LF-S11 Benchtop CFR21 Part 11 Compliant CCI Tester

Pharmaceuticals

Non-Invasive, Non-destructive Integrity Inspection System for laboratory and in process control applications.

Ampoules

BFS

Bottles

Carpoules

Cartridges

FFS

Filled Pharmaceutical Monobloc Aerosol Cans

Pouches

Prefilled Syringes

Vials

Flowpacks

Strip Packs

Tech specifications

Highlights

Quick and sensitive test
Compact & maintenance free
3 configurations: BASIC, XL, SY
Vacuum and positive pressure testing
Applicable to any type of pharmaceutical containers
Solutions in place for PFS, LVP, cartridges

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LF-S11 | Benchtop CFR21 Part 11 Compliant CCI Tester

Technical Features

Container Application: Vials, PFS, Pouches, Strip Packs, Strip, BFS, Cartridges, Ampoules, Carpoules, PFS Nest, Flowpack, Bottles, Filled Pharmaceutical Monobloc Areosol Can, FFS, other Medical devices
Products: Lyo, Liquid, Powder, Solid, Semi-solid
Container Dimensions: Up to 1000 ml
Testing time: From a few seconds to about 1 minute according to container size
Technology: CCIT
Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum & Pressure Decay Method
Inspection Capabilities: Microleaks detection

Additional Benefits

Quick format change over
Automatic plunger stopping device for PFS
Auto-diagnostics verifies optimal working condition of the testing chamber and enables machine start-up
Easy, quick and safe remote access
Barometric Compensation system to avoid any vacuum level reading variations
Highly functional, intuitive HMI
Real time display of testing cycle diagrams, statistical raw data
Storage of records: maintenance, production, alarms

Technology

Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
- Vacuum Decay Method
- Pressure Decay Method
Measurement system comprises applying a pressure differential into an airtight testing group enclosing the container.
The test objective is to detect container leakages by measuring the reached pressure level as well as the pressure change over test time.
Lid deflection technology can also be implemented to detect leaks on foils of cups or pouches together with Vacuum Decay method.

Quality Assurance

Equipment test method refers to:
- FDA 21 CFR part 11 as well as EMA Annex 11
- United States Pharmacopoeia - USP General Chapter «1207» “Packaging Integrity Evaluation”
- EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
- PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
- Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”

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