Production Facilities

Our manufacturing facilities and equipment are qualified for the manufacture of sterile products according to EU GMP Guideline, Annex 1.

 

CCMP

GMP- Facility

Cleanroom

290 sqm

70 sqm

Units

2

One media preparation room per unit, one isolator per media preparation room

2

One media preparation room  with two isolators 

Suites

8

4

Clean room classes

D-A

D-A

Media preparation

In Isolators (H2O2 vaporisation between two manufacturing cycles) or sterile filtration

In Isolators (H2O2 vaporisation between two manufacturing cycles) or sterile filtration

Cryo storage

maximum 15 storage container

2 storage container

QC area

128 sqm

30 sqm