Wednesday, September 27, 2023

Launch of RABS

Dita Parmová

Head of GMP Compliance

RABS (Restricted Access Barrier System) is a technological solution that combines the advantages of traditional cleanrooms and isolators. It is designed to minimize the risk of product contamination during production processes while increasing production quality and efficiency by limiting the access of personnel and other sources of contamination to critical production areas. From perspective of Annex 1 and our customers, it is a necessity that we have to implement if we want to continue with production on line 1.

Advantages of RABS

  • Increased safety – RABS reduces the risk of product contamination by isolating the production area from the surrounding environment physically.
  • Efficiency – compared to traditional cleanrooms, with RABS we can achieve higher production capacity with lower energy and maintenance costs.
  • Cost reduction – although the initial investment in RABS can be quite high, cleaning and validation costs are lower in the long run.

Challenges

As with most new technologies, the introduction of the RABS required a significant initial investment. A big challenge was the correct installation of the equipment itself, as it required a complex reconstruction of the production area.

Since we were introducing the RABS into an already functioning production environment, its integration and coordination with existing systems and processes was also a challenge. However, the final qualification confirmed that the RABS is working in accordance with the expected parameters.

Launch of RABS

According to Annex 1, the introduction of the RABS represents a significant step forward in the field of pharmaceutical production. It offers a number of benefits, including increased product safety and improved efficiency of our production processes. Although there are some challenges associated with its implementation and use, we believe that the benefits will outweigh any potential disadvantages.

Currently, three batches of Media Fill are being produced and then we will start commercial production and everyday work with RABS. It is already clear that we are not on the finish line yet, but we have another period of improvement ahead of us so that we can provide the best service possible to our customers.

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