Pharmaceutical & Medical Device Testing (E&L, Sterility, Biocompatibility)

From material screening to extractable and leachable (E&L) assessment, our chemical characterization testing supports medical device biocompatibility testing under ISO 10993-17 and ISO 10993-18 by identifying extractables, leachables, and degradation products with confidence.

Follows AAMI TIR30 and other standards, providing end-to-end validation from protocol design to documentation, ensuring cleaning processes meet regulatory and audit requirements.

Analyzes metals, polymers, etc. using SEM-EDS, XRD, FTIR, DSC/TGA per ISO 10993, plus failure analysis and reverse engineering.

Detects residual disinfectants (EO, ECH, etc.) with ICH Q2(R1) validated methods, including toxicological assessment and regulatory submission documents for FDA/EU/NMPA.

Performs mechanical, thermal, and surface tests per international standards; accelerated aging per ASTM F1980 to predict device shelf life.

Evaluates degradation kinetics under physiological conditions per GB/T 16886 series; multi-point sampling until full absorption; supports absorbable devices.

Performed in ISO Class 5 and 7 cleanroom environments, our microbiological services include bioburden, sterility, and antimicrobial performance testing in accordance with ISO 11737, ASTM E2149, and related standards.

Provides drug adsorption, stability, and E&L analysis; supports FDA/EU/NMPA submissions; helps clients obtain FDA 510(k) clearance within 7 days.

Uses validated in vitro methods to characterize drug elution profiles for complex combination devices such as stents, bone cements, and antimicrobial dressings.

Employs Lhasa Suite (Derek/Sarah Nexus) with a 5000+ toxicology database to deliver toxicological assessment reports accepted by global regulators.

Using a QbD-based approach and an extensive extractables knowledge base, we support packaging qualification, analytical evaluation, and toxicological risk assessment for submission-ready regulatory documentation.

Our container closure integrity testing (CCIT) services include microbial challenge, dye ingress, and helium leak testing for sterile packaging and sterile barrier systems, with helium sensitivity down to 10⁻¹⁰ atm·cc/s and alignment with USP <1207>.

Bacterial retention testing | Filter integrity testing | Adsorption testing | Extractables & leachables (E&L) analysis

Deterministic methods: vacuum helium mass spectrometry | helium leak detection (sniffer mode) | vacuum decay | pressure decay | high-voltage leak detection (HVLD) | laser-based headspace analysis

Probabilistic methods: bacterial immersion | aerosol microbial challenge | methylene blue dye ingress | underwater bubble emission | fluorescent tracer detection

Microbial limits testing | Bioburden testing | Sterility testing | Bacterial endotoxin testing | Antimicrobial effectiveness testing for sterile and non-sterile pharmaceutical products

Water system validation | HVAC system validation | Disinfectant validation

Cylinder plate method (agar diffusion) | Turbidimetric method | Chemical and physicochemical methods (HPLC, GC)

Applicable products include: multi-dose eye drops, oral liquid preparations, cosmetics, and antimicrobial material evaluation.

Our pharmaceutical packaging testing services include extractables and leachables (E&L) studies for glass, elastomer, and polymer packaging systems, including ampoules, vials, prefilled syringes, infusion bags, and ophthalmic containers, supported by QbD and PQRI-based strategies.

Dual risk assessment per USP <1665> and BPOG. Identifies extractables for fluid transfer, filtration, container closure, and metal systems.

E&L studies for injection, infusion, catheters, and combination products. QbD-based full lifecycle risk management. Materials: glass, polymer (PVC, TPU, PP), elastomer, SS316L.

We offer 11 validated CCIT approaches, including helium leak detection, vacuum and pressure decay, HVLD, microbial challenge, and dye ingress, to support sterile packaging evaluation for vials, prefilled syringes, biologics, and other high-value products.

Rubber: particle shedding, puncture force, sealing, heavy metals. Glass: thermal expansion, B₂O₃ content, hydrolytic resistance, light transmittance. Metal: coating adhesion, strength, elemental impurities.

Global registration and DMF filing for pharmaceutical packaging materials. End-to-end services from strategy to approval. FDA and NMPA approvals obtained.