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To help our customers comply with their validation requirements Enercon is pleased to offer a Validation Program for its complete line of air-cooled and water-cooled induction cap sealers. Complete Installation Qualification (IQ), Operational Qualification (OQ), and Product Qualification (PQ) protocol support is available. On-site engineering assistance is also available. Documentation includes but is not limited to:
- IQ
- Process and control system overview
System and Options Installation Verification
Switch Settings
Operational Requirement Verification
System Operational and Safety Checks - OQ
- System Performance Testing
Standard Option Performance Testing
Cap Inspection System Performance Testing - PQ
- Container, Cap, Liner and Product Specifications
Operational Parameters
Test Equipment Traceability Log
Exception Log
Maintenance and Operational Training Log
- Additional Deliverables include:
- System drawings and Utilities
Utility Requirements
Operating Manuals
Replacement Parts Listings
Troubleshooting Guide
Sales Documentation
Training Program Outline
Exception Log
Test Equipment Requirement
Test Equipment Traceability Log
Maintenance and Operational Training Log Available on CD-ROM
- Onsite Assistance:
- Execution of the qualification protocols is the responsibility of the end user. Enercon offers on-site engineering assistance for the execution of the protocols and for personnel training.
For more information on Enercon's validation program call 262-255-6070 or contact us on the web.
FDA Validation Definitions*
- Validation
- Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
- Validation Protocol
- A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.
- Installation Qualification (IQ)
- Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
- Process (operational) performance qualification (OQ)
- Establishing confidence that the process is effective and reproducible.
- Product performance Qualification (PQ)
- Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.
Enercon systems are designed to operate in a maximum ambient temperature of 40°C (104°F) @ 80% relative humidity, non-condensing.
*Source: Guideline on General Principles of Process Validation, May 1987
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