Focus on Training, Competence, and Unwavering Cross-Contamination Control in Cleanrooms

August 4, 2023 |

Focus on Training, Competence, and Unwavering Cross-Contamination Control in Cleanrooms

In the realm of pharmaceutical manufacturing, cleanrooms play a pivotal role in upholding the highest standards of quality and safety. As part of our ongoing commitment to excellence, MCR Group places a strong emphasis on robust training, competence, and stringent cross-contamination mitigation measures. Let’s delve into the key elements that underscore our approach:

Minimised Personnel Numbers: At MCR Group, we understand that personnel represent the most significant risk of introducing microbial contaminants. Through meticulous risk assessments, we ensure that personnel numbers are minimised per area, reducing potential contamination risks.

Controlled Access and Oversight: Our approach to cleanroom management encompasses controlled access and ongoing quality assurance oversight.

Comprehensive Training Program: To maintain the highest standards of hygiene and contamination control, our training program for cleanroom personnel is thorough and all-encompassing. It includes essential elements such as hygiene, cleanroom practices, contamination control, aseptic techniques, basic microbiology, and a keen awareness of potential safety implications arising from product sterility loss.

Aseptic Process Qualification: For Grade A and B cleanrooms, aseptic process qualification is a cornerstone of our approach, ensuring stringent adherence to sterile manufacturing conditions.

Ensuring Competency: MCR Group prioritises competency assurance for cleanroom personnel. We differentiate between “qualified” and “unqualified” operators, ensuring that every team member is well-equipped to execute tasks with the utmost precision.

Stringent Garment and Access Control: Our attention to detail extends to attire and access control. We strictly prohibit outdoor clothing (with the exception of personal underwear) in changing rooms and do not permit smartphones in clean areas.

Dedicated Gown Processing: Gowns used in cleanrooms are processed in dedicated laundry facilities, ensuring they are suitable to prevent shedding and have no adverse effects on product integrity. The process of cleaning, evaluating, and sterilising gowns is meticulously qualified.

Monitoring for Gowning Qualification: MCR Group identifies specific locations on operators’ gowns that require monitoring as part of gowning qualification. This proactive approach enhances the overall cleanliness and hygiene standards.

Defined Gown Usage Limit: We define the maximum time a gown can be worn, ensuring strict adherence to optimal cleanliness standards at all times.

Airflow Visualisation Studies: As part of our operator training program for Grade A areas, we recommend and conduct airflow visualisation studies. This proactive measure empowers operators with a comprehensive understanding of the cleanroom environment.

How MCR Can Empower Your Compliance: At MCR Group, we take pride in our comprehensive GMP training program. It goes beyond mere training and places a significant emphasis on assessing competency to ensure superior cleanroom practices. Our tailored training program for Grade A and B areas aligns with the latest Annex 1 requirements, fostering a culture of compliance and continuous improvement. Furthermore, we maintain close collaboration with industry-leading vendors in the gowning sector, ensuring that our procedures, practices, and training remain in sync with the latest developments and requirements. With MCR Group as your partner, you can be assured of unwavering focus on training, competence, and cross-contamination control, culminating in the highest standards of pharmaceutical manufacturing.

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