Laboratorio MicroBios launches its new Clean Room, approved by the Spanish Agency of Medicines and Medical Devices, for the performance of sterility tests.
The new Clean Room at MicroBios Laboratory is equipped with the latest technology and aligned with the highest quality standards currently required by AEMPs and included in Annex 1 of the GMPs, allowing sterility tests to be carried out with the maximum guarantees and safety.
This new facility has a surface area of 30.7 m2, divided into two areas: a preparation area with classification C and a second area with classification B for carrying out analyses and studies. This second area is also equipped with a laminar flow cabinet. The useful surface area of the facility is completed by the two existing Sterile Access System (SAS) or passage chambers designed to guarantee safety during the transfer of products between the different areas, as well as with the outside.
Sterility tests are already being carried out in the MicroBios Laboratory Clean Room, both by direct seeding and by STERITEST filtration. In addition, the laboratory is planning to start up several studies of different types that require classified rooms with high technical equipment.
The start and development of this new facility has been a challenge for the Microbios Laboratory team and a major investment. This goal has now been achieved, doubling the operating capacity of the laboratory and forming part of its ambitious expansion plan.
The new Clean Room at MicroBios Laboratory is equipped with the latest technology and aligned with the highest quality standards currently required by AEMPs and included in Annex 1 of the GMPs, allowing sterility tests to be carried out with the maximum guarantees and safety.
This new facility has a surface area of 30.7 m2, divided into two areas: a preparation area with classification C and a second area with classification B for carrying out analyses and studies. This second area is also equipped with a laminar flow cabinet. The useful surface area of the facility is completed by the two existing Sterile Access System (SAS) or passage chambers designed to guarantee safety during the transfer of products between the different areas, as well as with the outside.
Sterility tests are already being carried out in the MicroBios Laboratory Clean Room, both by direct seeding and by STERITEST filtration. In addition, the laboratory is planning to start up several studies of different types that require classified rooms with high technical equipment.
The start and development of this new facility has been a challenge for the Microbios Laboratory team and a major investment. This goal has now been achieved, doubling the operating capacity of the laboratory and forming part of its ambitious expansion plan.
