The
following is a partial list of some of the equipment the VTI
team has qualified: :
- Autoclaves
- Bioreactors
- Blenders
- Cappers
- Centrifuges
- Chromatography Systems
- CIP & COP Systems
- Depyrogenation Ovens
- Depyrogenation Tunnels
- Encapsulators
- Fermenters
- Filtration Systems
- Fluid Bed Dryers
- Freezers
- Fume Hoods
- Glassware / Vial Washers
- Glove Boxes
- Granulators
- IncubatorsTanks
- Inspection Systems
- Lyopholizers
- Milling machines
- Packaging Equipment
- Pumps
- Refrigerators
- SIP Systems
- Storage Chambers
- Tablet Presses
- Thermal Validation
- Tunnels
- Ultrafiltration / Difiltration Systems
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Our Philosophy:
A Hands-On Approach:
The VTI Team will deliver planning, teamwork, communication,
and effective project controls required for successful project
execution. Our employees have the hands-on personal experience
and the depth of experience in commissioning and validation
to ensure compliance with the applicable regulations and client
requirements. We will integrate the ISPE Baseline Guide approach
into the project the construction, commissioning and qualification
phases to stream line the qualification process. Our experienced
Project Managers will work with your project team to define
project goals and expectations and the achievement of these
goals will be communicated through Weekly Project Status Reports,
Action Item Lists, 2-Week Look Ahead Lists, On-Line Budget
Tracking, and Weekly Meeting Minutes.
The following are some of the service we
provide:
- System/Equipment Impact and Criticality Assessments:
- Validation Program Development
- Policies and Procedures
- User Requirements
- Design Specifications
- Design Qualification Protocols and Summary Reports
- Qualification Protocol Preparation and Execution
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Commissioning Protocols
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Standard Operating Procedures (SOPs) Development
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