Facility Design Tutorial
This tutorial is designed to enhance knowledge of
biotechnological/pharmaceutical processes. The topics
covered within this tutorial will give preliminary
explanations and conclusions. However, references for more
in depth study will be provided. It is strongly suggested that
you investigate these references.
Overview
Introduction
– Description of facility design and why it is important to chemical engineers.
Equipment
– This section will describe equipment considerations during facility design.
Utilities
– This section will describe implications of facility design concerning facility
utilities.
Waste Systems
– This section describes the role of waste disposal when developing a facility.
Storage
– This section will discuss the impact of raw materials and final product storage
on facility design.
Conclusions
Introduction
The overall goal of process development is to implement a conceptual
design into a manufacturing scale. For this reason, chemical engineers
have to consider the implications of facility design.
In facility design, the manufacturing process concept is transformed into a
physical process within a facility. For this reason, a detailed block flow
diagram (BFD) should be created. The facility can be designed from this
BFD.
This tutorial will describe a few of the aspects that should be taken into
consideration when designing a facility for a pharmaceutical/biotech
product.
Regulations
The pharmaceutical/biotech industry is regulated by Food and Drug
Administration (FDA). The FDA in turn sets guidelines for facility design,
but these are only broadly define acceptable limits. The manufacturer
ultimately decides how to implement these regulations.
The main regulations for facility design comes from the US Federal
Standard 209E (FED-STD-209E). This document specifically sets the
standards for air handling within the facility. It defines the amount
permissible per particulate size. This limit in turn determines the
classification of the process rooms within the facility.
Regulations
Facilities must also comply to current Good Manufacturing Processes
(cGMP). cGMP is a system of good manufacturing procedures and
techniques that ultimately protect the patient. As the name implies, the
standard are periodically updated to reflect changes within the industry.
For facilities, the regulations are defined in the US Code of Federal
Regulations, specifically, 21 CFR 211.42 - 211.58.
Equipment
One of the main considerations for the development of facility is the
equipment needed for the manufacturing process. One should assess what
is needed based on the BFD.
Since this project is a retrofit of an existing facility, consideration should be
taken into what existing equipment can be utilized. If the equipment meets
the specifications for the process, one should considering using them. This
will save the company money and time.
However, many times equipment cannot be used for various reasons (out of
spec., intrinsic problems, etc.). At this point, new equipment should be
purchased and incorporated into the facility.
Equipment
When incorporating this new equipment certain consideration should be
made. Can the equipment physically be moved into the building? Is the
facility processing room(s) big enough for the equipment? Is construction
needed to build or refurbish the facility in order to accommodate the
equipment.
These are just a few of the consideration a engineer must take into account
with process equipment. Other will arise pending on the specific piece of
equipment. The facility should be designed around these aspects.
Utilities
Engineers should also consider the facility utilities during conceptual
design. Since the nature of the product is pharmaceutical/biotech , many
specific systems have be considered.
The systems include, but are not limited too, water for injection (WFI),
clean in place/steam in place (CIP/SIP), HVAC, compressed air, etc.
(Explanations and references are given in the ‘Information’ section of this
website). HVAC and CIP/SIP are needed to ensure human safety and
minimal product contamination. Whereas WFI and compressed air are used
in the manufacturing process.
Since this situation involves a retrofit, these systems may already be in
place. But are they accessible for the equipment? Do they meet the
specifications of the process? Will any system need to be updated or
modified? These are just a few of the questions that should be considered.
Waste Systems
Once again, since this product is biological, there may be special
regulations that exists to guide this process. In addition, engineers should
make sure waste treatment facilities are safe for man as well as nature.
It is certain that the manufacturing process will generate significant wastes
associated with fermentation and purification. The facility must be able to
dispose of these wastes effectively and safely.
For biotech industries the main concern of waste treatment is the
recombinant host. This organism may pose health threats if it is released
untreated into the environment. Methods of disposal vary pending on the
organism. This should be kept in mind when design the waste treatment
facility.
Waste Systems
So, where will these wastes go? Are there facilities already existing that
can handle these wastes? Are they sufficient in size and capacity? Are a
few more questions that should be assessed when designing the waste
treatment section of the facility.
Broad guidelines exist for waste systems as documented by the US Code of
Federal Regulations (CFR). As mentioned earlier these codes include:
– 40 CFR Part 261
– 40 CFR Part 264
Storage
Storage of raw materials and products also has special consequences in the
pharmaceutical/biotech context. These materials have to be quarantined
when raw materials are received and after product packaging. This ensures
that the materials avoid contamination while also minimizing human
exposure. During this time, the new materials are properly labeled and
tested before dispensing into the facility. The packaged product, on the
other hand, awaits shipping.
When the facility become functional these raw materials and final products
will need a place for storage. This is yet another consideration an engineer
must make during facility design.
Do these storage rooms already exist? Can a existing room(s) be modified
to accommodate these materials? Is there a need to build a new storage
facility? An engineer should ponder these questions.
Conclusions
The design of a biological facility is multifaceted. Implementation of the
processing equipment is just the first step in designing an effective facility.
The aforementioned information is a starting point for considering
decisions about facility design. Ultimately, particular decisions will be
based on manufacturing needs, the BFD, and the existing facility.
Resources
[1] Facility regulations: www.fda.gov
– 21 CFR Part 211:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cf
m
– FED-STD-209E
[2] Waste treatment regulations:
– 40 CFR 261
– 40 CFR 264
[3] Industrial contact: Bob Perrone - Fluor Daniels.
[4] Cole, Graham C. Pharmaceutical Production Facilities. Taylor &
Francis Inc., 1998.
