Misom Labs, Malta
Fabtech Technologies has worked on the Misom Labs pharmaceutical manufacturing facility in Malta. Of all the projects published on this site, this is the only one inside the European Union.
Looking for Misom Labs itself? This is the website of Fabtech Technologies. We are the engineering company that worked on the plant. For information about Misom Labs as a business, please see their own website.
Why an EU location changes the engineering
This section describes projects of this type in general. It does not describe what was delivered at this facility.
A plant inside the European Union is designed to meet EU-GMP.
These are the European Union's rules for good manufacturing practice. Where the product is sterile, Annex 1 of these rules applies in particular.
For a buyer, the main difference is not that the rules are stricter in general. The difference is that inspectors visit the plant in person.
They check the documents as closely as they check the rooms.
So more of the work moves to the early part of the project. Design qualification is the formal check of the design before building starts.
Here it is no longer a formality.
At this step, the team justifies and records the airflow design, the pressure cascade (the steps in air pressure from one room to the next), and the routes that materials and people follow.
When an inspector arrives, the documents either already prove the design, or they do not.
If the plant supplies the EU, the team writes up the qualification sequence from the start. It uses the format that the European regulator expects.
The cleanroom systems and the HVAC (heating, ventilation and air conditioning) are designed for the cleanroom grade that the process needs. The grade in the room's name alone does not decide this.
Malta is also a small island. Logistics and site access limit how the team can bring in equipment and put it in place.
This is more a planning problem than an engineering problem. It is easier to solve early.
Fabtech in Europe and the Mediterranean
Our published projects in and around the Mediterranean include this facility and Sanofi in Egypt.
In the clients' own words on the projects portfolio, they also include Laboratorie Biorem and SARL CPCM in Algeria.