Microbiological Cleaning in Cleanrooms in CDMO Operation

In the pharmaceutical industry, hygiene and microbiological cleaning and cleanliness standards in production areas are extremely strict. Maintaining the correct environmental conditions in clean rooms is essential for ensuring the safety and quality of medicinal products. In Poland, as in many other countries, this responsibility either rests with process employees, who are directly involved in production, or it is outsourced to external companies that provide hygiene services.

Why Mabion Replaced Outsourced Cleanroom Hygiene in CDMO Operations

Outsourcing has its advantages: it reduces the burden on internal company structures, provides flexibility, and enables the use of specialised service providers with experience and resources. However, this model also carries certain risks, primarily relating to maintaining uniform CDMO hygiene standards, continuity of knowledge and responsibility for critical areas. Frequent staff turnover in external companies, differences in training approaches and limited knowledge of the specifics of a given production plant can all have a negative impact on the stability and efficacy of the cleanroom microbiological cleaning process.

Mabion decided to move away from the commonly used outsourcing model in favour of building an internal, specialised team responsible for the microbiological hygiene of production areas. This strategic decision was aimed at increasing control over cleaning processes, improving the effectiveness of hygiene measures, and ensuring compliance with pharmaceutical regulations and the required quality standards. Strengthening alignment with CDMO client expectations by ensuring compliance not only with GMP (Good Manufacturing Practice) but also with individual regulatory documents and audit requirements for individual projects is key to successful collaboration.

Building an In-House Cleanroom Hygiene Team for Microbiological Cleanliness

One of the biggest challenges was finding the right people. Unlike external companies, which have their own staff databases and training systems, we opted to assemble a team from the ground up. Candidates for the microbiological cleanliness assurance and maintenance unit were recruited from a wide range of industries, often completely unrelated to pharmaceuticals. We attracted individuals from the food industry, cleaning services, catering, logistics and even those with no prior professional experience in manufacturing.

I was personally responsible for trainings and implementation of cleanroom standards. My experience of working with various clients in the pharmaceutical industry, including large international corporations and smaller local companies, enabled me to identify the key areas of the training process and develop a method of implementation that combined theoretical knowledge with intensive practical training. In a service provider context, this training had to cover not only general GMP requirements but also customer-specific quality agreements, which often define or specify cleaning frequencies, agent rotation policies, and environmental monitoring acceptance criteria.

From the outset, we emphasised the importance of understanding what a clean environment actually is and why maintaining the right microbiological conditions is crucial for ensuring the safety of the final product. Employees had to learn how to perform cleaning procedures and understand the basics of the quality system, the principles of GMP, and the importance of personal hygiene, behaviour in controlled areas and proper clothing.

Hygiene Procedures and Cleanroom Protocol Development

The next challenge entrusted to us was to conduct a comprehensive analysis and update certain hygiene procedures, as well as creating new ones from scratch. These procedures would regulate the team’s daily work and provide a clear framework for minimising the negative impact of personnel on maintaining the required cleanliness classes and on the processes carried out. Developing a complete set of procedures also strengthened the microbiological cleanliness management system. This included cleaning schedules, disinfection schemes, methods for evaluating the effectiveness of hygiene measures and detailed instructions on using cleaning and disinfecting agents.

Another important aspect was creating procedure diagrams, which are standardised descriptions of actions to be taken in specific situations, such as exceeding microbiological cleanliness limits, internal and external, planned and unplanned service activities or responding to an emergency. These diagrams provided the team with a clear way to respond to every possible situation, significantly reducing the risk of errors and irregularities.

A key objective of the project was to minimise the impact of human error on the microbiological cleanliness of the rooms, while ensuring that hygiene measures did not interfere with production processes. In practice, this required close coordination with the production, planning and quality departments, flexibility from the microbiological cleanliness team in adapting to the work schedule, as well as ensuring that hygiene activities were fully synchronized with CDMO client timelines and product release milestones.

Long-Term Impact of Microbiological Cleanliness on CDMO Quality Systems

Building a new team and changing strategy around cleanliness has brought a number of tangible benefits. First and foremost, we have achieved a significant improvement in the repeatability and effectiveness of hygiene measures, which has directly translated into a consistently clean environment and a reduction in microbiological risks. Employees became part of the organisation — they understood its mission, participated in internal training and, over time, began to actively contribute to the company’s culture of quality.

Unlike outsourced employees, the internal team was more involved in production processes and better integrated with operational teams. The number of errors resulting from misunderstandings or a lack of knowledge of procedures decreased. Moreover, the ability to quickly adapt cleaning protocols to changing regulatory guidelines or unique client audit findings has significantly increased customer confidence in Mabion as a reliable CDMO partner. This also enabled us to respond more quickly to emerging problems and adapt procedures flexibly to changing operating conditions or new inspection guidelines, further strengthening microbiological cleanliness in CDMO environments.

Over the following months, the team expanded and its competencies were systematically developed. Currently, we implement effective hygiene measures throughout the plant and participate in optimisation projects, testing new cleaning agents and equipment, and validation activities. Validation of cleaning agents and disinfectants, conducted in line with USP and EMA requirements, has become a permanent element of our operations, supporting compliance and customer audit readiness. The team has become an integral part of the quality assurance system, and its importance and role within it have grown significantly.

In summary, creating and strengthening an internal microbiological cleanliness team at Mabion was an accurate and right decision. Although the initial stage required considerable work, time and resources, we can now speak of complete success. Our experience shows that it is worth investing in developing your own structures, particularly in areas critical to the quality and safety of medicinal products.

FAQ

Prepared by:

Kamil Powierża

Manufacturing Site Hygiene Unit Manager

k.powierza@mabion.eu

Kamil Powierża

Manufacturing Site Hygiene Unit Manager

Since 2019, Kamil Powierża has been part of Mabion, where he is responsible for maintaining microbiological cleanliness in the production area. He began building his cleanroom experience in 2005 while working for a major facility management company serving various sectors such as food, cosmetics, medical infrastructure, hospitals, and medical universities. He has worked with both global pharmaceutical corporations and small local laboratories and startups. He has completed numerous short- and long-term training courses led by American, British, and Irish organizations specializing in cleanroom operations. Kamil has been a dedicated supporter of his team, combining technical knowledge with hands-on experience. He brings full commitment and passion to his work, ensuring the highest standards of cleanliness.