CLEANROOM

Our cleanrooms for sterile manufacturing of MSC cellular products are built accordingly to meet current Good Manufacturing Practices (cGMP) of the Pharmaceutical Inspection Co-operation Scheme, ISO cleanroom guidelines and World Health Organization guidelines on GMP.

CELESTIALAB

The cleanrooms in our facility are classified as Grade B and C according to the table of clean room classification below:

Cleanliness Level

 

 

Grade

Maximum concentration limits (particles/m3 of air)
for particles equal to and larger than the considered sizes shown
At restIn operation
≥0.5 µm≥5.0 µm≥0.5 µm≥5.0 µm

Extremely clean

 

Clean

A3,520203,52020
B3,52029352,0002,900
C352,0002,9003,520,00029,000
D3,520,00029,000Not definedNot defined