Cleanroom Manufacturing Services

Operating five ISO Class 8 and 7 fully ISO 13485 accredited cleanrooms totalling 10 000 sq m, our facilities provide a range of high level cleanroom capabilities for the medical device and pharmaceutical industry.

The production and assembly of our customers Class I, II and III reusable and disposable medical devices and their secondary pharma packaging services are all carried out in our controlled cleanrooms. We use HEPA filters which assist in the critical prevention control of bacteria and organisms in a positive air environment. Every step of the assembly process is constantly monitored to ensure the flow of materials and people are preventing contamination including the planning of equipment placement and materials to ensure no mix ups or further contaminations.

ISO Class 7 Cleanroom Information

  •  EU GMP: C
  •  Air changes per hour required: 30-60
  •  High efficiency penetration air (HEPA) Filtration giving 99.9% efficiency

ISO Class 8 Cleanroom Information

  •  EU GMP: D
  •  Air changes per hour required: 10-25
  •  High efficiency penetration air (HEPA) Filtration giving 99.9% efficiency

Class D Cleanroom (cGMP)

We have clean areas for carrying out less critical stages in the manufacturing of sterile products. 

SteriPack's expertise:

ISO class 7 & 8, grade D & C cGMP medical devices and pharmaceutical products cleanroom manufacturing services. 

cleanroom contract manufacturing

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