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Documentation

Each INVpack machine is subject to a rigorous set of tests, with or without the presence of the client.

At INVpack, we simulate the production process that the machine must carry out in the client’s facilities, verifying all the agreed technical specifications.

The production tests are carried out at the maximum agreed speed, using the client’s product and film. Specific measurement instruments are used to verify filling and sealing tolerances even under the most unfavourable conditions.

Finally, the machine is tested at the client’s location with INVpack’s technicians, providing advice and training to those the client designates as responsible for production and/or maintenance.

All INVpack machines come with the following documentation:

  • Project planning
  • Coil plan, Layout of the machine, PID
  • List of consumption (electric + air)
  • FAT Protocol and Planning
  • Installation instructions
  • Electrical and pneumatic schemes
  • European certificate of conformity
  • User manual
  • Maintenance manual
  • List of alarms
  • Instructions for format change
  • List of recommended lubricants
  • Instructions and cleaning, inspection and lubrication planning
  • List of replacement parts
  • Programme security copy (Back up/Restore)

Following the general regulations of each project:

  • Machinery Guideline 2006/42/CE
  • Electromagnetic Compatibility Guideline 2004/108/CE
  • Low tension regulations Guideline 2008/95/CE
  • Working devices Guideline 89/655/CE

Pharma documentation:

  • Functional specifications
  • Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ)
  • Risk analysis
  • Certificates of materials in contact with the product
  • Documentation and calibration records

Following pharma sector regulations:

  • GMP annex 15
  • FDA 21 CFR PART 11

We simulate the production processes

We verify all agreed technical specifications