Comprehensive ISO 11608 Validation
for Needle-Based Injection Systems

Ensuring Safety, Quality, & Reliability

Needle-Based Injection System Testing

Millions of patients worldwide rely on needle-based injection systems for life-saving medications. But how can you guarantee their safety, quality, and reliability? At Purple Diamond, our experts provide comprehensive ISO 11608 validation to ensure the safety, efficacy, and reliability of devices like pen injectors, autoinjectors, and on-body delivery systems.

Our testing services offer you peace of mind in an industry where there’s no room for error. Whether you’re developing single or multi-dose containers or pre-filled syringes, we provide the expertise, equipment, and experience to ensure your medical device packaging not only meets but exceeds ISO standards.

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What is ISO 11608?

ISO 11608 provides vital guidelines for the design, development, and testing of needle-based injection systems.

ISO 11608 standards apply to various need-based injection systems, including autoinjectors, pen injectors, pre-filled syringes with safety systems, and on-body delivery systems. Developed to treat diabetes, chronic pain, or arthritis, these devices require precision and sterility to protect patient safety. This standard guides the manufacturing, testing, and distribution of these devices, providing manufacturers with a roadmap for ensuring the devices meet stringent requirements for quality, functionality, and safety. Compliance with ISO 11608 ensures that these devices are reliable, effective, and safe for patients, while also helping to meet regulatory requirements and enhance patient confidence in their treatments.

Benefits of Needle-Based Injection System Testing:

Regulatory Compliance

Precision & Accuracy

Consistency & Standardization

Patient Safety

Quality Assurance

Cost-Effectiveness

Compliance, Safety, & Quality

Purple Diamond is a leader in medical device packaging validation. 

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Needle-Based Injection System Testing

Here at Purple Diamond, we offer stability testing, accelerated aging, container closure integrity, and more to help your needle-based injection system meet the standards set forth by ISO 11608. 

Transportation Simulation

Simulate drops, vibrations, & other effects of transportation on your packaged product.

Temperature
Testing

Subject your product to temperature extremes to ensure integrity, functionality, & safety.

Stability
Testing

Assess the performance of your device after exposure to various environmental conditions.

Accelerated
Aging

See how your medical device withstands the test of time with accelerated aging testing.

Container Closure Integrity

Ensure your devices have stable barriers to prevent product leakage or contamination.

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Frequently Asked Questions

What are the key parts of ISO 11608?

Injection system testing includes several parts:

  • Part 1: Requirements and test methods for needle-based injection systems
  • Part 2: Needles requirements
  • Part 3: Finished containers compatibility
  • Part 4: Electromechanical injectors
  • Part 5: Automated functions
  • Part 6: On-body delivery systems
  • Part 7: Accessibility for persons with visual impairment

What testing is required to comply with ISO 11608?

Testing includes dose accuracy validation, durability under stress, compatibility with medications, and usability assessments under real-world conditions. At Purple Diamond, we can also perform transportation testing, accelerated aging, stability storage, and environmental testing. 

What types of devices require ISO 11608?

  • Autoinjectors
  • Pen injectors
  • Pre-filled syringes with safety systems
  • On-body delivery systems (OBDS)

These devices can be designed for single or multiple doses, refillable or disposable use, intradermal, subcutaneous, or intramuscular delivery.

Who needs to comply with ISO 11608?

Medical device manufacturers, pharmaceutical companies, and developers of combination products involving injection systems must comply with ISO 11608 needle-based injection system testing to gain regulatory approval.

How can Purple Diamond assist with ISO 11608 compliance?

Purple Diamond can perform ISO 11608 validation as part of our product testing capabilities. We can assess the compatibility of your medicinal product with its primary or secondary container. In addition, we can perform CCIT, accelerated aging, and stability tests, among others, to ensure your injection device is safe and effective for its intended use. 

Validate Your Injection Systems

Partner with Purple Diamond to ensure your injection systems meet ISO 11608 standards and ensure precision & accuracy.

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Why Purple Diamond?

As an ISO-accredited facility, Purple Diamond is trusted by top medical device manufacturers for precision testing and compliance validation. From transportation simulation to accelerated aging, we provide end-to-end validation for needle-based injection systems.

With a history of successful partnerships, Purple Diamond delivers tailored testing solutions that streamline regulatory approval and enhance patient safety. Ready to get started? Request a consultation with our team.

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Ready to take the next step? Request a quote today and discover how our needle-based injection system testing can ensure
quality, safety, & compliance.

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