Clean Room Bags Production | www.boelnordic.com

Clean room packaging

  • Primary and secondary packaging material
  • Protect against contamination in cleanroom production
  • GMP- and cleanroom qualified
  • For pharmaceuticals, medical devices, chemicals, automotive, (micro) electronics, food
Quality Control of Clean Room F

GMP philosophy

  • Cleanroom production (ISO 14644 – Class 8, GMP C in operation)
  • Integrated pest control / HACCP-principles / cleaning procedures
  • GMP designed manufacturing process, documentation / training
  • Traceability / validation / change control
  • Raw-materials in compliance with EU regulations, EU-Pharmacopoe / FDA / USP
  • Final protective packaging (“bag-in-bag”)
  • ISO 9001: 2008, EC-quality checklists, in-process-control, Certificate of Analysis
  • Consistently documentation / specification: raw-materials and process
  • Particle and bioburden Monitoring

Clean room films & bags

Our Partner Strubls vision is to supply best quality, know-how and service to realize a maximum of added value. The production system is covered by an integrated quality management system certified according to ISO 9001 which is permanently developing the products and process quality. GMP principles are installed and monitored over all process steps.

Packaging material used in cleanroom production facilities must meet the same quality requirements like the produced products. Only cleanroom packaging materials are able to eliminate contamination risks caused by packaging materials. This is valid all over the cleanroom-value-chain from rawmaterials via components up to consumer products. Particle and bio-burden monitoring systems ensures stable low- germ and low-particle cleanroom quality.

Clean Room Films & Bags | www.boelnordic.com