Descripción
Pharmaceutical Packaging Leak Detection Built for Compliance
The DVACI CDV Pharma is a leak detection system designed for pharmaceutical packaging integrity testing, supporting compliance with USP <1207.2>, USP <381>, European Pharmacopoeia 3.2.9, 21 CFR Part 11, ASTM F2096, and other applicable international standards.
Purpose-built for the demands of pharmaceutical quality control, the CDV Pharma is available in two configurations: the CDV Pharma V&P, which performs vacuum testing, internal and external pressure testing, and dye penetration testing using methylene blue, and the CDV Pharma, which performs vacuum leak detection testing. Both are housed in a single compact benchtop system.
Thwing-Albert Instrument Company is the exclusive US distributor for DVACI leak testing equipment, providing local sales, technical support, and service across North America.
Two Configurations Available
The CDV Pharma is offered in two distinct configurations to match your testing methodology and regulatory requirements:
CDV Pharma V&P — Vacuum + Pressure
The full-capability configuration supporting vacuum testing, internal pressure testing, external pressure testing, and dye penetration testing using the methylene blue methodology with combined vacuum and pressure application. Compliant with ASTM D3078, D4991, D5094, D6653, and F2096, and all applicable pharmaceutical standards.
CDV Pharma — Vacuum Only
A focused vacuum leak detection configuration for laboratories whose testing protocols require vacuum-based integrity testing without pressure or dye methodology. Compliant with ASTM D3078, D4991, D5094, and D6653.
Applications
The CDV Pharma is designed for leak detection in rigid and flexible pharmaceutical packaging, including:
- Ampoules and vials
- Blisters and bottles
- Sealed pharmaceutical packages
- Any packaging requiring dye penetration, vacuum, or pressure integrity testing
ORION Touchscreen Control Platform
The CDV Pharma is powered by the ORION operating system — a PLC-based control platform developed by DVACI — accessed through an intuitive color touchscreen interface. ORION delivers the data integrity and traceability features required in regulated pharmaceutical environments:
- Automatic storage of all test results
- Digital data export for integration with laboratory and quality systems
- Advanced user and permission management with role-based access
- Audit-ready records to support 21 CFR Part 11 compliance (optional)
- Integration with external systems
Regulatory Standards Supported
- USP <1207.2> — Package Integrity Evaluation: Vacuum Decay Leak Test Method
- USP <381> — Elastomeric Closures for Injections
- European Pharmacopoeia 3.2.9
- JP 7.03 — Japanese Pharmacopoeia
- ASTM F2096 — Bubble Emission Leak Test
- ASTM D3078 — Flexible Packaging Leak Test
- ASTM D4991 — Empty Rigid Container
- ASTM D5094 — Rigid Container with Liquid
- ASTM D6653 — Transportation/Altitude Simulation
- MGA 0486 / FEUM — Mexican Pharmacopoeia
- 21 CFR Part 11 — Electronic Records and Signatures (optional)
Chamber Options & Specifications
Two Pharma-optimized chamber sizes are available, both featuring an increased internal height designed to accommodate pharmaceutical packaging formats and reduce dye consumption:
| Specification | CDV2 | CDV3 |
|---|---|---|
| Internal Dimensions (L × W × H) | 280 × 200 × 150 mm (11″ × 8″ × 5.9″) | 450 × 300 × 150 mm (18″ × 12″ × 5.9″) |
| Chamber Weight | 16 kg | 30 kg |
| Chamber Material | Clear acrylic, 30mm thick | |
| Power Supply | 110–220 VAC | |
| Maximum Supported Vacuum | –900 mbar / –26.5 inHg | |
| Maximum Internal Pressure (V&P only) | 2 bar / 59 inHg | |
| Maximum External Pressure (V&P only) | 500 mbar / 14.7 inHg | |
| Vacuum Generation | Hybrid Venturi — Pump 110/220V or Venturi | |
| External Pressure Source (V&P only) | Compressed air | |
| Internal Pressure Source (V&P only) | Water system | |
| Compliance | CE | |
| Equipment Warranty | 12 months | |
Design and Construction
The CDV Pharma features a compact, robust, and modern design suitable for pharmaceutical laboratory and production environments. The clear acrylic chamber allows unobstructed visual inspection throughout the entire test cycle, while the modular design simplifies installation, maintenance, and future system configurations.
The independent control module and PLC-based platform ensure process stability and electronic protection, with individual components designed to be replaced or serviced as needed to minimize downtime.
Why Source from Thwing-Albert?
As the exclusive US distributor for DVACI leak testing equipment, Thwing-Albert provides:
- Domestic sales and technical support based in the United States
- Faster lead times and simplified procurement for US customers
- Application expertise across packaging integrity testing methods
- A trusted partner with decades of experience in physical testing instrumentation
Contact our team to discuss your specific packaging integrity testing requirements and determine which CDV Pharma configuration is right for your application.
