Cleanroom Manufacturing

Operating five Class 100,000, fully ISO 13485 accredited cleanrooms totalling 8700 sq m with completion in September 2019 of a further 700 sq m to increase total cleanroom size to 9400 sq m total, 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 and II 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: 60-90
  •  Micron sizes 5.0µ and 0.5µ.
  •  High efficiency penetration air (HEPA) Filtration giving 99.9% efficiency

ISO Class 8 Cleanroom Information

  •  EU GMP: D
  •  Air changes per hour required: 5-48
  •  Micron sizes 5.0µ and 0.5µ.
  •  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. The number of particles at rest follows a class 100k requirement. Air change requirements are related to the various sizes of our rooms.

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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