Contamination control does not begin at the cleanroom door. This article explores how behavioral practices, routines and leadership consistency shape contamination risks earlier in pharma operations. Drawing on Aptar Pharma Injectables’ approach to EU GMP Annex 1, it highlights the role of structured expectations and quality culture.
A large part of contamination control is shaped before anyone enters a controlled environment.
In the previous blog, we looked at contamination control through a physical environment lens. We walked the sites, reviewed flows and examined how operational realities shape risk in practice.
The next step took us somewhere less technical, but arguably even more decisive.
People play a critical role. A robust CCS goes far beyond the operator at the equipment. It depends on the collective commitment of every function across the organization.
The first challenge is to make it a truly company-wide project and bring everyone on board.
In practice, contamination control often starts earlier than expected.
Looking beyond the cleanroom
When contamination control is discussed, attention naturally goes to classified environments, isolators or monitoring systems. These are essential - the result of informed decisions built on rigorous risk analysis - but they represent only part of the picture.
A significant part of contamination control for our pre-filled syringe components and vial containment solutions is shaped before entering controlled environments. It lies in routines, gowning discipline, team interactions and the consistency with which expectations are applied every day. This became clear in our work: if a Contamination Control Strategy (CCS) reflects how risks are truly managed in practice, then behavior must be treated as an integral part of that system.
What we put in place
This led Aptar Pharma Injectables to structure behavioral expectations more explicitly.
Internally, this took shape through what we described as a structured "code of practice" for behavior. The objective was clear: define consistent, visible expectations directly linked to contamination control.
Work focused on hygiene and gowning discipline, behavior in controlled environments, change management, escalation practices and cleaning routines.
These topics were already part of our GMP practices, but we challenged our own GMP modules covering them, and took the opportunity to completely rebuild our training programs. We rethought the messages, their impact, the visuals, the key takeaway statements and the way knowledge is formally acknowledged. We then re-trained our entire workforce: not only operators and technicians on the shop floor, but every associate across the organization, all the way up to our leadership team.
We re-invested a full-day seminar with all the leaders of the organization, along with the mentors and on-the-job trainers — more than 250 people in total. A program of this scale can only succeed if it is truly embodied by frontline leaders and by those who train our new employees at the workstation.
This day allowed us to realign everyone around the same message across sites, raise awareness of what is really at stake, build conviction, and equip these leaders with the arguments they need to become the transmission belt of the program, and to make a tangible, personal commitment in support of the initiative.
In parallel, gowning practices were further aligned, including the introduction of a standardized approach from the very entry into production areas.
What this revealed
A few observations from this phase may also be useful beyond our own operations:
More broadly, contamination control is not only technical. It is also operational, and part of that operation is human routine.
For readers across pharma manufacturing and the supply chain, making behavioral expectations concrete early on helps maintain consistency where it matters most.
Looking ahead
This phase made one thing clear: contamination control is reinforced not only through systems and design, but also through routines and day-to-day discipline.
In the next blog, we will explore how audits and observations evolved at Aptar Pharma Injectables to support ongoing operational control.