Today, we support you on your projects concerning the development of blood processing equipments for “Labile Blood Products”.
C-LAB guarantees to you
the best levels of quality
in terms of:
Reliability
- Automated and standardized checks compared to the manual method
Simplicity
- For the operator, whose handling and workstation are optimized
Standardization
- And automatic process reproducibility
Traceability
- Of your production results
Productivity gain
- In Blood Banking Procedures
ACÉMIS France developed, the only device that checks welded tubes for airtightness
- From 1 to 6 tubings
- Any connection type
- Operating mode in only four production steps
- Usability : touch-screen
- A record of unit numbers, type of blood products and sterile connecting devices can be carried out via scanning barcodes
- Reports printed on request
- Regular cleaning of the circuit can be performed
The CE-marking represents the compliance of C-LAB towards CE directive 2004/108/CE:
- concerning electromagnetic compatibility according to EN 61326-1,
- CE directive 2006/95/CE for low voltage safety according to EN 61010-1
- and CE directive 2011/65/CE on the restrictions of the use of hazardous substances in electrical and electronic equipment.
Good Practice Guidelines for sterile connection topic in Blood Establishments
2016/1214 european directive recommends that european blood centers take into account the instructions of the PA/PH/TS (13) 15 3R Good Practice Guidelines
Specifications
- Product code: C-LAB
- Size (HxWxD): 355mm x 375mm x 390mm
- Weight: 29lb 12oz
- Voltage input: 230V AC +/- 10%
- Voltage frequency: 50Hz
- Power: < 130W
- Primary Fuse: 250V 2x2AT
- Inlet Pressure: 0-2.5bars
- Environment of use: Operating temperature : 59°F to 77°F
- Working temperature: 41°F to 95°F
- Maximum altitude: 6561ft 8.158in
- Relative humidity < 90% (non-condensing)
- Storage conditions: 14°F to 122°F
- Pollution degree: 2
- Protection degree: IPX0
- Communication port: RS-232 for bar code reader RJ-45 cable in grade 6E for Ethernet connection
- Compliance with: European Directives: 2004/108/EC EN61326-1 EMC Class B 2006/95/EC EN61010-1 ed3 Safety 2011/65/EC RoHS
- EMC Classification: Group 1, Class B
Accessories:
AC power cord, bar code reader, support, cable, Instructions for use – French, c-lab.exe and firmware.exe softwares, PC, Router + Professional Office Pack + RJ45 cable in grade 6E , Printer (optional)
C-LAB, tested by « EFS Bourgogne/Franche-Comté »
Christian Naegelen report from the Montpellier 2017 SFTS exhibition
In connection with the evaluation of the system, duplicated tests were carried out on tubings with 6 welded tubes (buffy coats pooling) or on tubings with only one welded tube.
The welded tubes were tested by the reference method of “Bourgogne-Franche-Comté” EFS (air leakage test) and by C-LAB.
The goal of these tests was to validate a wide range of physical quantities (pressure value, duration, pressure differential), the quick couplers to interconnect C-LAB and tubings and the process. The embedded software was optimized to make it more functional and allow traceability of procedures and test results.
As a first step, a series of tests enabled to determine the pressure values and durations to implement depending on the kind of tubings used (single or multiple connections).
The embedded software was optimized to ensure data reading, traceability of blood unit numbers, sterile connecting devices, technicians, parameters and results of controls.
The experiment was conducted within a ten months time. 6213 tubings were controlled by the reference method and C-LAB. 9 non-compliant connections were detected by the 2 testing procedures.
In our experience, it takes 8 min 36 s to check the airtightness of 12 sterile connections following the reference method while it takes only 3 min 20 s for the same operation using C-LAB.
Total time taken (operator and machine ones) to check 12 sterile connections is approximately 10 min 40 s with automatic procedure. However, checks are carried out in masked time during blood platelets preparation step.
