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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.
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.
3) Standard & custom built systems.
4) Engineered for highest level of protection and safety.
5) 35 years of industry experience.
6) Meet or exceed all performance and conformance standards.
7) Provided fully certified and validated systems Pharmaceutical, Bio Technology, Semi Conductor, Optics and Chemical industries.
8) Precision stainless steel, steel and plastics fabrication.
9) 45,000 sq ft. of manufacturing space.
Continued…
About Us: Products & Capabilities
10) Advanced state of the art equipment.
11) Highly developed quality assurance and testing protocols.
12) Customer support and service through all aspects of system development
13) Complete installation services, field certification and testing
14) Experienced and innovative sales, design, and engineering staff
15) Highest quality products at competitive prices
16) On-time delivery
17) Dedication to provide full spectrum services,
products & technologies
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…
Controlled Environment…Do you need one?
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…
Do you need a Controlled Environment?
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.
Controlled Environment…What kind do You need?
Manufacturing
• Over 35 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 environmental systems providing controlled human access.
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 air-conditioning 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
StandardsAll 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…
StandardsAll ISI Products Meet or Exceed The Following Standards.
Current CGMP Standards
AABC National Standards
Nano Containment Isolation per development 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
Testing Validation Certification
9) Smoke Pattern Testing
10) Air Flow Certification Testing
11) Filter Challenge Leak Detection
12) CIP Test and Certification
13) Mass Spectrometer Particle Level Test
14) Surface Finish Certification Test
15) Operator Exposure Level Testing
16) Die Penetration Testing
1) Pressure Decay Testing
2) Ammonia Rag Litmus Leak Testing
3) Ultrasonic Leak Detection Testing
4) Mass Spectrometer-Leak Detection
Test (Helium)
5) Containment Integrity Testing
6) Material Transfer Integrity Testing
7) Glove/Filter Change Out Integrity Test
8) Flow Characterization Test
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…
• 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
• 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
• 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.
Airborne Particulate Control
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…
• 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.
Clean Environments
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.
3. 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…
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.
Operating Parameters
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.
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.
EnclosuresIsolation 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.
PlasticsWe offer custom designed systems manufactured in a variety of materials for specific material resistance and product contact requirements.
Materials include:• Polypropylene• PVC• Acrylic• Polycarbonate
Isolators
We manufacture a complete line
of Barrier Glovebox Isolators and
process-specific designed and
engineered systems, providing
versatility of design and meeting the
highest standards of containment.
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 TransferIsolation Systems Inc. designs and manufactures a complete line of entry systems providingcontrolled 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 withmodular structural suspension systems.
ISI LinecardPos/Neg Pressure Glove Box Isolation Systems
Laminar Flow Recirculating Glove Box Isolators
Sterility Test Glove Box Isolators
Potent Compound Glove Box Isolators
Explosion Proof Powder Transfer Glove Box Isolator
Static Glove Box Isolators
Horizontal Laminar Flow Consoles
Horizontal Reverse Flow Consoles
Sampling and Containment Booths
Ceiling Suspended Vertical Laminar Modules
Modular Fan Filter Units
Class 100 Mobile Clean Rooms
Softwall Clean Room/Process Enclosures
Modular Hardwall Cleanroom Systems -HWCR Series
Modular Clear Rigid Wall Cleanroom - CRW Series
Class 100 Portable Transfer Cart Systems
Single Pass Class100 Vert. Lam. Flow Work Stations
Vert. Lam. Flow Recirculating and Exhaust Hoods
Continued…
Vertical Negative Pressure Containment Hoods
Polypropylene Vertical Laminar Flow Exhaust Hoods
Vert. Laminar Flow Single Pass Straddle Workstations
Air Shower Clean Room Entry Systems
Positive Pressure Air Lock Entry Systems
Personal Decontamination Misting Showers
Air Shower Cart Entry Systems
High Containment Rapid Transfer Ports - RTP Systems
Coved Corner Interlocking Pass Thru
Laminar Flow Interlocking Pass Thru
Constant Volume Fume Exhaust Hoods
General Laboratory Fume Exhaust Hoods
Supplemental Air Fume Exhaust Hoods
HEPA Filtered Garment & Material Storage Cabinets
Hood and Console Base Cabinets
Flexible Curtain Barrier Systems
Class 100 Clean Room Luminaries
Tear Drop Air Foil Luminaries
Flow-Thru Clean Room Luminaries
ISI Linecard
Customer List (Ltd)
AGFA
AMGEN
AVENTIS PASTEUR
AIR PRODUCTS
BAYER
BRISTOL MEYERS SQUIB
MYLAN LABORATORIES
JACOBS ENGINEERING
LOCKWOOD GREENE
JOHNSON & JOHNSON
MONSANTO
MOTOROLA
NOVARTIS
PFIZER
MERCK
DPT LABORATORIES
MANNKIND CORP
ELI LILLY
FLUOR DANIEL
GENECORE
IBM
IEDCO
Customer List (Ltd)
B BRAUN
Q-ONE BIOTECH
SCHERING PLOUGH
SANOFI PHARMA
TORCON CONSTRUCTION
GLAXO SMITH KLINE
ABBOTT LABORATORIES
ADP MARSHALL
INTEL
KONICA IMAGING
LIPISOME
LUCENT
TEXAS INSTRUMENTS
WYETH LEDERLE
NEW ENGLAND BIO TECH
BOEHRINGER INGEL-HIEM ACCO ENGINEERING
APPLIED MATERIALS
DMV INTERNATIONAL
BARKLEY WHITE
DUPONT PHARMA
BENVENUE LABS
HOSPIRA
QUINLAN CONSTRUCTION
AMRI
CHICAGO AEROSOL