INVpack has an area responsible for generating and ensuring that equipment includes the next technical documentation:

  • Machine drawings: Coil plan, Layout, Electrical & Pneumatic drawings, P&ID
  • Electrical & Pneumatical components list
  • Bill of material (Spare parts, Replacements and Recommended lubricant)
  • Technical data and required supplies
  • Installation manual
  • Operation & user manual
  • Maintenance & cleaning manual
  • Programme security copy (Backup/Restore)
  • European Conformity Certificate

And assure that machine is in concordance with safety regulations (2006/42/CE, Electromagnetic Compatibility Guideline 2004/108/CE, and Low-Tension Regulations Guideline 2008/95/CE).

In addition to the documentation required for use, operation, and maintenance, also the customer can request the following services:

Oriented to Pharma sector, according to GMP annex 11 & 15, US 21 CFR Part 11 and GAMP 5, INVpack offers Machine Qualification Package which integrates:

  • Validation Master Plan (VMP)
  • Risk Analysis in line with ICH Q9 (RA)
  • Functional Specifications (FS)
  • Design Specifications & Qualification (DS/DQ)
  • Hardware & Software Specifications (HSS)
  • Hardware & Software Qualification (HSQ)
  • Factory Acceptance Test (FAT)
  • Site Acceptance Test (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)

Focus on Food sector and agreeing with ISO 22.000, presents Risk Analysis & Control Critical Points (HACCP) focus on equipment and Certificates of materials in contact with the product (in agreement with CE 1935/2004 & CE 10/2011).

Regarding User Safety Terms, Machine Failure Mode and Effects Analysis (FMEA) and in Explosion Safety Terms, Equipment Explosion Risk Evaluation Study (ATEX) are also provided.