Transcript Isolation Specific Engineered Products and Equipment This presentation is intended as a general overview of the products and capabilities of ISI.

Isolation Specific
Engineered Products
and Equipment
This presentation is intended
as a general overview of the
products and capabilities of ISI.
We hope that the information
provided within is sufficient for
the purpose of providing You the
information required in specifying
your clean room equipment
or containment system.
Controlled Environment…
Do you need one?
Our environment contains large amounts of
contamination, both gaseous and particulate.
However, the application of controlled
environments pertains primarily to the problem of
airborne particulate control and containment.
Thus, the control, containment and extraction of
contamination within clean and aseptic areas
is critical to high-yield and efficient production.
Continued…
Do you need a
Controlled Environment?
Such operations are performed in controlled spaces wherein:
1.) Containment levels are established
2.) Airborne particulate is contained or limited
3.) Air flow patterns are selected
4.) Environmental temperature and humidity are
controlled
5.) Air pressure is is selected and regulated
6.) Special construction materials and equipment are
utilized
7.) Operating procedures are regulated
Continued…
Controlled Environment…
What kind do
You need?
These spaces may be…
rooms, workstations, barrier isolators,
process enclosures, mini-environments,
containment systems, glove boxes,
restricted access barrier systems
or designated classified areas
within a room or existing environment.
About Us; Products & Capabilities
1)
10 years of providing full service design, engineering,
and manufacturing.
2)
100% Successful Manufacturing Validation and
Certification of all systems built.
2)
Standard & custom built systems.
3)
Engineered for highest level of protection and safety
4)
35 years of industry experience
5)
Meet or exceed all performance
and conformance standards
2)
Provided fully certified and validated systems
Pharmaceutical, Bio Technology, Semi Conductor,
Optics and Chemical industries.
3)
Precision stainless steel, steel and plastics
fabrication
4)
45,000 sq ft. of manufacturing space
Continued…
About Us; Products & Capabilities
9)
Advanced state of the art equipment.
10)
Highly developed quality assurance and testing protocols
11)
Customer support and service through all
aspects of system development
12)
Complete installation services, field certification and testing
13)
Experienced and innovative sales, design,
and engineering staff
14)
Highest quality products at competitive prices
15)
On-time delivery
16)
Dedication to provide full spectrum services,
products & technologies
Manufacturing
• Over 30 years of experience in precision manufacturing
• Developed proven manufacturing methods and techniques
• Provide certifiable and validated products/systems
• Custom extruded sealing gasket
• Extruded aluminum shapes
• Thermoformed or fabricated plastic
Fit & Finish
Continued…
Fit & Finish
Terminology
1.) CONTROLLED ENVIRONMENT:
A specially constructed enclosed area
environmentally controlled with respect
to airborne particulates, temperature,
humidity, air pressure, air-flow patterns,
air movement and lighting.
2.) AIRLOCK/PASS THRU:
A transition enclosure for material movement into
and out of the isolator that maintains primary containment.
3.) RAPID TRANSFER PORT (RTP):
Contained portal for transfer of highly hazardous materials
into and out of isolator utilizing sealed canisters or bags
and interlocking inner and outer doors.
Continued…
Terminology…
4.) WORK STATION:
An open or enclosed work area or
surface with direct HEPA-filtered air supply.
5.) ISOLATOR:
A specially constructed enclosure to encapsulate
specific processes within an existing environment
enabling the precise control of environmental conditions
within and to provide protection for product or personnel.
6.) MINI-ENVIRONMENT:
An assemblage of equipment that creates a work space
specifically intended to control contamination and to
provide protection to either operator or product.
Continued…
Terminology…
7.) CRITICAL SURFACE:
The surface of the work part that is to be protected from
particulate contamination or the surface of equipment that
contacts product.
8.) LAMINAR AIR FLOW:
Air flow in parallel flow lines with uniform velocity and minimum
eddies. Air flow becomes “laminar” at velocities of 70-120 fpm (feet
per minute).
9.) LAMINAR FLOW ENCLOSURE:
A clean enclosure specifically designed for laminar air flow
throughout generally providing Class 100 conditions within
through HEPA filtration
Continued…
Terminology…
10.) RANDOM FLOW (NON-LAMINAR FLOW) ENCLOSURE:
A clean room with no requirements for uniform air flow patterns
through work area but generally providing Class 100 condition
within through HEPA filtration.
11.) LAMINAR AIR FLOW WORK STATION (HOODS):
A work station with laminar air flow through work area operating
under either positive or negative pressure.
12.) DESIGN CONDITIONS:
The environmental conditions for which the clean space or
isolator is designed.
13.) RESTRICTED ACCESS BARRIER SYSTEMS (RABS):
Isolated controlled environmental systems.
Continued…
Terminology…
14.) OPERATIONAL CONDITIONS:
The environmental conditions which must be maintained in the
operation of a clean space or isolator.
15.) HIGH EFFICIENCY PARTICULATE AIR FILTER (HEPA):
A filter with an efficiency rating in excess of 99.99% eff. at 0.3
microns, as determined by specific particle introduction aerosol
testing in accordance with military specification MIL-STD-282.
16.) ULTRA HIGH EFFICIENCY PARTICULATE AIR FILTER (ULPA):
A filter with an efficiency rating in excess of 99.9999% eff. at 0.12
microns.
17.) PARTICLE SIZE:
The maximum linear dimension of diameter of a particle.
Continued…
Terminology
18.) MICRON:
One Millionth of a meter.
19.) MICROGRAM:
One Millionth of a gram.
20.) NANOMETER:
One Billionth of a meter.
21.) NANOGRAM:
One Billionth of a gram.
Terminology
22.) PRIMARY AIR:
Air recirculating through HEPA filters producing laminar
flow or regulated air changes per hour.
23.) SECONDARY AIR:
That portion of primary air introduced and circulated by airconditioning equipment into the primary air loop.
24.) MAKEUP AIR:
Air introduced to the secondary air system
for ventilation and pressurization.
25.) CLEAN IN PLACE (CIP):
Internal cleaning/washing device or system
located within isolator.
Required Cleanliness Levels
Room Classification
based on Air Changes per Hour
Per Federal Standard 209
Comparison of Particle Sizes
Operator Exposure Containment
Level Classifications
Testing Validation Certification
1) Pressure Decay Testing
9) Smoke Pattern Testing
2) Ammonia Rag Litmus Leak Testing
10) Air Flow Certification Testing
3) Ultrasonic Leak Detection Testing
11) Filter Challenge Leak Detection
4) Mass Spectrometer-
12) CIP Test and Certification
Leak Detection Test (Helium)
13) Mass Spectrometer Particle Level Test
5) Containment Integrity Testing
14) Surface Finish Certification Test
6) Material Transfer Integrity Testing
15) Operator Exposure Level Testing
7) Glove/Filter Change Out Integrity Test
16) Die Penetration Testing
8) Flow Characterization Test
Standards
All ISI Products Meet or Exceed The Following Standards.
All Applicable ISO Standards and Guidelines
Federal Standard 209E
IEST-RP-CC-002.2
IEST-RP-CC-006.3
IEST-RP-CC-006-84T
NSF/ANSI
ASHRAE applications Hand Book Sec-16
MIL Std-1425A
AGS-G001
AF Tech Order-T.O.00-25-203
Continued…
Standards
All ISI Products Meet or Exceed The Following Standards.
Current CGMP Standards
AABC National Standards
Nano Containment Isolation per development guidelines
SEMPACS Developing Guidelines
OEL Conformance Testing for Levels–1,2,3,4,5 as required
USP-797
EC Guide for Manufacture of Sterile Medicinal Products ANNEX-1
NIOSH
OSHA
Unidirectional Air Flow
(Laminar Flow)
•
When the total air volume within a space moves in one direction at a
uniform speed of between 70 - 110 FPM, its individual molecules
assume parallel paths, or streamlines. The physics of this phenomenon
allow for these streamlines of air to bend around objects and obstacles
without losing laminarity or losing the particles which they carry.
•
Maintaining air flow laminarity within clean areas -and around and over
your processes- will keep airborne contaminants (emanating from
workers, nearby shedding processes and products) from fouling your
critical process. The principle of laminar air flow is vital in
contamination control. Air flow laminarity is a major component in the
design and maintenance of clean environments.
Airborne
Particulate Control
•
Airborne particulate matter can be of organic or inorganic origin.
Most contamination-control problems concern the total
contamination within the air. Airborne particles range in size from
0.001 microns to several hundred microns.
•
Before any methods of contamination control of airborne particles
can be successfully applied, a decision must be made as to how
critical this particulate matter is to the process or operation in
question. At the same time, consideration must be given to the
quantity of particles of a given size that might be present at a
specific point within an area.
Continued…
Airborne
Particulate Control
•
Since a definite relationship exists between the size of a particle and
the time in which it may be airborne, it is most meaningful to
discuss particles by quantity of a given size.
Both Fed. Std. 209-E and AF Technical Order
00-25-03 show typical relationships.
•
To further analyze your contamination control
requirements, the source of contamination
should be considered. Basically, this is divided
into external sources and internal sources.
Continued…
Airborne
Particulate Control
•
For any given space, there exists the
external influence of atmospheric contamination,
which inevitably finds its way into all areas of our working
environment. This external contamination is generally introduced
through air-conditioning systems which supply the workspace. In
addition, external contamination can infiltrate through doors,
penetrations or cracks within the enclosure. This contamination can
generally be controlled by the level of filtration utilized in
conjunction with clean-area pressurization.
Continued…
Airborne
Particulate Control
•
Internal sources of contamination are caused through the
introduction of equipment, material and personnel within an area.
Contamination is created by every activity involving friction between
surfaces. For example, the simple act of writing with a pencil on a
piece of paper creates a cloud of very fine carbon particles and
paper fibers. Even the movement of two pieces of metal together
generates particulate matter which can be aerosolized to form very
fine metallic dust. However, the greatest source of internal
contamination is people. We continually shed particles. That
amount can vary from as few as several hundred particles per hour
to several thousand.
Equipment and
System Alternatives
•
A full choice of equipment and easily erectable modular panelized
enclosures are readily available, along with ceiling systems, clean
room specific lighting, motorized and non-motorized ceiling-
mounted filtration modules and environmental control components
that are sent to the user for installation. These modular enclosures
effectively control, reduce and eliminate the effects of generated
particulate contamination on your critical processes.
Clean Environments
•
Principles of contamination control can be applied to a simple tabletop
workstation to produce Class 100 levels of cleanliness, permitting the
most sensitive operations to be performed within a particulate-free
environment. When larger areas are required,
a question that must be addressed by users of
clean spaces is: “What type of clean
environment is required?”
•
One approach is to convert an existing area into
a clean room via retrofit. If a convenient sized space
exists within a facility, it is often sensible to convert it,
thereby realizing a substantial cost reduction.
Continued…
Clean Environments
•
A second approach is to purchase a pre-packaged
modular clean room that can be adapted to the
requirements of the process or facility within which
it is to be installed.
•
A third approach is to analyze the process to be housed
and define all specific parameters required in developing
a mini-environment or glovebox specifically designed to
isolate your process under controlled conditions within
your ambient environment, thereby reducing your facility’s
operating cost and the risk of operator-introduced contamination
or operator exposure to hazardous compounds.
Operating Parameters
1.
CLEANLINESS - Expressed as a classification per Fed.Std. 209E (e.g.,
Class 100, Class 10,000, Class 100,000), this parameter is the basis of
much of the room design. It is important to know what you require since an
over-designed room can be costly to build and costly to operate.
2.
OPERATING PRESSURE - Generally expressed in Water Column (wg.)
Pressure conditions should be established based on process and
containment requirements. Positive pressure conditions are generally
created for product protection or gas introduction preventing contaminates
infiltration. Negative pressure conditions provide operator protection.
Assuring containment of potent compounds and other hazardous
substances. System operating pressures should be established
early in design phase.
1.
TEMPERATURE - If the process is not affected by temperature/humidity
conditions which fall outside of human comfort ranges, do not specify tight
tolerances. A good specification is 70º F±2 and 30-70% RH. Any tighter
tolerance will result in unnecessarily escalated costs
Continued…
Operating Parameters
4.
LIGHTING LEVEL - A level of 100 foot-candles at the work surface is more
than adequate for close assembly work. High levels are costly in terms of
energy consumption. Lower levels can be maintained by control switching.
5.
PROCESS FLOW - This deals with the process being carried out within the
room or system. The process will dictate the materials of construction of
the room as well as the layout of the facility. The process should be defined
as completely as possible before the clean room or process enclosure is
designed. This sounds elementary, but a poorly defined process will result
in an unsatisfactory solution, or one in which modifications are being made
before the paint is dry.
Booths
Isolation Systems Inc. designs,
engineers and manufactures
high-containment and extraction
booths to specification.
We meet the most stringent
containment levels for specific
applications.
Enclosures
Isolation Systems Inc. designs and
manufactures a versatile line of Modular
Cleanroom Containment and Laboratory
Automation Enclosures.
Modular panelized construction assures
ease of installation, expansion and
customization.
Available in both Positive and Negative
pressure configurations. Conforming to all
operational classifications and standards.
Hoods
We provide a complete line of
Hoods and Consoles for multiple
process applications including
Laminar Flow, Containment,
Exhaust,& Re-circulating systems.
Custom design is our specialty.
Isolators
We manufacture a complete line
of Barrier Glovebox Isolators, and
process specific designed and
engineered systems providing
versatility of design meeting the
highest standards of containment.
Plastics
We offer custom designed
systems manufactured in a variety of
materials for specific material resistance
and product contact requirements.
Materials include:
• Polypropylene
• PVC
• Acrylic
• Poly Carbonate
Material
Transfer
Isolation Systems Inc. manufactures
a complete line of modular systems
for material and personnel transfer
applications insuring …
•
•
•
•
•
Cleanroom area control
Aseptic area control
Containment
Product protection
Decontamination
Personnel Transfer
Isolation Systems Inc. designs and
manufactures a complete line of entry
systems providing controlled personnel
access to sensitive areas.
Modular design allows for ease of installation.
These systems can be shipped assembled or
knock down and can be assembled in field.
Systems can be configured for…
• Wet Misting Shower
• Decontamination Shower
• Air Shower and Air Lock applications
Downflow
Modules
Isolation Systems Inc. designs and manufactures a complete line
of Modular Ceiling-Suspended Downflow Hepa-filtration Systems.
Systems can be provided with
temperature and humidity control,
self-powered or ducted supply.
Systems can also be engineered with
modular structural suspension systems.
ISI Linecard
Pos/Neg Pressure Glove Box Isolation Systems
Ceiling Suspended Vertical Laminar Modules
Laminar Flow Recirculating Glove Box Isolators
Modular Fan Filter Units
Sterility Test Glove Box Isolators
Class 100 Mobile Clean Rooms
Potent Compound Glove Box Isolators
Softwall Clean Room/Process Enclosures
Explosion Proof Powder Transfer Glove Box Isolator
Modular Hardwall Cleanroom Systems -HWCR Series
Static Glove Box Isolators
Modular Clear Rigid Wall Cleanroom - CRW Series
Horizontal Laminar Flow Consoles
Class 100 Portable Transfer Cart Systems
Horizontal Reverse Flow Consoles
Single Pass Class100 Vert. Lam. Flow Work Stations
Drum Sampling and Powder-Weigh Booths
Vert. Lam. Flow Recirculating and Exhaust Hoods
Continued…
ISI Linecard
Vertical Negative Pressure Containment Hoods
Laminar Flow Interlocking Pass Thru
Polypropylene Vertical Laminar Flow Exhaust Hoods
Constant Volume Fume Exhaust Hoods
Vert. Laminar Flow Single Pass Straddle Workstations
Air Shower Clean Room Entry Systems
Positive Pressure Air Lock Entry Systems
General Laboratory Fume Exhaust Hoods
Supplemental Air Fume Exhaust Hoods
HEPA Filtered Garment & Material Storage Cabinets
Hood and Console Base Cabinets
Personal Decontamination Misting Showers
Flexible Curtain Barrier Systems
Air Shower Cart Entry Systems
Class 100 Clean Room Luminaries
High Containment Rapid Transfer Ports - RTP Systems
Coved Corner Interlocking Pass Thru
Tear Drop Air Foil Luminaries
Flow-Thru Clean Room Luminaries
Customer List
AGFA
MERCK
JACOBS ENGINEERING
AMGEN
DPT LABORATORIES
LOCKWOOD GREENE
MANNKIND CORP
AVENTIS PASTEUR
JOHNSON & JOHNSON
ELI LILLY
AIR PRODUCTS
MONSANTO
FLUOR DANIEL
BAYER
GENECORE
MOTOROLA
BRISTOL MEYERS SQUIB
IBM
NOVARTIS
MYLAN LABORATORIES
IEDCO
PFIZER
Customer List
B BRAUN
APPLIED MATERIALS
INTEL
Q-ONE BIOTECH
DMV INTERNATIONAL
KONICA IMAGING
BARKLEY WHITE
LIPISOME
DUPONT PHARMA
LUCENT
BENVENUE LABS
TEXAS INSTRUMENTS
TORCON CONSTRUCTION
HOSPIRA
WYETH LEDERLY
GLAXO SMITH KLINE
QUINLAN CONSTRUCTION
NEW ENGLAND BIO TECH
ABBOTT LABORATORIES
AMRI
BOEHRINGER INGEL-HIEM
ADP MARSHALL
CHICAGO AEROSOL
ACCO ENGINEERING
SCHERING PLOUGH
SANOFI PHARMA
AZO