AIREGARD ES Energy Saver Horizontal Laminar Flow Clean Workstation Model NU-301/E Console Model Operation and Maintenance Manual

October, 2012 Revision 2 Series 60

(115VAC ONLY)

Manufactured By: NuAire, Inc. 2100 Fernbrook Lane Plymouth, MN 55447 Toll-Free: 1-800-328-3352 In Minnesota: (763)-553-1270 Fax: (763)-553-0459

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AIREGARD ES Energy Saver Horizontal Laminar Flow Clean Workstation Model NU-301/E Console Model Operation and Maintenance Manual Table of Contents Section No. 1.............................................................................. General Description Section No. 2.............................................................................. Models & Features Section No. 3.............................................................................. Warranty Section No. 4.............................................................................. Shipments Section No. 5.............................................................................. Installation Instructions 5.1 ............................................................................................Location 5.2 ............................................................................................Set-up Instructions 5.3 ............................................................................................Certification Testing Methods and Equipment Section No. 6.............................................................................. Operating the Laminar Flow Clean Workstation 6.1 ............................................................................................Operator Controls & Indicators 6.2 ............................................................................................Operating Guidelines 6.3 ............................................................................................Ergonomics 6.4 ............................................................................................Cleaning Procedures Section No. 7.............................................................................. General Maintenance 7.1 ............................................................................................Fluorescent Lamp Bulb Replacement 7.2 ............................................................................................HEPA Filter Replacement 7.3 ............................................................................................Prefilter Replacement Section No. 8.............................................................................. Polycarbonate Material Compatibility Section No. 9.............................................................................. Error Indicators and Troubleshooting Section No. 10............................................................................ Optional Equipment 10.1 ..........................................................................................Ultraviolet Lamp Section No. 11............................................................................ Electrical/Environmental Requirements Section No. 12............................................................................ Disposal and Recycle Insert……........................................................................................Replacement Parts

Manual Drawings BCD-06890................................................Specification Drawing NU-301/E Assembly Drawings BCD-06891………………………………HEPA Filter Replacement Electrical Drawings BCD-14957................................................Electrical Schematic 115V BCD-14958................................................Electrical Schematic 230V

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AIREGARD ES Energy Saver Horizontal Laminar Flow Clean Workstation Models NU-301/E Manufactured By: NuAire, Inc., Plymouth, Minnesota

1.0

General Description

NuAire Horizontal Laminar Flow Clean Workstations utilize the newest technologies in laminar airflow design, materials and manufacturing processes. The clean workstation can be used where clean airflow per ISO 14644-1 is required for the preparation of injectable drugs, IV solutions, tissue culture, optics, microelectronics, etc. The clean bench should not be used for any work that involves biological agents assigned a level of Risk 1 through 4 as classified by the Centers for Disease Control (CDC), Atlanta, Georgia, since the horizontal flow offers no personnel protection against these agents. The clean bench should only be used to protect the product from contamination. A significant number of design innovations give the NuAire Laminar flow equipment superior performance qualities in airflow, lighting, noise levels and vibration.

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1.1 Safety Instructions These safety instructions describe the safety features of the Horizontal Laminar Flow Clean Workstation model NU-301/E. The workstation has been manufactured using the latest technological developments and has been thoroughly tested before delivery. It may, however, present potential hazards if it is not used according to the intended purpose or outside of operating parameters. Therefore, the following procedures must always be observed: • The workstation must be operated only by trained and authorized personnel. • For any operation of this unit, the operator must prepare clear and concise written instructions for operating and cleaning, utilizing applicable safety data sheets, plant hygiene guidelines, and technical regulations, in particular. o which decontamination measures are to be applied for the workstation and accessories, o which protective measures apply while specific agents are used, o which measures are to be taken in the case of an accident. • Repairs to the device must be carried out only by trained and authorized expert personnel. • Keep these operating instructions close to the unit so that safety instructions and important information are always accessible. • Should you encounter problems that are not detailed adequately in the operating instructions, please contact your NuAire Representative of NuAire technical Services. 1.2 Explanation of Symbols

! WARNING !

Safety alert symbol indicates a potentially hazardous situation which, if not avoided, could result in death of serious injury.

CAUTION

Safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

CAUTION:

CAUTION used without the safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in property damage. Potential electrical hazard, only qualified person to access.

 NOTE:

Used for important information.

Flammable Hazard

Biohazard Hazardous Gases! Personal Protection Equipment Required. Ground, Earth Chemical Hazard

Lead Free

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2.0

Models and Features

NuAire's model number NU-301/E designates the basic design series of Horizontal Laminar Flow Clean Workstations with the blower/motor located below the work surface (i.e. console series). Model numbers are shown below. Model Number NU-301-324 NU-301-330 NU-301-330E NU-301-336 NU-301-424 NU-301-430 NU-301-430E NU-301-436 NU-301-524 NU-301-530 NU-301-530E NU-301-536 NU-301-624 NU-301-630 NU-301-630E NU-301-636

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3.0

Warranty

NuAire, Inc. warrants Horizontal Laminar Flow Clean Workstation w/ECM motor (AIREGARD ES) that it will repair F.O.B. its factory or furnish without charge F.O.B. its factory a similar part to replace any material including HEPA filters in its equipment within 60 months after the date of sale if proved to the satisfaction of the company to have been defective at the time it was sold provided that all parts claimed defective shall be returned, properly identified to the company at its factory, charges prepaid. Factory installed equipment or accessories are warranted only to the extent guaranteed by the original manufacturer, and this warranty shall not apply to any portion of the equipment modified by the user. Claims under this warranty should be directed to NuAire, Inc. setting forth in detail the nature of the defect, the date of the initial installation and the serial and model number of the equipment. This warranty shall not apply to any NuAire product or part thereof, which has been subject to misuse, abuse, accident, shipping damage, improper installation or service, or damage by fire, flood or acts of God. If the serial number of this product is altered, removed or defaced as to be illegible, the warranty shall be null and void in its entirety. The warranty is for the sole benefit of the original purchaser and is not assignable or transferable. Prior to returning any item, for any reason, contact NuAire, Inc. for a Return Authorization Number. This number must accompany all returns. Any product shipped to NuAire without this number will be returned, refused shipment or collect freight.

4.0

Shipments

NuAire takes every reasonable precaution to insure that your AIREGARD Clean Workstation arrives without damage. Motor carriers are carefully selected and shipping cartons have been specially designed to insure your purchase. However, damage can occur in any shipment and the following outlines the steps you should take on receipt of a NuAire AIREGARD Clean Workstation to be sure that if damage has occurred, the proper claims and actions are taken immediately. 4.1 Damaged Shipments 4.1.1

Terms are factory, unless stated otherwise. Therefore, it is important to check each shipment before acceptance.

4.1.2

If there is visible damage, the material can be accepted after the driver makes a notation on the consignee's copy of the freight bill. Then an inspection must be made to verify the claim against the carrier. This inspection is the basis of your filing the claim against the carrier.

4.1.3

If concealed damage is found, it is absolutely necessary to NOTIFY THE FREIGHT AGENT AT ONCE and request an inspection. Without this inspection, the transportation company may not accept a claim for loss or damage. If the carrier will not perform the inspection, an affidavit must be prepared stating that he was contacted on a certain date and that he failed to comply with the request. This, along with other papers in the customer's possession will support the claim.

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5.0

Installation Instructions 5.1 Location Within the laboratory, pharmacy, production area, etc., the ideal location for the clean bench is away from personnel traffic lanes, air vents (in or out), doors and/or other source of disruptive air currents. If drafts or other disruptive air currents exceed the face velocity of the HEPA filter, the potential exists for contaminated air to enter the work area of the workstation. Please note, however, that the work area has been constructed to minimize the effect of air currents by providing sidewalls that are an extension of the HEPA filter flow area.

Where space permits, a clean six (6) inch (152mm) area should be permitted on each side of the workstation for maintenance purposes. The electrical outlet into which the workstation is connected should be readily accessible. The workstation shall be positioned as not to obstruct the power supply outlet or the circuit breaker distribution panel. 5.2 Set-Up Instructions Remove outer shipping protection (carton or crating). If the workstation is fastened to a base skid, it is usually the best procedure to leave the skid in place until the workstation is located in its approximate position to facilitate ease in handling. It can then be removed from the skid by removing the four bolts holding the workstation to the skid. 5.2.1

Leg Levelers Install leg levelers in the bolt holes previously used for the base packing skid. Level the unit with a bubble level by adjusting leg levelers.

5.2.2

Gas Service NuAire doesn't recommend the use of natural gas within the clean bench, but if gas service is determined to be necessary for the application by the appropriate safety personnel, appropriate safety measures must take place. Once the determination has been made by the appropriate safety personnel, the application of natural gas must be performed in accordance to national, state and local codes. IT IS ALSO STRONGLY RECOMMENDED THAT AN EMERGENCY GAS SHUTOFF VALVE BE PLACED JUST OUTSIDE THE CLEAN BENCH ON THE GAS SUPPLY LINE.

CAUTION

!

All NuAire clean benches meet the safety requirements of UL and CSA for Laboratory Equipment. To comply with these safety requirements, NuAire uses only certified gas valves. In addition, if external piping is required, only black pipe is used for this application. As previously stated NuAire doesn't recommend the use of natural gas within the clean bench and ASSUMES NO RESPONSIBILITY FOR ITS USE. USE AT YOUR OWN RISK. The Bunsen burner flame within the clean bench disrupts the laminar air stream, which must be maintained for maximum efficiency. IF THE PROCEDURE DEMANDS USE OF A FLAME, A BUNSEN BURNER WITH ON DEMAND IGNITION IS STRONGLY RECOMMENDED. DO NOT USE CONSTANT FLAME GAS BURNERS.

!

CAUTION

During use, the Bunsen burner should be placed to the rear of the workspace where resulting air turbulence will have a minimal effect. OM0210 Rev 2 October/2012

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5.2.3

Plumbing Services Ground key cocks with the type of service specified by the snap-in button on the handle, are located in the work zone. The ground key cocks are not recommended for pressures over 30 p.s.i. Reducing valves should be installed external to the workstation if necessary. Ground key cocks should never be used for oxygen service. A special needle valve for oxygen service is required and available upon request. External connection is to 3/8 inch (10mm) FPT coupling through the sidewalls. Connection to plant utilities should be made with proper materials for the individual service and according to national and/or local codes. Observe all labels pertaining to the type of service and operating pressure.

5.2.4

 NOTE:

5.2.5

Electrical Services The horizontal laminar flow work station may be "hardwired" (optional) or connected via an electrical power cord, which is standard. The unit requires 115/230 VAC, 60/50 Hz, single phase. (Current rating varies per workstation size, reference Electrical/Environmental Requirements). It is recommended that power to the unit be on its own branch circuit, protected with a 15 or 20 Amp circuit breaker or fuse at the distribution panel. THIS UNIT CONTAINS ELECTRONIC BALLASTS FOR THE FLUORESCENT LIGHTING. ELECTRONIC BALLASTS OPERATE WITH HIGH INRUSH CURRENT. IT IS NOT RECOMMENDED TO USE THIS PRODUCT WITH GROUND FAULT CIRCUIT INTERRUPTERS (GFCI'S) BECAUSE THE BALLASTS MAY CAUSE THE GFCI TO TRIP. If a "hardwired" (conduit) connection is desired, an electrical junction box is provided on the top of the workstation with a removable cover. All wiring connections to the junction box should be done according to the National Electrical Code and/or local codes by a qualified electrician. Final Assembly The exterior surfaces and viewing glass are easily cleaned with any mild household detergent cleaner using a soft cloth. Harsh chemicals, solvent-type cleaners and abrasive cleaners should not be used. Do not attempt to clean the HEPA filter media. Workstation interior walls or work surface is easily cleaned with any mild household detergent cleaner using a soft cloth. Turn the workstation on and let it operate for 60 minutes before using it as a clean bench.

5.3 Certification Testing Methods and Equipment After installation and prior to use, NuAire recommends that the workstation be recertified to factory standards. At a minimum, the following tests should be performed: 1. HEPA filter media 2. Filter frame leak test 3. Airflow velocities The testing methods and equipment required are specified on the factory inspection report included with this manual.

 NOTE:  NOTE:

IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED TECHNICIAN WHO IS FAMILIAR WITH THE METHODS AND PROCEDURES FOR CERTIFYING CLEAN BENCHES. AFTER THE INITIAL CERTIFICATION, NUAIRE RECOMMENDS THAT THE WORKSTATION BE RECERTIFIED AT A MINIMUM ON AN ANNUAL BASIS AND AFTER EVERY FILTER CHANGE OR MAINTENANCE ACTION OR ANY TIME THE OPERATOR FEELS IT IS NECESSARY.

Note that NuAire clean benches, filters and seals provide premium performance; Quality control in both design and manufacturing insure superior reliability. However, protection to the product is so important, that certification to the performance requirements should be accomplished as stated to insure conformance to factory standards.

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6.0

Operating the Laminar Flow Clean Workstation 6.1 Operator Controls and Indicators The following is a description of the controls and indicators provided on the NU-301 clean benches. 6.1.1

Fluorescent/UV Light Switch This switch provides on/off control for the fluorescent light and/or the ultraviolet (UV) light if present (optional). With the UV light option, the switch provides for on-center off-on operation so that both the fluorescent light and the UV light cannot be energized at the same time. Proper care should be exercised when the UV light is on.

6.1.2

Blower Switch The blower switch applies power to the internal blower/motor when in the ON position.

6.1.3

Indicator Light - Blower A green neon indicator light is located next to the blower on/off switch and lights when power is applied to the motor/blower.

6.1.4

Circuit Breaker - Blower The blower motor is protected with a circuit breaker. The circuit breaker, in conjunction with the motor's thermal protector, is designed to open under locked rotor or half-wave power conditions. Should the circuit breaker open, merely depress the button to reset. If the circuit breaker continually opens, a failure has occurred in the motor or solid-state speed controller. Consult a qualified repair technician or NuAire, Inc. for replacement.

6.1.5

Airflow Control Potentiometer The operating horizontal airflow within the workstation (80-100 LFPM (.41 to .51 m/s) is controlled by a DC motor speed control. The DC motor speed control, controls the EC motor by providing a pulsed width modulation (PWM) signal of 2.5 to 8.0 VDC that is sent to the EC motor. This adjustment should only be made by a qualified technician employing the proper instruments in order to insure airflow.

6.1.6

Minihelic Gauge The minihelic gauge displays the static pressure within the pressure plenum supplying air to the HEPA filter. The gauge is calibrated in "inches of water gauge" pressure. As the HEPA filter loads with particulate matter, the amount of static pressure will increase, giving an indication of the "health" of the workstation. The initial pressure reading will be approximately 0.50" (13mm) w.g. + 0.05" (2mm) w.g depending on altitude from sea level. The workstation should be checked for proper airflow at each 0.1-inch (2mm) increase in static pressure.

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6.2 Operating Guidelines Operate the laminar flow workstation continuously. The unit will then remain in its initially clean condition. If, for any reason, the unit is turned off, the face of the protective screen in horizontal airflow units should be cleaned - preferably with a small brush. Clean the interior surfaces with lukewarm water and a mild detergent. Turn the unit on and permit to operate for 15 minutes before resuming operations. Allow only essential items in the work station. Objects should not be placed between the HEPEX and any point where the clean environment must be maintained. New items introduced into the work area should be placed downstream of items already in the work zone for several minutes to allow contaminants to flush off. Note that plastic parts may carry a static charge which may require special handling in order to remove contaminants. Particular care must be exercised in placing equipment within the work space. Where possible, equipment should be placed on perforated platforms to allow air movement under as well as around the object. All work should be performed with the operator's hand or head downstream of the critical process points. Unnecessary movement with the work station should be kept to a minimum. If workstation is used in a manner not specified by NuAire, the protection provided by the equipment may be impaired. 6.2.1

Operating Sequence A. Start Up Turn on workstation blower and lights, check air intake ports of the workstation to make sure they are unobstructed. The workstations are provided with gauges which indicate pressure differentials across the filters. They indicate when to replace the filters, dependent upon the blower fan capacity. Blower speed must only be readjusted by qualified maintenance technicians. B.

Some workstations are equipped with ultraviolet (UV) lights. These must be turned off during the day while laboratory personnel are occupying the room. Good procedure includes the decontamination or wipedown of workstation surfaces with chemical disinfectant before work commences. This practice eliminates the need for UV lights, whose primary utility in this application is inactivation of surface contamination since the filters effectively remove all airborne contaminants. UV lights, therefore, are not recommended.

C.

Allow blowers to operate for a minimum of 5 minutes before aseptic manipulations are begun in the workstation. An additional advantage is obtained from purification (filtration) of the room air circulated through the equipment. Because of the characteristic contributed to the quality of the laboratory environment, some owners leave them in operation beyond the time of actual use.

D. Minimize Room Activity - Activity in the room itself should be held to a minimum. Unnecessary activity may create disruptive air currents, as well as interfere with the work of the operator. A person walking past the front of the workstation can cause draft velocities up to 175 FPM, which are sufficient to disrupt the air balance of the Laminar Flow Unit. E.

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Utilize Unidirectional Airflow - The operator must keep two important facts in mind: 1) The air, as supplied to the work area through the HEPEX is contaminant-free. 2) Airborne contamination generated in the work area is controlled by the unidirectional flow of parallel air streams. A solid object placed in a laminar air stream will disrupt the parallel flow and consequently, the capability of controlling lateral movement of airborne particulates. A cone of turbulence extends behind the object and laminarity of the air stream is not regained until a point is reached downstream, approximately equal to three to six times the diameter of the object. Within the parameters of this cone, particles may be carried laterally by multidirectional eddy currents.

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6.3 Ergonomics Ergonomics, the study or accommodation of work practices is extremely important for proper workstation usage and user health and safety. An evaluation of normal work practices should be performed with each user when working in a workstation. Evaluation criteria should be at a minimum: a. Proper user posture b. Effective workzone layout for work practice c. Vision or sightlines For each of the above evaluation criterion, several aids may be supplied to accommodate the user. • Ergonomic chair - A six-way articulating seat and back control for personalized adjustment to assure proper user posture. Be sure feet are resting on the floor, chair foot support or foot rest. Also be sure back is fully supported with proper chair adjustments. • Forearm/elbow support - The workstation is provided with a forearm support on the work access opening. Periodic mini-breaks during work practice should be taken resting forearm to avoid stress and fatigue. Elbow rests are optional that can provide support for particular work practices, such as pipetting. • Effective workzone layout - Always prepare your work procedure to minimize reach to avoid neck and shoulder stress and fatigue. Rotating tables are optional to maximum workzone and minimize reach. • Vision and sightline - Always prepare your work procedure to eliminate glare and bright reflections on the window. Keep your window clean and sightlines clear to your effect workzone. 6.4 Cleaning Procedures 6.4.1

To Clean Polycarbonate Side Panels Use a damp soft cloth with a mild soap or mild inorganic acids/bases such as sodium-hydroxide, sodiumhypochlorite or mild bleaches or 3% peroxide. DO NOT USE ORGANIC SOLVENTS, SUCH AS ALCOHOL, KETONES, ACETONE, TOTUOL, ETC., ON THE POLYCARBONATE - IT CAN CRAZE THE SURFACE UNDER CERTAIN CONDITIONS OF SURFACE STRESS AND HUMIDITY.

CAUTION

!

6.4.2

Recommendations for Cleaning Spills on the Work Surface 1. Discontinue work process if feasible and turn the blower motor off. 2. Inspect spill. 3. If contents of spill are potentially harmful, wear appropriate personnel protection equipment. 4. Remove debris from spill and wipe up liquids cautiously to prevent further contamination. 5. Broken containers and contaminated cleaning materials should be disposed of in appropriate disposal containers (depends on type of contamination). 6. Wipe surfaces clean: a.

!

Apply appropriate disinfecting solution to clean bench surface. Most surface disinfectants require a specific contact time, depending upon the microbiological agents used within the workstation. CONSULT APPROPRIATE DISINFECTANT DOCUMENTATION FOR PROPER APPLICATION AND SAFETY PRECAUTIONS.

CAUTION

DISINFECTANTS THAT USE CHLORIDES AND HALOGENS WILL CAUSE DAMAGE TO THE STAINLESS STEEL SURFACES IF LEFT ON FOR LONG PERIODS OF TIME.

b. After the specified contact time, wipe up excess disinfectant. IF THE DISINFECTANT USED CONTAINS CHLORIDES OR HALOGENS, RE-WIPE ALL SURFACES WITH 70% AHCOHOL OR SIMILAR NON- CORROSIVE ANTI-MICROBIL AGENT TO PREVENT DAMAGE TO STAINLESS STEEL SUFACES 7.

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Leave the unit running for 5 to 30 minutes before continuing work to allow the system to purge itself.

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7.0

General Maintenance

CAUTION

!

All maintenance actions on this equipment must be performed by a qualified technician who is familiar with the proper maintenance procedures required for this equipment. This includes both certification as well as repair.

7.1 Fluorescent Lamp Bulb Replacement The fluorescent bulbs are T8, cool white, electronic start and obscured from direct view by Plexiglas diffuser. The life rating of a bulb is 9000 hours based on three hour burning cycles. To replace a bulb: 1. 2.

First, switch the workstation light switch off. Second, remove the front cover. Two knurled thumbscrews on either side of the front panel light cover. And either one (for 3 or 4 ft. units) or two (for 5 to 6 ft. units) knurled thumbscrews below the front cover through the Plexiglas top panel. Once removed, the bulbs are directly exposed. The lamp bulbs are removed by rotating until the pins can be pulled down. Reverse the procedure to reinstall the lamp assembly.

3. 4.

7.2 HEPA Filter Replacement The HEPA filter, under normal usage and barring an accident (puncture), does not need replacement until the efflux velocity cannot be maintained at 90 LFPM (.457 m/s) + 10%. This may permit the HEPA filter efflux average to be as low as 81 LFPM (.411 m/s), as long as no point falls below 70 LFPM (.355 m/s). Use only replacement filters of the same rated flow and size as originally installed to insure proper airflow and HEPA filter lifetime can be achieved. The HEPEX system is removed as follows (see also the procedures on Drawing BCD-06891): 1. 2. 3. 4. 5. 6.

Remove the prefilter screen by unscrewing 4 screws per screen. Remove the prefilters. Remove Clamping Strap holding HEPEX plastic plenum to Blower. Remove the HEPA filter protective screen. Remove the diffuser lip. Remove the HEPEX filter by tipping the top forward -- then lifting completely out.

 NOTE: 7. 8.

This step usually requires 2 people for the removal and replacement of the HEPEX.

Replace new HEPEX by proceeding through the disassembly steps backwards. For complete confidence that the Clean Bench is providing the bio-clean environment desired -- the bench should be checked for filter integrity and airflow by a competent technician. Airflow velocity should be regulated to an average 90 FPM (.457 m/s) (via the solid state motor speed control on the blower (16); Cleanliness should meet Federal Standard 209c, Class 10 conditions.

7.3 Pre-Filter Replacement The replacement interval depends on the contaminant (large particles or lint) in the room -- a typical period is every 3 months. The prefilters are located at the bottom of the workstation.

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7.4 Airflow Calibration The NU-201 Airflow calibration consists of airflow velocity adjustments. This work should be done only by a qualified technician who can measure the airflow from the filter with a suitable velometer. NuAire provides one adjustment to set the workstation airflow velocity. This is a PWM signal adjustment via DC motor speed control. The workstation is considered to be certifiable if the following airflow measurement is present. Workzone average: 90LFPM ± 10 LFPM (.46 mls ± .05mls) Before starting airflow calibration procedure, let the workstations run for at least 10 minutes. Step 1: Air velocity readings are taken on a 12 inch (305mm) grid, in a plane parallel to and 6 inches (152mm) from the filter surface. No reading should be taken closer than 6 inches (152mm) from the inner edge of the filter frame. Step 2: If necessary, adjust airflow control potentiometer, located under the removable cap plug on front panel, to the above stated airflow requirements. The speed control (see photo below) provides more feedback to the Service Technician in that there is a calibration mode push button next to the potentiometer that when pushed activates the calibration mode. There is also an LED to indicate you are in calibration mode. It will then remain in calibration mode until no potentiometer adjustment is made for 1 minute or the LED indicator is off. At that point, the current RPM and PWM signal values will be stored as the starting point and the calibration mode will be exited. The calibration mode can be accessed as needed to achieve the stated airflow requirements. Be sure to allow cabinet to run 1 minute before any blower on/off action is taken.

Potentiometer

Push Button LED

Test Data:

Number of Readings:

Average Velocity:

Acceptance Criteria: 1. Average Velocity = 80 to 100fpm (.41 to .51mls) 2. Individual readings must be within ± 20% of the Average Velocity. OM0210 Rev 2 October/2012

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ft./min. m/s

7.5 HEPA Filter Leak Test In order to check filter and filter seal integrity, the HEPA filter media and seals must be directly accessible, by the measuring instrument. The challenge material (i.e. PAO) should be supplied in the front grill of the workstation. An upstream challenge may be taken by using the minihelic gauge pressure supply tube if desired. The diffuser is secured by thumb screws on the sides. Once removed the diffuser can be lifted up slightly using the small handles and removed from the cabinet. Model Size 324 330 336 424 430 436

2

2

Filter Area (ft )(m ) 6 (.170) 7.5 (.213) 9 (.255) 8 (.227) 10 (.283) 12 (.340)

Model Size 524 530 536 624 630 636

2

2

Filter Area (ft )(m ) 10 (.283) 12.5 (.354) 15 (.425) 12 (.340) 15 (.425) 18 (.510)

Laskin Nozzle Concentration Formula # Nozzles x 135 CFM x 100 ug/L CFM

=

Challenge Concentration (ug/L)

# Nozzles x 229 CMH x 100 ug/L CFM

=

Challenge Concentration (ug/L)

7.6 Cleanliness Classification Test for Pharmacy Application 1 If this cabinet is going to be used within pharmacy, per USP797 , the cabinet must be tested to assure compliance to 2 ISO 14644-1:1999, Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness . The cleanliness classification test is performed using a particle counter to measure particle counts within the cabinet workzone. Turn on cabinet and let warm up for several minutes. Turn on particle counter and flush out sample tubing line to remove latent particles. Set the particle counter to measure 0.5 micron or larger particles at the appropriate measuring rate. 3

“Operational Particle Count Test ” Position the particle counter isokinetic probe at a point 6 inches (152mm) upstream of the aseptic manipulation area (hand convergence point) and mounted so as not to interfere with the operator’s hand movement. The pharmacy operator will simulate IV manipulation during the particle count test using non-hazardous materials. A minimum of three (3) 1-minute particle counts shall be sampled and recorded while the user simulates aseptic compounding manipulations. “At Rest Particle Count Test” Take 5 test points in 1-minute intervals on a grid, in a horizontal plane as measured approximately 6-inches (152mm) parallel to the diffuser. The grid location is designed as the diffuser center point and each corner measured 6-inches (152mm) from the inside perimeter. Record the 5 particle count values for each of the test points over the 1-minute sample time. All final count particle concentrations and calculated 95% upper confidence limit shall not exceed 3520 particles per cubic meter (ppcm) or (100 particles per cubic feet (ppcf).

1

USP28-NF23: United Stated Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, USA, www.usp.org.

2

ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments-Classification of Air Cleanliness, International Organization for Standardization, Case Postale 56, CH-1211 Geneve 20, Switzerland

3

CAG-002-2006: CETA Compounding Isolator Testing Guide, Controlled Environment Testing Association, 1500 Sunday Drive, Suite 102, Raleigh, NC 27607, USA, www.cetainternational.org

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8.0 Polycarbonate Material Compatibility 8.1 Polycarbonate sheet is resistant at 70° to these chemicals. Amyl alcohol Aluminum chloride Aluminum sulphate Ammonium chloride Ammonium nitrate Ammonium sulphate Antimony trichloride Arsenic acid Butyl alcohol Calcium nitrate Chlorinated Lime Paste Chrome alum Chromic acid (20%) Citric acid (40%) Copper chloride Copper sulphate Formic acid (10%) Formalin (30%) Glycerine Heptane

Hydrochloric acid (10%) Hydrogen peroxide (30%) Hydrofluoric acid (10%) Isopropyl alcohol (70%) Lactic acid (20%) Magnesium chloride Magnesium sulphate Maganese sulphate Mercuric chloride Nickel sulphate Nitric acid (10%) Nitric acid (20%) Oleic acid Oxalic acid Pentane Phosphoric acid (10%) Potassium bromate Potassium bromide Potassium nitrate

Potassium perchlorate Potassium permanganate Potassium persulphate Potassium sulphate Silicone oil Silver nitrate Sodium bicarbonate Sodium bisulphate Sodium carbonate Sodium chloride Sodium hypochlorite Sodium sulphate Stannous chloride Sulfur Sulfuric acid (>10%) Sulfuric acid (50%) Tartaric acid (30%) Zinc chloride Zinc sulphate

8.2 Polycarbonate sheet is not resistant to these chemicals. Acetaldehyde Acetic acid (conc.) Acetone Acrylonitrile Ammonia Ammonium fluoride Ammonium hydroxide Ammonium sulfide Benzene Benzoic acid Benzyl alcohol Brake fluid Bromobenzene Butylic acid Carbon tetrachloride Carbon disulfide Carbolic acid Caustic potash solution (5%) Caustic soda solution (5%)

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Chloroform Chlorothene Chlorobenzene Cresol Cutting oils Cyclo hexanone Cyclohexene Dimethyl formamide Dioxane Ethane tetrachloride Ethylamine Ethylene dichloride Ethyl ether Ethylene chlorohydrin Formic acid (conc.) Freon (refrigerant & propellant) Gasoline Lacquer thinner Methyl alcohol

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Methylene chloride Nitrobezene Nurocellulose lacquer Ozone Phenol Phosphorous hydroxy chloride Phosphorous trichloride Proplonic acid Pyridine Sodium sulfide Sodium hydroxide Sodium nitrate Sylfuric acid (1%) Tetrahydronaphthalene Thiophene Toluene Turpentine Xylene

9.0

Error Indicators & Troubleshooting Audible alarms and error indicators occur for a variety of reasons. Whenever an alarm condition is present, the audible alarm and error indicator will be presented and stay on until the error is cleared. When presented with an error indicator, please perform the following: Step 1: NOTE ALL ERROR INDICATORS. When the workstation is running, any and all red indicators display an error. Step 2: VERIFY ERROR INDICATORS. Error indicators can be verified by turning the erred function on/off. Step 3: MONITOR RE-OCCURRENCE OF ERROR INDICATORS. If re-occurrence of the error indicator is immediate or daily, use guide below to correct the situation. Error Indicator Troubleshooting Guide Error Indicator

Indicator

Correction

Clean bench fluorescent lights won't turn on.

Check blower/light circuit breaker on top of control center. Check fluorescent lamps. Check voltage to light ballasts. Check ballast. Check light switch.

Clean bench blower won't turn on.

Check blower/light circuit breaker on control center. Check voltage to blower. Check wiring to blower. Check blower capacitor. Check blower motor. (Note: blower motor has internal thermal protector. Let blower motor cool off for a minimum of 30 minutes to assure thermal protector is not open.)

Clean bench ultraviolet light won't turn on.

Check blower/light circuit breaker on top of control center. Check ultraviolet lamp. Check voltage to ultraviolet ballasts. Check ballast. Check light switch.

Blower/lights circuit breaker continues to trip after reset.

Check for short on output of circuit breaker. Replace circuit breaker. Isolate output of circuit breaker by disconnecting control center connectors, light circuit, motor voltage regulator, etc. to isolate the short.

Minihelic gauge

OM0210 Rev 2 October/2012

Minihelic gauge reads "NO" or "LOW FLOW"

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Check minihelic gauge operation. Check for pinched tubing in control center. Make sure airflow is not too low.

10.0

Optional Equipment

10.1 Ultraviolet Lamp 10.1.1

Overview The germicidal ultraviolet is primarily intended for the destruction of bacteria and other micro-organisms in the air or on directly exposed surfaces. Approximately 95% of the ultraviolet radiations from germicidal tubes are in the 253.7 nanometer region. This is the region in the ultraviolet spectrum which is near the peak of germicidal effectiveness. The exposure necessary to kill bacteria is the product of time and intensity. High intensities for a short period of time, or low intensities for a longer period are fundamentally equal in lethal dosage on bacteria (disregarding the life cycle of bacteria). The intensity of light falling on a given area is governed by the inverse law; that is the killing intensity decreases as the distance increases from the tube. The germicidal tube is placed in the workstation to provide an average intensity of 100 microwatts per centimeter (for a new tube) falling on the horizontal plane defined by the bottom of the work surface. The minimum requirement per paragraph 5.12 of NSF Standard 49 to 40 microwatts per square centimeter (Reference NSF standard 49, June 1976). The UV light on/off switch is located in the Service Control Center and is wired with the fluorescent light switch so that the UV light cannot be used when the fluorescent light is on.

10.1.2

Precaution The rays from germicidal tubes may cause a painful, but temporary irritation of the eyes and reddening of the skin if of sufficiently high intensity, or if exposure covers a prolonged period of time. For this reason, one should avoid direct eye and skin exposure to ultraviolet light. If exposure cannot be avoided, it is necessary for personnel to wear eye goggles or face shields, and long sleeve gowns with rubber gloves.

10.1.3

Maintenance The output of an ultraviolet lamp deteriorates with burning age. The useful life of the lamp is approximately 7000 hrs. under specific test conditions. If the tube is turned on every day for 12 hours, the tube will last approximately two years. It is recommended that either a time schedule be established or the tube's output be measured periodically and the tube replaced when its output falls below 40 microwatts per square centimeter or exceeds 7000 hours of operation. Lamps should be allowed to operate approximately 5 to 10 minutes (longer when the lamp is in low temperatures) to warm up sufficiently and wiped clean of dust or dirt before reading the output with a meter. Even minute amounts of dust will absorb ultraviolet energy. The lamp may be cleaned with a lint-free cloth dampened with alcohol or ammonia and water.

OM0210 Rev 2 October/2012

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Energies Required to Destroy Some Microorganisms by Ultraviolet Radiations Mold Spores Penicillium roqueforti Penicillium expansum Penicillium Digitatum Aspergillus glaucus Aspergillus Flavus Aspergillus niger Rhizopus nigricans Mucor racemosus A Mucor racemosus B Oospora lactis Yeasts Saccharaomyces Ellipsoideus Saccharomyces cerevisiae Brewer's yeast Baker's yeast Common yeast cake Bacteria Strep. lactis Strep. Hemolyticus (alpha type) Staph. aureus Staph. albus Micrococcus sphaeroides Sarcina lutea Pseudomonas fluorescents Escerichia coli Proteus vulgaris Serratia marcescens Bacillus subtilis Bacillus subtilis spores Spirillum rubrum

Microwatt Seconds per cm/2 26,400 22,000 88,000 88,000 99,000 330,000 220,000 35,200 35,200 11,000

Protozoa Paramecium

Microwatt Seconds per cm/2 200,000(a)

Nematode Eggs

40,000(b)

Virus Bacteriophage(E.Coli) Tobacco mosaic Influenze

6,600 440,000 3,400(d)

13,200 17,600 13,200 6,600 8,800 13,200 8,00 5,500 6,600 5,720 15,400 26,400 7,040 7,040 7,480 6,160 11,000 22,000 6,160

References (a) Luckiesh, Matthew (1946) Application of Germicidal, Ethyemal and Infrared Energy D. Van Nostrand o., New York, New York. pp. 253 (b) Hollaender, Alexander (1942) Aerobiology, A.A.A.S. (for 90% inactivation). pp. 162 (c) Ellis, C. and Wells, O.O. (1941) The Chemical Action of Ultraviolet Rays Reinhold Publishing Corp. pp. 713-714 (d) Hollaender, A., Oliphant, J.W. (1944) The Inactivation Effect of Monochromatic Ultraviolet. Radiation on Influenze Virus (for 90 1/2 inactivation) Jour. of Bact. 48, pp. 447-454 (e) This table, "Energies Required to Destroy Some Microorganisms by Ultraviolet Radiations" comes from the Westinghouse brochure entitled - "Westinghouse Sterilamp Germicidal Ultraviolet Tubes" OM0210 Rev 2 October/2012

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11.0

Electrical/Environmental Requirements

11.1 Electrical (Supply voltage fluctuations not to exceed +/- 10%) Electrical NU-301-330 NU-301-330E NU-301-336 NU-301-424 NU-301-430 NU-301-430E NU-301-436 NU-301-524 NU-301-530 NU-301-530E NU-301-624 NU-301-630 NU-301-630E NU-301-636

Voltage 115 Volts 230 Volts 115 Volts 115 Volts 115 Volts 230 Volts 115 Volts 115 Volts 115 Volts 230 Volts 115 Volts 115 Volts 230 Volts 115 Volts

Phase 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Frequency 60 Hz 50 Hz 60 Hz 60 Hz 60 Hz 50 Hz 60 Hz 60 Hz 60 Hz 50 Hz 60 Hz 60 Hz 50 Hz 60 Hz

Current (Amps) 8 8 8 8 8 8 10 10 10 10 10 10 10 15

Outlet Current (Optional) 10 10 10 10 10 10 10 10 10 10 10 10 10 10

11.2 Operational Performance (for indoor use only) Environmental Temperature Range: 60°F-85°F (15.6°C – 30°C) Environmental Humidity: 20%-60% Relative Humidity Environment Altitude: 6562 Feet (2000M) 11.3 Light Exposure Standard Fluorescent Lighting @ 150 ft. candles (1614 LUX) maximum intensity. 11.4 Installation Category: 2.0 Installation category (overvoltage category) defines the level of transient overvoltage which the instrument is designed to withstand safely. It depends on the nature of the electricity supply and its overvoltage protection means. For example, in CAT II, which is the category used for instruments in installations supplied from a supply comparable to public mains such as hospital and research laboratories and most industrial laboratories, the expected transient overvoltage is 2500V for a 230V supply and 1500V for a 120V supply. 11.5 Pollution Degree: 2.0 Pollution degree describes the amount of conductive pollution present in the operating environment. Pollution degree 2 assumes that normally only non-conductive pollution such as dust occurs with the exception of occasional conductivity caused by condensation. 11.6 Chemical Exposure Chemical exposure should be limited to antibacterial materials used for cleaning and disinfecting. Chlorinated and Halogen materials are not recommended for use on stainless steel surfaces. 11.7 EMC Performance (classified for light industrial) Emissions: EN61326 Immunity: EN61326 The EMC performance requirements are generated within the product enclosure. The enclosure will be all metal grounded to earth. In addition, the membrane front panel will also include a ground plane for maximum protection and an electrostatic shield.

! WARNING

OM0210 Rev 2 October/2012

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12.0

Disposal and Recycle Workstations that are no longer in use and are ready for disposal contain reusable materials. ALL components with the exception of the HEPA filters may be disposed and/or recycled after they are known to be properly disinfected.

 NOTE:

Follow all local, state and federal guidelines for disposal of HEPA filter solid waste. BIOHAZARD

!

CAUTION

Prior to any disassembly for disposal, the workstation must be decontaminated.

RECYCLE

Component Main Workstation Worksurface Side Panels Side Panel Control Center Diffuser Filter Hepex Bag Blower Wheel & Housing Motor Printed Wiring Assembly Wire Ballasts Connectors Hardware



LEAD FREE

Material Painted Steel Wood/Stainless Steel Polycarbonate Aluminum Painted Steel Aluminum Wood PVC Steel Various Steel/Copper Lead Free Electronic PVC Coated Copper Various Steel, Electronic Nylon Stainless Steel and Steel

Note: Material type can be verified with use of a magnet with stainless and aluminum being non-magnetic.

OM0210 Rev 2 October/2012

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OM0210 Rev 2 October/2012

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OM0210 Rev 2 October/2012

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