Specification
Vindon has been manufacturing controlled environment chambers for over 40 years and it is these units, with proven reliability and very accurate control of temperature and humidity, that are used in the Vindonwestech storage suite.
- Purpose built stability storage facility close to all transit links (airports & road networks)
- Vindonwestech service professionals on call at all times
- Full spare parts inventory on site for all chambers
- Backup generator
- 24/7/365 facility support & maintenance
- In house Eurotherm datalogging & monitoring system (NIST Traceable)
- Data backed up offsite daily
- FDA Title 21 CFR part 11 compliant monitoring system including logging temp, humidity, entry/exit of chamber
- System regularly validated
- Over 60 years combined experience
- Dedicated QA/QC department
- ISO 9001 compliant (est. certification Dec 2010)
- Full Standard Operating Procedures (SOP’s) – available on request
- Detailed reports available
- Advanced scheduling system for client pull returns
- Full confidentiality of samples. i.e. All projects are labeled with a project and client assigned name
- Same day or next day sample returns to anywhere in the contiguous USA
- All shipments are assigned an individual tracking number
- A full complement of temperature controlled shipping packages including dry-ice, ambient & 2ºC to -8ºC dependent on required condition
- Datalogged transport of samples to monitor compliance
- Partnership with global logistics leader
- Full alarm system including motion and smoke detectors will monitor the facility environment every second of every day
- All access points in the building will have alarm contacts
- Closed circuit television, assisted by monitors outside the building for personnel or vehicle activity
- Provides a safe and secure environment for all samples
designed to meet all ICH harmonised tripartite guidelines and validated annually
Vindonwestech has both option 1 and option 2 validated light cabinets which conform to ICH - Q1B
Our photostability cabinets have been designed to meet all ICH Harmonised Tripartite guidelines covering Stability Testing of new drugs, drug products and photostability testing. (Q1B).
The cabinets are validated annually with all the documentation being pre-authorised for use prior to the commencement of the validation. The validation and associated documentation are completed by trained Vindon engineers. The completed documentation is checked by another validation engineer before a final chech and approval by the Vindon QA department.
Our in-house Service Engineers service the cabinets annually, in-line with Vindon's rigorous service procedures. Which includes replacing the calibrated LUX and UVA sensors every two years.
All of our photostability cabinets are connected to our data acquisition system which is CFR21 part 11 compliant. The validated data acquisition system continually monitors the LUX and UVA levels within the cabinet.
