Validation Made Easy

Pharmaceutical Validation

Validation Made Easy

Every Serpa Packaging machine is designed from the ground up for pharmaceutical applications and as such is extremely validation friendly. Clean cGMP construction allows for easy maintenance and product cleanup as well as easy maintenance.

 

Our balcony cartoners are designed for bottles, blisters, vials, ampules, pouches and medical devices. The clean fall through design is ideally suited for the pharmaceutical industry.

 

Our servo driven, balcony design casepackers are the cleanest and quietest in the industry! With compact footprints and simple operation, these machines are an industry favorite for the complete access and clean features needed in pharmaceutical environments.

 

Our validation team includes internal technical writers and our external validation group, SMB Validation & Compliance Group. Full GAMP documentation is available, as well as full validation protocols including IQ/OQ and PQ protocols. Field execution is available to help you rapidly get the project complete and into production. At Serpa Packaging, your line validation is made easy!

VALIDATION DOCUMENTATION

  • GAMP Documentation
    • Functional Requirement Specification
    • Detailed Design Document
    • FAT Protocol
  • Protocols
    • Installation Qualification
    • Operation Qualification
    • Performance Qualification
    • Line Qualification
  • Protocol Execution
  • Validation Made Easy