CONTAMINATION CONTROL

Contamination Control is central to everything we do and manufacturers need to assess all potential microbial entry points. We assist companies in developing, robust Contamination Control Strategies across their entire operation to align with the new requirement of EU Annex 1, including audits and remediation plans for:

• Facilities and Equipment - Manufacturers need to know the risks posed by their facility, cleanrooms, HVAC, airlocks, and equipment and we assist with identifying and prioritizing these risks. 

• Personnel - The contamination potential due to personnel is minimised with a combined approach of awareness training, GMP training, gowning qualification and operator monitoring. 

• Utilities - Critical utilities (water, steam and gases) are a major constituent of most products and pose a unique risk. 

• Raw Materials and In Process Control - The Raw Material (RM) specification should be prepared for all GMP supplies and consumables, and have risk based release checks performed on receipt. Procedures should state how the material is identified, inspected and accepted or rejected.

• Product Containers and Closures - Product containers especially final fill containers are high risk items and pose a real risk to patients if handled incorrectly. 

• Vendor Management - Supplier Assurance ensures that GxP materials, equipment and sub-contracted services are purchased from approved supplier and that all new suppliers are assessed in a controlled manner. It should also define requirements for vendor audits and corrective actions. 

• Outsourced Services - Suppliers of services (suppliers, test houses, subcontractors, services and distributors) should be categorised using a risk-based approach, and assigned a risk classification depending on their risk to the process. 

• Process Risk Assessments - A Microbial Control FMEA assists manufacturers identify potential microbial entry and proliferation points. 

• Validation - All validation activities should be defined in the Validation Master Plan. All GxP systems should be validated in accordance with EU Annex 15, EU Annex 11, US FDA 21 CFR Part 11 requirements. This should include facilities, utilities, equipment, process, monitoring systems, temperature control units and shipping validation. 

• Maintenance and Calibration - All maintenance and calibration should be either performed in-house by qualified staff or outsourced to specialist vendors that have undergone qualification under the Supplier Management Program.

• Cleaning and Disinfection - Facilities should have a fully defined cleaning procedure to ensure the facility is cleaned and disinfected correctly and at an appropriate frequency to ensure a high level of environmental control and the required environmental standards are maintained.

• Monitoring Systems - Appropriate and validated monitoring systems should be in place to monitor viable and non-viable particulate matter in your cleanroom, especially in Grade A/B areas.

• Detection and Prevention - Internal and External Audits, trending, and Corrective And Preventative Actions (CAPA's) are all critical to detect and prevent non-compliance and potential contamination events. 

• Continuous Improvement - An important aspect of contamination control is transparent quality management oversight so that the senior leaders in the organization can pre-empt potential contamination issues. Key Performance Indicators (KPI's) and a culture of continuous improvement ensure high compliance levels. 

 

We work in collaboration with your onsite team to develop robust Contamination Control Strategies. We have different options to suit your needs, feel free to schedule a call to see where we can help.