Deterministic · USP <1207.2> · ISO 15747

Helium leak testing is a deterministic container closure integrity test method - it measures the actual leak rate through any pathway in the closed vial system. The vial + stopper + crimp seal assembly is pressurised with helium tracer gas; a mass spectrometer downstream measures any helium escaping through micro-leaks in the closure interface. Pass threshold: < 1×10⁻⁶ mbar·L/s.

Deterministic - measures actual leak rate

Detects micro-leaks invisible to dye tests

Pass: < 1×10⁻⁶ mbar·L/s per assembly

Documented in CoA per production lot

Deterministic · ASTM F2338 · automated

The pressure decay test pressurises the sealed vial headspace to a set level then measures pressure loss over a defined time interval. Any pathway for gas escape - at the crimp skirt–vial neck interface, through the stopper puncture zone, or through micro-cracks - produces a measurable pressure drop. Pass threshold: < 5 mbar decay over 60 seconds. Automated testing allows 100% lot sampling on production batches.

Non-destructive - vials usable after test

Automated - supports 100% lot sampling

Pass: < 5 mbar loss over 60 sec

Detects crimp interface and stopper channel leaks

Probabilistic · USP <1207.3> · AQL

The dye ingress test submerges sealed vials in a methylene blue dye solution under vacuum then atmospheric pressure, then visually inspects vial contents for dye intrusion. Any integrity failure allowing liquid ingress is visible as blue contamination of the product. Applied as an AQL (Acceptable Quality Level) sampling method - zero dye-positive vials per 1,000 tested per lot is the acceptance criterion.

Visual confirmation of gross seal failures

AQL sampling - 0/1,000 acceptance per lot

Complementary to deterministic He/PDT methods

Results documented in lot CoA

Physical QC · per lot · dimensional

The crimping process applies the aluminium skirt to the vial neck by compressing it with a crimping head. The final crimp height (distance from the top of the skirt to the vial shoulder after crimping) and crimp removal torque are measured for every production lot. Crimp height out of specification indicates under-crimping (leak risk) or over-crimping (vial neck fracture risk).

Crimp height: 11.0 ± 0.3 mm (20mm standard)

Removal torque: ≥ 1.2 N·m (tamper resistance)

100% in-line measurement on production line

Stability simulation · -80°C to +40°C

Pharmaceutical products undergo freeze-thaw cycles during shipping (cold chain), lyophilization, and storage. The crimp seal must maintain integrity across the full temperature range from -80°C (ultra-low temperature biologics) to +40°C (accelerated stability). Type qualification testing includes integrity measurement pre- and post-thermal cycling to confirm seal performance is retained across the temperature range.

Temperature range: -80°C to +40°C qualified

He leak rate maintained post-thermal cycling

Suitable for lyo, frozen biologics, ambient storage

Per lot · all test results · regulatory

Every production lot of 20 mm crimp seals is released with a Certificate of Analysis confirming Al alloy composition (ICP-OES), sheet thickness, cap outer diameter, crimp height acceptance range, helium leak test result, pressure decay result, dye ingress AQL result, and RoHS declaration. The CoA is issued per lot number and is the primary document for your incoming inspection and regulatory submission support package.

Al purity (EN AW-1050A) · dimensions

He leak rate · PDT result · dye AQL

RoHS declaration · lot number traceability

Available for regulatory DMF / CTD submission

General · primary product colour

The default pharmaceutical injectable presentation colour. Used when no specific clinical colour code applies - the product baseline. Most widely stocked colour in hospital pharmacy dispensaries.

High dose · controlled · urgent

High-alert medications, concentrated electrolytes, controlled drug preparations, and high-dose strength products. Red triggers visual confirmation steps in double-check protocols for high-risk medications.

Vitamins · electrolytes · lower strength

Supportive care products, vitamin preparations, standard electrolyte solutions, and lower dose strength variants of a product available in multiple strengths differentiated by cap colour.

Biologics · specialty pharma · high-value

High-value biological drug products, specialty therapeutic injectables, growth hormones, and oncology products where the gold or amber cap reflects the premium product positioning and high manufacturing cost.

Neurological · oncology · off-label

Specialty pharmaceutical categories including neurology, psychiatry, and oncology products. Purple/violet is increasingly used for oncology product differentiation in hospital pharmacy dispensing systems.

Cytotoxic · restricted dispensing

Products requiring additional safety precautions, cytotoxic preparations, restricted-use medications, and products requiring specific handling protocols. Orange signals the need for additional caution steps.