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C L E A N R O O M



Cleanroom technology has continuously evolved and progressed in leaps and bounds due to the increasing demands of the latest regulatory standards on product isolation and operator safety. Cleanroom design is now a critical factor in the ultimate success or failure of the complete facility and impacts significantly on the overall operating costs.

Steady control of temperature and humidity levels within the production areas is becoming more essential as the products become less tolerant to contamination and dimensional fluctuation. Quality Control and Assurance demand improved product reliability and consistency and less wastage.

The ultimate test of clean manufacturing facility is invariably the quality and consistency of the products manufactured. The facility design will assess the user requirements, process equipment requirements, production and support facility layout, desired operating parameters, desired air cleanliness standard, services requirements, environmental protection and waste treatment standards and requirements, desired air distribution, industrial ventilation details, product and basic ingredient listings. As part of the clean facility design, we would investigate and obtain a thorough understanding of the process material and personnel flow. This knowledge is a prerequisite to proper planning in order to achieve integrity of the air cleanliness within the production areas in the facility design.

APC recognizes that heating, ventilation and air-conditioning (HVAC) plays a major role in the final outcome of a clean manufacturing facility design and impacts greatly on the initial and operating costs. APC would evaluate HVAC systems in terms of their abilities to efficiently achieve and maintain steady and desired conditions within the clean manufacturing facility under different ambient weather conditions. APC understands that the HVAC system must be flexible enough to achieve the desired conditions in the cleanrooms as constructed, without cross-contamination of products and be able to achieve the desired air distribution and diffusion.

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Services

APC Can design your next cleanroom

  • From a conceptual design to a fully operational turn-key cleanroom facility
  • Construction management to manage all phases of construction
  • Cleanroom certification for compliance to ISO 14644, Australian GMP standards, FM and NFPA
  • Project Management to manage all phases of building, engineering, procurement, sub-contractor qualifications, site management, start-up, test, commission and certification
  • Facility management system design, installation, testing and performance validation to ensure requlatory compliance
  • DQ, IQ & PQ Validation
  • Laboratory Information Management Systems (LIMS)