Cleanroom cell according to GMP

In the pharmaceutical industry and in the food industry as well as in pharmacies, manufacturing and filling processes are increasingly carried out under cleanroom conditions. Production according to this guideline is also used in the cosmetics and feed industries.

The Spetec cleanroom module, which has already established itself in many other market segments, is now also available in GMP-compliant design.

GMP (Good Manufacturing Practice) refers to the guidelines for quality assurance of production processes and environments during the manufacture of pharmaceuticals and active ingredients.

Spetec offers support from planning, production, commissioning to qualification.

As a service, the following qualifications are offered:

- DQ (Design Qualification)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)

Spetec cleanroom modules are always designed and planned according to customer specifications.

Seamless ceilings and walls enable very good cleanability. Sharp corners and edges are generally avoided for this reason. The material is made of brushed stainless steel and is therefore resistant to cleaning agents typically used in pharmaceutical manufacturing.

The module is made entirely of stainless steel and, in terms of surface roughness, complies with GMP guidelines.

The mobile cleanroom module is an affordable alternative to a complete cleanroom. Using profile technology, the size of the cleanroom module can be freely selected (up to 100 sqm).

By combining individual laminar flow modules of different sizes, the effective cleanroom area can be variably determined. Production lines or conveyor belts can also be integrated into the cleanroom module. It can be equipped with pass-throughs, changing rooms, or entrance airlocks.

Used are flow modules from the SuSi series (super silent), which were recently introduced. These are characterized by particularly quiet operation. They are also equipped with a filter change indicator.

With H14 filters, cleanliness classes A to D (ISO classes 5 to 8) are achieved. Due to the laminar airflow, there is no exchange with contaminated air from outside under the flow modules.