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Cleanroom Cross Contamination Controls
Contamination Controls for Cleanroom Environments

florida cleanroom systems 080   Effective contamination and cross contamination control in cleanroom environments must take place on several levels to assure product or process integrity. From standard operating procedures(SOP) to gowning and de-gowning protocols the opportunities for contamination of a cleanroom process or product can happen at the procedural level, design of the HVAC systems, pressurization, and airflow, or process flow and personnel flow levels.

   In sterile cleanroom processes contamination will lead to down time and product loss while the cleanroom zone is shut down for decontamination procedures. It is far less costly to invest in protocols and mechanisms that will prevent contamination than to remedy it after the fact.

Sources of Cleanroom Contamination:
  • Personnel Flow, improper gowning and de-gowning procedures, personnel flow patterns, inadequate utilization of change rooms, airlocks, and pass through devices.
  • Process or Product Flow, receiving of raw materials, testing and quarantine of substandard materials, flow of product through cleanroom zones.
  • Air Flow, improper design of HVAC systems, cleanroom zones, cascading differential pressurization of zones, return air systems, and shared air handling systems.
  • Inadequate Physical Barriers such as change rooms, airlocks, air showers, HEPA filtered pass through devices, and gowning and de-gowning rooms.
  • Personnel Training and Supervision related to correct interpretations of SOP's and gowning and de-gowning protocols.
  • Cleaning and Sanitizing of cleanroom surfaces leaving chemical cleaning solution residue on surfaces of gaps.
  • Inadequate Cleanroom Design of sterile cleanroom environments or work stations.   

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   Cleanroom design for sterile and non sterile cleanroom environments varies greatly in cost, design principles, and construction methods. The importance of differentiating between the two methods and designing and constructing appropriately will mitigate all chances of contamination from the cleanroom systems.

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