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What we do
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USP 1664
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USP 1664.1
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What we do
E&L
Extractables and Leachables study
GOOD to know I
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2021
2022
2023
E&L case study
FDA 사례연구
MFDS 사레연구
Medical Device 사례연구
USP 1663
BRIFING
PURPOSE
KEY TERMS
SCOPE
BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
EXTRACTION TIME & TEMP
CHARACTERIZING THE EXTRACT
SUMMARY
Example Extractables Profiles—Materials Chara
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
SAMPLE PREPARATION
VALIDATION
LEACHABLES–EXTRACTABLES CORRELATION
SIMULATION STUDYS
INORANIC LEACHABLES
USP 1664.1
INTRODUCTION
KEY TERMS
LEACHABLES ASSESSMENT
DOSAGE FORM TYPES
CONSIDERATIONS
ICH Q3E
Concept
PQRI
PQRI Guidance
PART III Best Practices for E&L Asseessment i
PART III-II Characterization
한국식약처고시
제2022-80호(22년11월)
용기적합성평가(MFDS)
가이드라인
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Container Closure Integrity
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Data integrity
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TUBING SELECTION GUIDE
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
Bio-Simplex®
Final Fill Custom Assemblies
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Saint Gobain
Texcell
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PARIS
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What we do
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Extractables and Leachables study
GOOD to know I
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USP 1663
USP 1664
USP 1664.1
ICH Q3E
PQRI
한국식약처고시
용기적합성평가(MFDS)
USP 665
Medical Device
Contract Service
M4 : The Common Technical Document (CTD)
Impurity
Protein Characterization
Particle
Container Closure Integrity
Cleanning Validation
Nitrosamine
PFAS
Data integrity
Other Service
SAINT-GOBAIN
TUBING SELECTION GUIDE
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
Bio-Simplex®
Final Fill Custom Assemblies
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Saint Gobain
Texcell
Becton Dickinson
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