Elastomeric closures are essential components in injectable pharmaceutical packaging. They ensure sterility, prevent contamination, and maintain drug efficacy. With the introduction of USP 382, pharmaceutical manufacturers must meet stricter requirements for Container Closure Integrity Testing (CCIT) to safeguard patient safety and regulatory compliance.
What is USP 382?
USP <382> is a new directive from the U.S. Pharmacopeia focusing specifically on elastomeric closures used in:
Vial and bottle stoppers
Plunger stoppers for syringes and cartridges
Needle shields and tip caps for pre-filled syringes
Piercing areas of BFS (Blow-Fill-Seal) containers
Access ports of IV bags and blow-molded infusion containers
This revision builds upon USP 1207, introducing a higher standard of testing sensitivity and reliability for pharmaceutical packaging.
Compliance Deadline – December 1st, 2025
By December 1st, 2025, all elastomeric closures that contact drug products must undergo integrity testing down to the Maximum Allowable Leakage Limit (MALL). This ensures the highest level of protection for sterile injectable products.
A key change in USP 382 is the requirement for a statistical sample size of at least 30 containers per test procedure, providing stronger validation of package integrity.
Why Elastomeric Closures Matter
Elastomeric materials are widely used in sterile packaging due to their flexibility, sealing ability, and compatibility with different container systems. However, their performance directly impacts:
Sterility assurance
Drug stability
Patient safety
Under USP 382, manufacturers must demonstrate that every elastomeric component maintains container closure integrity throughout the product lifecycle.
Testing Requirements under USP 382
To comply with USP 382, companies must integrate robust CCIT methods capable of detecting micro-leaks. Common technologies include:
Vacuum Decay – Highly sensitive for micro-leaks
High-Voltage Leak Detection (HVLD) – For non-destructive testing of parenteral products
Helium Mass Spectrometry – For ultra-sensitive leak detection
In some cases, multiple methods may be required to ensure comprehensive evaluation.
Preparing for USP 382 Compliance
Pharmaceutical companies should act now to prepare for the December 1st, 2025 deadline:
Review all elastomeric closure systems in use
Validate test methods according to USP 382 and USP 1207
Establish compliant sampling and statistical practices
Partner with experts in CCIT to implement reliable solutions
