IND Review Chart (for submission of IND to CDER). NDA Review Chart (for submission to CDER). A Warning Letter. Picture of a Clean Room. Incoming air supply. Ceiling. HEPA filter. Diagram of the Flow Pattern of HEPA-Filtered Air Through a Typical Clean Room. Exhaust unit.
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Items of clean room equipment
How clean rooms are classified:
Two standards are used to classify clean rooms. The first, Federal Standard 209E, is used domestically and the newer standard is TC 209 from the International Standards Organization (ISO). Both standards classify a clean room by the number of particles found in the laboratory’s air. If a laboratory is a class 10 clean room by the Federal Standards, there are less than 10 particles per cubic foot. The following chart relates FS to ISO classifications and recommended action levels of microbiological quality, i.e. the maximum levels in the clean room air that microorganisms should be allowed to reach:
aParticles are of size 0.5 μm; the standard varies for particles of different sizes.
bcfu means colony forming units.
c Samples from Class 100 (ISO 5) environments should normally yield no
Principle of operation
0.5-2.0 M NaCl
Non-ionic detergents (0.1-1.0%)
NaOH (0.1-1.0 M)
Acetic acid (20-50%)
EDTA (~1.0 mM)
Most CIP protocols would make use of two or more of these agents,
allowing them to percolate sequentially through the column at a slow
flow rate. Contact time can range from several minutes to overnight.
Sodium hydroxide (NaOH) is particularly effective at removing most
of Purified Protein
Preparation & Posidyne-
Filtration of Required Buffers
(Addition of Necessary Buffers,
Purified (Thawed) Protein,
and other Ingredients)
Filtration of Formulated
Material through a
0.22 micron Filter
Schematic of Formulation-Fill Unit Operation Sequence
Filling of Vials
(The unit operation train will be different for a sustained-delivery formulation or
a formulation that requires the use of a delivery device)