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IND Review Chart (for submission of IND to CDER)

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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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diagram of the flow pattern of hepa filtered air through a typical clean room

Incoming air supply

Ceiling

HEPA filter

Diagram of the Flow Pattern of HEPA-Filtered Air Through a Typical Clean Room

Exhaust unit

Items of clean room equipment

slide6

Clean Room Classification

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:

slide7

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

microbiological contaminants.

generalized clean room design

Transfer lock

door

Transfer lock

Generalized Clean Room Design

Clean room

Entry of

raw material

Entry of

personnel

(changing

room)

Transfer lock

Bench

Exit of

personnel

(changing

room)

Exit of

product

a peristaltic pump
A Peristaltic Pump

Principle of operation

Fluid

Rotor

Flexible Tubing

slide17

On/Off valve

Steam

(in)

Steam (out)

Water

(in)

Water (out)

  • Diagram of a typical jacketed processing vessel
  • Such vessels are usually made from high grade stainless steel
  • By opening or closing the appropriate valves, steam or cold water can be circulated
  • through the jacket
  • In this way the vessels contents can be heated or cooled, as appropriate
  • In addition, passage of steam through the jacket of the empty vessel will effectively
  • sanitize its internal surfaces
the range of cip agents most often used to clean sanitize chromatographic columns
The range of CIP agents most often used to clean/sanitize chromatographic columns

0.5-2.0 M NaCl

Non-ionic detergents (0.1-1.0%)

NaOH (0.1-1.0 M)

Acetic acid (20-50%)

Ethanol (~20%)

EDTA (~1.0 mM)

Protease solution

Dilute buffer

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

contaminant types.

slide19

Sterilization-in-

Place Module

slide20

Bulk Freeze-Thawing

of Purified Protein

Preparation & Posidyne-

Filtration of Required Buffers

Formulation Process

(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)