PERFORMANCE QUALIFICATION OF CLOSURE PROCESSING SYSTEM CUM HPHV STEAM STERILIZER (AUTOCLAVE) PART-1
NAME OF EQUIPMENT: CLOSURE PROCESSING SYSTEM CUM HPHV STEAM STERILIZER (AUTOCLAVE)
MAKE: M/s. MACHIN FABRIK
ABOUT HPHV STEM STERILIZER:
HPHV Steam Sterilizers are critical equipment in pharmaceutical manufacturing, ensuring product sterility and safety. They utilize high pressure and temperature steam to eliminate microorganisms, including spores, from various items like glassware, instruments, and packaging materials. The process involves a series of steps, including preheating, sterilization hold, and drying, to achieve thorough decontamination. HPHV sterilizers are rigorously validated and monitored to maintain consistent performance and meet stringent regulatory standards. Their effectiveness is essential in preventing contamination and ensuring the quality of pharmaceutical products.
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Content
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Protocol Approval
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Objective
Scope
Responsibility & Identification of execution team
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Responsibility and Identification of Execution Team
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Frequency of qualification
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Equipment Description
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Methodology
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Acceptance Criteria
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Records of observations
Discrepancy and corrective action report
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Comilation, review and summary report
Abbreviations
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Definitions
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Annexures
References
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