Meet Annex 1 gowning guidelines with expert Ivy Louis

With over 30 years of experience in the industry, Ivy Louis is the Founder of Vienni Training & Consulting LLP. She is also a member of the Parenteral Drug Association (PDA) and the Society for Sterility Assurance Professionals (SfSAP). Louis holds a Master’s degree in Pharmaceutical Sciences and an MBA in Human Resource Management.

In an interview with Lindström, Ivy discusses current trends, leadership, and gowning practices in the pharma sector. Annex 1 gowning guidelines and requirements are becoming more stringent, but what does this mean for the future of pharmaceutical manufacturing? Watch the video and read the article to learn more:

Guidelines for choosing a textile provider in pharma

Cleanroom garments need to maintain the highest levels of cleanliness. The environments where they are used are highly regulated and require precision, especially in the pharmaceutical and semiconductor industries; the garments worn within this controlled environment play a crucial role in safeguarding products, processes, and, most importantly, personnel.

According to Ivy, the current status of garments and gowning is that they don’t receive much attention. Often, in-house resources are employed to ensure that appropriate garments are always available.

Considering Annex 1 and its implications with respect to contamination control strategies, I believe garments become the frontline barrier for contamination control. It is not very easy for us in the next 10-15 years to imagine that people would disappear completely from the operations. People are still an integral part of the operations in a pharmaceutical setup. That is where contamination starts to become a problemIvy Louis, Founder of Vienni Training & Consulting LLP

It is crucial to protect the environment and to protect the people. In turn, this is where the requirements of a garment or textile manufacturer become important. Annex 1 is paving the way in terms of how people ought to re-look at their methodologies and processes of selecting a garment manufacturer.  

Annex 1 gowning recommendations

The tabular columns in Annex 1 are specific and elaborate. The kind of gowning that people have to adopt varies based on four different grades A-D.

No person is allowed to be in grade A, so the requirements for people’s gowning really start in grade B. The quality of gowns in grade B has very critical requirements, not only when considering the construction materials but also in the reuse categories that people have. Single-use gowns would be an easy choice, but they are not a sustainable option. However, Annex 1 does not discuss this issue.

As a garment customer, I would endorse that grade B gowns need to be equivalent, if not more stringent to the grade A. However, in grades C and D, there is an industry thought process that allows for downscaling the strict requirements. This most likely increases the risk of contamination possibilities. The moment you scale down the stringent requirements, the barrier mechanisms also scale down. So, although Annex 1 does not emphasize it, choosing garments for grades D and C is also important in minimizing contamination risks and implementing barrier systems.IIvy Louis, Founder of Vienni Training & Consulting LLP

As Annex 1 discusses, being logical and practical when thinking about barrier systems makes it easier to craft a strategy for the material and process of gowning in all three grades of D, C, and B.

Meeting requirements while preserving operational- and cost-effectiveness

The core competence of pharmaceutical companies is manufacturing. What complicates things is bringing everything surrounding manufacturing into the manufacturing portfolio. It is smart to consider what would make the operation processes easier or better, such as investing in laundry management or gowning activities as an outsourced activity.

“Gowning is just one way to control contamination. However, aligning it with the manufacturing policies requires a lot of money, time, and resources,” Ivy says.

Therefore, it is smart to let someone else manage the gowning process. Meanwhile, pharmaceutical manufacturers can hone all their resources and expertise in the manufacturing process itself.

Annex 1 comes with stricter cleanliness and sterility standards

Overall, Ivy sees that the pharmaceutical industry aligns relatively well with Annex 1 requirements. However, looking at the finer details, there is a need for redesigning the gowning processes. Gowning in grade B environments, which is the critical area, is quite good. On the contrary, gowning in non-classified areas is not in line with the requirements and expectations of Annex 1.

If we classify operations into critical and non-critical, the non-critical operations might need to be brought up to the standards. A common misconception in the pharmaceutical industry is that you do not need to pay attention to the lower classified areas. This is due to the fact that they are not in direct proximity to the products manufactured. I think if a shift happens there, increasing the control and monitoring of the periphery of critical operations, we can better control the contamination within the critical areas. It will contribute to higher and better assurance of unsullied and contamination-free operations.Ivy Louis, Founder of Vienni Training & Consulting LLP

What makes a leader in the pharmaceutical industry

Lastly, touching on leadership in the industry, Ivy believes a shift is needed in how we look at leadership. She elaborates that leadership is not limited to the topmost hierarchy in the organisation. It needs to be built into the system across the line of control. “As an operator, that person also needs to have leadership. This enables people to do things right the first time. For this, there is a huge amount of responsibility and accountability. It needs to cascade across the entire organisation.”

The industry’s limitations are in looking at leadership with a very myopic view and developing skillsets at the top of the pyramid. I think it is required across the hierarchy, specifically where decisions are made. Strategic decisions might be made at the top, but tactical decisions need to be made across the hierarchy.