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Solution for your package integrity test

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QESSE CCI 1021 vacuum decay leak tester in stainless steel with a 13.3 inch touchscreen and a test chamber
Result
PASS = CONFORM SAMPLE
Measurement cycle
< 15 seconds
Limit of detection
< 0.05 cc/min ≈ 1.5 µm*
CCI 1021 · Vacuum decay

CCI 1021 is a vacuum decay testing instrument designed to verify the integrity of containers and packages made of glass, plastic, metal and flexible composite materials. The test does not compromise the integrity of the packages. Unlike traditional methods (such as blue dye and microbial ingress tests), vacuum decay requires no gas and generates no waste.

Reference methods and compliance
ASTM F2338Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
USP <1207>Reference method for CCI 1021, VOLTA and CCI 1000 FAD
EU GMP Annex 1EU Guidelines GMP Medicinal for Human and Veterinary Use
EU GMP Annex 11Computerised systems
21 CFR Part 11Integrated audit trail and data integrity
PDA TR No. 27Pharmaceutical Package Integrity
CE markedEMC / Low Voltage
Non-destructiveQuantitative, deterministic results
Products

One system for multiple applications

Pre-installed software, 21 CFR Part 11 compliant, designed and developed in-house by Qesse.

Vacuum decayCCI 1021 vacuum decay leak tester

CCI 1021

Vacuum Decay Leak Tester

Is my container leaking? Is my packaging still airtight? CCI 1021 is the answer.

Test principle
Vacuum decay in rigid or flexible chamber. Non destructive. No gas required
Reference methods
ASTM F2338, USP <1207>
Limit of detection
< 0.05 cc/min (approx. 1.5 micron nominal hole size)*
Measurement cycle
< 15 seconds
HMI
13.3” Touchscreen HMI, one-touch operation
Software
Integrated audit trail 21 CFR Part 11 compliant
Weight
22 kg
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HVLDVOLTA high voltage leak detection unit with touchscreen and sample holder

VOLTA

High Voltage Leak Detection

VOLTA is a nondestructive High Voltage Leak Detection (HVLD) benchtop unit for package integrity testing of liquid filled containers.

Test sensitivity
Below 1 micron*
Results
Deterministic PASS/FAIL
Type
HVLD μE – micro Energy (typical below 100 mJ released to sample)
Regulatory standards
USP <1207>, EU GMP Annex 1
Measurement cycle
< 10 seconds
HMI / PLC
13.3” Touch Screen Windows base, by Siemens® / PLC Siemens®
Network
RJ 45 Ethernet – OPC UA
Weight
40 kg
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Vacuum decayCCI 1000 FAD vacuum decay leak tester with automatic drawer and touchscreen

CCI 1000 FAD

Flexible automatic drawer

A non destructive vacuum decay leak tester equipped with an automatic test chamber optimized for non-porous flexible and semi-rigid packaging.

Test principle
Vacuum decay (ASTM F2338). Non destructive
Reference methods
ASTM F2338, USP <1207>
Formats
Up to 700 × 400 mm
Test chamber
Automatic opening/closure. Safety lock of drawer
Output
Pass / fail with large green/red lights and number shown
Data
Export in csv format via USB or Ethernet cable. Audit trail available for CFR 21 Part 11 (option)
Compliance
CE Marked
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Simple workflow

Detect micro leaks without spoiling the package.

Each measurement can be completed in less than 15 seconds. The result is immediately displayed and requires no interpretation.

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Place the sample inside the test chamberThe CCI 1021 test chambers are interchangeable and connect quickly and easily to the instrument without the need of tools.
Specifications

From measurement to trusted data.

< 15s
Measurement cycleCCI 1021
< 0.05cc/min
Limit of detection, approx. 1.5 micron nominal hole size*CCI 1021
< 1µm
Test sensitivity*VOLTA
700 × 400mm
Bigger formats with low effort for the operatorsCCI 1000 FAD

* Test sensitivity may vary based on the combination of package/product.

Applications

The right chamber for the right package.

Containers and packages made of glass, plastic, metal and flexible composite materials.

Sachets, stick packs, pouches and bags tested on the CCI 1000 FAD
CCI 1000 FADSachets, stick packs, pouches, bags and medical devices, up to 700 × 400 mm.

Container types

  • AmpouleCCI 1021VOLTA
  • VialCCI 1021VOLTA
  • Pre-filled syringeCCI 1021VOLTA
  • CartridgeCCI 1021VOLTA
  • BFS ContainerCCI 1021VOLTA
  • IV BagCCI 1021VOLTA
  • Pouch / SachetCCI 1021CCI 1000 FAD
  • Small-size bulk containerCCI 1021
  • Ophthalmic dropper tipCCI 1021
  • AutoinjectorCCI 1021
  • Stick packs, bags, medical devicesCCI 1000 FAD
Full service

Beyond the instrument.

Qesse’s team of professionals does not merely manufacture the equipment; it also offers specialized services.

  1. Feasibility studies
  2. Method development
  3. Certified positive controls (Defective Samples)
  4. IQ/OQ/PQ cGMP Validation
  5. FAT Factory Acceptance Test
  6. Calibration & maintenance
  7. Calibrated flowmeterOptional
  8. Certified built-in orifice for system suitabilityOptional
News

Find news, knowledge and applications

All news
EventsPast event

CPHI 2026

We exhibited at CPHI Milan, Hall 9 stand 9J116. Date: 6-8 October 2026. Location: Fiera Milano.

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ArticleHVLD

High-Voltage Leak Detection (HVLD) for Container Closure Integrity Testing in Pharmaceutical Packaging

High-Voltage Leak Detection (HVLD) has emerged as a deterministic, non-destructive technology capable of detecting micro-defects.

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NewsCCI 1000 FAD

New CCI 1000 FAD – flexible automatic drawer

We are happy to announce our most recent instrument dedicated to flexible packaging, the CCI 1000 FAD.

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Find us at the officeVia Liverno 11, 15069 Serravalle Scrivia (AL) – ITALY
Give us a ring+39 0143 62422
Mon - Fri, 8:00-18:00

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