Medical packaging and conditioning in cleanroom
Certificated ISO 13485
ISO 13485 certificate

Laboratory Control and Validation

Laboratory Control and Validation

Accelerated aging

According to standard ASTM F 1980 v.2007

Three ovens at 50 ° C and 60 ° C.

Validations conditioning

According to standards ISO 11607-1,ISO 11607 - 2 and NF EN 868 - 5

Integrity testing, peelable, resistance, "bubble test" and "crash test"

On blisters and pouches

Test residual moisture

Cleaning Validation

According to standard NF 94 - 091

Validation of orthopedic implants, dental and medical fabrics before final packaging

particle counting

On particles> 16 microns

On orthopedic implants, dental and medical fabrics