Drick DRK-YZ02 Positive-Pressure Syringe Seal Integrity Tester
| Brand | Drick |
|---|---|
| Model | DRK-YZ02 |
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Price Range | USD 7,000 – 14,000 |
Overview
The Drick DRK-YZ02 Positive-Pressure Syringe Seal Integrity Tester is an automated, pressure-decay-based instrument engineered for deterministic, non-destructive evaluation of container closure integrity (CCI) in pre-filled syringes and other rigid or semi-rigid parenteral packaging. It operates on the principle of controlled pressurization followed by high-resolution monitoring of pressure decay over time—enabling quantitative assessment of leak rates in accordance with ASTM F2338–22 (Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method) and aligned methodologies for positive-pressure decay testing. Designed for routine QC laboratories in pharmaceutical manufacturing, contract development and manufacturing organizations (CDMOs), and regulatory-compliant R&D facilities, the DRK-YZ02 delivers repeatable, operator-independent results essential for validation studies, stability protocols, and batch release testing under cGMP environments.
Key Features
- Automated positive-pressure decay protocol with programmable test parameters: pressurization time, stabilization duration, measurement interval, and pass/fail thresholds.
- High-precision digital pressure transducer (±0.1% FS typical accuracy) coupled with temperature-compensated sensing to minimize drift during extended hold periods.
- Dedicated syringe fixture system accommodating standard ISO 11040–4 compliant syringe barrels (1 mL to 10 mL), including glass and polymer variants with Luer-lock or fixed-tip configurations.
- Integrated pneumatic control unit with oil-free, corrosion-resistant air supply path—compliant with ISO 8573–1 Class 2 particulate and Class 3 moisture specifications.
- Self-diagnostics at startup, real-time error logging, and hardware interlocks to prevent unsafe pressurization sequences.
- Modular design supporting future integration into automated line sampling stations via RS-232 or optional Ethernet/IP interface.
Sample Compatibility & Compliance
The DRK-YZ02 accepts syringes fitted with elastomeric plungers and crimp-sealed rubber stoppers, including bromobutyl, chlorobutyl, and fluoropolymer-coated formulations. It is validated for use with silicone-oil-lubricated and non-lubricated configurations per USP guidance on package integrity evaluation. The system supports IQ/OQ documentation packages and meets foundational requirements for FDA 21 CFR Part 11 compliance when deployed with audit-trail-enabled software (see Software & Data Management). Test methods are traceable to NIST-calibrated pressure standards, and the platform is suitable for inclusion in regulatory submissions requiring demonstration of CCI robustness across shelf life, shipping simulation, and accelerated aging conditions.
Software & Data Management
The DRK-YZ02 runs on embedded firmware with a touchscreen HMI interface enabling intuitive method setup, real-time curve visualization, and immediate pass/fail classification. Optional PC-based software (DRK-CCI Suite v3.x) provides full 21 CFR Part 11 compliance features: electronic signatures, role-based access control, immutable audit trails, and secure data export in CSV, PDF, and XML formats. All test records include metadata such as operator ID, timestamp, environmental temperature/humidity (via optional external sensor input), and raw pressure-vs.-time datasets. Data files are structured to align with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for GLP/GMP audits.
Applications
- Final container closure integrity verification prior to sterile product release.
- Comparative evaluation of stopper formulation, needle shield design, or crimping force impact on seal performance.
- Supporting root cause analysis during deviation investigations involving particulate ingress or moisture uptake.
- Method suitability testing for lyophilized and liquid-filled syringes subjected to thermal cycling or mechanical shock.
- Qualification of secondary packaging systems (e.g., blister + carton) where syringe integrity must be preserved throughout distribution.
FAQ
What leak rate detection limit does the DRK-YZ02 achieve under standard operating conditions?
The system reliably detects leak rates down to approximately 1 × 10⁻⁶ mbar·L/s (equivalent to ~0.1 µm equivalent hole diameter under ISO 15612 reference conditions), subject to test duration, sample geometry, and environmental stability.
Is the DRK-YZ02 suitable for testing syringes containing sensitive biologics or high-value APIs?
Yes—the non-destructive, dry-air-based methodology avoids contact with product, eliminating contamination risk and preserving sterility. No vacuum exposure or tracer gases are required.
Can the instrument be qualified per Annex 1 (EU GMP) requirements for aseptic processing environments?
The DRK-YZ02 is designed for off-line testing in controlled QC labs. Its construction, materials of contact (316L stainless steel, PTFE, and FDA-compliant elastomers), and cleaning validation support Annex 1-aligned qualification when integrated into a documented CCI control strategy.
Does Drick provide installation qualification (IQ) and operational qualification (OQ) documentation?
Yes—comprehensive IQ/OQ templates, calibration certificates, and factory-verified performance reports are supplied with each unit, fully customizable to site-specific SOPs.
