Facility Design Tutorial

Grfrankl

Description

Facility Design TutorialThis tutorial is designed to enhance knowledge of biotechnological/pharmaceutical processes. The topics cal processes. The topics covered within this tutorial will give preliminary nve preliinary explanations and conclusions. However, references for more in depth study will be provided. It is strongly suggested that you investigate these references. OverviewIntroduction – 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.ConclusionsIntroductionThe 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 tech ...

Informations

• Publié par: Phawyer
• Nombre de lectures: 17
• Langue: English

Extrait

Facility Design Tutorial

This tutorial is designed to enhance knowledge of b i o t e c h n o l o g i c a l / p h a r m a c e u t i c a l   p r o c e s s e s .    T h e   t o p i c s   covered within this tutorial will gi ve preli minary 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 chemic al engineers. Equipment  This section will describe equipment considerations during facil ity design. Utilities  This section will describe implications of facility design conce rning facility utilities. Waste Systems  This section describes the role of waste disposal when developin g 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 concep tual design into a manufacturing scale.  For this reason, chemical en gineers have to consider the implications of facility design.

In fac il ity de sign, the manufact uring process concept is transfo rmed into a physical process within a facility. For this reason, a detailed block flow diagram (BFD) should be created.  The facility can be designed f rom this BFD.

This tutori al will des cribe a fe w o f the aspects that  should be taken into consideration when designing a facility for a pharmaceutical/bio tech product.

Regulations

The pharmaceutical/biotech industry is regulated by Food and Dru g Administration (FDA). The FDA in turn sets guidelines for facility design, but these are only broadly define acceptabl e limits. The manufa cturer ultimately decides how to im plement these regulations.

The main regulations for facility design comes from the US Feder al Standard 209E (FED -STD-209E). This document specifically sets the standards for air handling within the facility. It defines the amount permissible per parti c ulate size.   T h is limit in turn de termines the classification of the proces s rooms within the facility.

Regulations

Facilities must also comply to current Goo d Manufacturing Proces ses (cGMP). cGMP is a system of good manu facturing   procedures and techniques that ultimately protec t the patient. As the name impl ies, th e   standard are periodic ally updated to reflect changes within the industry. For facilities, the regulations ar e defined i n the U S   C o d e   o f   F e deral Regulations, specific ally, 21 CFR 211.42 -211.58.

Equipment

One o f  th e ma in considerations for the development of facility i s t h e   equipment needed for the manufactu ring process. One should assess what is n eeded based on the BFD.

Since this project is a retrof it of an existing facility, consideration should be taken into wh at existing equipment can be utilized. If the equi pment meets the specifications for the proces s, one should considering using them. This   will save the company money and time.

Howev e r, ma ny tim es equipm ent ca nnot be used for various reasons (out of spec., intrinsic problems, etc.). At this point, new equipment should be purchased and incorporat ed into the facility.

Equipment

When incorporating this new equi pment certain consideration shou ld be made.   Can the equipment physica lly be   mov ed into th e building? Is the facility processing room(s) big enough for the equipment? Is construction needed to build or refurbish th e facility in order to accommodat e the equipment.

These are just a few of the consideration a engineer must take i nto account with process equipment. Other will a rise p ending on the specifi c piece of equipment. The facility should be designed around these aspects .

Utilities

Engineers should also consider the facility utilities during con ceptual design.  Since the nature of the pr oduc t is pharm aceutical/biot ech , many specifi c systems have be considered.

The systems include, but are not limited too, water for injectio n (WFI), clean in place/steam in place (C IP/SIP), HVAC, compressed air, e tc. (Explanations and references are given in the Information sect ion of this   website). HVAC and CIP/SIP are needed to ensure human safety an d minimal product contaminati on. Whereas WFI and compressed air ar e u sed in the manufacturing process.

Since this situation involves a retrofit, these systems may alre ady be in place.   But are they a ccessible for the equipment? Do they meet the specifications of the process? W i l l   a n y   s y s t e m   n e e d t o b e u p d a t ed or modifi ed? These are just a few of the questions that should be considered.

Waste Systems

Once again, si nce th is product is  b i ological, th ere may be speci al regulations that exists to guide this process. In addition, eng ineers should make sure wa ste treatment facilit ies are safe for man as well as nature.

It is certain that the manufact u ring process will generate significant was tes associated with fermentation and purification. The facility mus t be abl e to dispose of these wastes effectively and safel y.

For biotech industries the main co ncern of waste treatm ent  is t he recombinant host. This organism may p ose health threats if it i s released untreated into the environment. Methods of disposal vary pendi ng on the organism. This shoul d be kept in mind when design the waste tre atment facility.

Waste Systems

So, where will these wastes go? Are there facilities already ex isting that can h andle these wa stes?   Are th ey sufficient in size and capaci ty? Are a few m ore questions that should be assessed when designing the wa ste 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 incl ude:

 40 CFR Part 261  40 CFR Part 264

Storage

Storage of  raw materi als an d pro ducts also has special consequen ces in the pharmaceutical/biotech context. These mat erials have to be quar antined when raw materials are received and after product packaging. Th is e nsures that the materials avoid contamin ation while also minimizing hum an exposure.   During t his time, th e new materials are properly labe led an d tested before dispensing into th e facility. The pa ckaged product, on the other hand, awaits shipping.

When the facility become function al these raw materials and fina l products will need a place for storage. This is yet another consideratio n an engineer must make during facility design.

Do th ese s torage rooms already ex ist? Can a existing room(s) be modified to accommodate these materi als? Is there a need to build a new storage facility? An engineer should ponder these questions.