Understanding FDA Approval and Laboratory Vials
A common misconception is that the FDA approves individual autosampler vials for analytical testing applications.
In most cases, the FDA does not approve or disapprove specific chromatography vials used in analytical laboratories. Instead, regulatory agencies focus on the suitability of the complete process, materials, validation data, and quality systems used within a regulated application.
Organizations performing regulated work should consult their Regulatory Affairs, Quality Assurance, or Compliance departments to determine applicable requirements for their specific use case.
Intended Use of RSA™ Autosampler Vials
RSA™ Autosampler Vials are designed for analytical laboratory applications, including:
- HPLC analysis
- UHPLC analysis
- LC-MS analysis
- Method development
- Quality control testing
- Research laboratory workflows
These vials are manufactured from high-quality Type 33 borosilicate glass and are produced without surface coatings that could potentially introduce additional sources of chemical interference.
Use in Regulated Applications
Additional evaluation may be required when vials are used in highly regulated environments.
Examples include:
- Human clinical testing
- Pharmaceutical packaging
- Diagnostic sample collection
- Diagnostic sample storage
- Regulated pharmaceutical workflows
In these applications, suitability must be established through appropriate validation and quality procedures.
Typical Validation Considerations
Depending on the intended application, organizations may evaluate:
Material Compatibility
Verification that vial materials do not adversely affect the sample, analytes, or analytical method.
Extractables and Leachables
Assessment of whether compounds from the vial could migrate into the sample under actual operating conditions.
Method Validation
Confirmation that the vial performs acceptably within the validated analytical procedure.
Regulatory Documentation
Evaluation of available documentation needed to support internal quality and regulatory requirements. Because requirements vary significantly by application, laboratories should establish validation protocols appropriate to their specific regulatory environment.
Why RSA™ Vials May Simplify Validation Efforts
RSA™ Autosampler Vials possess several characteristics that may support laboratory validation activities.
Type 33 Borosilicate Glass Construction
High-quality borosilicate glass is widely used throughout analytical laboratories due to its chemical resistance and suitability for a wide range of applications.
No Surface Coatings
RSA™ vials do not utilize surface coatings that may require additional evaluation during method validation studies.
Low Adsorption Design
The vial design is intended to support reliable sample handling while minimizing unwanted analyte interaction with internal vial surfaces.
Low Extractables Profile
Materials are selected to help reduce the potential introduction of interfering compounds into analytical workflows.
Consult Your Regulatory Team
When considering the use of any vial in regulated environments, laboratories should consult internal regulatory and quality experts regarding:
- Validation requirements
- Documentation needs
- Regulatory submissions
- Risk assessments
- Material qualification procedures
These departments are best positioned to determine whether a particular vial is appropriate for a specific regulated application.
Key Takeaways
- The FDA does not typically approve or disapprove individual autosampler vials for analytical testing.
- RSA™ Autosampler Vials are intended for analytical laboratory applications including HPLC, UHPLC, and LC-MS.
- Regulated applications may require additional validation and qualification activities.
- Material compatibility, extractables, leachables, and method validation studies may be required depending on the application.
- RSA™ vials are manufactured from Type 33 borosilicate glass and contain no surface coatings.
- Regulatory and quality departments should determine suitability for specific compliance requirements.
