SlideShare a Scribd company logo

Analytical methods in CleaningValidation.docx

Download as DOCX, PDF
••
M
Markus Janssen

Table of analytical techniques used in cleaning validation

Science
1 of 1
Download to read offline
1
Method Main advantages Limitations Sensitivity Suitability Compound- specific, highly sensitive Method development per compound, time- consuming ppb range Most APIs, high- potency drugs, known detergents Extremely specific (targeted proteins, allergens) Expensive, limited residues Low ng/mL (very high) Biologics, proteins, allergenic APIs Broad, rapid, easy to implement, low running costs Not compound- specific, affected by low solubility 1-50 ppb carbon / nitrogen Diverse/ multiproduct lines, changeovers Simple, quick, low cost Only detects ions, not organic compounds Low µS/cm range Strongly ionic detergents, WFI/cleaning water Fast, cost- effective Only for UV- active residues ppm–ppb range Dyes, colored APIs/cleaners Simple, indicative Non-specific, not quantitative pH unit scale Cleaning agents, acids/bases Microbial detection Slow, not chemical- specific 1-2 cfu/cm² Microbial risk, sterile processing

More Related Content

PPTX
Analytical Profile Index (API) & Automated Machines
Zari Esa M. Saleh
 
PPTX
microbial limit testdfffffffffffffff.pptx
marwakhalifa1991
 
PPTX
Microbiology Laboratory Qualifications and Microbial Testing Techniques
KavitaBhatt14
 
PPTX
AUTOMATION IN MICROBIOLOGY
VaisHali822687
 
PPTX
Automation in bacteriology (dr.sumesh)
SUMESH KUMAR DASH
 
PPTX
Cleaning validation
Vinay Jain
 
PPTX
Automated methods in the microbiology lab
Faris K
 
PPTX
Environmental monitoring
vaibhav16528
 
Analytical Profile Index (API) & Automated Machines
Zari Esa M. Saleh
 
microbial limit testdfffffffffffffff.pptx
marwakhalifa1991
 
Microbiology Laboratory Qualifications and Microbial Testing Techniques
KavitaBhatt14
 
AUTOMATION IN MICROBIOLOGY
VaisHali822687
 
Automation in bacteriology (dr.sumesh)
SUMESH KUMAR DASH
 
Cleaning validation
Vinay Jain
 
Automated methods in the microbiology lab
Faris K
 
Environmental monitoring
vaibhav16528
 

Similar to Analytical methods in CleaningValidation.docx (20)

PPTX
Recent advancement in laboratory techniques
Arunadevi Subramani.B
 
PPTX
Enhancing Volatile Organic Compounds in Water
Shimadzu Scientific Instruments
 
PPTX
GC Agilent .pptx
Mohamad Mukharir
 
PPTX
CLEANING VALIDATION for M.pharm and industry person
abhishek pandey
 
PPTX
seminar on industrial visit by varaprasad padala
Varaprasad Padala
 
PDF
Cleaning Validation in Pharmaceutical Manufacturing - A Regulatory Perspectiv...
Obaid Ali / Roohi B. Obaid
 
PDF
LC-IR Hyphenated Technology For Excipient Analysis-FDA USP Seminars-1-13-2010
mzhou45
 
PDF
Analytical Capabilities
ejmckee
 
PPT
MicroPRO, A Rapid Microbiology Method Based on Flow Cytometry
guest32bcc5
 
PPTX
Cleaning of equipment
Apurvashukla20
 
PDF
Cleaning validation
Alekya Chinki
 
PPTX
My Industrial Training
Abhishek Mishra
 
PDF
SiriusT3 Brochure
Jon Mole
 
PDF
SiriusT3 Brochure
Jon Mole
 
PPTX
Cleaning validation
Indo-Soviet Friendship college of pharmacy,Moga,Punjab,India
 
PPT
Cleaning_Validation of Clean Room Facility.ppt
NorhansaifSherabah
 
PPT
Impurity Analysis Using a New High-Sensitivity UHPLC Detector
Shimadzu Scientific Instruments
 
PDF
High Purity Standards Catalogue 2019
AlexWood93
 
PDF
High Purity Standards Reference Standards Catalogue
Greyhound Chromatography and Allied Chemicals
 
PDF
USDA Lehotay ITSP QuEChERS Chromatographia-2016
Kim Gamble
 
Recent advancement in laboratory techniques
Arunadevi Subramani.B
 
Enhancing Volatile Organic Compounds in Water
Shimadzu Scientific Instruments
 
GC Agilent .pptx
Mohamad Mukharir
 
CLEANING VALIDATION for M.pharm and industry person
abhishek pandey
 
seminar on industrial visit by varaprasad padala
Varaprasad Padala
 
Cleaning Validation in Pharmaceutical Manufacturing - A Regulatory Perspectiv...
Obaid Ali / Roohi B. Obaid
 
LC-IR Hyphenated Technology For Excipient Analysis-FDA USP Seminars-1-13-2010
mzhou45
 
Analytical Capabilities
ejmckee
 
MicroPRO, A Rapid Microbiology Method Based on Flow Cytometry
guest32bcc5
 
Cleaning of equipment
Apurvashukla20
 
Cleaning validation
Alekya Chinki
 
My Industrial Training
Abhishek Mishra
 
SiriusT3 Brochure
Jon Mole
 
SiriusT3 Brochure
Jon Mole
 
Cleaning validation
Indo-Soviet Friendship college of pharmacy,Moga,Punjab,India
 
Cleaning_Validation of Clean Room Facility.ppt
NorhansaifSherabah
 
Impurity Analysis Using a New High-Sensitivity UHPLC Detector
Shimadzu Scientific Instruments
 
High Purity Standards Catalogue 2019
AlexWood93
 
High Purity Standards Reference Standards Catalogue
Greyhound Chromatography and Allied Chemicals
 
USDA Lehotay ITSP QuEChERS Chromatographia-2016
Kim Gamble
 
Ad

Recently uploaded (20)

PPTX
Embark on a journey of cell division and it's stages
sakyierhianmontero
 
PDF
A deep Search for Ethylene Glycol and Glycolonitrile in the V883 Ori Protopla...
Sérgio Sacani
 
PPTX
Hepatopulmonary syndrome power point presentation
raknasivar1997
 
PPTX
Laboratory design and safe microbiological practices
Akanksha Divkar
 
PDF
Renewable Energy Resources (Solar, Wind, Nuclear, Geothermal) Presentation
RimshaNaeem23
 
PDF
NSF-DOE Vera C. Rubin Observatory Observations of Interstellar Comet 3I/ATLAS...
Sérgio Sacani
 
PPTX
Pengenalan Sel dan organisasi kehidupanpptx
SuntiEkaprawesti1
 
PPTX
RED ROT DISEASE OF SUGARCANE.pptx
BikramjitDeuri
 
PDF
JADESreveals a large population of low mass black holes at high redshift
Sérgio Sacani
 
PPT
1a. Basic Principles of Medical Microbiology Part 2 [Autosaved].ppt
separatedwalk
 
PPTX
Cell Structure and Organelles Slides PPT
JesusNeyra8
 
PPTX
The Obesity Paradox. Friend or Foe ?pptx
drdgd1972
 
PDF
A water-rich interior in the temperate sub-Neptune K2-18 b revealed by JWST
Sérgio Sacani
 
PPTX
ANTIANGINAL DRUGS.pptx m pharm pharmacology
46JaybhayAshwiniHari
 
PPTX
Q1_Science 8_Week4-Day 5.pptx science re
AizaRazonado
 
PPTX
Home Garden as a Component of Agroforestry system : A survey-based Study
AkhangshaRoy
 
PPTX
Sleep_pysilogy_types_REM_NREM_duration_Sleep center
muralinath2
 
DOCX
Echoes_of_Andromeda_Partial (1).docx9989
yakshitkrishnia5a3
 
PPTX
Role of GIS in precision farming.pptx
BikramjitDeuri
 
PDF
Migrating Katalon Studio Tests to Playwright with Model Driven Engineering
ESUG
 
Embark on a journey of cell division and it's stages
sakyierhianmontero
 
A deep Search for Ethylene Glycol and Glycolonitrile in the V883 Ori Protopla...
Sérgio Sacani
 
Hepatopulmonary syndrome power point presentation
raknasivar1997
 
Laboratory design and safe microbiological practices
Akanksha Divkar
 
Renewable Energy Resources (Solar, Wind, Nuclear, Geothermal) Presentation
RimshaNaeem23
 
NSF-DOE Vera C. Rubin Observatory Observations of Interstellar Comet 3I/ATLAS...
Sérgio Sacani
 
Pengenalan Sel dan organisasi kehidupanpptx
SuntiEkaprawesti1
 
RED ROT DISEASE OF SUGARCANE.pptx
BikramjitDeuri
 
JADESreveals a large population of low mass black holes at high redshift
Sérgio Sacani
 
1a. Basic Principles of Medical Microbiology Part 2 [Autosaved].ppt
separatedwalk
 
Cell Structure and Organelles Slides PPT
JesusNeyra8
 
The Obesity Paradox. Friend or Foe ?pptx
drdgd1972
 
A water-rich interior in the temperate sub-Neptune K2-18 b revealed by JWST
Sérgio Sacani
 
ANTIANGINAL DRUGS.pptx m pharm pharmacology
46JaybhayAshwiniHari
 
Q1_Science 8_Week4-Day 5.pptx science re
AizaRazonado
 
Home Garden as a Component of Agroforestry system : A survey-based Study
AkhangshaRoy
 
Sleep_pysilogy_types_REM_NREM_duration_Sleep center
muralinath2
 
Echoes_of_Andromeda_Partial (1).docx9989
yakshitkrishnia5a3
 
Role of GIS in precision farming.pptx
BikramjitDeuri
 
Migrating Katalon Studio Tests to Playwright with Model Driven Engineering
ESUG
 
Ad

Analytical methods in CleaningValidation.docx

  • 1. Method Main advantages Limitations Sensitivity Suitability Compound- specific, highly sensitive Method development per compound, time- consuming ppb range Most APIs, high- potency drugs, known detergents Extremely specific (targeted proteins, allergens) Expensive, limited residues Low ng/mL (very high) Biologics, proteins, allergenic APIs Broad, rapid, easy to implement, low running costs Not compound- specific, affected by low solubility 1-50 ppb carbon / nitrogen Diverse/ multiproduct lines, changeovers Simple, quick, low cost Only detects ions, not organic compounds Low µS/cm range Strongly ionic detergents, WFI/cleaning water Fast, cost- effective Only for UV- active residues ppm–ppb range Dyes, colored APIs/cleaners Simple, indicative Non-specific, not quantitative pH unit scale Cleaning agents, acids/bases Microbial detection Slow, not chemical- specific 1-2 cfu/cm² Microbial risk, sterile processing