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Production Area
In order to minimize the risk of a serious medical hazard due to cross- contamination,
dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly sensitizing materials
e.g. penicillins or biological preparationse.g. from live micro-organisms. The production of certain additional products, such as
certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal
products should not be conducted in the same facilities . For those products, in
exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary
validations are made. The manufacture of technical poisons, such as pesticides
and herbicides, should not be allowed in premises used for the manufacture of medicinal products.
.
2. Chapter 3: Premises and Equipment
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2. Chapter 3: Premises and Equipment
Dedicated and self-contained facilities for medical hazard
Highl se sitizi g ate ials
e.g. pe i illi d ugs
Biologi al p epa atio s
e.g. li e i o‐o ga is s
o tai e t isolato
A epta le Dail E posu e ADE O upatio al E posu e Li its OEL
Risk of a serious medical hazard
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No Haza d
No Haza d
No Haza d
No Haza d
No Haza d
Haza d With
Co tai e t No
Haza d Sepa ate
Mate ial Pe so el
Flo Sepa ate
all
Buildi g ust e desig ed a d o st u ted ith o tai e t
SegregationＧofＧHazardousＧFactory
2. Chapter 3: Premises and Equipment
No Haza d
No Haza d
No Haza d
No Haza d
No Haza d
No Haza d
Haza d
P o le : Haza d a o ta i ate to o Haza d.
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SegregationＧofＧHazardousＧFactory
2. Chapter 3: Premises and Equipment
Air Lined Suit forＧOperatorＧprotection
IsolatorＧ forＧOpenＧoperation
Haza d NON‐Haza d
H
H Co ido
H
H H
H P o ess
oo P o ess
E uip e t Co ido
SA G F
AHU
RA
Pa D
C S u e
EA FA
EA H
±
All Fresh HVAC
HEPA on Return Duct
Negative Pressure Control
Segregate OverＧCeiling
P o ess oo
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Where starting and primary packaging materials, intermediate or bulk products
are exposed to the environment, interior surfaces walls, floors and ceilings should be smooth
, free from cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and, if
necessary, disinfection.
Pipe work, light fittings, ventilation points and other services should be designed
and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the
manufacturing areas. .
2. Chapter 3: Premises and Equipment
