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Extractables & Leachables
For Pharma
USP <661-665>
USP <1663-1664>
Accelerated Aging Studies
Elemental Impurities
Method Development
Method Validation
CCIT
Leak Detection Technologies
Laser-Based Gas Headspace Analysis
High Voltage Leak Detection (HVLD)
Vacuum Decay Testing
Cryogenically-Stored Products
Deep-Cold and Ultra-Cold Stored Products
ICH Stability and Sample Storage
Residual Seal Force (RSF)
Shipping Studies
Particulate Analysis
USP 788 Particulate Matter in Injections
USP 790 Visible Particulates in Injections
Contamination Control and Source Determination Investigations
Difficult-to-Inspect Parenteral (DIP) Products
ID Testing for Visible Particle Defects and Foreign Particulate Matter
Release Testing for USP 787, 788, 789; EP 2.6.20; JP 6.07
Rinse Studies for Primary Containers, Closures, Ready-To-Use (RTU), and Single-Use Systems (SUS) Products
Glass Delamination
USP 1660 Glass Delamination Screening and Testing
Glass Inner Surface Analysis
Extracted Elements in Solution
Lamellae and Visible and Subvisible Glass Particles
Aggressive Screening Conditions Studies
Screening Strategy for Drug Products and Glass Vials
Early Predictive Screening Studies
Functional Testing
USP 382
Break Loose Glide Force
Container Closure Integrity Testing (CCIT)
Needle and Spike Access Functional Suitability Tests
Packaging & Delivery System Integrity Tests
Plunger Functional Suitability Tests
Residual Seal Force (RSF)
Tip Cap and Needle Shield Functional Suitability Tests
Medical Device Analysis
Early-Phase Development
Resources
About Gateway Analytical
Accreditations & Certifications
Articles & Publications
Brochures
Career Opportunities
Case Studies & Webinars
Conferences & Events
News & Press Releases
Posters & Presentations
Contact An Expert
CONTACT
Home
Extractables & Leachables
For Pharma
USP <661-665>
USP <1663-1664>
Accelerated Aging Studies
Elemental Impurities
Method Development
Method Validation
CCIT
Leak Detection Technologies
Laser-Based Gas Headspace Analysis
High Voltage Leak Detection (HVLD)
Vacuum Decay Testing
Cryogenically-Stored Products
Deep-Cold and Ultra-Cold Stored Products
ICH Stability and Sample Storage
Residual Seal Force (RSF)
Shipping Studies
Particulate Analysis
USP 788 Particulate Matter in Injections
USP 790 Visible Particulates in Injections
Contamination Control and Source Determination Investigations
Difficult-to-Inspect Parenteral (DIP) Products
ID Testing for Visible Particle Defects and Foreign Particulate Matter
Release Testing for USP 787, 788, 789; EP 2.6.20; JP 6.07
Rinse Studies for Primary Containers, Closures, Ready-To-Use (RTU), and Single-Use Systems (SUS) Products
Glass Delamination
USP 1660 Glass Delamination Screening and Testing
Glass Inner Surface Analysis
Extracted Elements in Solution
Lamellae and Visible and Subvisible Glass Particles
Aggressive Screening Conditions Studies
Screening Strategy for Drug Products and Glass Vials
Early Predictive Screening Studies
Functional Testing
USP 382
Break Loose Glide Force
Container Closure Integrity Testing (CCIT)
Needle and Spike Access Functional Suitability Tests
Packaging & Delivery System Integrity Tests
Plunger Functional Suitability Tests
Residual Seal Force (RSF)
Tip Cap and Needle Shield Functional Suitability Tests
Medical Device Analysis
Early-Phase Development
Resources
About Gateway Analytical
Accreditations & Certifications
Articles & Publications
Brochures
Career Opportunities
Case Studies & Webinars
Conferences & Events
News & Press Releases
Posters & Presentations
Contact An Expert