slide1 n.
Skip this Video
Loading SlideShow in 5 Seconds..
IND Review Chart (for submission of IND to CDER) PowerPoint Presentation
Download Presentation
IND Review Chart (for submission of IND to CDER)

Loading in 2 Seconds...

play fullscreen
1 / 20

IND Review Chart (for submission of IND to CDER) - PowerPoint PPT Presentation

  • Uploaded on

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.

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

PowerPoint Slideshow about 'IND Review Chart (for submission of IND to CDER)' - brandon-nieves

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
diagram of the flow pattern of hepa filtered air through a typical clean room

Incoming air supply


HEPA filter

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

Exhaust unit

Items of clean room equipment


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:


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


Transfer lock

Generalized Clean Room Design

Clean room

Entry of

raw material

Entry of




Transfer lock


Exit of




Exit of


a peristaltic pump
A Peristaltic Pump

Principle of operation



Flexible Tubing


On/Off valve



Steam (out)



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.



Place Module


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)