Regulations
CODES FOR 2004
AND BEYOND
and
Codes
For
Biotech
Facilities
Slide 1
Presented by:
Reinhard Hanselka
Integrated
Engineering
Services
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
1966
and
Codes
For
Biotech
Facilities
Slide 2
REGULATORY
STRUCTURE
AND
STANDARDS
Presented By:
© Copyright 2003
Integrated
Engineering
Services
1
Regulations
1990
and
Codes
For
Biotech
Facilities
Slide 3
REGULATORY
STRUCTURE
AND
STANDARDS
Presented By:
© Copyright 2003
2004
CALIFORNIA CODES
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 4
Presented By:
© Copyright 2003
Integrated
Engineering
Services
2
2004
CALIFORNIA CODES
Regulations
and
Codes
For
Biotech
Facilities
California adopts NFPA
5000™, Building
Construction and Safety
Code™, and NFPA 1,
Uniform Fire Code™
Slide 5
NFPA codes will serve as basis for
statewide model codes
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Bio-- Tech
Bio
CURRENT
Laboratory
CODES
Facilities
UFC 79
Flammable
Liquids
NFPA 26
Laboratories
Using Chemicals
NFPA 66
Flammable &
Combustible Liquids
Regulations
NFPA 45 – Laboratory
Standards
and
Codes
NFPA 30 Flammable &
Combustible liquids
For
Biotech
NFPA 329 Flammable
Liquids - Underground
UFC 74
Compressed
Gases
UFC 75
Cryogenic
Fluids
Facilities
Slide 6
NFPA 63
Compressed Gases
& Cryogenic Fluids
NFPA 50
Bulk Oxygen Systems
NFPA 50A
Gaseous Hydrogen
NFPA 50B
Liquified Hydrogen
UFC 80
Hazardous
Materials
NFPA 60
Hazardous
Materials
NFPA 64 – Corrosive
Solids & Liquids
NFPA 67
Flammable Solids
NFPA 68 - Highly Toxic &
Toxic Solids & Liquids
Requirements
for Laboratory
Facilities
© Copyright 2003
NFPA 70 - Oxidizers &
Organic Peroxides
NFPA 71 - Pyrophoric
Solids & Liquids
NFPA 72 - Unstable Reactive
Solids & Liquids
NFPA 73 - Water Reactive
Solids & Liquids
NFPA 43A
Oxidizers
NFPA 43B
Organic Peroxides
Presented By:
Integrated
Engineering
Services
3
PERMIT PROCESS
Architectural
Structural
Mechanical
Electrical
Bldg..
Traffic
New
Bio/Pharm
R&D Lab
Water Purveyor
Planning
and
Codes
For
Biotech
Facilities
Slide 7
Architectural
Plumbing
Energy
Arborist
Regulations
Public Works
CEQA
Sanitary Sewer
Security
Industrial Waste
Police
Planning
POTW
Wastewater
Fire Protection
Elevators
HazMat
Fire
Fire
HMPB
Boilers
Construction
State
Compressors
RMP
UST
DHS – Controlled
Substances
Generators
CUPA
SPCC / AGST
BAAQMD
Haz-Waste
Air Emissions
County
County
DEA - Precursors
Cafeteria
Federal
Env. Health
Operational
© Copyright 2003
CHANGES IN
REGULATORY
OVERSIGHT
ATF – Alcohol Tax
Presented By:
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 8
• Increased awareness of
hazards associated with
laboratories
• Requirement for inventory
submittals in accordance
with the Building Code
• Focus on applicants to
define intended use, as
well as hazards
© Copyright 2003
Presented By:
Integrated
Engineering
Services
4
REGULATORY
CONCERNS
A cor
roHiR
AT
A fire occurred when a flask
containing
an
solvent
veEsE
u
nRdEeSr Ts
JU
tororganic
IN
E
Recently,
it
was
IR
agignition.
F
,
a
T
AS
e
c
At the
of aXstir
in
the
hazardous
waste
L
B
A
h
c
cracked
andBUniversity
leaked
onto
plate
causing
L
U
a
e
E
binetThe
mica
IENnCivers
SCdrum
discovered
INEaby
l hofume
Vgallon
itywithin
facility,
a IR
55that
UC
fire was
extinguished
a lsprinkler
the
od in hood.
unde30
aborcontaining
atoryree pexploded,
perchloric
acid fume
rpglerapropagated
gallons
of mixed
organic
solvents
duate a
Without
the sprinkler
the
incident
have
h waseo
eaP
Twould
rl)y -(A
.
if
al
t
lo
C
hood
was
heavily
m
h
,
e
E
er
e
orse
sitestoto the
launching
IRVIN
upward
into
ceiling.
niar
outside
the hood
and caused
Luar
damage
re
ngcheAxw
of
cthe
kssignificant
, ye
i
d
e f an
l
re
contaminated
with
y
ag
p
ju
,
am
l
in
d
o
e
n
in
significant
no oneswas
wer fire ensured.
io
laboratory…
in $1
millioonon
0nLuckily
f
r
e
o
as
w
tyn.
ch
si
potentially
explosive
u
t of tthe Uin
aer
as m organic
s sdrum
hurt. The
andmixed
ebxypalofisolvents
tandi
he honivthe
in
re
sion solvent
ted
perchloric
acid
iewnhce ng
dwaste
inflicsalts.
had been
wasconsolidated
from
icalosc
o cu
en th
Irvine's phcys
ron
,
r
ia
e
n
or
ay
if
d
al
.
containers
the e
of Cfrom laboratories
dM
uptethroughout
er
re
fi
e
h
xT
si
e
th
of
r
campus.building.
cond floo
se
e
th
Recently, a steel
lecture
bottle
ty
on
n
n
afternoo
range Cou
located within a yhood
in g,
a said an O
s
stor build
. Authoritie
an
m
spokes
yexplosive
laboratory ruptured
with
it
or
e
th
th
u
r
A
te
e
is
Fir
nty Reg
force. The explosion
occurred
nge Couat
told the Ora about 3:45 p.m. as a
night and no oneaswas
present
in
an
zene under
dis ter beg
purified ben a second
entthe
the laboratory at
the
time
of
d
u
st
e
at
u
on
grad
stem
ntilation sy
incident. There
was, however,
a hooded ve
significant damage
to the lab hood.
floor lab…
© Copyright 2003
REGULATORY
CONCERNS
• Development in research
technology and methods
has outpaced:
?Code Development
Process
?Current Laboratory
Practices
Regulations
and
Codes
For
Biotech
Facilities
Slide 9
Presented By:
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 10
Presented By:
© Copyright 2003
Integrated
Engineering
Services
5
CODE DEFICIENCIES
• Current codes do not
adequately address:
?Biohazards
?Cytotoxic Agents
?Potent Compounds
?Radioactives
Regulations
and
Codes
For
Biotech
Facilities
Slide 11
Presented By:
© Copyright 2003
INDUSTRY CHANGES
• Industry shift towards
more chemical intensive
research:
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 12
?Small Molecules
?Combinatorial Chemistry
?Medicinal Chemistry
Presented By:
© Copyright 2003
Integrated
Engineering
Services
6
QUANTITIES OF CHEMICALS
IN SMALL MOLECULE LABS
Regulations
and
Codes
For
Biotech
Facilities
Slide 13
QUANTITY (GALLONS)
2500
1950
2000
1500
Storage
1000
500
Use-Closed
Use-Open
828.5
459
240
120
30
0
Exempt
Typical
CLASS 1B FLAMMABLE LIQUIDS
© Copyright 2003
Presented By:
Integrated
Engineering
Services
QUANTITIES OF CHEMICALS
IN QA/QC LABS
Regulations
and
Codes
For
Biotech
Facilities
Slide 14
500
QUANTITY (GALLONS)
450
400
350
300
Storage
Use-Closed
Use-Open
250
200
150
100
50
0
Exempt
Typical
CLASS 1B FLAMMABLE LIQUIDS
© Copyright 2003
Presented By:
Integrated
Engineering
Services
7
INDUSTRY CHANGES
• Laboratories have become
more equipment and
chemical intensive
Regulations
and
Codes
For
Biotech
Facilities
Slide 15
?Increase in HPLC use
?High throughput HPLC’s
?Prep HPLC’s
Presented By:
© Copyright 2003
INDUSTRY CHANGES
• R&D Operations have
become automated
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 16
?DNA sequencing
?DNA synthesizers
?Bulk laboratory systems
Presented By:
© Copyright 2003
Integrated
Engineering
Services
8
Regulations
INDUSTRY CHANGES
• Scale of laboratory
“R&D” functions has
increased
and
Codes
For
Biotech
Facilities
Slide 17
?Numerous fume hoods
?12’ to 20’ hoods
?20L to 30L reactors
Presented By:
Integrated
Engineering
Services
© Copyright 2003
CALIFORNIA
CODES
2004 - 2007
Regulations
and
Codes
For
Biotech
Facilities
Slide 18
Presented By:
© Copyright 2003
Integrated
Engineering
Services
9
MODEL CODE
ADOPTION
2003 NFPA 5000
2004 CBC
2003 NFPA 1
2004 CFC
2003 UMC
2004 CMC
2003 UPC
2004 CPC
Adopted with State
amendments
Regulations
and
Codes
For
Biotech
Facilities
Slide 19
Presented By:
Integrated
Engineering
Services
© Copyright 2003
ADOPTION TIME
LINE ?
Adoption
Dec. 2004?
Published
Jan. 2005?
Local Amendments
?
Enforced
June 1, 2005?
Regulations
and
Codes
For
Biotech
Facilities
Slide 20
Presented By:
© Copyright 2003
Integrated
Engineering
Services
10
LABORATORIES
• NFPA 45 – NFPA 1 Chap.26
• Does not apply to:
?Diminutive <1.1Gal,75scf
?Pilot Plants
?NFPA 704 <1
?Manufacturing Plants
?Incidental labs
?Radioactive labs
Regulations
and
Codes
For
Biotech
Facilities
Slide 21
• HEALTH CARE
OCCUPANCIES
Presented By:
© Copyright 2003
Integrated
Engineering
Services
Regulations
Exempt Amounts
• BatteriesBatteries - Chapter 52
• Highly Toxics – 40 lbs.
• Radioactives – OTHER
AGENCY
• Irritants – NOT REGULATED
• Sensitizers - NOT
REGULATED
• Carcinogenics – NOT
REGULATED
?Construction Materials
Exemption
© Copyright 2003
and
Codes
For
Biotech
Facilities
Slide 22
Presented By:
Integrated
Engineering
Services
11
Regulations
VENTILATION
and
Codes
For
Biotech
Facilities
• Key Mitigator – For All
Hazardous Conditions
• Capture Velocity –
?100 FPM ?
?Per Vapor Pressure ?
• Consistent with ACGIH
Slide 23
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – Chapter 5
and
Codes
For
Biotech
Facilities
• PERFORMACE CODE
Slide 24
?Designer Acceptable to AHJ
?Sources of Data Revealed
?Final Determination by AHJ
?Operations Manual to AHJ
?Info Transfer to FD
?Design Maintenance
?Annual Certification
Presented By:
© Copyright 2003
Integrated
Engineering
Services
12
Regulations
CMC CHAPTER 3
and
Codes
For
Biotech
Facilities
Slide 25
• Gas Room Exhaust to
an approved exhaust
system
? in conformance with
the CMC (California
Mechanical Code).
Presented By:
Integrated
Engineering
Services
© Copyright 2003
SPECIAL
INSPECTIONS
Regulations
and
Codes
For
Biotech
Facilities
-
© Copyright 2003
Structural
Finishes
Smoke Control
Stairs and Railings
Piping and Services
Penetration &
Joints
Slide 26
Presented By:
Integrated
Engineering
Services
13
CHAPTER 35
Regulations
and
Codes
For
35.4.2.5 Seismic
Biotech
Facilities
Slide 27
- Seismic Use Group
- ASCE 5, 6, 7
I factor
Spectral Resp. Acc.
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CMC
2004
and
Codes
For
Biotech
Facilities
Slide 28
Presented By:
© Copyright 2003
Integrated
Engineering
Services
14
Regulations
CMC -CHAPTER 1
• Maintenance – As
Constructed
• Hazardous Condition
Abated
• Moved Equipment = New
• Unsafe Equipment!
and
Codes
For
Biotech
Facilities
Slide 29
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CMC - CHAPTER 2
and
Codes
For
Biotech
Facilities
• Standards of quality
• Approved qualified welder
Slide 30
?ASME
• Refrigerants
?Recycled
?Recovered
?Reclaimed
Presented By:
© Copyright 2003
Integrated
Engineering
Services
15
Regulations
CMC - CHAPTER 5
• Pharmacies [CA]
?A pharmacy shall have a
designated area for preparation
of sterile products which is
ventilated in a manner so as
not to interfere with laminar air
flow
?Bio-hood required for preparing
parenteral cytotoxic agents
and
Codes
For
Biotech
Facilities
Slide 31
?Class II, Type A or B laminar hood
?Bag in – Bag out filter
?Plenums must be negative
pressure and leak tight
?Also refer to CBC
© Copyright 2003
FUME HOODS
Presented By:
Integrated
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Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 32
Presented By:
© Copyright 2003
Integrated
Engineering
Services
16
FUME HOODS
SPRINKLERS
• CFC Laboratory fume hoods where
flammable materials are dispensed
shall be protected by an automatic
fire--extinguishing system.
fire
• NFPA 4545-6.10 Exception 2
“If a hazard assessment shows that
an automatic extinguishing system
is required, then the applicable
system shall be provided.”
• S.C. County local Fire Code
amendments requires fire protection
for all workstations containing
hazardous materials.
© Copyright 2003
SPRINKLERS IN
DUCTS
Regulations
and
Codes
For
Biotech
Facilities
Slide 33
Presented By:
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
• Sprinklers in ducts
Slide 34
?2004 CMC 502 –Ducts
containing flammable
vapors that exceeds 25%
of the LEL shall be
flammable product
conveying.
Note: Previous code referenced 10% of the
LEL.
© Copyright 2003
Presented By:
Integrated
Engineering
Services
17
SPRINKLERS IN
DUCTS
Regulations
and
Codes
For
Biotech
Facilities
• CMC / CFC Conflict
?2001 CFC 207 still
defined flammable
vapors as that
exceeding 10% of the
LEL.
?2004 CMC 1407.3.2.3
and CFC 5101.104 still
require gas detection
at 20% of the LEL.
Slide 35
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CMC – CHAPTER 5
and
Codes
For
Biotech
Facilities
• Product Conveying Duct –
Class 1 to 5
• Fire Protection for
Commercial
Cooking Appliances
Slide 36
?Scope
?CO2
Presented By:
© Copyright 2003
Integrated
Engineering
Services
18
Regulations
CMC – CHAPTER 6
• Duct Systems
?Quality Standards
and
Codes
For
Biotech
Facilities
Slide 37
?Metal Duct
?Installation
?Flame Spread
?Galvanized Sheet Metal
?Signal System - Fire,
Smoke, etc…
?Smoke Control
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CMC – CHAPTER 10
and
Codes
For
Biotech
• Relief Valve
• Steam & Hot Water Boilers
• Automatic Boilers
Facilities
Slide 38
?Limit Devices
• Non Combustible Floors
Presented By:
© Copyright 2003
Integrated
Engineering
Services
19
Regulations
CMC – CHAPTER 11
and
Codes
For
Biotech
Facilities
• Refrigeration
Slide 39
?Listed Type
?Safety Classification
?Purity
?New, Recovered & Reclaimed
?Emergency Ventilation Control
?Discharge @1/2 IDLH
?NH3
Presented By:
© Copyright 2003
Integrated
Engineering
Services
Regulations
CMC – CHAPTER 11
and
Codes
For
Biotech
Facilities
• High Probability
• Low Probability
• Machinery Room –
Special Occupancy per NFPA 5000
• Monitoring
Slide 40
Presented By:
© Copyright 2003
Integrated
Engineering
Services
20
Regulations
CMC – CHAPTER 12
and
Codes
For
Biotech
Facilities
• Hydronics
Slide 41
?Steam & Water
?Material
?Fabrication
?Testing
? >100 psi or >50 psi over
operating pressure
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CMC –CHAPTER 14
and
Codes
For
Biotech
Facilities
• Special Piping and
Storage Systems
• Inspection:
Slide 42
? >100 psi
? >1.5 x Max Oper. Pressure
? ANSI B31.3
Presented By:
© Copyright 2003
Integrated
Engineering
Services
21
PIPE RACK
Regulations
and
Codes
For
Biotech
Facilities
Slide 43
Presented By:
Integrated
Engineering
Services
© Copyright 2003
CMC – CHAPTER 14
(CONT.)
Regulations
and
Codes
For
Biotech
Facilities
Slide 44
• HPP Fluids
?In Accordance with Fire
Code
?Excess Flow Control
?All Welded
?Gas Detection
Presented By:
© Copyright 2003
Integrated
Engineering
Services
22
CALIFORNIA FIRE
CODE
Regulations
and
Codes
For
Biotech
Facilities
Slide 45
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – Chapter 1
and
Codes
For
Biotech
Facilities
• Equivalencies,
Alternatives and
Modifications
• Enforcement Assistance
• Delegation of Authority
• Existing Conditions
Slide 46
?Life Safety
• Stop Uses
© Copyright 2003
Presented By:
Integrated
Engineering
Services
23
Regulations
CFC – CHAPTER 2
and
Codes
For
Biotech
Facilities
• REFERENCED
PUBLICATIONS
• NFPA - 108 Referenced Standards
& Codes
• ANSI, API, ASME, ASTM,
ATA, CGA, IAS, ISO,
NRFC, RVIA, UL, ULC, US
Government
© Copyright 2003
CFC – CHAPTER 3
Definitions
Slide 47
Presented By:
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 48
Definitions
• Classifications of Occupancy
Hazards for extinguishers
• Clean Zone
• Pyrophoric Gas a.i.t
<1400oF?
• Hazard of Contents
HH,HH1,HH2,HH3,HH4,HH5,
Low Hazard, Ordinary Hazard
© Copyright 2003
Presented By:
Integrated
Engineering
Services
24
Regulations
CFC – Chapter 3
and
Codes
For
Biotech
Facilities
- Compatible Material–
Material–
Oxidizer ONLY ?
- Storage
Slide 49
- Detached
- High Piled
- Isolated
Presented By:
Integrated
Engineering
Services
© Copyright 2003
CFC – CHAPTER 3
definitions
Regulations
and
Codes
For
Biotech
Facilities
Slide 50
• Classification of Oxidizers
NFPA 430
• Major Repair Garage
• Minor Repair Garage
• Storage
?High Piled
?Isolated
?Detached
?Segregated
© Copyright 2003
Presented By:
Integrated
Engineering
Services
25
CFC – Chapter 3
cont.
Regulations
and
Codes
For
Biotech
Facilities
• Protected Above Ground
Tank - NFPA 2085
• UL 300 – For restaurants
• Smoke Detector for
HVAC
• Open vs. Closed
Slide 51
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – Chapter 4
and
Codes
For
Biotech
Facilities
General Safety
• Safety from Fire Objective
• Safety during Building Use
• Safety from HAZMAT
• Prescriptive/Performance
• Egress Safety
Slide 52
Presented By:
© Copyright 2003
Integrated
Engineering
Services
26
CFC – Chapter 5
Performance Based
Regulations
and
Codes
For
Biotech
Facilities
- Approved Qualifications??
- Independent Review
- Sources of Data
- Custom Operation &
Maintenance Manual
- Info. Transfer to Fire
- Annual Certification
3rd Party
Slide 53
Presented By:
Integrated
Engineering
Services
© Copyright 2003
CFC Chapter 5
cont.
Regulations
and
Codes
For
Biotech
Facilities
• HAZARDOUS MATERIALS
– the 10 Commandments
5.1.12.1
• REQUIRED DESIGN
SCENARIO
?FIRE
?EXPLOSION
?USE SAFETY
© Copyright 2003
Slide 54
Presented By:
Integrated
Engineering
Services
27
HazMat 10
Commandments
Regulations
and
Codes
For
Biotech
Facilities
1.
Minimize the potential
occurrence of unwanted
releases, fire, or other
emergency incidents.
Minimize the potential failure
of buildings, equipment, or
processes.
Minimize the potential
exposure of people or
property to unsafe
conditions or events
Minimize the potential for an
unintentional reaction that
results in a fire, explosion,
or other dangerous
condition
Provide a means to contain,
treat, neutralize, or
otherwise handle plausible
releases of hazardous
materials.
2.
3.
4.
5.
6.
Provide appropriate safeguards
to minimize the risk of and limit
damage and injury…
7.
Detect hazardous levels of
gases or vapors that are
dangerous to health and alert
appropriate persons…
8.
Maintain power to provide for
continued operation of
safeguards and important
systems…
9.
Maintain ventilation where
ventilation is relied upon to
minimize the risk of emergency
conditions
Slide 55
10. Minimize the potential for
exposing combustible
hazardous materials to
unintended sources of ignition.
Presented By:
© Copyright 2003
CFC – CHAPTER 10
General Fire Safety
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
- NFPA 101 – Retroactive
- Owner, Occupant are
both responsible
- Maintenance & Testing
- Drills - Fire and Seismic
- Emergency Plans
- Christmas Trees
Slide 56
Presented By:
© Copyright 2003
Integrated
Engineering
Services
28
CFC – CHAPTER 11
Building Services
Regulations
and
Codes
For
Biotech
Facilities
- Electrical Safety NFPA 70
- Temporary wiring Max. 90
Days.
- HVAC NFPA 90A & 90B
- Elevators and Escalators
Slide 57
- ANSI A17.1
Presented By:
© Copyright 2003
CFC – Chapter 11
cont.
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
• Heating Appliances NFPA
31 & NFPA 54
• Kerosene/Oil Burners
• Emergency & Standby
Power
NFPA 110, NFPA 37,
NFPA 111
- Smoke Control
© Copyright 2003
Slide 58
Presented By:
Integrated
Engineering
Services
29
CFC – Chapter 12
Fire Protection
• Maintenance of Fire Safe
Construction per NFPA 220
• Fire Doors and Windows
per NFPA 80.
• Firestop Systems NFPA
101, ASTM EE-814
• Smoke Dampers/Detectors
Regulations
and
Codes
For
Biotech
Facilities
Slide 59
Presented By:
Integrated
Engineering
Services
© Copyright 2003
CFC – CHAPTER 13
Fire Protection
Regulations
and
Codes
For
Biotech
Facilities
•
•
•
•
•
NFPA
NFPA
NFPA
NFPA
NFPA
101
13, 13R and 13D
70
72
20
Slide 60
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© Copyright 2003
Integrated
Engineering
Services
30
CFC – CHAPTER 14
Means of Egress
Regulations
and
Codes
For
Biotech
Facilities
• Exit Access Corridors
• Exits per NFPA 101
• Doors and Latches –
NFPA 101
• Stairway/Exit Marking
• Occupant Load
Slide 61
Presented By:
© Copyright 2003
CFC – CHAPTER 16
Const.,Alter,Demo
-
NFPA 241 & App. By AHJ
Heating Equipment
Waste Disposal
Flammables per NFPA 11-66
Fire Protection
Owners Responsibility
Proven Water Supply
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 62
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© Copyright 2003
Integrated
Engineering
Services
31
San Jose Mercury News
A fire broke out Monday afternoon, August 19, at
Santana Row, a $750,000,000 retail and
residential complex under construction in west
San Jose. Flying embers set several homes and
apartments to the south on fire, displacing over a
hundred residents. A total of 11 alarms
responded to all related fires. More than a dozen
neighboring fire departments assisted San Jose in
controlling the blaze…
Regulations
and
Codes
For
Biotech
Facilities
Slide 63
Presented By:
© Copyright 2003
CFC – CHAPTER 18
Access and Water
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
• Adequate Access Roads
• Multiple Access Roads
20’
• No Obstructions
• Adequate Water Supply
Slide 64
Presented By:
© Copyright 2003
Integrated
Engineering
Services
32
CFC – CHAPTER 20
Occup. Fire Safety
Regulations
and
Codes
For
Biotech
Facilities
•
•
•
•
•
NFPA 101
Exit Markings
Drills per NFPA 101
Care Facilities
Fire Safety Plan per
NFPA 101
• Ambulatory Health Care
Slide 65
Presented By:
Integrated
Engineering
Services
© Copyright 2003
EVACUATION PLAN
Regulations
and
Codes
For
Biotech
Facilities
Slide 66
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© Copyright 2003
Integrated
Engineering
Services
33
CFC – CHAPTER 23
Cleanrooms
Regulations
and
Codes
For
Biotech
Facilities
• NFPA 318318- similar to Art.
51
Slide 67
Presented By:
© Copyright 2003
Integrated
Engineering
Services
Regulations
CFC CHAPTER 24
and
Codes
For
Biotech
Facilities
• Dry Cleaners NFPA 32
Slide 68
Presented By:
© Copyright 2003
Integrated
Engineering
Services
34
CFC – CHAPTER 25
Temporary Structures
Regulations
and
Codes
For
Biotech
Facilities
•
•
•
•
Tents and Canopies
NFPA 101
NFPA 102
Similar to UFC Art. 32
Slide 69
Presented By:
© Copyright 2003
CFC – CHAPTER 26
Labs using Chem.
• Primary Document NFPA 45
• Labs in Health Care
Facilities
• NFPA 801 – Radioactives
• NFPA 495 – Explosives
• Exemptions:
?Less than 1.1 Gal, or
?75 scf of gas
© Copyright 2003
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 70
Presented By:
Integrated
Engineering
Services
35
Regulations
CFC – CHAPTERS
and
Codes
For
Biotech
Facilities
• Chapter 28 – Marinas
• Chapter 29 – Parking
Garages
• Chapter 30 – MV Dispensing
and Repair Facilities
• Chapter 31 – Forest Products
• Chapter 40 – Dust Exp. Prev.
Slide 71
Presented By:
© Copyright 2003
CFC – CHAPTER 41
Hot Work
• Similar to UFC 49. Except
Electric Welding Exempt
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 72
?NFPA 51
• Management
Responsibility
• Permit by PAI
Presented By:
© Copyright 2003
Integrated
Engineering
Services
36
CFC – CHAPTER 43
Coat,Spray&Dip
Regulations
and
Codes
For
Biotech
Facilities
•
•
•
•
Comply with NFPA 33
Comply with NFPA 70
NFPA 30
NFPA 13, NFPA 17, NFPA
12
• NFPA 2001
Slide 73
Presented By:
© Copyright 2003
CFC – CHAPTER 50
Commercial Cooking
Equipment
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 74
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© Copyright 2003
Integrated
Engineering
Services
37
Regulations
CFC – CHAPTER 51
and
Codes
For
Biotech
Facilities
• Industrial Ovens
Slide 75
?Safety Controls
?Ventilation
?Fuel Safety
?Excess Temperature Control
?Conveyor Interlock
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – CHAPTER 53
and
Codes
For
Biotech
Facilities
• Refrigeration
Slide 76
?Classification – NFPA
?Vapor Alarms – Retroactive
?Auto Shutdown
?Change = Approval
?Maintenance by CMC
Presented By:
© Copyright 2003
Integrated
Engineering
Services
38
Regulations
CFC – CHAPTER 52
and
Codes
For
Biotech
Facilities
• Stationary Lead Acid
Battery Systems
Slide 77
?Scope – 100 gal. in
Sprinklered
Occupancies & 50 Gal.
in Non-sprinklered
?1 hr. Separation
?Spill Control
Presented By:
© Copyright 2003
Integrated
Engineering
Services
Regulations
and
BATTERY
ROOM
EXPLOSION
Codes
For
Biotech
Facilities
Slide 78
Presented By:
© Copyright 2003
Integrated
Engineering
Services
39
Regulations
EXPLOSIVE LIMITS
Chemical
Acetone
Acetylene
Ammonia
Gasoline
Hydrogen
Methane
Toluene
LEL
2.5%
2.5%
15%
1.4%
4.0%
5.0%
1.2%
UEL Optimal
15%
5.0%
83%
8.0%
28% 17%
7.6% 1.6%
75%
8.0%
15%
9.0%
7.1% 2.5%
and
Codes
For
Biotech
Facilities
Slide 79
Presented By:
© Copyright 2003
PRESSURE/VACUUM
RELIEF VENTS
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 80
Presented By:
© Copyright 2003
Integrated
Engineering
Services
40
Regulations
CFC – Chapter 66
Bonding of Vessel & Piping
?Solvent Distillation – Listed
(O.K.)
?Vessel Regulated (>60 gal)
and
Codes
For
Biotech
Facilities
Slide 81
?Normal & Emergency
Venting Required
?Above Ground Tank and
Vaults
Presented By:
© Copyright 2003
PROTECTED
ABOVEGROUND TANKS
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 82
Presented By:
© Copyright 2003
Integrated
Engineering
Services
41
PROTECTED
ABOVEGROUND TANKS
Regulations
and
Codes
For
Biotech
Facilities
Slide 83
Presented By:
© Copyright 2003
Integrated
Engineering
Services
FLAMMABLE LIQUID CABINT
Regulations
and
Codes
For
Biotech
Facilities
Slide 84
Presented By:
© Copyright 2003
Integrated
Engineering
Services
42
CFC-CHAPTER 60
Hazardous Materials
Regulations
and
Codes
For
Biotech
Facilities
Slide 85
• Over Control Area Quantity
• EXEMPTIONS x 10
• CLASSIFICATIONS
?Physical Hazards
?Health Hazards - Not Irr.,
Sens., OHH
Presented By:
© Copyright 2003
Integrated
Engineering
Services
Regulations
CFC – CHAPTER 60
and
Codes
For
Biotech
Facilities
•
•
•
•
•
HMMP, HMIS
Unauthorized Release
Signs/ Identification
Electrical per NFPA 70
Separation of
Incompatibles
• Seismic
Slide 86
Presented By:
© Copyright 2003
Integrated
Engineering
Services
43
Regulations
CFC – CHAPTER 60
and
Codes
For
Biotech
Facilities
• Maintenance Required
• Defective Equip. Replaced
• Protection Levels:
?Level 1- Pyro, explosives
?Level 2 – Fl 1A,B,C-ClI, III,
FG>15psig
?Level 3 – Aerosols, FL <15psig
?Level 4 – Corrosive, H Tox, Tox
?Level 5 - Semiconductor
Slide 87
Presented By:
Integrated
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Services
© Copyright 2003
Regulations
SEPARATION
• Incompatible materials
must be separated by:
and
Codes
For
Biotech
Facilities
Slide 88
? 20 feet
? Noncombustible partition
?Separate approved cabinets
Presented By:
© Copyright 2003
Integrated
Engineering
Services
44
SEPARATION
Regulations
and
Codes
For
Biotech
Facilities
Slide 89
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Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – CHAPTER 60
and
Codes
For
Biotech
Facilities
• Hazardous Materials
(cont.)
Slide 90
?Equipment and Machinery
Listed or Approved
?Defective Equipment
Removed from Service
Presented By:
© Copyright 2003
Integrated
Engineering
Services
45
CFC – CHAPTER 60
Regulations
and
Codes
For
• Design and Construction
?Piping , tubing, valves,
fittings and related
components used for
hazardous materials shall be
in accordance with the
following:
?Piping, tubing, valves, fittings
and related components shall
be designed and fabricated
from materials compatible with
the material and…
?Seismic
© Copyright 2003
Biotech
Facilities
Slide 91
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Integrated
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Regulations
PIPING EXPANSION LOOP
and
Codes
For
Biotech
Facilities
Slide 92
Presented By:
© Copyright 2003
Integrated
Engineering
Services
46
Regulations
Chapter 60
and
Codes
For
Biotech
•
•
•
•
•
Materials?
304
316
317
C-20
Facilities
Slide 93
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Chapter 60
Regulations
and
Codes
For
Biotech
•
•
•
•
SPECIAL ALLOYS
Monel
Nickel
Hastelloy
?B,C,D
Facilities
Slide 94
Presented By:
© Copyright 2003
Integrated
Engineering
Services
47
Regulations
PIPE CROSS SECTION
and
Codes
For
Biotech
Facilities
Slide 95
Presented By:
© Copyright 2003
CFC – CHAPTER 63
Comp.Gas & Cryo
•
•
•
•
•
•
•
•
•
In Accordance with NFPA 55
Radioactive Gases NFPA 801
Medical Gas NFPA 99
Oxygen Cyl. NFPA 51
Acetylene NFPA 51A
ETO - NFPA 560
Lab Gases NFPA 45
Toxicity CGAPCGAP -20
Exhaust & Handling NFPA 55
© Copyright 2003
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 96
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Integrated
Engineering
Services
48
Regulations
CFC – CHAPTER 63
and
Codes
For
Biotech
Facilities
- No Basement Storage of
reactive gas
• Signage
• Ignition Source Control
• Gas Storage
Slide 97
?Gas Room
?Gas Cabinet
?Exhausted Enclosure
Presented By:
© Copyright 2003
MEDICAL GAS
FIRE
Integrated
Engineering
Services
Regulations
and
Codes
For
Biotech
Facilities
Slide 98
CYLINDER
STORAGE
LOCATION
Presented By:
© Copyright 2003
Integrated
Engineering
Services
49
CYLINDER REMNANTS
Regulations
and
Codes
For
Biotech
Facilities
Slide 99
Presented By:
Integrated
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Services
© Copyright 2003
CALIBRATION
Regulations
and
Codes
For
Biotech
Facilities
Slide 100
Presented By:
© Copyright 2003
Integrated
Engineering
Services
50
Regulations
CFC – CHAPTER 64
and
Codes
For
Biotech
Facilities
• CORROSIVE SOLIDS and
LIQUID
Slide 101
?Liquid Cabinet
Construction
?Seismic Shelves
• FOR GAS STORAGE
?Gas Tight Valve Caps
?Secured Handles
?Coffins – Training Req.
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – CHAPTER 63
and
Codes
For
Biotech
Facilities
• Outdoor Storage –
Slide 102
?Sprinklered Canopy
• Emergency Shutoff
• Flammable Gas
• Oxidizer Gases
Presented By:
© Copyright 2003
Integrated
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Services
51
Regulations
EMERGENCY CONTROLS
and
Codes
For
Biotech
Facilities
Slide 103
Presented By:
Integrated
Engineering
Services
© Copyright 2003
Regulations
CFC – CHAPTER 66
Flam.&Comb.Liq.
and
Codes
For
Biotech
Facilities
Slide 104
NFPA 30A
NFPA 99
NFPA 45
NFPA 37
NFPA 32
NFPA 30
NFPA 36
NFPA 33
NFPA 34
NFPA 35
Presented By:
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Integrated
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Services
52
CFC – CHAPTER 60
HAZARDOUS
MATERIALS
NFPA 64 – Corrosive
Solids & Liquids
NFPA 69 LPG &
LNG
NFPA 67
Flammable Solids
Regulations
and
Codes
For
Biotech
Facilities
Slide 105
NFPA 68 - Highly Toxic &
Toxic Solids & Liquids
NFPA 60
NFPA 70 - Oxidizers &
Organic Peroxides
NFPA 61 – Aerosol
Products
NFPA 71 - Pyrophoric
Solids & Liquids
NFPA 73 - Water Reactive
Solids & Liquids
NFPA 72 - Unstable Reactive
Solids & Liquids
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Services
© Copyright 2003
CFC
• Appendices
Regulations
and
Codes
For
Biotech
Facilities
Slide 106
?Ozone Generation
?Fire Flow
?Classification
?LC 50 for Mixtures
?Hazard Ranking
?Relief for Above Ground
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Integrated
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Services
53
BIO-SAFETY
CONCERNS
• Bio
Bio--Safety Controls
Regulations
and
Codes
For
Biotech
Facilities
Slide 107
?LABORATORY PRACTICES &
TECHNIQUES
?SAFETY EQUIPMENT (PRIMARY
BARRIERS)
?FACILITY DESIGN
(SECONDARY BARRIERS)
• Not addressed in current
codes
Presented By:
Integrated
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Services
© Copyright 2003
BIO-SAFETY 1
Regulations
and
Codes
For
Biotech
• LABORATORY PRACTICES &
TECHNIQUES
?Personnel Training
?Personal Protection
Equipment
Facilities
Slide 108
Presented By:
© Copyright 2003
Integrated
Engineering
Services
54
BIO-SAFETY 2
Regulations
and
Codes
For
Biotech
• SAFETY EQUIPMENT (PRIMARY
BARRIERS)
?Biological Safety Cabinets
(BSCs)
?Enclosed Containers &
Hoods
?Centrifuge Cups
Facilities
Slide 109
Presented By:
Integrated
Engineering
Services
© Copyright 2003
BIO-SAFETY 3
Regulations
and
Codes
For
Biotech
• FACILITY DESIGN
(SECONDARY BARRIERS)
?Separation of Laboratory
Work Area
Facilities
Slide 110
?Isolation
?Treatment
?Airlocks
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Integrated
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Services
55
Regulations
CONCLUSION
and
Codes
For
Biotech
Facilities
• My conclusion is My
beginning.
• A rational and balanced
approach to safety issues
based on Current Data.
• “The greatest barrier to
learning the truth is to be
convinced that you already
know it.”
© Copyright 2003
Slide 111
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56