Gateway Analytical was founded around the identification of foreign and unknown particulate matter in pharmaceutical products. That forensic foundation gives us a uniquely investigative understanding of how drug formulations, packaging materials, container-closure systems, components, and processes interact.
Today, we apply this expertise across particulate investigations, container closure integrity, subvisible particle characterization, and packaging component functional suitability.
Investigate the Evidence Solutions Behind Product-Quality Risk
How We Power Power Your Lab Results:
- Investigate Unexpected Findings
- Understand Potential Sources & Causes
- Evaluate Product-Package Interactions
- Interpret Analytical Results
- Support Scientifically Defensible Decisions
Accelerating Medicine Your Journey Tomorrow Together
Subvisible Particle Characterization & Product Insight
Go beyond particle counts to understand the population
Particle counts can indicate that something changed, but it may not explain what changed, why it changed, or what the particle population means for a biologic or complex formulation.
Gateway Analytical combines compendial particle testing with orthogonal characterization to help customers evaluate particle concentration, size, morphology, composition, behavior, and potential source.
- Flow Imaging Microscopy
- Light Obscuration
- Microscopic Particle Counting
- Particle Morphology & Classification
- Silicone Oil & Proteinaceous Particle Evaluation
- Intrinsic & Extrinsic Particle Differentiation
- Biologics Formulation & Stability Studies
- Release & Stability Testing for USP
Packaging Component Functional Suitability
Demonstrate that components and delivery systems perform as intended
Packaging components must perform reliably under compendial requirements and product-specific conditions. Gateway Analytical evaluates the mechanical and functional behavior of elastomeric components, container-closure configurations, and parenteral delivery systems.
Our particulate and package interaction experience provides an important perspective when performance, material behavior, component interfaces, or system configuration may contribute to an observed issue.
- USP Funtional Suitability
- Needle Penetration
- Needle Self-Healing Capacity
- Spike Access & Penetration
- Residual Seal Force
- Break-Loose & Glide Force
- Tip-Cap & Needle-Shield Removal
- Pull-Off Force, Torque, Compression, & Displacement
- Custom Force-Profile Testing
Particulate Risk Investigation and Root-Cause Resolution
Identify the unknown. Narrow the source. Move the investigation forward
A visible or foreign particle can place product release, complaint closure, regulatory response, and patient confidence at risk.
Gateway Analytical identifies, characterizes, compares, and interprets particulate-related data to help determine what the particle may be, where it may have originated, and what the findings mean for the investigation.
- Visible & Foreign Particulate Identification
- Complaint & Deviation Investigations
- Recurring Particulate Issues
- Defect & Reference Libraries
- Intrinsic, Extrinsic, & Inherent Particle Evaluation
Container Closure Integrity & Package Performance
Select the right integrity approach for the product and package
Container closure integrity depends on more than selecting an available technology. The method must fit the product formulation, container configuration, closure system, potential leak mechanism, and study objective.
Gateway Analytical combines deterministic CCIT technologies with an investigative understanding of package materials, components, interfaces, and product-package interactions.
- CCIT Method Selection & Feasibility
- Vacuum Decay
- High-Voltage Leak Detection
- Laser-Based Headspace Analysis
- Vials, Prefilled Syringes, & Cartidges
- Flexible or Difficult-to-Inspect Configs
- Shipping, Cold-Chain, & Lifecycle Studies
- USP Support
Explore the Investigative Difference from Gateway Analytical
Precision Analytical Testing Through the Lens of Pharmaceutical Forensics
Gateway Analytical was built to investigate foreign and unknown particulate matter, not to operate as a general laboratory dabbling in particle identification while focused on a broad testing portfolio. Investigating particulate matter requires more than identifying a material. Gateway Analytical conducts tests through the lens of pharmaceutical forensics, connecting analytical findings with product, package, material, and process context. This requires understanding the relationships among:
- Drug Formulations
- Glass, Elastomers, Polymers, Metals, & Other Materials
- Container-Closure Systems
- Packaging & Delivery-System Components
- Manufacturing & Filing Processes
- Component Interfaces & Mechanical Behavior
- Product Storage, Shipment, & Use Conditions
What are you trying to solve?
You do not need to know the right test before contacting Gateway. Start with the observation, event, or decision creating uncertainty. Our scientists can help identify the analytical path that fits your product, package, and objective.
We found visible particles in our product.
Identify and characterize the particulate matter, explore potential sources, and determine the next investigative step.
We need to investigate a complaint or deviation.
Develop an evidence-based approach to characterize the observed defect or to support a complaint, deviation, or regulatory response.
We have a recurring particulate issue.
Compare findings across batches, processes, materials, or sites to identify patterns and narrow potential sources.
We need to select a CCIT method.
Evaluate the product, package, closure system, leak mechanism, and study objective to determine appropriate method fit.
Particle counts are not explaining our biologic.
We use imaging, morphology, and orthogonal analysis to develop a more complete view of the particle population.
We need to demonstrate USP functional suitability.
Evaluate the functional performance of elastomeric components and parenteral packaging or delivery systems.
Analytical Evidence Across the Product Lifecycle
- Development and Formulation
- Package and Component Selection
- Method Selection and Validation
- Process and Package Qualification
- Release and Stability
- Shipping and Cold-Chain Evaluation
- Supplier, Material, & Component Changes
- Complaint and Deviation Investigations
- Recurring Defect Prevention
- Regulatory Response & Continued Assurance
Analytical Evidence Requires Interpretation
Precision Analytical Testing Through the Lens of Pharmaceutical Forensics
The Analytical Approach from Gateway Analytical
Pharmaceutical Forensics Expertise
Microscopy and Spectroscopy
Particle Morphology and Composition
Product-Package Interaction Knowledge
Mechanical and Functional Testing
GMP-Centered Study Execution & Reporting
Looking for Clarity on Product-Quality Decisions?
Ensure drug product and medical device safety through our pharmaceutical forensics approach to evidence, study design, interpretation, and decision support for pharmaceutical and medical device companies across the globe.
Biologics & Protein Therapeutics
Flow Imaging Microscopy (FIM/MFI) and orthogonal testing to instantly separate protein aggregates from silicone oil and foreign debris. By tracking particle morphology across formulation and packaging changes, we give you the technical clarity to de-risk development and satisfy regulatory scrutiny.
Sterile Injectables & Parenteral Manufacturers
Delivering rapid, definitive particulate identification, complaint investigation support, and root-cause resolution alongside cGMP USP particulate testing to keep your operations moving. Paired with deterministic Container Closure Integrity Testing (CCIT) and USP <382> functional suitability evaluations.
Advanced Therapies (Cell & Gene Therapy)
Gateway Analytical specializes in forensic particulate investigations, single-use component evaluations, and cryogenic container performance studies tailored to the ever-evolving regulatory compliance landscape.
The Analytical Approach from Gateway Analytical
Define the question
We begin with the event, observation, risk, or decision driving the study, not simply the requested test.
Understand the system
We consider the drug product, formulation, materials, container, closure, components, process conditions, and relevant lifecycle stage.
Select the approach
We identify the methods, comparisons, controls, and complementary techniques appropriate for the question.
Interpret the evidence
We evaluate the findings in context, including what the data support, what they do not establish, and where additional evidence may be needed.
Support the decision
We provide clear results and scientific interpretation to help customers determine an appropriate next step.
Scientific Support for Regulated Product-Quality Decisions
- USP Functional Suitability
- USP Subvisible Particulate Matter in Therapeutic Protein Injections
- USP Particulate Matter in Injection
- USP Particulate Matter in Ophthalmic Solutions
- USP Package Integrity Evaluation
- USP Measurement of Subvisible Particulate Matter
- USP Visual Inspection of Injections
- Relevant FDA and international regulatory expectations
Featured Technical Resources
Using Flow Imaging Microscopy to Understand Subvisible Particles in Biologics
Learn how particle images and morphology can provide information that concentration and size data alone may not reveal.
Selecting a Container Closure Integrity Test Method
Considerations for aligning method capabilities with the product, package configuration, potential leak mechanism, and study objective.
Using Source-Comparison Studies in Particulate Investigations
Explore how reference materials and comparative analysis can help narrow potential particulate sources.
What Does USP Require for Functional Suitability?
Review the purpose of the chapter and the product-specific considerations that may affect study design.
Discuss Protein Testing Needs with our Experts
- cGMP Compliant & FDA, EMA, DEA Registered Laboratory Facility
- Specialized in Particulate Identification & Material Characterization
Have a complex product-quality question? Let’s define the right analytical path forward.
Gateway Analytical applies pharmaceutical forensics, specialized analytical testing, and expert interpretation to help regulated life science companies understand particulate, package integrity, subvisible particle, and component performance challenges. Contact our team to discuss your next product.
Particulate Risk Investigation and Root-Cause Resolution
Container Closure and Product-Package Integrity
- Cryogenic Packaging & Transport Simulation Studies
- Vacuum Decay Studies
- MicroCurrent High Voltage Leak Detection (HVLD)
- Laser-Based Gas Headspace Analysis
- Vials, Syringes, Cartridges, & Difficult Configurations
- Custom Method Development and Validation Across Multiple Platforms
- “Which CCIT Method Fits My Package?” use-case page
Visible & Subvisible Particle Characterization: Beyond Compendial Counts
Parenteral Packaging Functional Suitability
Biologics & Protein Therapeutics
Flow Imaging Microscopy (FIM/MFI) and orthogonal testing to instantly separate protein aggregates from silicone oil and foreign debris. By tracking particle morphology across formulation and packaging changes, we give you the technical clarity to de-risk development and satisfy regulatory scrutiny.
Sterile Injectables & Parenteral Manufacturers
Gateway delivers rapid, definitive particulate identification, complaint investigation support, and root-cause resolution alongside cGMP USP particulate testing to keep your operations moving. Paired with deterministic Container Closure Integrity Testing (CCIT) and USP <382> functional suitability evaluations.
Advanced Therapies (Cell & Gene Therapy)
Gateway specializes in low-volume particulate investigations, single-use component evaluations, and cryogenic container performance studies tailored to this evolving regulatory landscape.
Solving Drug Product Risks with Gateway Analytical. Applying Lifecycle Quality Risk Intelligence.
At Gateway Analytical, we apply Lifecycle Quality Risk Intelligence to connect analytical evidence across your entire product journey—combining rapid root-cause particulate identification, deterministic container closure integrity, subvisible particle characterization, and functional suitability testing.
By translating isolated laboratory data into long-term product understanding, we give your quality, operations, and regulatory teams the technical clarity and scientific proof needed to mitigate risk, resolve deviations, and release product with total confidence.
Technical Documentation & Resources
Connecting Analytical Evidence Across Your Drug Product Journey
By bridging our four core service areas: Particulate Investigations, Container Closure Integrity, Subvisible Characterization, and Functional Suitability—we transform routine laboratory data into deep product understanding, investigation readiness, defect prevention, and total regulatory confidence.
