SlideShare uma empresa Scribd logo
1 de 30
Process Gas and Compressed Air Systems Gilberto Gonzalez-Rivera QA Advisor IPR Pharmaceuticals, Inc.
Industrial Utilities ,[object Object],[object Object],[object Object],[object Object]
Pharmaceutical Utilities ,[object Object]
Process Gas and Compressed Air ,[object Object],[object Object]
Regulations ,[object Object],[object Object],[object Object],[object Object]
Regulations ,[object Object],[object Object],[object Object]
Regulations ,[object Object],[object Object],[object Object]
Process Gas and Compressed Air ,[object Object],[object Object]
Compressed Gas Uses
Design ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Minumum Requirements
Installation Requirements (IQ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Installation Requirements (IQ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Operational Requirements (OQ) ,[object Object],[object Object],[object Object],[object Object]
Operational Requirements (OQ) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Operational Requirements (OQ) ,[object Object],[object Object]
Operational Requirements (OQ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Performance Qualification ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
System Testing - Pressure ,[object Object],[object Object]
System Testing - Flow ,[object Object],[object Object],[object Object]
System Testing - Purity ,[object Object],[object Object]
System Testing - Hydrocarbon ,[object Object],[object Object]
System Testing – Dew Point ,[object Object],[object Object],[object Object]
System Testing - Particulate ,[object Object],[object Object],[object Object]
System Testing - Microbial ,[object Object],[object Object],[object Object]
Definitions ,[object Object],[object Object],[object Object]
Cleanroom Standards ,[object Object],[object Object],[object Object]
Standards Conversions
Cleanroom Classifications
Compressed Air Systems

Mais conteúdo relacionado

Mais procurados

Validation of hvac
Validation of hvacValidation of hvac
Validation of hvacK Manivannan
 
Cleanroom Qualification
Cleanroom QualificationCleanroom Qualification
Cleanroom QualificationAnwar Munjewar
 
Water system validation by- Akshay kakde
Water system validation by- Akshay kakdeWater system validation by- Akshay kakde
Water system validation by- Akshay kakdeAkshay Kakde
 
Environmental monitoring - nonviable particle testing
Environmental monitoring - nonviable particle testingEnvironmental monitoring - nonviable particle testing
Environmental monitoring - nonviable particle testingJerry Fahrni
 
Good containment practices
Good containment practicesGood containment practices
Good containment practicesSambhujyoti Das
 
Validation utility system
Validation utility systemValidation utility system
Validation utility systemPRANJAY PATIL
 
Validation of dry heat sterilization
Validation of dry heat sterilizationValidation of dry heat sterilization
Validation of dry heat sterilizationDeepak Shanbhag
 
Cleanroom, Classification, Design and
Cleanroom, Classification, Design and Cleanroom, Classification, Design and
Cleanroom, Classification, Design and Ahmadreza Barazesh
 
Risk Issues Environmental Monitoring of Cleanrooms
Risk Issues Environmental Monitoring of CleanroomsRisk Issues Environmental Monitoring of Cleanrooms
Risk Issues Environmental Monitoring of Cleanroomsnetomoney
 

Mais procurados (20)

Hvac part 3
Hvac part 3Hvac part 3
Hvac part 3
 
Validation of hvac system
Validation of hvac systemValidation of hvac system
Validation of hvac system
 
Validation of hvac
Validation of hvacValidation of hvac
Validation of hvac
 
Auditing of hvac by parag
Auditing of hvac by paragAuditing of hvac by parag
Auditing of hvac by parag
 
ENVIRONMENTAL MONITORING
ENVIRONMENTAL MONITORINGENVIRONMENTAL MONITORING
ENVIRONMENTAL MONITORING
 
Environmental Monitoring 2019
Environmental Monitoring 2019Environmental Monitoring 2019
Environmental Monitoring 2019
 
Autoclave
AutoclaveAutoclave
Autoclave
 
Cleanroom Qualification
Cleanroom QualificationCleanroom Qualification
Cleanroom Qualification
 
Presentation of industrial pharmacy 2
Presentation  of industrial pharmacy 2Presentation  of industrial pharmacy 2
Presentation of industrial pharmacy 2
 
Water system validation by- Akshay kakde
Water system validation by- Akshay kakdeWater system validation by- Akshay kakde
Water system validation by- Akshay kakde
 
Environmental monitoring - nonviable particle testing
Environmental monitoring - nonviable particle testingEnvironmental monitoring - nonviable particle testing
Environmental monitoring - nonviable particle testing
 
Good containment practices
Good containment practicesGood containment practices
Good containment practices
 
Validation utility system
Validation utility systemValidation utility system
Validation utility system
 
Validation of dry heat sterilization
Validation of dry heat sterilizationValidation of dry heat sterilization
Validation of dry heat sterilization
 
Cleanroom, Classification, Design and
Cleanroom, Classification, Design and Cleanroom, Classification, Design and
Cleanroom, Classification, Design and
 
Stability pharma
Stability pharmaStability pharma
Stability pharma
 
Presentation of industrial pharmacy 2
Presentation of industrial pharmacy 2Presentation of industrial pharmacy 2
Presentation of industrial pharmacy 2
 
HVAC training 2020
HVAC  training 2020HVAC  training 2020
HVAC training 2020
 
steam sterilization validation
steam sterilization validation steam sterilization validation
steam sterilization validation
 
Risk Issues Environmental Monitoring of Cleanrooms
Risk Issues Environmental Monitoring of CleanroomsRisk Issues Environmental Monitoring of Cleanrooms
Risk Issues Environmental Monitoring of Cleanrooms
 

Semelhante a Validación De Sistemas De Gases De Proceso

Contamination Control in Cleanrooms_Dr.A. Amsavel
Contamination Control in Cleanrooms_Dr.A. AmsavelContamination Control in Cleanrooms_Dr.A. Amsavel
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
 
Sterile products manufacturing
Sterile products manufacturingSterile products manufacturing
Sterile products manufacturingDr. Samia
 
HVAC Validation (Air Handling Units).pdf
HVAC Validation (Air Handling Units).pdfHVAC Validation (Air Handling Units).pdf
HVAC Validation (Air Handling Units).pdfBALASUNDARESAN M
 
Clean Room - A compendium according to approved guidelines.
Clean Room - A  compendium according to approved guidelines.Clean Room - A  compendium according to approved guidelines.
Clean Room - A compendium according to approved guidelines.Md Mosaruf Hossan
 
One slider for qualification and validation of depyrogenation and sterilizati...
One slider for qualification and validation of depyrogenation and sterilizati...One slider for qualification and validation of depyrogenation and sterilizati...
One slider for qualification and validation of depyrogenation and sterilizati...Palash Das
 
Validation utility system
Validation utility systemValidation utility system
Validation utility systemArpitSuralkar
 
Technical Process Instruction Work Sample
Technical Process Instruction Work SampleTechnical Process Instruction Work Sample
Technical Process Instruction Work SampleSharon O'Toole
 
2008 11 25_gmp-an1_en
2008 11 25_gmp-an1_en2008 11 25_gmp-an1_en
2008 11 25_gmp-an1_enDo Thanh Hoan
 
GOOD MANUFACTURING PRAC.pptx microbiology for pharm d
GOOD MANUFACTURING PRAC.pptx  microbiology for pharm dGOOD MANUFACTURING PRAC.pptx  microbiology for pharm d
GOOD MANUFACTURING PRAC.pptx microbiology for pharm dtehseenmalik450
 
Sterile process validation
Sterile process validationSterile process validation
Sterile process validationSagar Savale
 
HVAC for non sterile dosage form
HVAC for non sterile dosage formHVAC for non sterile dosage form
HVAC for non sterile dosage formMoataz Helmy
 
Validation of Heat ventilation air conditioning
Validation of Heat ventilation air conditioningValidation of Heat ventilation air conditioning
Validation of Heat ventilation air conditioningPrashant Tomar
 
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...Công ty Cổ phần Tư vấn Thiết kế GMP EU
 
Qualification of gc equipment by manoj kumar
Qualification of gc equipment by manoj kumarQualification of gc equipment by manoj kumar
Qualification of gc equipment by manoj kumarhimaja donthula
 
Bluon TdX 20 Compared to R-22 Testing Summary
Bluon TdX 20 Compared to R-22 Testing SummaryBluon TdX 20 Compared to R-22 Testing Summary
Bluon TdX 20 Compared to R-22 Testing SummaryBluon Energy
 
Trs 961 (2011) annex 6 - who gmp for sterile pharmaceutical products
Trs 961 (2011)   annex 6 - who gmp for sterile pharmaceutical productsTrs 961 (2011)   annex 6 - who gmp for sterile pharmaceutical products
Trs 961 (2011) annex 6 - who gmp for sterile pharmaceutical productsQC at MinhDan Pharmaceutical
 

Semelhante a Validación De Sistemas De Gases De Proceso (20)

Contamination Control in Cleanrooms_Dr.A. Amsavel
Contamination Control in Cleanrooms_Dr.A. AmsavelContamination Control in Cleanrooms_Dr.A. Amsavel
Contamination Control in Cleanrooms_Dr.A. Amsavel
 
Sterile products manufacturing
Sterile products manufacturingSterile products manufacturing
Sterile products manufacturing
 
HVAC validation.pdf
HVAC validation.pdfHVAC validation.pdf
HVAC validation.pdf
 
HVAC Validation (Air Handling Units).pdf
HVAC Validation (Air Handling Units).pdfHVAC Validation (Air Handling Units).pdf
HVAC Validation (Air Handling Units).pdf
 
Clean Room - A compendium according to approved guidelines.
Clean Room - A  compendium according to approved guidelines.Clean Room - A  compendium according to approved guidelines.
Clean Room - A compendium according to approved guidelines.
 
One slider for qualification and validation of depyrogenation and sterilizati...
One slider for qualification and validation of depyrogenation and sterilizati...One slider for qualification and validation of depyrogenation and sterilizati...
One slider for qualification and validation of depyrogenation and sterilizati...
 
Validation utility system
Validation utility systemValidation utility system
Validation utility system
 
Autoclave validation maliba
Autoclave validation malibaAutoclave validation maliba
Autoclave validation maliba
 
Technical Process Instruction Work Sample
Technical Process Instruction Work SampleTechnical Process Instruction Work Sample
Technical Process Instruction Work Sample
 
2008 11 25_gmp-an1_en
2008 11 25_gmp-an1_en2008 11 25_gmp-an1_en
2008 11 25_gmp-an1_en
 
GMP EU annex 1
GMP EU annex 1GMP EU annex 1
GMP EU annex 1
 
GOOD MANUFACTURING PRAC.pptx microbiology for pharm d
GOOD MANUFACTURING PRAC.pptx  microbiology for pharm dGOOD MANUFACTURING PRAC.pptx  microbiology for pharm d
GOOD MANUFACTURING PRAC.pptx microbiology for pharm d
 
Sterile process validation
Sterile process validationSterile process validation
Sterile process validation
 
HVAC for non sterile dosage form
HVAC for non sterile dosage formHVAC for non sterile dosage form
HVAC for non sterile dosage form
 
Validation of Heat ventilation air conditioning
Validation of Heat ventilation air conditioningValidation of Heat ventilation air conditioning
Validation of Heat ventilation air conditioning
 
Qualification of gc equipment
Qualification of gc equipmentQualification of gc equipment
Qualification of gc equipment
 
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào c...
 
Qualification of gc equipment by manoj kumar
Qualification of gc equipment by manoj kumarQualification of gc equipment by manoj kumar
Qualification of gc equipment by manoj kumar
 
Bluon TdX 20 Compared to R-22 Testing Summary
Bluon TdX 20 Compared to R-22 Testing SummaryBluon TdX 20 Compared to R-22 Testing Summary
Bluon TdX 20 Compared to R-22 Testing Summary
 
Trs 961 (2011) annex 6 - who gmp for sterile pharmaceutical products
Trs 961 (2011)   annex 6 - who gmp for sterile pharmaceutical productsTrs 961 (2011)   annex 6 - who gmp for sterile pharmaceutical products
Trs 961 (2011) annex 6 - who gmp for sterile pharmaceutical products
 

Validación De Sistemas De Gases De Proceso