INTRODUCTION

This presentation is intended to be general in nature; we hope that the information provided within is sufficient for the purpose of providing you the information required for helping in specifying your clean room equipment or containment system.

DO YOU NEED A CLEAN ENVIRONMENT?

Our environment contains large amounts of contamination, both gaseous and particulate. However, the application of clean rooms pertains primarily to the problem of airborne particulate contamination control. Thus, the removal and elimination of these contaminants within clean areas has become critical to ensure high-yield and efficient production for many advanced precision manufacturing processes and technologies.
Such operations are performed in clean spaces wherein:

1.) airborne particulate generation is limited

2.) air flow patterns are selected

3.) temperature and humidity are controlled

4.) air pressure is regulated

5.) special construction materials and equipment are utilized

6.) operating procedures are regulated.

These spaces may be rooms, workstations, process enclosures, barrier isolators, glove boxes, containment systems, mini-environments or designated classified areas within a room or existing clean environment.
Obviously, if the controlled conditions described above are relative to your manufacturing, assembly or laboratory operation, a controlled environment has become necessary.

TERMINOLOGY

1.) CLEAN ROOM: a specially constructed enclosed area environmentally controlled with respect to airborne particulates, temperature, humidity, air pressure, air-flow patterns, air movement and lighting.
2.) WORK STATION: an open or enclosed work area or surface with direct HEPA-filtered air supply.
3.) MINI-ENVIRONMENT/ISOLATOR: a specially constructed enclosure to encapsulate specific processes within an existing environment enabling the precise control of environmental conditions within.
4.) CRITICAL SURFACE: the surface of the work part that is to be protected from particulate contamination.
5.) 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).
6.) LAMINAR FLOW CLEAN ROOM: a clean room specifically designed for laminar air flow throughout.
7.) RANDOM FLOW (NON-LAMINAR FLOW) CLEAN ROOM: a clean room with no requirements for uniform air flow patterns through work area.
8.) LAMINAR AIR FLOW WORK STATION: a work station with laminar air flow through work area.
9.) DESIGN CONDITIONS: the environmental conditions for which the clean space or isolator is designed.
10.) OPERATIONAL CONDITIONS: the environmental conditions which must be maintained in the operation of a clean space or isolator.
11.) 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.
12.) ULTRA HIGH EFFICIENCY PARTICULATE AIR FILTER (ULPA): a filter with an efficiency rating in excess of 99.9999% eff. at 0.12 microns.
13.) PARTICLE SIZE: the maximum linear dimension of diameter of a particle.
14.) PRIMARY AIR: air recirculating through HEPA filters producing laminar flow or regulated air changes per hour.
15.) SECONDARY AIR: that portion of primary air introduced and circulated by air-conditioning equipment into the primary air loop.
16.) MAKEUP AIR: air introduced to the secondary air system for ventilation and pressurization.

CLEANING AIR

Federal standards have been established for room air cleanliness which describe how clean the air is in a given area. Per Federal Standard 209E, numeric classification means how many particles larger than 0.5 microns are acceptable within a classified clean environment. Hence, a Class 100 environment would mean that no more than 100 particles larger than 0.5 microns would exist in any given cubic foot of air, Class 1,000 would mean 1,000 particles and so on.
Clean rooms, enclosures and laminar flow work stations will remove airborne particles through HEPA or ULPA filtration of air entering an environment. Our standard HEPA filter will intercept and trap 99.99% of all particles .3 microns or larger, to meet or exceed Class 100 standards for particulate control. The use of ULPA filtration will boost your environment classification to Class 10. The required level of cleanliness will vary from process to process.

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.

WHAT IS A MICRON?

A micron (micrometer) is one-millionth of a meter. In the English system, a micron equals 1/25,400th of an inch.
Some examples of relative size might be useful for comparison purposes. Typically, the naked eye can see particles as small as 40 microns; a human hair is approximately 100 microns in diameter; milled flour can contain particles as small as 1 micron; tobacco smoke is composed of particles as minute as .01 microns an as large as 1 micron; bacteria range in size from .3 microns to 30 microns.

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.
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.
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.
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.
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 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 ROOM OPERATING PARAMETERS

1.) ROOM 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.) ROOM TEMPERATURE/HUMIDITY- 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.
3.) 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.
4.) 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. If the process is general in nature a more flexible layout is necessary. 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. A knowledgeable process design consultant will have experience in process flow and will be able to offer valuable assistance.
Now let us investigate some of the solutions offered by Isolation Systems Inc.

SOFT WALL CLEAN ROOMS

Isolation Systems, Inc. has designed and engineered the SWCR Series with careful attention to user needs. This product’s development has been guided by the results of our extensive market research and industry expertise. Its modular component system makes it highly adaptable to your specific soft wall clean room requirements at low cost. Our SWCR/MCR Series offers easy assembly, operational efficiency and rugged, long-lasting construction. Its frame structure can be erected within the tightest spaces, due to our innovative drop lock assembly system. This system is easily customized and can be designed and engineered to fit your specific process or space requirements. Utilizing our structural rafter and header adapters we can create a free structural span of up to 24 ft. Our ceiling system creates an impervious barrier against particulate infiltration. Combined with our seal track curtain enclosure, you are assured a contaminant-free environment. Our standard kit assemblies will be shipped within ten weeks of receipt of your purchase order. Our soft wall (SWCR) clean room systems are available in room classification ratings of CL 100,000, CL 10,000, CL 1,000, CL 100 and CL 10 (ULPA).Our Mobile system (MCR) is available in CL-100 and CL-10.

The CRW Series is the next step up in Simplex/Isolation Systems Inc. clean room enclosure line. Its modular assembly makes its installation extremely cost-effective. The structural frame is constructed of clear anodized architectural aluminum glazed with 1/4 inch full-light clear acrylic panels. This system provides permanent aesthetic appeal while enabling full visual monitoring of the activities or processes enclosed within.
Highly versatile, this single-pass system can be configured to create either entire room environments or adapted to create specific process or equipment mini-environments.
HEPA filtered air is provided by our FFU series (Motorized Fan Filter Unit). You can choose from a complete line of light fixtures and ceiling systems to complete this clean envelope.
This system is available in all clean room classifications and can be designed and developed to fit your specific requirements.

HARD WALL

CLEAN ROOMS

Simplex/Isolation Systems has developed this innovative pre-engineered clean room that allows specification, purchase and installation of a complete hard wall modular clean environment . The HWCR series modular clean envelope system features single-pass air flow and versatile construction allowing for easy expansion or relocation if required.
Structural load-bearing three inch wall panels are manufactured in standard 4 ft. by 10 ft. sections, featuring a high-density foam core and faced with a variety of non-particulating clean room certifiable materials on both sides. A clear anodized connection system allows for quick installation providing low-profile joints where wall sections meet.
Isolation Systems also offers several clean room rated ceiling grid systems into which our complete line of clean room class rated luminaries are mounted.
To provide up to a Class 10 environment, our FFU series (Motorized Fan Filter Unit) is an integral part of this clean room system. When these components are set into place they provide a complete envelope seal, forming a totally leak-free environment.
This modular system is offered in sizes varying from 100 sq. ft. to well in excess of 1000 sq. ft. With Isolation Systems HWCR single-pass clean rooms you purchase both the performance and aesthetics of a permanently built structure at considerable savings.

Our most versatile modular clean room filtration system the CVLF module can be utilizes for both vertical and horizontal class-100 laminar flow applications. This system is commonly used to covert existing space into class-100 recirculating clean space or in new construction of clean manufacturing suites.
The advantages of the CVLF system are that the plenum is completely enclosed and having an integral blower and return air system, eliminating the cost of in-place construction of ceiling plenums ,return ducts, and remote supply ducting to filtration modules. Our gel to knife edge filter seal insures against air bypass of filtration system.All filters are room side replaceable for ease of maintanence.This system also features integral fluorescent lighting . This is a complete clean room system provided in one modular unit.

AIR SHOWER ENTRY

SYSTEM (ASET SERIES)

Isolation Systems has designed and engineered the AS Series (Air Shower Entry System) with careful attention to user needs. This product has been specially designed to meet customer requirements for ease of installation, rugged construction and long lasting aesthetic appeal. It has been engineered for modularity offering lightweight cold roll steel or stainless steel interlocking panelized construction. Unidirectional air jet nozzles providing 6000 fpm at nozzle outputs insure complete occupant blow-off. Our specially designed and engineered programmable logic controller activates all system functions and allows for user interface in modification of functions. Our system can be assembled in half the time of traditional systems.
The development of our Modular Power Head Low Pressure Air Delivery System allows our basic unit to be easily adapted for any custom configuration (tunnel assemblies, low-profile side mounted power head, left- and right-turn orientations and remotely located power head) at low customer cost. We believe- and are sure you will agree-ours is the finest engineered entry system in the industry.

VERTICAL LAMINAR FLOW

STRADDLE SYSTEM

This system has been designed and engineered to provide basic vertical laminar flow protection through full overhead HEPA coverage (Class 100) Its modular component system makes it highly adaptable to your specific vertical laminar flow requirements at low cost. Though offered in standard product-line configurations, this system is easily customized to fit your specific process needs.
See our catalog for a full description of this product.

LAMINAR FLOW

CONSOLES AND HOODS

Since cost is typically a factor in evaluating any effort to improve the quality of the product or process, the initial investment is usually in laminar flow work stations. These may be vertical or horizontal flow stations. Perhaps the most popular is horizontal where the air is drawn from the space and directed by a centrifugal blower through a HEPA filter horizontally toward the operator seated at the front of the work station. The clean air is continually passing over the work surface and then out into the “dirty” room. The operator is outside the work space, although the operator’s hands - suitably gloved - do extend into the clean area. The air moving into the room at a velocity of 90 fpm tends to keep any outside contamination from moving into the work area.

In a vertical laminar flow station the air is introduced from above and moves vertically downward over the work area. The air leaving the HEPA filter is quite clean; however, a shortcoming of this type of station is that an operator, leaning over the work, would tend to “shed” onto the surface. As mentioned earlier, this shedding will contaminate. Vertical work stations are used in recirculating applications, or where fumes are generated and must be removed and exhausted. It would be wise to be aware of the possible source of contamination and insure that the operator using this type of station is well trained.

CLASS 100 PORTABLE

TRANSFER CART

Isolation Systems Inc. has developed this unique product with application flexibility and durability in mind. Our transfer cart is easily modified for diverse applications due to its modular design . Battery powered this system can provide up to Class-10 protection under either laminar or turbulent flow conditions for up to 2 hours under battery power only. When connected to power this system will operate as a Clean Storage Cabinet indefinitely. This system has been engineered to ensure safe and effective material and product transfer between clean areas and process stations under isolated and controlled conditions. Our Portable Transfer Cart is manufactured exclusively of stainless steel to provide rugged durability in high traffic applications. Its coved interior wall to floor and ceiling transitions allow for simple and effective cleaning. This system can be supplied to operate under either positive, negative pressure conditions. It can be modified for recirculating or single pass air flow. Double sided access allows for ease of loading and unloading. Integral interlock for doors is also available. The PTC system can easily be configured to meet any specified transfer requirement. For further information about this product please do not hesitate to contact us. Or simply go to our catalog page .

GLOVEBOX

ISOLATORS

All Isolation Systems Glove Box Isolators are designed , engineered and manufactured to the highest standards,(Per AGS-G001) utilizing state of the art design and manufacturing processes and techniques. Our systems are constructed of a minimum of 14ga. 304 or 316L stainless steel with a #4 finish on both interior and exterior surfaces. Transfer pass boxes and Rapid Transfer ports can be integrated into any system. HEPA and ULPA filtration at supply and exhaust is standard. All HEPA and ULPA filtered isolators operate at Class 100 or Class 10 conditions. Complete Exposure level Testing is offered ,performed by a board certified Industrial Hygienist for Containment Levels 3,4,and 5. Seal integrity and pressure decay tests are performed on all systems.
Glove Box isolator technology should be considered when the ultimate in operator or product protection is required. Isolation Systems has developed Isolator technologies for the full range of operating conditions and process requirements for Pharmaceutical , Bio Technology , Chemical and Semiconductor industries ect;. Product types offered are, Potent Compound , Sterility Test , Laminar Flow , Closed Loop and Positive and Negative Pressure Glove Box Isolators systems. It should be noted however that all critical containment systems are designed specifically to individual customer process and containment specifications and safety requirements.

DRUM SAMPLING

AND POWDER WEIGH BOOTHS

All Isolation Systems Drum Sampling and Powder Weigh Containment Booths are designed , engineered and manufactured to the highest standards, utilizing state of the art design and manufacturing processes and techniques. Our systems are constructed of a minimum of 16ga. 304 or 316L stainless steel with a #4 finish on all exterior surfaces. Special attention is taken to create seamless surfaces within chamber.High volume HEPA filtration at low wall exhaust collection intakes is standard. Down flow supply air is HEPA filtered to provide Class 100 conditions within operator breathing zones. Fine particle Pre-filtration is provided at exhaust intakes down stream of HEPA filters.Multi-staged pre-filtration is also available.Complete control and alarm systems are standard with all systems. Systems can be configured for single pass exhaust or recirculating operation.Complete Exposure level Testing is offered ,performed by a board certified Industrial Hygienist for Containment Level 3 operation. Filter seal integrity and air flow tests and mapping are performed on all systems. See sample test protocols and certification reports attached.
Sampling Booth technology should be considered when the ultimate in operator protection is required for open batch transfers or weighing operations are required. Isolation Systems has provided Sampling Booth systems for the full range of operating conditions and process requirements for Pharmaceutical , Chemical and Semiconductor industries ect;. Product types offered are, Negative Pressure Single Pass Down Flow with 100% exhaust and Recirculating Closed Loop. Note : Closed Loop systems require a percentage of exhaust discharge to maintain negative pressure within booth. All critical containment systems are designed specifically to individual customer process and containment specifications and safety requirements.

In closing, be assured that this organization is dedicated to providing a full spectrum of contamination control technologies, services and equipment to meet the ever-expanding needs of our customers. Our substantial design and engineering capabilities can be brought to bear in solving the most complex clean room, clean process, custom equipment design requirements or special performance specifications.
Again, we are a company dedicated to providing quality, cost-effective solutions to your airborne contamination control requirements.