Clean Room, OM Pharma: two new classified areas (WSL premises and media preparation)
OM Pharma is an international pharmaceutical group specialising in innovative patient-focused pharmaceuticals and solutions. The group is notably responsible for developing, manufacturing and marketing pharmaceutical products offering targeted care.
Looking to respond to increased activities, OM Pharma called on our clean room expertise to revamp an area of 50 m2.
So far, many activities shared a single space. To satisfy the requirements for research and development in the field of bacterial strains, the company opted to create two highly secure controlled-atmosphere areas reserved exclusively for this activity.
A clean room has a twofold primary objective, namely to protect against external contamination and contain internal contamination. In order to meet OM Pharma’s needs in terms of ISO Classes 7 and 8 (under ISO 14644-1), we placed particular emphasis on several points:
- Temperature control
- The stirring rate according to the desired particle classification
- The creation of personal and hardware special airlock systems (including pass-throughs)
- Limitation of contamination from staff with the implementation of a dressing procedure recommended for ISO 7 and ISO 8
To meet these safety, efficiency and comfort challenges, our engineers combined a range of skills and conducted studies of partitions, utilities, electricity, ventilation and automation, all integrated into a 3D model.
With a view to simplifying validations (outside the scope of SP groups), we adjusted the flow and pressure constraints during study phases in collaboration with the ventilation supplier. A fire safety study was also requested and followed up to meet AEAI requirements.
The project’s phases were:
- Basic Study
- Detailed study and definition of fixed values
- Drafting of specifications
- Requests for proposals from suppliers and comparisons
We began by removing the existing partitions and electrical passageways in order to create two ISO 7-8 Grade C-D areas (controlled-atmosphere areas for the less critical stages of sterile drug manufacturing) so that we could expand the technical area.
We installed a ventilation system to control the dust level and limit the risk of contamination: the air is forced into different areas defined upstream (AFD – Air Flow Diagram design). We used a 3D model to guarantee supply air conditions in the area (flow rate, pressure, temperature).
We secured a perfect seal by installing partitions that are easy to clean and disinfect, fixed internal windows and a false ceiling between 2.5m and 2.7m. In particular, H14 terminal filters were installed in false ceilings to guarantee clean, particle-free air. For automation, a dedicated PLC cabinet was created to control the facility and attain user-defined setpoints while monitoring the different variables in the premises.
Several pieces of equipment were installed in accordance with the user’s needs to ensure everyone’s safety and prevent any contamination:
- Monoblock grommets with an interlocking system enable the passage of material without compromising the purity and pressure characteristics of the clean room, while also preventing cross-contamination
- Fitted furniture at the partition level (benches and storage cupboards) and a resin floor with integrated skirting boards for easy cleaning
- Personal access SASs have been created so that users can equip themselves easily and quickly in compliance with the site’s existing dressing procedures
- An easy-to-clean, self-breaking partition was added to ensure rapid evacuation and direct outdoor access in accordance with fire safety studies.
”This project was especially interesting to follow. The SP engineers working together with the various suppliers managed to find technical solutions that not only met the user's needs, but also adapted to the space and size of the 50 m2 area.Michael PeytrignetProcess Engineer
The entire clean room technology of SP Groups fits within these premises. They are now approved and have passed the validation process.
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