Cleaning, conditioning, labelling
For devices that require sterilisation, STATICE suggests specific procedures depending on the devices or products with a range of facilities:
- 70° ethanol and ultrasounds tanks
- Ultrasound tanks with anti-bacterial and antifungal cleaning
- Final cleaning with alcohol and wiping prior to conditioning in an ISO5 controlled environment.
The aforementioned procedures are validated depending on clients' requirements, and the associated testing and controls can be undertaken by Statice:
- COT Total Organic Components
- HCT Total Hydro-Fuels
- LAL Residual Endo-toxins
- (Bioburden) Initial Contamination
STATICE has a range of thermo-sealants which enables conditioning the devices either in bags or in blisters.
STATICE applies the EN ISO11607-2 standards for conditioning goods, and guarantees the following procedures:
- Leak testing
- Peelability testing
- Pull testing.
The cleaning and conditioning processes are done under the ISO5 standards.
Upon request, STATICE can provide further specific operational Quality Control conditions with regularly maintained and specifically designed equipment, and STATICE is able to provide all of the corresponding certificates for Quality of Installations.
With a large selection of thermal printing machinery, STATICE can also offer specific labelling and/or bar-coding or any other needs. STATICE is also available to provide consultancy and an objective approach regarding the applicable standards for labelling or the best format to be used under EN 980 and EN 1041 standards.
The procedures are subject to rigorous and strict vigilance, and in particular:
- The design following the validation of a 'Ready To Print' format
- 3 levels of quality control for the series.