EAST COAST VALIDATION SERVICES, LLC is a Validation, Project Management, and Validation Maintenance Systems service company serving the Biotech and Pharmaceutical industries.
Founded in 2005, East Coast has over twenty years experience in GMP operations which enables us to provide high quality, cost effective service to industries regulated by the FDA.
Validation and Commissioning
Equipment
- Cycle Development
- Executing and Summarizing IQs, OQs, and PQs for GMP Production Equipment, such as:
- Bioreactors
- Harvest, Buffer and Media Vessels
- Purification Equipment
- Controlled Temperature Units (CTUs) - Refrigerators, Freezers, Incubators and Finished Product Warehouses
- Fillers and Cappers
- Vial and Stopper Washers
- Autoclaves
- Glasswashers
- Depyrogenation Ovens
Critical Utility Systems
- High Purity Water Systems (WFI, USPW)
- Clean Compressed Air
- Pure Steam
- Compressed Gases
- HVAC Systems
Cleaning Validation
- Development of Validation Rationales for defining Cleaning Acceptance Criteria
- IQs and OQs for COP and CIP Systems
- PQs for cleaning processes for small components as well as for large equipment and skids
Sterilization Validation
- PQs for verifying sterilization of small components in autoclaves or dry heat ovens
- PQs for verifying sterilization of large equipment and skids
- Sterilization Expiry of sterilized vessels
Automation Validation
Development of prevalidation documents such as User Requirements Specifications, Requirements Traceability Matrices and Configuration Specifications to integrate with system IQ, OQ and PQ.
Cycle Development
Design and implementation of Cycle Development tests for autoclave cycles, (including compliance with EU Sterilizer requirements) as well as Cleaning Cycle Development tests for establishing Acceptance Criteria and CIP cycle parameters.
Commissioning
- Impact Assessment of systems and equipment per ISPE Guidelines
- Development and implementation of Commissioning Plans and documents to integrate with Validation
- Goal is to minimize repeat testing