ISO 11040 is a multi-part international standard titled:
“Prefilled syringes”
It provides detailed specifications for the design, materials, dimensions, testing, and performance of prefillable syringes made of glass and plastic, including components like plungers, barrels, needles, and tip caps.
The standard consists of the following key parts:
| PartTitle | |
| ISO 11040-1 | Glass barrels – Dimensions and tolerances |
| ISO 11040-2 | Plunger stoppers for glass barrels |
| ISO 11040-4 | Glass barrels for injectables and sterilization processes |
| ISO 11040-6 | Plastic barrels – Requirements and test methods |
| ISO 11040-8 | Filled syringes – Requirements after filling |
| ISO 11040-7 | Finished prefilled syringes – Packaging systems |
| ISO 11040-5, -9 | Additional requirements for containers and combi-systems |
In today’s pharmaceutical supply chain, product integrity, dosing accuracy, and user safety are critical. Prefilled syringes must be designed and manufactured to the highest standards to prevent:
❌ Contamination risks
❌ Dosage inaccuracy
❌ Material incompatibility with drugs
❌ Mechanical failure during injection
❌ Regulatory rejection by FDA, EMA, or CDSCO
ISO 11040 ensures that prefilled syringes are tested, validated, and fit-for-use, reducing risks for manufacturers, healthcare professionals, and patients alike.
Implementing ISO 11040 enables consistency, safety, and performance in prefillable syringe systems:
🧪 Material and Dimensional Standardization
Ensures compatibility of components like stoppers, barrels, and plungers.
🛡️ Sterility and Cleanroom Compatibility
Designed to withstand sterilization methods including autoclaving, gamma, and EtO.
📦 Improved Drug Delivery Accuracy
Maintains exact dosage and prevents leaks or air entrapment.
✅ Supports Global Regulatory Approvals
Required for CE marking, US FDA, and WHO PQ for injectable devices.
🔄 Interoperability with Auto-Injectors & Safety Devices
Makes syringe systems compatible with advanced drug delivery platforms.
With GMC’s consulting services, adopting ISO 11040 gives your business a strong edge in product quality and regulatory readiness:
✅ Accelerate Regulatory Approvals
Smooth submission of device dossiers to FDA, EMA, CDSCO, and WHO.
✅ Reduce Quality Issues and Recalls
Prevent failures related to leakage, breakage, or sterility compromise.
✅ Strengthen OEM and Pharma Partnerships
Meet the standard expectations of large pharmaceutical clients and contract manufacturers.
✅ Increase Market Access Globally
Sell your prefilled syringes in regulated markets with confidence.
✅ Align with ISO 13485 and MDR/IVDR Requirements
Seamless integration with quality management systems and EU regulations.
✅ Support Innovation in Drug Delivery
Design new syringe formats with compatibility to smart delivery or biotech molecules.
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Growth Management Corporation is a management consulting firm that provides consulting, training, implementation, and certification services and solutions to organizations of all sizes, and all domains.
