Particle Monitoring Plans

The production of medical products such as pharmaceuticals and medical devices requires some level of particle and cleanroom monitoring. Every cleanroom used in these industries must have in place an environmental monitoring program. Particle monitoring is an important and often overlooked part of any EM Program. Particle monitoring in these environments should be more then annual certification by a 3rd party contractor. Our services include  developing a compliant particle monitoring plan based on industry regulations, guidelines and risk assessment.   

Services Provided:

• Audit of existing particle and environmental monitoring plans, systems or suppliers
• Risk Assessment for particle monitoring plan creation
• Particle monitoring plan creation
• User Requirement Specification creation for Particle Monitoring Systems
• Project consulting for particle monitoring system specification, design, vender  selection, document review and final installation
• Independent particle monitoring system audit

The largest particle counter installations have been in electronic manufacturing facilities. Data  provided from this application is part of an overall process control  system. Understanding where and how to monitor is critical in gathering  data and turning it into meaningful information for decision making. In addition the process and cleanroom monitoring can be utilized to offset annual cleanroom certification cost with a properly designed particle monitoring plan.

Services Provided:

• Audit exsiting particle monitoring plans
• Identify critical and busy locations for particle monitoring based upon risk analysis
• Particle monitoring plan creation
• Creation of SOPs for particle monitoring 
• Project consulting for particle monitoring system
• Independent particle monitoring system audit

Aerospace and Defense cleanrooms are some of the largest single room cleanrooms ever built. Ceiling heights in high bay cleanrooms can be 30 meters (100 ft). Contamination  monitoring is critical as products produced here are often one of a kind and extremely expensive. Risk assessment is a critical tool to establish a particle monitoring plan. Often very little can be provided in terms of detail as to the nature of the cleanroom or products produced in assessing risk. This is due to the security of the cleanroom, the products produced and the type of operations carried out. Our experience in these applications allows end users to address  contamination risks, without having to compromise security.

Services Provided:

• Evaluate cleanroom floor plans to establish cleanroom monitoring protocols
• Particle monitoring plan creation
• Creation of SOPs for particle monitoring 
• Project consulting for particle monitoring system
• Independent particle monitoring system audit