water isconstantly recirculated and sprayed into the top of storage vessels. The effect of such gases being present in the steam supply to a sterilizer can be the same as air, none sterilization of the volume they occupy.

Superheated steam
Superheated steam is steam at a temperature above its boiling point for its pressure. Superheated steam is a clear colourless gas that will not condense until its...
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