SMA Microbial Air Sampler
Contents
1. SS rotameter The SMA ROT SS Rotameter is attached to the compressed air line prior to sampling and flow regulated from the petcock valve of the compressed air gas line Once flow is regulated the unit is removed and replaced with the SMA CA Atrium This assures direct testing of air gas from the compressed air line to the SMA CA Sampler without the intrusion of the metering device SMA Battery Operated Portable Compressed Air Sampler The SMA Battery Operated Portable Compressed Air Sampler provides calibrated air flow calibrated memory preset timing 0 2 micron filtered exhaust 316L cabinetry and 4 hour continuous operation This self contained unit is an excellent choice for those operations demanding calibrated preset features in a portable compressed air sampler Order Compressed Air Sampler Parts Description SMA 304 CA 25 304 Stainless CA 25 ml fill level SMA 316 CA 25 316 Stainless CA 25 ml fill level SMA ROT SS Stainless Steel Rotameter SMA ROT STD Rotameter Stand SMA CA200 SMA Portable Compressed Air Sampler Available Technical Data Supplements Upon Request SMA 4001 SMA Compressed Air Validation Report SMA 3002 SMA Atrium User Manual Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 11 Section 5 SMA MicroPortable P100 amp P200 Bu Se my 32 f 14 i 72. SMA 505 Replaceable Filter Membranes 10 SMA 506 Disposable Dust Covers 10 SMA 600 316L Stainless Steel MicroPortable Stand optional wheels SMA 601 Anodized Aluminum MicroPortable Stand optional wheels Available Technical Data Supplements Upon Request SMA 5001 SMA MicroPorable Validation Report SMA 5002 2 SMA MicroPortable User Manual Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 Section 6 SMA Control Centers 1 10 Locations SMA CC 5 SMA CC 10 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 14 SMA Multi Location Control Centers The SMA Control Centers are available in two models The EX Model Control Center requires the end user to supply a vacuum source either from a central vacuum system or a separate vacuum pump The CC Model Control Center is designed and supplied with an external pump exception to the SMA CC 1 that incorporates an internal pump The SMA Control Centers provide calibrated flow regulation timing and the ability to connect our OneTouch Command System Accessory specified separately in the pages to follow The following are brief descriptions of the available SMA Control Centers Available in 115 V AC or 220V AC SMA EX 1 The SMA EX 1 is designed for use
3. When Sampling is complete the unit switches vacuum to this location Thus air flow is constantly pulled from the isolator eliminating the possibility of contamination ingress Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 25 Section 9 Ordering SMA Products Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 Order Atriums SMA AA 25 SMA AA 32 SMA AA B SMA AA T 25 SMA AA T 32 SMA 304 25 SMA 304 32 SMA 304 RE 25 SMA 304 RE 32 SMA 304 CA 25 SMA 304 CA 32 SMA 304 B SMA 304 T 25 SMA 304 T 32 SMA 304 RE TO 25 SMA 304 RE TO 32 SMA 316 25 SMA 316 32 SMA 316 RE 25 SMA 316 RE 32 SMA 316 CA 25 SMA 316 CA 32 SMA 316 B SMA 316 T 25 SMA 316 T 32 SMA 316 RE TO 25 SMA 316 RE TO 32 SMA LID Rotameters ROT AL ROT SS OVERVIEW 26 ORDERING INFORMATION Description Orifice Top Unit Series Anodized Aluminum SMA Anodized Aluminum SMA Anodized Aluminum SMA Bottom Anodized Aluminum SMA Top Anodized Aluminum SMA Top 304 Stainless Steel SMA 304 Stainless Steel SMA 304 Stainless Steel REMOTE SMA 304 Stainless Steel REMOTE SMA 304 Stainless Steel Comp Air 304 Stainless Steel Comp Air 304 Stainless Steel SMA Bottom 304 Stainless Steel SMA Top 304 Stainless Steel SMA Top 304 Stai
4. 10 Location OneTouch Outlet Kit 2 OneTouch Outlet Kit 1 Plenum Wire w connectors Hytel Bevaline Tubing Veltek Associates Inc 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 208 or 220 V 115V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V 115 or 220 V No Pump No Pump No Pump No Pump Includes Pump Includes Pump Includes Pump Includes Pump Includes Pump OneTouch Option Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Portable Option Portable Option Portable Option Portable Option Portable Option OneTouch Box OneTouch Wall Box OneTouch Wall Monitor OneTouch Wall Monitor OneTouch Wall Monitor OneTouch Wall Monitor OneTouch Wall Monitor OneTouch Wall Monitor OneTouch Option OneTouch Option Wire Sold Per Foot Tubing Sold Per Foot 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 28 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98
5. integration of multi orifice top or the remote sampling probe provides the user with the ability to sample for over 120 CFM without agar desiccation The SMA Atrium uses a media fill level of 25 ml standard from most suppliers The SMA MicroPortable operates by measuring the Cubic Feet or Liters dependent on model chosen that have been sampled Preset volumes can be programmed and stored into the memory of the counter from 1 Cubic Foot or Liter to 999999 Cubic Feet or Liters The simple recall of the programmed user preset volumes assures future sampling is done without the need to re enter sample volumes Thus user error is eliminated during the next sample Order MicroPortable Description SMAP100 CFM or Liters CFM or Liter unit with Recharger Kit Filter Kit and 1 SMA Sampling Head 5 CFM Flow Rate SMAP200 01 CFM or Liters CFM or Liter unit with Recharger Kit Filter Kit and 1 SMA Sampling Head 1 and 5 CFM Option Flow Rate SMAP200 02 CFM or Liters CFM or Liter unit with Recharger Kit Filter Kit and 1 SMA Sampling Head Dual 2 Preset Programmable Volume Feature SMAP200 01 CFM or Liters CFM or Liter unit with Recharger Kit Filter Kit and 1 SMA Sampling Head 1 and 5 CFM Option Flow Rate and Dual 2 Preset Programmable Volume Feature SMA 316 TO 25 Additional SMA Multi Orifice Sampling Head SMA 316 RE PROBE Additional SMA Remote Probe Sampling Head SMA 503 Additional Recharger 115 V AC or 220 V AC SMA 504 Carrying Case
6. most suppliers and each level delineates a unique sampling condition The use of the SMA 25 ml fill unit provides the user the ability to sample up to 90 minutes on one agar plate The SMA 32 ml fill unit increase possible sampling time to 4 hours on one agar plate Operation of the Unit The SMA Atrium requires only a vacuum source to operate Vacuum options can include either central vacuum systems or one of the VAI 1 10 location control centers Order Top Orifice Choice Atrium Description SMA AA 25 or 32 1 2 1 4 or 3 32 Anodized Aluminum 25 ml or 32 ml fill level SMA 304 3 32 25 or 32 1 2 1 4 or 3 32 304 Stainless 25 ml or 32 ml fill level SMA 316 3 32 25 or 32 1 2 1 4 or 3 32 316 Stainless 25 ml or 32 ml fill level SMA WALLATR N A Atrium Wall Bracket removable Specify top orifice size when ordering The 1 2 orifice is standard Available Technical Data Supplements Upon Request SMA 3001 SMA Atrium Validation Report SMA 3002 SMA Atrium User Manual Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 7 Section 3 SMA Remote Sampler SMA 316 RE 25 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 8 SMA Remote Atrium In some instances the use of the SMA R
7. the presence of microbial and particulate contaminants within air and on products deemed suitable for clean room operations VAI s ECMD manufactures the SMA Microbial Air Sampler Systems The Helmke Yeich H Y Tumble Drum Tester and the VTC Variable Temperature Controller The SMA Microbial Air Sampler Systems are designed to test air within the clean room setting to determine the level of viable contamination that is present The SMA Microbial Air Sampler Systems have been used for over 14 years by pharmaceutical and biotechnology organizations worldwide The SMA Micro Sampler Systems offer a complete range of products to meet all requirements for quantitative microbial air evaluation The SMA Systems include the SMA Atrium SMA Remote Sampler SMA Compressed Air Sampler SMA CC Facility Control Centers SMA ISO CC Isolator Control Centers and the SMA MicroPortable The SMA Atrium and Facility Control Centers with OneTouch Command Systems features afford the ability to test multi locations either simultaneously or independently Outlined in the pages to follow the SMA Micro Sampler Systems and SMA One Touch Command Systems are available in models that test from one 1 to ten 10 locations The SMA ISO CC Isolator Control Centers are designed for use with isolation barriers systems and incorporate OneTouch Command System features for testing 1 to 10 locations simultaneously or independently The SMA product line also includes the SMA Micr
8. with central vacuum systems or external pumps The unit incorporates 1 rotameter 1 programmable memory timer and a solenoid in a 316L stainless steel cabinet The unit is small 8 L x 8 W x 6 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium SMA CC 1 The SMA CC 1 is designed for use as a stand alone unit The unit incorporates 1 rotameter 1 programmable memory timer a solenoid and a 1 CFM pump in a 316L stainless steel cabinet The unit is small 16 L x 12 W x 8 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium SMA EX 2 no pump and SMA CC 2 includes pump The SMA EX 2 and SMA CC 2 enables 2 location testing simultaneously or independently The unit incorporates 2 rotameters 2 programmable memory timers and 2 solenoids in a 316L stainless steel cabinet The unit measures 16 L x 12 W x8 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA CC 2 unit includes a 3 4 HP pump SMA EX 3 no pump and SMA CC 3 includes pump The SMA EX 3 and SMA CC 3
9. 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 20 SMA OneTouch Table Mount Microbial Air Sampling System The SMA OneTouch System removes SMA PLTWIRE to OneTouch Locati wall tion One wire for each location SMA VH 3 8 Hytrel Vacuum Tubing Black SMA VAR 3 8 Vardex Vacuum Tubing Grey for bends to eliminate kinking Data from the Control Center Time of Sample Date of Sample Length of Sample Time Volume of Sample Total Location of Sample Future Plate Bar Code Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 electronic devices from the area Within the area is only a flush mount or table top start module and an SMA Atrium that is connected by 1 4 ID tubing to a stainless steel quick disconnect outlet cover on the OVERVIEW 21 SMA OneTouch Flush Mount Microbial Air Sampling System SMA PLTWIRE to Vacuum Sensor 1 Wall Monitor SMA PLTWIRE to OneTouch Location One wire for each location SMA VH 3 8 Hytrel Vacuum Tubing Black gt SMA VH 3 8 The SMA OneTouch System removes electronic devices from the area Within the area is only a flush mount or table top start module and an SMA Atrium that is connected by 1 4 ID tubing to a stainless st
10. 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 16 SMA OneTouch Command System The SMA OneTouch Command System moves quantitative microbiological sampling into the future The SMA OneTouch Command System has been installed and is in operation at many pharmaceutical and biotechnology operations worldwide This system removes all electronics and vacuum pumps from the aseptic area The system requires only the OneTouch Remote Start Module various options and the SMA Atrium to be placed in the aseptic area All other components and vacuum pumps are located remotely and controlled remotely from the aseptic area This system requires hard wiring of both the vacuum tubing and electronic plenum wiring for the OneTouch Point of Sample Boxes Additionally VAI has developed an accompanying computer software data base that enables the data transfer of time of sample sample date length of sample sample location entry results and other features providing the first computer microbial system in the marketplace The OneTouch Command System utilizes the SMA Atrium and one of the SMA Control Centers previously described Normally the SMA Atrium and SMA Control Centers operate or begin sampling as controlled from the front panel of the SMA Control Center The OneTouch Command System adds two components to the system the OneTouch Point of Sample Box and the OneTouch Facility Control Module that remotely starts sampling and eliminates t
11. Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 19 Connections to the Clean Room Vacuum Tubing Installation Vai OneTouch SMA OT OC 1 Kit 1 Installation Wall Cavity Ta avity Wall Cavity 3 8 ID Hytrel Bevaline Tubing Exterior Wall Exterior Wall TIEM JOHSJUT wall plate fitting ng Reinforced Tubing SMA RI 3 8 eliminates kinking 4 Reinforced Tubing SMA RI 3 8 JBA Joo Uy eliminates kinking 8 Stainless Steel 8 Stainless Steel Screw A k Disconnect Quick Disconnect Quick Dis 1 4 ID Tubing to D 1 4 ID Tubing to SMA Atrium SMA Atrium Stainless or C Elbow coonsetlan to SMA RI 3 8 Tubing OneTouch Wire OneTouch Cable to from Control Center SMA OT 02 Box Val OneTouch SMA OT OC 3 Kit 3 Installation Wall Cavity 3 8 ID Hytrel Bevaline Tubing Exterior Wall ITEM JOTOTUT 8 Stainless Steel Screw 518 to 3 connector OneTouch Cabel from Control Center 1 4 ID Tubing to e SMA Atrium Thug fitting CC 1 2 3 5 3 8 ce OneTouch Cable to from CC 10 SMA OT 02 Box 8 Stainless Steel Screw Quick Disconnect or Permanent 1 4 ID Tubing to SMA Atrium Stainless or Copper Elbow conection to SMA RI 3 8 Tubing Veltek Associates Inc Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460
12. CFM SMAP200 03 Liter SMAP200 02 CFM SMAP200 01 Liter SMAP200 02 CFM SMAP200 03 CFM SMA 500 SMA 501 SMA 502 SMA 503 SMA 504 OneTouch System SMA OT 01 SMA OT 02 SMA OT 03 1 SMA OT 03 2 SMA OT 03 3 SMA OT 03 4 SMA OT 03 6 SMA OT 03 10 SMA OT OC 2 SMA OT OC 1 SMA OT PW SMA OT VH OVERVIEW 27 ORDERING INFORMATION cont 1 LOCATION EX Control Center 2 LOCATION EX Control Center 3 LOCATION EX Control Center 5 LOCATION EX Control Center 1 LOCATION CC Contro1 Center 2 LOCATION CC Control Center 3 LOCATION CC Control Center 5 LOCATION CC Control Center 10 Port Control Center with Pump Min 208 V AC Vacuum Sensor 10 PT Portable Unit with Recharger Liter Display Portable Unit with Recharger CFM Display Portable with Reharger and 1 and 5 CFM Flow Portable with Recharger 2 User Preset 28 and 141 LPM Flow Portable with Recharger and 2 User Preset Volume Selections Portable with Reharger and 1 and 5 CFM Flow Portable with Recharger and 2 User Preset Volume Selections Portable with Recharger 2 User Preset and 1 and 5 CFM Flow Optional P100 Stainless Steel Top Lid Optional P100 Disposable Dust Covers 10 Optional P100 Carrying Case Optional P100 Filter Membranes 10 Optional P100 Additional Recharger OneTouch Table Mount Box OneTouch Wall Monitor Flush Moniotr 1 Location Flush Moniotr 2 Location Flush Moniotr 3 Location Flush Moniotr 4 Location Flush Moniotr 6 Location Flush Moniotr
13. H ff p gig HAW Hif i HL P r Z SMA P100 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 12 SMA MicroPortable Viable Air Sampler The SMA MicroPortable is a rechargeable battery operated microbial air sampler for determining the level of existent viable contaminates in their aseptic manufacturing operations The SMA MicroPortable is designed of 316L mirror finished stainless steel The unit incorporates calibrated air flow digital readout in cubic feet per minute or liters 1 CFM 28 3 LPM and or 5 CFM 141 5 LPM flow rates dual user preset sampling volumes and filtered exhaust The unit utilizes the popular SMA Atrium Top that can be completely sterilized via steam heat or ETO The SMA MicroPortable is sized at 10 inches in height by 6 inches in width and weighs only 12 pounds This unit operates for 8 hours continuously without need for recharging Recharging of the unit takes approximately 45 minutes and can operate while being recharged The unit can be located near filling processes or located remotely with the incorporation of the remote sampling probe that can be sterilized prior to use Media Usage and Operation The SMA MicroPortable has been designed to provide a tortuous path that air must travel and assures a 95 capture efficiency of 0 5 micron particles and larger The
14. O1 of Locations SMA OneTouch Modular Wall Control Box SMAOT 02 SMA OneTouch Point of Sample Box SMAOT 03 1 2 3 4 6 or 10 SMA OneTouch Flush Mount Modules 1 2 3 4 6 10 location SMA PLTWIRE Plenum Wiring ordered and priced per foot SMA VH HYTREL Vacuum Tubing ordered and priced per foot SMA OT 0C 1 Single Stainless Outlet Cover w Fittings Penetration Kit 1 SMA OT OC 2 Dual Stainless Outlet Cover w Fittings Wall Cavity Adapter Kit 1 SMA OT OC 3 Vacuum Outlet Cover w Fittings Kit 3 Available Technical Data Supplements Upon Request SMA 3001 SMA Atrium Validation Report SMA 6002 SMA Control Center User Manual Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 17 How Does the SMA OneTouch Work Very simply one of the VAI Control Centers are chosen based on the number of locations desired to be sampled The control center and applicable pump are placed outside the clean room area On the rear of the SMA Control Center is a 9 pin cable connection point There are three 3 connection points for each location chosen The plenum wire depicted in the picture below is connected to the rear of the control center and then run to one of the SMA OneTouch Modules The OneTouch Modules are available in 3 styles The three types are A Point of Sample Style SMA OT 02 A Wall Box Module Style SMA OT 1 of Locat
15. OVERVIEW 1 SMA Microbial Air Sampler System Product Guide Copyright June 1998 All rights Reserved en ON a m Val Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 Section 7 Section 8 Section 9 OVERVIEW 2 Table of Contents Welcome to ECMD SMA Atrium SMA Remote Sampler SMA Compressed Air Sampler SMA MicroPortable P100 amp P200 SMA Control Centers 1 10 Locations SMA OneTouch Command System SMA ISO CC Control Centers 1 10 Locations Ordering SMA Products complete guide Val Veltek Associates Inc ll 039 West Bridge Street Phoenixville PA 19460 4218 1 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 3 Section 1 Welcome to ECMD ll Val Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 4 WELCOME TO ECMD Environmental Control Monitoring Division VAIT s Environmental Control Monitoring Division ECMD has addressed the needs of the Pharmaceutical Biotechnology Semi Conductor and Electronics industries by designing a complete range of air testing equipment ECMD products are designed to test for
16. and construction assures that a sterile test instrument is present to evaluate possible viable contaminants The SMA Compressed Air Sampler can be completely sterilized via steam heat or ETO Constructed of either 304 or 316L stainless steel the Atrium is very durable and needs little maintenance The Atrium is sized at 4 1 2 in diameter by 2 1 2 inches in height This compact size of the unit provides the opportunity to locate the sampling device where space is limited The small size of the unit coupled with its simplistic operation has enabled many operations to more accurately report air gas quality and reduce false positives from operators Media Usage and Operation The unit can be easily and aseptically connected to the desired points of sample by use of sterile 3 8 PVC tubing Connections are made from the top orifice of the SMA CA Atrium directly to regulated compressed air gas locations At a flow rate of 1 2 CFM the unit has been tested and validated to achieve a 95 capture efficiency Exhaust air is released from underneath the unit directly to the environment without affecting the sample in progress The SMA CA Atrium uses a 100 mm plate with a media fill of 25 ml standard from most suppliers The use of the SMA 25 ml fill unit provides the user the ability to sample up to 90 CFM on one agar plate Airflow regulation can be accomplished either by the installation of a pressure regulator valve at point of sample or by use of the SMA ROT
17. d time period and then automatically turns off the vacuum to the SMA Atrium The timers run separately from each other while utilizing a common vacuum source The SMA CC 10 unit includes a5 HP pump This unit is designed to be integrated with our SMA OneTouch System requiring remote location of the control center and pump Order Description of SMA Control Centers SMA EX 1 1 Location EX without pump Control Center SMA EX 2 2 Location EX without pump Control Center SMA EX 3 3 Location EX without pump Control Center SMA EX 5 5 Location EX without pump Control Center SMA CC 1 1 Location CC Control Center with internal pump SMA CC 2 2 Location CC Control Center with external pump SMA CC 3 3 Location CC Control Center with external pump SMA CC 5 5 Location CC Control Center with external pump 1 timer 5 rotameters SMA CC 5 5 5 Location CC Control Center with external pump 5 timers 5 rotameters SMA CC 10 10 Location CC Control Center with external pump Available Technical Data Supplements Upon Request SMA 3001 SMA Atrium Validation Report Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 15 SMA 6002 SMA Control Center User Manual Section 7 SMA OneTouch Command System SMA OT 02 SMA OT 03 2 SMA OT 01 3 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983
18. e system The timer once activated samples from the Atrium through the solenoid to the Rotameter where volume is gauged and then proceeds to the control center vacuum pump Once sampling is complete the timer signals the solenoid to switch the airflow direction to the isolators central vacuum system all isolator units incorporate this as a standard feature This assures that air is always being pulled from the isolator either in a sampling condition or a pause position directing airflow to the isolator vacuum system This design prevents the return of air into the isolator as flow is always being pulled outward Alleviating the return of outside air to the isolator system assures integrity of the environment The unit is delivered ready to use with all solenoids contained within the control center This design also permits continuous sampling to be conducted up to 3 hours on one agar plate Product Specifications Air Flow 1 CFM Air Flow Accuracy 5 Maximum Sample Volume 999 99 CFM Maximum Temperature through Solenoids 480 F Connections from Control Center to Atrium 1 4 NPT Connection to Isolator Vacuum System 1 4 NPT Connections from CC to Pump SMA CC 2 3 8 ID SMA CC 3 amp 5 1 2 ID SMA CC 10 1 1 4 ID Voltage CC 115V AC or 220V AC Amps 15A Calibration Annual OneTouch Ready Yes Order Description of ISO Control Centers SMA CC II 1 Port Control Center w internal pump SMA CC 2I 2 Port Control Cente
19. eel quick disconnect outlet cover on the wall SMA VAR 3 8 Vardex Vacuum Tubing Grey for bends to eliminate kinking SMA VH 1 4 Vacuum Tubing to Atrium Data from the Control Center Time of Sample Date of Sample Length of Sample Time Volume of Sample Total Location of Sample Future Plate Bar Code Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 22 Section 8 SMA ISO CC Control Centers 1 10 Locations For Pictures See SMA Control Centers Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 23 SMA ISO CC Microbial Air Sampler The SMA ISO feature is an adaptation done to our CC 1 CC 2 CC 3 CC 5 and CC 10 Control Centers The system design permits the highest level of confidence for sampling within the isolator and assures the non aspiration or return of possible contaminants from the exterior environment to the isolator or barrier unit All VAI CC control centers can be adapted to operate in the ISO Mode Integration of a 2 way solenoid between the rotameter and the SMA Atrium provides the automatic switching of airflow at the completion of sampling from SMA Control Center to the isolator vacuum system The SMA Control Center Timer is the brains of th
20. emote Atrium may be necessary when the size of the SMA Atrium while small may be too large to fit into a location deemed critical to be tested for microbial contaminants The SMA Remote Atrium is designed with one extension tube protruding from the top This tube may serve as a connection point for either disposable tubing or stainless steel connections By use of the SMA Remote SMA Remote Atrium a user can locate the Atrium away from the point of sample The SMA Remote Atrium can be completely sterilized via steam heat or ETO Constructed of either 304 or 316L stainless steel the Atrium is very durable and needs little maintenance The Atrium is sized at 4 1 2 in diameter by 1 1 2 inches in base height with an extension tube for tubing connection on top of the unit This compact size of the unit provides the opportunity to locate the sampling device near filling processes where space is limited The small size of the unit coupled with its simplistic operation has enabled many operations to more accurately report air quality near fill areas and reduce false positives from operators Air Flow and Media Usage The SMA Remote operating at an air flow of 1 cubic foot per minute 1 CFM has been designed to provide a tortuous path that air must travel and assures a 95 capture efficiency of 0 5 micron particles and larger The SMA Remote Atrium integrates a 3 8 ID connection that easily attaches to presterilized tubing The SMA Remote Atrium utiliz
21. enables 3 location testing simultaneously or independently The unit incorporates 3 rotameters 3 programmable memory timers and 3 solenoids in a 316L stainless steel cabinet The unit measures 10 L x 12 W x 10 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA CC 3 unit includes a 1 0 HP pump SMA EX 5 no pump and SMA CC 5 includes pump The SMA EX 5 and SMA CC 5 enables 5 location testing done simultaneously The unit incorporates 5 rotameters 1 programmable memory timer and 1 solenoid in a 316L stainless steel cabinet The unit measures 12 L x 17 W x 8 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA CC S unit includes a 1 0 HP pump SMA CC 10 includes pump The SMA CC 10 enables 10 location testing simultaneously or independently The unit incorporates 10 rotameters 10 programmable memory timers and 10 solenoids in a 316L stainless steel cabinet The unit measures 23 L x 28 W x 22 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specifie
22. es a 100 mm plate filled to either 25 ml or 32 ml of nutrient media These fill levels are standard from most suppliers and each level delineates a unique sampling condition The use of the SMA 25 ml fill unit provides the user the ability to sample up to 60 minutes on one agar plate The SMA 32 ml fill unit increase possible sampling time to 2 hours on one agar plate Operation of the Unit The SMA Remote Atrium requires only a vacuum source to operate Vacuum options can include either central vacuum systems or one of the VAI 1 10 location control centers Order Remote Atrium Description SMA 304 RE 25 or 32 304 Stainless 25 ml or 32 ml fill level SMA 316 RE 25 or 32 316 Stainless 25 ml or 32 ml fill level Available Technical Data Supplements Upon Request SMA 3001 SMA Atrium Validation Report SMA 3002 SMA Atrium User Manual Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 9 Section 4 SMA Compressed Air Sampler SMA 316 CA 25 SMA CA 200 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 10 SMA Compressed Air Sampler The SMA Compressed Air Gas Atrium is used for the quantitative collection of microorganisms that may be present in compressed air and gas lines The design
23. he need to access the control center OneTouch Point of Sample Box The OneTouch Point of Sample Box is as the name suggests the controller that begins sampling at the desired location of the SMA Atrium The OneTouch Point of Sample Box measures 4 L X 3 W X 3 H The box contains a system ready light a sample in progress light a sample completion light and a reset operate button These components are all contained in a 316L mirror finished stainless steel cabinet that is completely sealed for disinfection purposes This control box signals back to the control center to begin sampling Upon user prompting the control center then operates per location for the time period and flow rate that has been preset at the control center Once time and flow have been initially set there is no need for resetting the flow and time aspects unless desired sampling time and distance of sample change The OneTouch Point of Sample Box can be set on surfaces or hard wired to a suitable mounting location on walls in benches or within the isolator OneTouch Facility Control Module Operating in the same fashion as the Point of Sample Box the OneTouch Facility Control Modules are either modular or pre made as a flush mount unit These units are accessories that are attached or flush mounted to desired wall locations and can remotely control sampling or are used to view where in the facility sampling is being conducted Order OneTouch Component Description SMAOT
24. ions A Flush Mount Facility Monitor Style SMA OT 03 of Locations These units are now connected to the unit and act as a remote start unit for the control center At the same time vacuum tubing SMA VH is also run from the control center to the desired point of sample where the SMA Atrium will reside At this point both the remote start capabilities and the connection for vacuum for the SMA Atrium are in place A user has only to touch the Start button on the respective SMA OneTouch Module and the control center will start sampling for the preset time period and the preset flow rate Once the sample is complete the control center resets itself and awaits the next command SMA Plenum Wire and SMA OT 02 SMA Flush Mount Wall Monitor Point of Sample Box SMA OT 03 2 This system removes all the electronics and the pump from the controlled area It assures the same sample volume and the same sample times are conducted without exception each time at the location desired The system also provides the ability to use one control center to serve various areas For example and SMA CC 10 can sample 2 locations in 5 different areas This dramatically cuts the costs associated with the purchase of 10 separate microbial air samplers The SMA OneTouch System also has accompanying software that will signal back to a computer data base items such as The time a sample was taken the date of a sample the time period sampling was conducted at 1 CFM o
25. nless Steel REMOTE Top 304 Stainless Steel REMOTE Top 316 Stainless Steel SMA 316 Stainless Steel SMA 316 Stainless Steel REMOTE SMA 316 Stainless Steel REMOTE SMA 316 Stainless Steel Comp Air 316 Stainless Steel Comp Air 316 Stainless Steel SMA Bottom 316 Stainless Steel SMA Top 316 Stainless Steel SMA Top 316 Stainless Steel REMOTE Top 316 Stainless Steel REMOTE Top 316 Stainless Steel SMA Cover Anodized Aluminum ROTAMETER Stainless Steel ROTAMETER 1 2 1 4 3 32 1 2 1 4 3 32 NA 1 2 1 4 3 32 1 2 1 4 3 32 1 2 1 4 3 32 1 2 1 4 3 32 NA NA NA NA NA 1 2 1 4 3 32 1 2 1 4 3 32 NA NA 1 2 1 4 3 32 1 2 1 4 3 32 NA NA NA NA NA 1 2 1 4 3 32 1 2 1 4 3 32 NA NA NA Specify Complete Unit Complete Unit Bottom Only Top Only Top Only Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Bottom Only Top Only Top Only Top Only Top Only Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Complete Unit Bottom Only Top Only Top Only Top Only Top Only Lid for SMA 0 90 SCFH 0 90 SCFH Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 Control Centers SMA EX 1 SMA EX 2 SMA EX 3 SMA EX 5 SMA CC 1 SMA CC 2 SMA CC 3 SMA CC 5 SMA CC 10 SMA CC 10 SN SMA MicroPortable SMAP100 Liter SMAP100 CFM SMAP200 01
26. oPortable and the SMA Compressed Air Sampler The SMA MicroPortable is a battery operated unit that can sample for 8 hours continuously The SMA Compressed Air Sampler is designed as a portable sampler to assist in delineating the microbial levels of compressed air and gas systems ECMD also manufactures the H Y Tumble Drum Tester The H Y Tumble Drum Tester is a recommended method for testing and disseminating the inherent contamination levels of products deemed suitable for the controlled environment by the Institute of Environmental Sciences RP3 4 ECMD s VTC Controller provides for the evaluation of possibly existent particulate within a volume of air from high temperature applications such as ovens and tunnels up to 1250 F The SMA products are described on the pages to follow Please contact VAI for additional product information at 1 888 4 STERILE Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 5 Section 2 SMA Atrium SMA 316 25 1 2 Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 6 SMA Atrium For over 15 years the SMA Atrium has been the chosen test method of many pharmaceutical and biotechnology organizations for determining the level of existent microbial contaminants in
27. r 28 3 LPM the location of sample and allow for result entries This software is presently in validation and is expected for release in June of 1999 However the system can be purchased and installed and will be computer ready when such software is complete Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 18 SMA OneTouch Command System Example System Flow Diagram Flow Diagram utilizes an SMA CC 10 in separate areas with both Point of Sample Boxes and Flush Mount Modules Aseptic Fill Area 1 Aseptic Fill Area 2 Laminar Flow Laminar Flow SMA OT 02 ka lt point of Sample Box Laminar Flow SMA OT 03 3 Flush To CC 10 To CC 10 To CC 10 OneTouch Connection Vacuum OneTouch Connection 3 4 5 Location 1 and 2 1 and 2 ud o C 10 n 2 acuum Rear View Die Location SMA Atrium Vacuum Connections 3 4 5 Q Vacuum PAON A Connection De ES P amp Su OneTouch Location 1A main start OneTouch Plenum Wire Connections FE 0 O DT D K K R Rp RP RG 7 o OneTouch Location 1B secondary start or view To CC 10 Vacuum Location 8 9 10 Laminar Flow SMA OT 03 1 Flush 10 To CC 10 OneTouch Connection Een To CC 10 To CC 10 Parlons dE Vacuum OneTouch Connection pen Location 8 and 9 3 4 5 Veltek
28. r w external pump SMA CC 3I 3 Port Control Center w external pump SMA CC SI 5 Port Control Center w external pump 1 timer 5 rotameters SMA CC 5 5I 5 Port Control Center w external pump 5 timers 5 rotameters SMA CC 10I 10 Port Control Center w external pump Available Technical Data Supplements Upon Request SMA 3001 SMA Atrium Validation Report SMA 6002 SMA Control Center User Manual Veltek Associates Inc 1039 West Bridge Street Phoenixville PA 19460 4218 Tel 610 983 4949 Fax 610 983 9494 http www sterile com SMA 98 3 8 27 98 OVERVIEW 24 SMA ISO CC OneTouch Isolator System Example System Flow Diagram Flow Diagram utilizes an SMA CC 5 5I with two 2 SMA OT 03 2 s and SMA OT 03 1 Flush Mount Modules Tunnel Transfer Area ah Exterior Wall SMA OT 03 1 Flush To CC 5 51 To CC 5 5I Vacuum OneTouch Location 1 Connection 1 Process Area 1 Process Area 2 SMA OT 03 2 Flush To CC 5 51 OneTouch 2 Connection 4 and 5 MER Sg o0 Osa 8 i g To CC 5 5I Vacuum Location 4 and 5 To CC 5 51 Vacuum Location 2 and 8 Rear View oe O D SA c Zo lt OneTouch Location 1A main start in 7 OneTouch Location 1B secondary start or view 4 OneTouch Plerum Wire Connections OneTouch Location 1C computer connection for data SMA CC 5 51 Ca romi S The Vacuum Purge Connection is connected to the Isolator Vaccum System
29. their manufacturing operations SMA Atrium is a unique microbiological air sampler that can be completely sterilized via steam heat or ETO Constructed of anodized aluminum 304 stainless steel or 316L stainless steel the Atrium is very durable and needs little maintenance The Atrium is sized at 4 1 2 in diameter by 1 1 2 inches in height This compact size of the unit provides the opportunity to locate the sampling device near filling processes where space is limited The small size of the unit coupled with its simplistic operation has enabled many operations to report accurately the air quality near fill areas and reduce false positives from operators Air Flow and Media Usage The SMA operating at an air flow of 1 cubic foot per minute 1 CFM has been designed to provide a tortuous path that air must travel and assures a 95 capture efficiency of 0 5 micron particles and larger The integration of 12 top orifices that are available in 1 2 1 4 and 3 32 provide the user the ability to sample for varying time periods Time periods can extend up to 4 hours on one plate Top orifice size is dependent upon the desired exposure time versus desiccation of the nutrient media The use of the 3 32 top orifices allows a maximum 60 minute exposure time while the 1 4 and 1 2 allow up to 4 hours dependent upon conditions The SMA Atrium utilizes a 100 mm plate filled to either 25 ml or 32 ml of nutrient media These fill levels are standard from
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