{"id":1114,"date":"2023-08-30T19:45:35","date_gmt":"2023-08-30T19:45:35","guid":{"rendered":"https:\/\/www.enerconind.com\/sealing\/?page_id=1114"},"modified":"2024-08-02T14:05:47","modified_gmt":"2024-08-02T14:05:47","slug":"validation-program","status":"publish","type":"page","link":"https:\/\/www.enerconind.com\/sealing\/cap-sealers\/accessories\/validation-program\/","title":{"rendered":"Validation Program"},"content":{"rendered":"\n\n\tHome<\/a> \u00bb Cap Sealers<\/a> \u00bb Accessories<\/a> \u00bb Validation Program\n\t\t

\n\t\t\tValidation Program\n\t\t<\/h1>\n\t\t\n\t\t\t

To help our customers comply with their\u00a0validation\u00a0requirements Enercon is pleased to offer a Validation Program for its complete line of 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:<\/p>\n\t\t\n\t\t\tIQ\n\t\t\n\t\t\tProcess and control system overview
\nSystem and Options Installation Verification
\nSwitch Settings
\nOperational Requirement Verification
\nSystem Operational and Safety Checks\n\t\t\n\t\t\tOQ\n\t\t\n\t\t\t

System Performance Testing
Standard Option Performance Testing
Cap Inspection System Performance Testing<\/p>\t\t\n\t\t\n\t\t\tPQ\n\t\t\n\t\t\t

Container, Cap, Liner and Product Specifications
Operational Parameters
Test Equipment Traceability Log
Exception Log
Maintenance and Operational Training Log<\/p>\t\t\n\t\t\n\t\t\tAdditional Deliverables include:\n\t\t\n\t\t\tSystem drawings and Utilities
\nUtility Requirements
\nOperating Manuals
\nReplacement Parts Listings
\nTroubleshooting Guide
\nSales Documentation
\nTraining Program Outline
\nException Log
\nTest Equipment Requirement
\nTest Equipment Traceability Log
\nMaintenance and Operational Training Log Available on CD-ROM\n\t\t\n\t\t\tOnsite Assistance:\n\t\t\n\t\t\t

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.<\/p>\t\t\n\t\t

\n\t\t\tFDA Validation Definitions*\n\t\t<\/h4>\n\t\t\t

Validation<\/strong>
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<\/strong>
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)<\/strong>
Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.Process (operational) performance qualification (OQ)<\/strong>
Establishing confidence that the process is effective and reproducible.Product performance Qualification (PQ)<\/strong>
Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.<\/p>\t\t\n\t\t\t\t\"Enercon\n\t\t\t\n\t\t\t\t\t\t\t\"Super\n\t\t\t\t\tON DEMAND WEBINAR\n\t\t

Achieve a Perfect Seal: Production Edition<\/h4>\n\t\t\t\t\t

Watch Now!<\/p>\t\t\t\t\n\t\t<\/a>\n\t\t

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