Services
ClearSphere provides its clients with a set of services that ensures their plant remains compliant with domestic and international standards. ClearSphere’s Validation Department provide services in the following areas:
- Cleanroom testing and qualification
- Powder booth testing
- Solvent Booth testing
- Biological Safety Cabinets testing
- Fume Cupboards testing
- Isolators
- Laminar Air Flow Benches (LAF)
- Air Handling Units (AHU)
- Emergency Maintenance and Re-validation
- Operator Training (on site)
- Re-balancing
- OEL Testing
- HEPA/ULPA Filters testing and re-placing
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Validation
ClearSphere’s team of engineers are all CTCB certified. They apply standard protocols and use regularly calibrated equipment. The company ensures that it delivers optimal solutions by basing its work on customer requirements and current plant or process-specific standards. Its Validation Services include:
- FDS – Functional Design Specification
- IQ – Installation Qualification
- OQ – Operational Qualification
Re-qualification
The FDA and IMB recommend that all companies have a contract outlining regular and emergency re-qualification. ClearSphere can provide such a service to cover all eventualities. Apart from the need to demonstrate a regular re-qualification, this service is essential after on-site works and installations.
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Planned Maintenance
The main focus of ClearSphere’s Planned & Emergency Maintenance Services is minimisation of downtime and in the case of Planned Maintenance – improved efficiency.
ClearSphere maintains and improves plant efficiency by implementing programs to optimise room air change rates, pressures and replacing filters, belts, drives, gauntlets and other consumables at recommended intervals.
ClearSphere develops and designs its planned maintenance programs with its clients. The programs typically address:
- Belts & Drives
- Seals
- Automatic Doors
- Sensors
- AHUs
- Ductwork
- Filters
- Chillers
- Consumables
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