- Testing Types
- USP ⟨670⟩ Auxiliary Packaging Components Testing
Terms and Conditions
Sample Submission Form
Overview
USP ⟨670⟩ establishes the testing framework for evaluating auxiliary components used within pharmaceutical packaging systems, including closures, liners, seals, gaskets, caps, and stopper assemblies. PLS Analytical performs USP ⟨670⟩ studies to help manufacturers assess whether these components are suitable for their intended application and support overall packaging system performance.
PLS Analytical performs USP ⟨670⟩ testing to evaluate the physical, chemical, and functional characteristics of auxiliary packaging components. Depending on the application, studies may include physicochemical characterization, compatibility assessments, functionality evaluations, and risk-based investigations that support packaging qualification, supplier approval, and regulatory submissions.
The performance of a pharmaceutical packaging system depends on every component functioning together as intended. Auxiliary components that are incompatible or inadequately characterized can affect container closure integrity, packaging performance, product stability, and long-term product protection.
PLS Analytical delivers USP ⟨670⟩ testing aligned with compendial requirements, helping manufacturers generate scientifically defensible data for packaging qualification, supplier qualification, and regulatory submissions.
Testing Services
PLS Analytical performs USP ⟨670⟩ testing to support packaging qualification, supplier evaluations, container closure system assessments, regulatory submissions, and lifecycle quality management activities.
Auxiliary Component Characterization
Auxiliary Component Characterization
Auxiliary component characterization evaluates the composition and critical attributes of packaging components used within pharmaceutical container systems. Scientifically robust data supports packaging qualification, component characterization, material property assessments, and supplier evaluation.
Compatibility & Safety Assessment
Compatibility & Safety Assessment
Compatibility and safety assessment evaluates the interaction potential between auxiliary packaging components and pharmaceutical packaging systems. Scientifically robust data supports compatibility assessments, packaging development, risk-based evaluations, component safety, and regulatory submissions.
Functional Performance Evaluation
Functional Performance Evaluation
Functional performance evaluation assesses whether auxiliary packaging components perform their intended protective and functional roles throughout product storage and use. Scientifically robust data supports container closure system qualification, stability programs, packaging functionality assessments, and commercial packaging qualification.
Extractables Risk Support Studies
Extractables Risk Support Studies
Extractables risk support studies evaluate the potential contribution of auxiliary packaging components to extractables and leachables assessments. Scientifically robust data supports packaging qualification, extractables and leachables strategies, lifecycle packaging management, and risk characterization.
Advantages
USP ⟨670⟩ testing provides the data needed to evaluate auxiliary packaging components as part of a comprehensive pharmaceutical packaging strategy.
Improved Packaging System Understanding
Component-level characterization helps manufacturers understand how individual packaging elements contribute to overall system performance and product protection.
Stronger Risk Management
Early identification of compatibility, safety, or functionality concerns helps reduce packaging-related risks before commercial implementation.
Better Supplier & Change Control Decisions
Objective testing data supports supplier qualification, material changes, packaging modifications, and lifecycle management activities.
