Isolation Specific Engineered Products and Equipment

1. Isolation Specific Engineered Products and Equipment

2. This presentation is intended as a general overview of the products and capabilities of ISI.

3. 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.

4. About Us: Products & Capabilities • 10 years of providing full service design, engineering, and manufacturing. • 100% Successful Manufacturing Validation and Certification of all systems built. • Standard & custom built systems. • Engineered for highest level of protection and safety. • 35 years of industry experience. • Meet or exceed all performance and conformance standards. • Provided fully certified and validated systems Pharmaceutical, Bio Technology, Semi Conductor, Optics and Chemical industries. • Precision stainless steel, steel and plastics fabrication. • 45,000 sq ft. of manufacturing space. Continued…

5. About Us: Products & Capabilities • Advanced state of the art equipment. • Highly developed quality assurance and testing protocols. • Customer support and service through all aspects of system development • Complete installation services, field certification and testing • Experienced and innovative sales, design, and engineering staff • Highest quality products at competitive prices • On-time delivery • Dedication to provide full spectrum services, • products & technologies

6. 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…

7. 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…

8. 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.

9. 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

10. Fit & Finish Continued…

11. Fit & Finish

12. 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…

13. 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…

14. 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…

15. 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…

16. 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…

17. 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.

18. 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.

19. Required Cleanliness Levels

20. Room Classification based on Air Changes per Hour Per Federal Standard 209

21. Comparison of Particle Sizes

22. Operator Exposure Containment Level Classifications

23. 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…

24. Standards All 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

25. 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 • 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

26. 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.

27. 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…

28. 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…

29. 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…

30. 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.

31. 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…

32. 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.

33. Operating Parameters • 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. • 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…

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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 • Polycarbonate

40. 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.

41. 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

42. 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

43. 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.

44. ISI Linecard Pos/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…

45. ISI Linecard 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 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

46. Customer List (Ltd) AGFA AMGEN AVENTIS PASTEUR AIR PRODUCTS BAYER BRISTOL MEYERS SQUIB MYLAN LABORATORIES • MERCK • DPT LABORATORIES • MANNKIND CORP • ELI LILLY • FLUOR DANIEL • GENECORE • IBM • IEDCO • JACOBS ENGINEERING • LOCKWOOD GREENE • JOHNSON & JOHNSON • MONSANTO • MOTOROLA • NOVARTIS • PFIZER

47. Customer List (Ltd) • B BRAUN • Q-ONE BIOTECH • SCHERING PLOUGH • SANOFI PHARMA • TORCON CONSTRUCTION • GLAXO SMITH KLINE • ABBOTT LABORATORIES • ADP MARSHALL APPLIED MATERIALS DMV INTERNATIONAL BARKLEY WHITE DUPONT PHARMA BENVENUE LABS HOSPIRA QUINLAN CONSTRUCTION AMRI CHICAGO AEROSOL INTEL KONICA IMAGING LIPISOME LUCENT TEXAS INSTRUMENTS WYETH LEDERLE NEW ENGLAND BIO TECH BOEHRINGER INGEL-HIEM ACCO ENGINEERING