Pharmagard™ Positive PressureRecirculating Compounding Aseptic Isolator Models NU-PR797-400/600 Bench/Console Operation & Maintenance Manual November, 2008 Revision 11 Manufactured by: NuAire, Inc. 2100 Fernbrook Lane Plymouth, Minnesota USA 55447 Toll Free: 1-800-328-3352 In MN: 763-553-1270 Fax: 763-553-0459 www.nuaire.com OM0141 Congratulations! You have just purchased one of the finest positive Pressure Recirculating Compounding Aseptic Isolators available. With proper care, maintenance (certification), and pharmacy procedure, this Isolator will give you years of product protection from particulate contaminants as prescribed in the USP 797. Please read this manual carefully to familiarize you with proper installation, maintenance, and operation of the Isolator. Other reference and guideline materials are available through the following web sites. www.usp.org www.ashp.org www.cdc.gov/niosh/ www.cetainternational.org OM0141 2 ABOUT THIS OPERATION & MAINTENANCE MANUAL The information contained in this manual is intended to reflect our current production standard configuration model along with the more frequently purchased options. Any unique additions/modifications/shop drawings are appended in the back flap of this manual, along with any modifications and/or additions to procedures as outlined in this manual. A copy of the original factory test report is also appended to this manual. In case this manual and/or test report is lost or misplaced, NuAire retains a copy in our files. A replacement copy can be obtained by calling or writing NuAire, Inc. stating the model number and serial number and a brief description of the information desired. OM0141 3 Pharmagard™ Positive Pressure Recirculating Compounding Aseptic Isolator Models NU-PR797-400/600 Operation & 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 NU-PR797 6.1 ........................................................................................Operator Controls & Indicators 6.2 ........................................................................................Operating Guidelines 6.3 ........................................................................................Operating Sequence 6.4 ........................................................................................Ergonomics 6.5 ........................................................................................Cleaning Procedure 6.6 ........................................................................................Sleeve/Glove Usage Section No. 7 .............................................................................General Maintenance 7.1 ........................................................................................Decontamination 7.2 ........................................................................................Fluorescent Lamp Bulb Replacement 7.3 ........................................................................................HEPA Filter Replacement 7.4 ........................................................................................Motor/Blower Replacement 7.5 ........................................................................................Airflow Calibration 7.6 ........................................................................................Filter Integrity Check 7.7 ........................................................................................Cleanliness Classification Test 7.8 ........................................................................................Enclosure Integrity Test 7.9 ........................................................................................Main Control Board Description & Replacement Section No. 8 .............................................................................Error Indicators & Troubleshooting Section No. 9 .............................................................................Remote Contacts Section No. 10 ...........................................................................Optional Equipment 10.1 .................................................................................Pharmagard Digital Monitor 10.2 .................................................................................Sharps/Garbage Disposal System for Non-Hazardous Drugs Section No. 11 ...........................................................................Electrical/Environmental Requirements Section No. 12 ...........................................................................Polycarbonate Material Compatibility Section No. 13 ...........................................................................Disposal and Recycle Insert..........................................................................................Replacement Parts MANUAL DRAWINGS ACD-10271............................................. NU-PR797 Airflow Schematic BCD-10107 ............................................. NU-PR797-400 Specification Drawing BCD-10108 ............................................. NU-PR797-600 Specification Drawing BCD-10313 ............................................. NU-PR797 Front Panel ASSEMBLY DRAWINGS BCD-10484 ............................................. Positive Isolator Sleeve/Glove Replacement Procedure BCD-10398 ............................................. NU-PR797 Base Assembly BCD-10399 ............................................. NU-PR797 Control Center BCD-10400 ............................................. NU-797 Bench Mount Installation BCD-10476 ............................................. NU-797 Telescoping Base Support BCD-10480 ............................................. NU-797 Adjustable Base Support BCD-10481 ............................................. Assy. Waste/Sharps Disposal for Non-Hazardous Waste ELECTRICAL SCHEMATICS BCD-09988............................................... NU-PR797-400/600 Electrical Schematic OM0141 4 OM0141 5 . Inc. Minnesota.Plymouth. U. the airflow is split to front to rear. up the rear divider panel and is recirculated again through the supply HEPA.Pharmagard™ Positive Pressure Recirculating Compounding Aseptic Isolator Models NU-PR797-400/600 MANUFACTURED BY: NuAire.0 General Description The Pharmagard model NU-PR797 positive pressure recirculating Compounding Aseptic Isolator (CAI) is a bench/table top model. Federal Standard 209E. An additional filter assembly on top of the Isolator brings in HEPA filtered room air to assure the Isolators continuous positive pressure. Once the air is through the work area. The NU-PR797 CAI is designed to provide a sterile positive pressure work environment for the compounding of non-hazardous drugs. . 1. Utilizing laminar flow assures a continuous stream of HEPA filtered air across the work zone and interchange areas assuring sterility and minimizing cross contamination. Class 100) conditions. Then proceeds under the work tray.A. optionally available with several base stand configurations for operation as a console model. The NU-PR797 Isolator creates HEPA filtered laminar flow supply at 20 air changes per minute within both the work zone and interchange areas to assure ISO Class 5 (formerly.S. CAUTION CAUTION used without the safety alert symbol indicates a potentially hazardous situation which.2 Safety Instructions These safety instructions describe the safety features of the PHARMAGARD Model NU-PR797 Isolator. • Keep these operating instructions close to the unit so that safety instructions and important information are always accessible. in particular. if not avoided. utilizing applicable safety data sheets. if not avoided. ! CAUTION: CAUTION indicates a potentially hazardous situation which. plant hygiene guidelines. • Repairs to the device must be carried out only by trained and authorized expert personnel.3 Explanation of Symbols ! WARNING WARNING indicates a potentially hazardous situation which. 1. please contact your NuAire Representative of NuAire technical Services. • Should you encounter problems that are not detailed adequately in the operating instructions. Flammable Hazard Ground. may result in property damage. o which decontamination measures are to be applied for the cabinet and accessories. however. • For any operation of this unit. The Isolator has been manufactured using the latest technological developments and has been thoroughly tested before delivery. Earth Hazardous Gases! Personal Protection Equipment Required. may result in minor or moderate injury. the operator must prepare clear and concise written instructions for operating and cleaning. Lead Free Chemical Hazard OM0141 6 . present potential hazards if it is not used according to the intended purpose or outside of operating parameters. and technical regulations. ) NOTE: Used for important information. if not avoided. Potential electrical hazard. o which measures are to be taken in the case of an accident. It may. could result in death of serious injury.1. the following procedures must always be observed: • The Isolator must be operated only by trained and authorized personnel. only qualified person to access. Therefore. OM0141 7 . 0 Models & Features The model NU-PR797.2. Positive Pressure Recirculating Compounding Aseptic Isolator is manufactured in two sizes: 4 ft. and 6 ft. OM0141 8 . OM0141 9 . OM0141 10 . 0 Warranty NuAire. shipping damage. If the serial number of this product is altered. Inc.2 If there is visible damage.1 Terms are factory. Claims under this warranty should be directed to NuAire. and this warranty shall not apply to any portion of the equipment modified by the user.B. 4.3. This along with other papers in the customer's possession will support the claim. it is important to check each shipment before acceptance. However. the transportation company may not accept a claim for loss or damage. The warranty is for the sole benefit of the original purchaser and is not assignable or transferable.3 If concealed damage is found it is absolutely necessary to NOTIFY THE FREIGHT AGENT AT ONCE and request an inspection. This warranty shall not apply to any NuAire product or part thereof which has been subject to misuse. the material can be accepted after the driver makes a notation on the consignee's copy of the freight bill. This number must accompany all returns. warrants that it will repair F. charges prepaid.O.1 Damaged Shipments 4.O. abuse. setting forth in detail the nature of the defect. OM0141 11 .B. its factory a similar part to replace any material in its equipment within 36 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.1. 4. Without this inspection. Therefore. removed or defaced as to be illegible. accident. Motor carriers are carefully selected and shipping cartons have been specially designed to insure your purchase. or damage by fire. for any reason. its factory or furnish without charge F.0 Shipments NuAire takes every reasonable precaution to assure that your PHARMAGARD Isolator arrives without damage. flood or acts of God. improper installation or service.1. the Warranty shall be null and void in its entirety. damage can occur in any shipment and the following outlines the steps you should take on receipt of a NuAire PHARMAGARD Isolator to be sure that if damage has occurred. Inc. Before returning any item. 4. an affidavit must be prepared stating that he was contacted on a certain date and that he failed to comply with the request. 4. contact NuAire for a Return Authorization Number.1. unless stated otherwise. Any product shipped to NuAire without this number will be returned refused shipment or collect freight. 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. If the carrier will not perform the inspection. Factory installed equipment or accessories are warranted only to the extent guaranteed by the original manufacturer. properly identified to the company at its factory. the proper claims and actions are taken immediately. the date of the initial installation and the serial and model number of the equipment. Where space permits. remove base plate holding bracket. To position higher.2. it may affect the process of work product movement in and out of the Isolator. it may affect ergonomic user comfort. but not necessary to locate the Isolator within an ISO Class 7 buffer air quality area. Being an Isolator. adjust the leg levelers first end-to-end. Adjustable base support can now be plugged in and height adjusted with up/down switch. IF FORKLIFT IS USED. bolts. Once Isolator is placed on floor with either castors or leg levels. IT IS RECOMMENDED THAT NO LESS THAN TWO PEOPLE PERFORM THE SKID REMOVAL AND CASTOR/LEG LEVELER ATTACHMENT PROCESS. attached to the Isolator at its lowest height. It can then be removed form the skid by removing the banding. Remove Isolator from skid by pushing Isolator off the skid one corner at a time attaching either castors or leg levelers on each corner as the base plates overhang the skid. 5. OM0141 12 . The Isolator is fastened to the base skid and it is usually the best procedure to leave the skid in place until the Isolator is located in its approximate location to facilitate ease in handling. IN ADDITION. LEAVE BASE PLATE SHIPPING BRACKET IN PLACE UNTIL ISOLATOR IS PLACED ON THE FLOOR. and screws holding the Isolator to the skid. the Isolator should be located away from personnel traffic lanes. then. follow the instructions below for Isolator removal from skid. If the Isolator is directly attached to the skid. disruptive air currents will not affect performance. remove and place on bench mount. However. If the Isolator is shipped with the base stand attached. Remove the skid brackets and banding holding Isolator to the base skid. or any other source of disruptive air currents.5. Re-install 3/8” bolts (2) on each leg to lock in desired height. the forks should avoid the filler panel area. PLEASE NOTE: THE BASE FILLER PANEL IF USING FORKLIFT. remove 3/8” bolts (2) on each leg and rise to desired height. PLEASE NOTE THE BASE FILLER PANEL IF USING A FORKLIFT.0 Installation Instructions 5. The electrical outlet into which the Isolator is connected should be readily accessible for maintenance purposes. air vents. processes and procedures requirements for each Isolator. The NSF approved leg levelers provide a ± 3/4" (20mm) adjustment. It is preferred. At a minimum.2 Set-up Instructions Remove outer shipping protection (carton or crating).1 Location The location or placement of the Isolator within the pharmacy or nursing station should consider contamination risks. attached to the Isolator at its lowest height. a clear 4" (102mm) area should be permitted on all sides of the Isolator. ) Note: There is a base filler panel on the Isolator bottom. CAUTION.3 Leveling w/Leg Levelers Using a level placed on the work tray. Remove the Isolator from the skid.2.2. 5.1 Telescoping Base Support (BCD-10476) The telescoping base stand is shipped installed. Remove the brackets and banding holding the Isolator to the base skid. Placing the Isolator away from disruptive air currents will assure maximum CSP sterility and user comfort. In addition. 5. The Isolator is attached to the skid in two methods depending upon the type of bench mount or base stand purchased. 5. front to back. doors. If using forklift.2 Adjustable Base Support (BCD-10480) The adjustable base support is shipped installed. 6 CAUTION: Use of explosive or flammable substances in this Isolator should be evaluated by your appropriate safety personnel. reference Electrical/Environmental Requirements). Connection to plant utilities should be made with proper materials for the individual service and according to national and/or local codes. A special needle valve for oxygen service or certified valve is required and available upon request. Plumbing Services Ground key cocks with the type of service specified by the removable button on the handle. OM0141 13 .2. attach plate mount covers. the joint between the bench and Isolator mounts may be sealed with silicon RTV to prevent spills from migrating under the bench mount system. 5.0 BAR). PLEASE NOTE THIS UNIT CONTAINS ELECTRONIC BALLASTS FOR THE FLUORESCENT LIGHTING. are located in the work zone. It is recommended that power to the unit be on its own branch circuit. 5. The Ground Key cocks are not recommended for pressure over 30 p. Attach the 2 X 2 bars to the bench with the brackets provided.4 Bench Mount Installation (BCD-10400) Place 2 X 2 bench mount bars on bench from front to rear the same width as the Isolator. If desired. Lastly. so the handle will be pulled forward to close the drain. The unit requires 115 VAC. Tighten so handle is located on the left side of valve. IT IS NOT RECOMMENDED TO USE THIS PRODUCT WITH GROUND FAULT CIRCUIT INTERRUPTERS (GFCI'S) BECAUSE THE BALLASTS MAY CAUSE THE GFCI TO TRIP.2. single phase (current rating varies per CAI size. Ground key cocks should never be used for flammable gasses or oxygen service. ) NOTE: No more than a 4-1/2 inch (144mm) 2 x 2 bar overhang is permitted for bench top installation. 5. Apply thread lock liquid provided in package and attach to threaded drain stub located on the bottom right side of the Isolator.2. ELECTRONIC BALLASTS OPERATE WITH HIGH INRUSH CURRENT. “hardwired”.i. Place the Isolator on the 2 X 2 bench mount bars. 60 Hz.2. remove from packaging.8 Electrical Services The NU-PR797 series Isolator is connected via an electrical power cord with hospital grade plug or optionally. Reducing valves should be installed external to the Isolator if necessary. protected with a circuit breaker or fuse at the distribution panel.2. If the drain valve requires installation. (2. Observe all labels pertaining to the type of service and operating pressure. All NuAire Isolator’s have precautionary warning labels that say the following: ! 5. External connection is to 3/8 inch NPT coupling in the inner sidewalls.5 Gas Service NuAire does not recommend the use of natural gas within the Isolator. Attach Isolator to the bars with plate mounts.7 Drain Valve The Isolator may or may not come with the drain valve installed depending upon the basestand type purchased.s.5. or other sharp instruments. AFTER THE INITIAL CERTIFICATION. Note that the Pharmagard Isolators. 5. located on top of the Isolator. NuAire recommends that the Isolator be certified or commissioned to factory standards. Please refer to section 12. NUAIRE RECOMMENDS THAT THE ISOLATOR BE RECERTIFIED AT A MINIMUM ON AN ANNUAL BASIS MORE OFTEN IF REQUIRED BY REGYLATORY REQUIREMENTS AND AFTER EVERY FILTER CHANGE OR MAINTENANCE ACTION OR ANY TIME THE OPERATOR FEELS IT IS NECESSARY. HEPA Filter Leak test 2. PLEASE VISIT THE NUAIRE WEBSITE WWW. protection to product and is so vital that certification to the performance requirements should be accomplished as stated by the factory standards. Enclosure Integrity test The testing methods and equipment required are specified on the factory inspection report included with this manual (see insert in back cover). 1.NUAIRE. Recommended cleaners for polycarbonate are: Formula 409 (for external surfaces only) Windex D w/Ammonia D (for external surfaces only) 70% Isopropyl Alcohol The use of polycarbonates has some important don'ts: • • Do Not use abrasive or high alkaline cleaners.0 for Polycarbonate material compatibility. filters.COM UNDER TECH-SERVICE SUPPORT AND REVIEW INDEPENDENT SERVICE TECHS FOR YOUR AREA. Do not attempt to clean the HEPA filter media. OM0141 14 .9 Final Assembly REMOVE THE PROTECTIVE CARDBOARD COVER OVER THE FILTERS. Do Not scrape with squeegees. Cleanliness Classification test 5. the following tests should be performed. Isolator interior walls or work surface are easily cleaned with any mild household detergent cleaner using a soft cloth.2. Downflow Velocity (calibration) test 3. and seals provide premium performance. IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED TECHNICIAN WHO IS FAMILIAR WITH THE METHODS AND PROCEDURES FOR CERTIFYING ISOLATORS. The powder coat urethane and polycarbonate glove port panel is easily cleaned with any mild household detergent.5. Use a soft cloth on the panels.3 Certification Testing Methods and Equipment After installation and before use. However. Isolator Pressure (calibration) test 4. At a minimum. razor blades. Quality Control in both design and manufacturing assure superior reliability. 60-lbs. Welded stainless steel 16GA./261 kg. Backwall One. on 0.Pharmagard™ Positive Pressure Recirculating Compounding Aseptic Isolator Models NU-PR797-400/600 Catalog Number Performance Specifications Style of Isolator Isolator Construction Interchange Chamber Diffuser for Air Supply (Metal) HEPA Filter Seal Type: Supply Filter-99. OM0141 15 ./73 kg. BTU./284 kg. 160-lbs. 14 1/8 (359) 24 (610) 27 3/8 (695) Fully closed to fully open 880 UL/UL-C Listed 115 5 3 8 14 GA .3 Wire. * For total weight. Hospital Grade Power Cord (one) *Crated Shipping Weight: *Net Weight: Net Optional Adjustable Automatic Base Stand Wt: Net Optional Telescoping Base Stand Wt: Net Optional Bench Mount Wt: Catalog Number NU-PR797-400 NU-PR797-600 Nominal 4 foot (1./27 kg./220 kg. 425-lbs. 15A 475-lbs./19 kg.3 microns Standard Services: Hospital Grade Duplex Outlet Optional Services: Service Valves 3/8" NPT Isolator Size Inches (mm): Height Height (Minimum w/opt./68 kg. Springloaded Under Negative Pressure One.99% Eff. 70-lbs. Per Hour Electrical: Volts. Type 304 pressure tight design Type 304 pressure tight design ISO Class 5 With ISO Class 5 With Internal/External Sealed Doors Internal/External Sealed Doors Non-flammable Non-flammable Neoprene. must select and add (1) of (3) base options./193 kg. 15A 625-lbs. 20-lbs.3 Wire. AC 60 Hz Amps: Blower/Lights Amps: Hospital Grade Duplex Amps: Total 12 ft. 20-lbs. Springloaded Under Negative Pressure Neoprene. Adjustable Base Stand) Width Depth (with Control Center) Work Zone Inches (mm): Width Height Depth (Center of Glove Port) Interchange Inches (mm) Width Depth (at Work Surface) Height Hinged Viewing Window (Polycarbonate) Heat Rejected. 150-lbs./19 kg.8m) CETA CAG-002-2006 CETA CAG-002-2006 ISO Class 5 (Laminar Flow) ISO Class 5 (Laminar Flow) Bench top/console Isolator Bench top/console Isolator Welded stainless steel 16GA. 575-lbs.2m) Nominal 6 foot (1. Backwall Up to 3 Up to 3 51 1/2 (1308) 81 1/2 (2070) 50 (1270) 32 1/2 (826) 51 1/2 (1308) 81 1/2 (2070) 74 (1880) 32 1/2 (826) 35 1/4 (895) 27 3/8 (695) 23 1/4 (591) 59 1/4 (1505) 27 3/8 (695) 23 1/4 (591) 14 1/8 (359) 24 (610) 27 3/8 (695) Fully closed to fully open 539 UL/UL-C Listed 115 3 3 6 14 GA ./32 kg. Control lights via solid-state switch. and outlets. Disable audible alarm switch with ring back function. Control supply blower motor with solid-state regulator via potentiometer. The control system consists of one electronic module and several discrete components that will perform the following functions: • • • • • • Control blowers via solid-state switch. controls the on/off functions of the blowers.6. Monitor and display airflow system performance via minihelic gauges. fluorescent lights. Control outlets via solid-state switch. The main control module.1.1 Electronic Control System 6. The NU-PR797 incorporates the use of an electronic module that improves the Isolator’s performance.0 Operating the NU-PR797 6.1 Overview The electronic control system is designed to service the control requirements of the NU-PR797 Isolator. Figure 1 OM0141 16 . through the use of the front panel. All the above functions are shown in a system block diagram (see Figure 1). 2.2.10” w. The gauge is calibrated in “inches of water gauge” pressure.6. See optional equipment section for greater detail.05” w.2 Front Panel The control system front panel contains the following functions described in detail (see Drawing BCD-10313).2. 6.g.1 Blower Keys The blower keys indicate and control ON/OFF power to the blower. The pressure monitor is calibrated in “inches of water gauge” pressure. pressure may drop.1. again the reading will increase back to normal.1.2. but will still read greater than 0. 6. OM0141 17 .1.g.1.g.50” w.00” w. 6.1.2.g.1. 6. the gauge reading will drop to 0. if the internal door is opened. the reading will decrease and read the same as the interchange chamber minihelic gauge.15” w. The gauge is calibrated in “inches of water gauge” pressure. If the external interchange door is opened. during normal operation. The interchange chamber positive pressure will read greater than 0. 6.2. The pressure monitor will read the same as the main chamber minihelic gauge and in addition.3 Outlet Keys The outlet keys indicate and control ON/OFF power to the outlets.5 Main Chamber Minihelic Gauge The main chamber minihelic gauge displays the positive static pressure within the main chamber.g.g. If the internal interchange door is opened the gauge reading will increase and read the same as the main chamber minihelic gauge. If the external interchange door is opened. allow a low/high alarm limit point to be set. Once the external interchange door is closed.4 Interchange Chamber Minihelic Gauge The Interchange chamber minihelic gauge displays positive static pressure within the interchange chamber.15” w. However.6 Pharmagard Digital Monitor (optional) The optional Pharmagard Pressure Monitor displays the positive static pressure within the main chamber.1. The main chamber positive pressure will read greater than 0. The default alarm limits is set to 0. during normal operation. 6.2 Light Keys The light keys indicate and control ON/OFF power to the fluorescent light. low and 0. high. OM0141 18 . and JP3 on the control board and the hidden key is the blower symbol on the front membrane panel.1. 6. A combination of 3 jumpers on the control board will activate a password sequence of the front membrane panel.1.6.1. 6. which varies the applied voltage from 70 to 115 VAC.3.3.1 Airflow Control The operating airflows within the Isolator as well as the inlet blower are controlled by potentiometers located in the control center controlling the operating voltage applied to the motor/blowers. The code for using a sequential password is: JP1 + + + - OM0141 Jumpers JP2 JP3 + + + + + + Password Sequence on off hidden on hidden off off on hidden off hidden on hidden on off hidden off on 19 . In the power off condition (Isolator is unplugged). During the power on condition (Isolator is plugged in).2 Blower Password Protection The blower may be operated by using a password. lights.3 Run Mode Operation Operation of the Isolator is initiated by plugging the power cord into the appropriate power connection. The other keys are the blower on and blower off switch. The jumpers are labeled JP1. JP2. the blower on/off switch will function with no password protection. The potentiometers as adjustable over 270 degrees with a slotted screwdriver. and outlets may be turned on. all calibration and running parameters will be stored in the microprocessor's EEPROM memory. If all three jumpers are on or off. the Isolator blowers. The complete test results are published in the NuAire Technical Bulletin GTB0150. This area remains at ISO Class 5 when the exterior access door is closed. published by USP. b. Do not use for compounding hazardous drugs. a. e. This area will remain at ISO Class 5 even if the exterior access door is open. The intent herein is to present general operational guidelines that will aid in the use of the Isolator to provide a sterile positive pressure work environment for the compounding of non-hazardous drugs. c. while testing for all basic performance criteria. and the work zone area. The work zone area also has constant Laminar airflow from the same supply HEPA filter.2 Operating Guidelines ! CAUTION.07 Recovery time determination test results were less than 1 minute. a. Adding a margin of safety to this value. The interchange area has constant laminar airflow from the supply HEPA filter. This Isolator can be used outside an ISO Class 7 clean room with no wait or purge time required during the material transfer process. The testing guide. OM0141 Know your "Safe Working Area" Personnel cleansing and garbing Product movement Utilize unidirectional airflow Employ aseptic techniques Know Your "Safe Working Area" The Isolator has two distinct areas.07) and preparation ingress and egress test (2. ASHP and the state boards must be observed.6. These tests are recovery time test (2. contamination will migrate into the workzone and require the Isolator start up operating sequence to be performed. however if both interior and exterior access doors are open. 2. 2. the interchange area. In addition to regulatory and recommended guidelines.09 Preparation ingress and egress test results indicated that all particle counts were well below ISO Class 5 levels. Regulatory and recommended guidelines. if the front-hinged window is opened. In addition. 20 . the possibility of contamination migrating into the work zone exists. The pre-planning necessary to develop these protocols is based on several fundamental considerations and each will contribute to optimum CAI use benefits. the operating guidelines are based on performance testing using the CETA CAG-002-2006 Compounding Isolator testing guide.09). d. has two tests directly impact operating guidelines. Procedure protocols defined in terms of the Isolator or control concepts unique to the Isolator must be developed in order to obtain a maximum potential for drug compounding efficiency and sterility. The testing guide recommends that the results of these tests are noted as shown below and displayed on the CAI. NuAire recommends a minimum of 5 minutes to establish the ISO Class 5 Environment within the workzone. Product Movement Always plan movement in and out of the Isolator. move materials into the interchange area. use the glove ports to access the interior door. During material removal. Properly balanced and properly used Isolators will do an excellent job of controlling airborne contamination. head. Then. No purge time is required for the interchange area due to the constant laminar airflow. The source of contamination is typically the room environment and the material handling process itself. c. particles may be carried laterally by multidirectional eddy currents. During material movement process. approximately equal to three to six times the diameter of the object. No shoe. perform hand hygiene and don sterile. perform material wipe down as required to assure no hazardous material is present d. ASHP and State Board Guidelines. Then reverse the material movement procedure to remove material from the Isolator. Within the parameters of this cone. then using the laminar airflow remove any final packaging and wipe down materials as they are placed on the interchange worksurface. OM0141 Employ Aseptic Techniques The operator must not assume an attitude of "let the Isolator do it" when performing procedures within an Isolator. Then close the interior door and perform aseptic compounding procedure. 21 . Normal pharmacy contamination control procedures and basic aseptic techniques are necessary to obtain maximum benefits from the Isolator. A cone of turbulence extends below the object and laminarity of the air stream is not regained until a point is reached downstream. the capability of controlling lateral movement of airborne particulates. Use standard pharmacy gown. Items should be localized on the work surface in "clean" and "dirty" groups. A solid object placed in a laminar air stream will disrupt the parallel flow and consequently. then close the exterior door. Utilize Unidirectional Air Flow The operator must keep two important facts in mind: (1) The air. Transfer of viable materials and manipulations which may generate aerosols should not be performed above sterile or uninoculated materials. Planning movement in and around the Isolator will increase efficiency and minimize the risk of contamination. Personnel Cleansing and Garbing Follow all personnel cleansing and garbing requirements per USP. gloves should be sanitized with adequate frequency with an effective disinfectant. e. Based on CETA CAG-002-2006 test results NuAire recommends at a minimum. is contaminant free and (2) airborne contamination generated in the work area is controlled by the unidirectional flow of parallel air streams in a top-to-bottom direction. as supplied to the work area through filters from the top.b. to open the exterior door. but the Isolator will not eliminate contact transmission of contamination. the Isolator interior door should always remain closed unless moving material from the interchange area to the workzone. facial hair or face covers are required. powder-free gloves. open and move material into the workzone. Typical product movement would be. This is also true for the exterior door. all basic clothing and personal hygiene requirements should be met. In general terms. only one person can enter the contiguous buffer area for the purposes of turning on the blower (for at least 30 minutes) and of sanitizing the work surface”. certain syringe designs require an aseptic connection immediately upon removal from the wrapper. move materials into the interchange area and remove final packaging using the laminar or first air and wipe down materials as they are placed on the interchange slide tray. After proper introduction into the Isolator of supply items required for and limited to the assigned operations. shipping containers. When the blower is turned off and before other personnel enter to perform compounding activities. they are so arranged that a clear.3 Materials & Equipment The apparatus and materials should next be placed into the Isolator. Assure the specified differential pressure between the pass-through and main chamber. Adding a margin of safety to this value. Gloves are sanitized with adequate frequency with an approved disinfectant.3 Operating Sequence 6. Per UPS 797. 6.1 Start Up Turn on Isolator blowers and lights. Alcohol should be allowed to air dry. c. the surfaces of the direct compounding environment are first cleaned with Purified Water to remove water-soluble residues.3. open interior door and pull the slide tray into the main working chamber. uninterrupted path of laminar or “first air” will bathe all critical sites at all times during the planned procedures. All supply items are arranged in the Isolator to reduce clutter and to provide maximum efficiency and order for the flow of work. and cardboard discarded. no objects may be place behind an exposed critical site in a horizontal position or above an exposed critical site in a vertical position. these items should not be brought into the main chamber. and after liquids are spilled. Assign operations so they are arranged that a clear. At no time should both doors be open simultaneously. the Pharmagard can achieve an ISO Class 5 environment in less than 1 minute.4 OM0141 Perform Work The work can now be performed. If totes. Then open the exterior door. NuAire recommends a minimum of 5 minutes to establish the ISO Class 5 environment within the workzone.3.2 Wipe Down At the beginning of each compounding activity session. through product testing. b. check pressure gauges on control panel to assure positive pressure is registering. a. That is. 6. uninterrupted path of HEPA-filtered air will bathe all critical sites at all times during the planned procedures. the same surfaces are sanitized with sterile 70% isopropyl alcohol. All procedures are performed in a manner designed to minimize the risk of touch contamination. All materials should be staged away from the Isolator. These items should be left on the slide tray to minimize the potential for contamination.3. 6. However. using a non-linting wipe. “When LAFWs or barrier isolators are used as the ISO Class 5 air quality environment. including during interruptions of less that 8 hours. Note. close the exterior door. or other effective disinfectant.3. the recommended standard operating procedure states. Immediately thereafter. or transport bags are used for material handling. These units are to be removed from the wrapper after placement in the main chamber. All normal work material should enter via the exterior and interior doors. Once all the materials are placed into the interchange chamber. 22 .6. USE OF CHLORINATED OR HALOGEN MATERIALS IN THE ISOLATOR MAY DAMAGE STAINLESS STEEL. The materials should then be brought over to the Isolator via a dedicated cart or other material moving device. their blowers must be operated continuously during compounding activity. plastic bags. If the hinged window is opened for material installation and additional 5 minutes of run time is required to purge the work zone from contaminants. d. which may support fungus growth. 6. bottles. Do not use Isolator as a depository for excess lab equipment during periods of non-operation.3. 6. the cabinet will increase in pressure and will increase in temperature. used syringes. and if the airflow is blocked. and other supplies are removed or discarded. OM0141 23 . Any paper removed must be properly disposed. and resulting spore liberation that contaminates the protected work environment.3. If the airflow is blocked by excessive buildup of particulate.e.3. but with a minimum of exit and re-entry into the Isolator to minimize the risk of introducing contamination into the aseptic work space. This area forms the air path to the supply motor/blower. A careful check of grills and diffuser grids should be made for spilled or splashed nutrients. vials. it could seriously affect the performance of the Isolator. f. After procedures are completed. 6. 6. The top prefilter may be vacuumed to remove particulate debris. toward the front is a prefilter combination. Therefore. etc. The exhaust filter may be replaced as necessary (see Replacement Parts List). THE PREFILTERS SHOULD BE CHECKED AND CLEANED NO LESS THAN ON A MONTHLY BASIS. or other defects.6 Paper Catch A permanent paper catch is installed behind the rear divider panel of the work zone.7 Prefilters Located on top of the Isolator. Therefore.5 Terminal Purging & Wipedown Following completion of work.3. This area forms the return air path to the motor/blower.8 Exhaust Filter Located on top of the Isolator. If the air flow is blocked by excessive buildup of particulate the performance of the cabinet could be seriously affected. g. The flow control plate located beneath the exhaust filter can be opened to decrease the pressure in the cabinet and to reduce the temperature.9 Shut Down Turn off blowers and lights.3. THE PAPER CATCH SHOULD BE CHECKED ON A ROUTINE basis if procedures dictate the use of paper products. The decontamination of the interior surfaces should be repeated after removal of all materials. After the preparations of every admixture. evidence of incompatibility. 6. The prefilters may also be replaced as necessary (see replacement parts list). the contents of the container are thoroughly mixed and then inspected for the presence of particulate matter. toward the back is an exhaust filter. This filter should be checked no less than twice a year. All rubber stoppers of vials and bottles and the neck of ampuls are sanitized with 70% isopropyl alcohol before the introduction of a needle or spike for the removal of product. allows the Isolator to run for 2-3 minute period without personnel activity to purge the unit. NuAire offers many ergonomic aids.4 Ergonomics Ergonomics. IF THE DISINFECTANT USED CONTAINS CHLORIDES OR HALOGENS. Evaluation criteria should be at a minimum: a.Always prepare your work procedure to eliminate glare and bright reflections on the window. Proper user posture b. • Vision and sightline . Cleaning under the worksurface and checking the paper catch should be performed on a routine basis depending upon product usage. Periodic mini-breaks during work practice should be taken resting forearm to avoid stress and fatigue.6.Always prepare your work procedure to minimize reach to avoid neck and shoulder stress and fatigue. Please refer to section 12.scientificvisions. Be sure feet are resting on the floor.com. Rotating tables are optional to maximum work zone and minimize reach. OM0141 NOTE: DISINFECTANTS THAT USE CHLORIDES AND HALOGENS WILL CAUSE DAMAGE TO THE STAINLESS STEEL SURFACES IF LEFT ON FOR LONG PERIODS OF TIME. Also. Use the following procedure too affectively clean or surface disinfect the Isolator work zone surfaces. Most surface disinfectants require a specific contact time. wipe up excess disinfectant. CONSULT APPROPRIATE DISINFECTANT DOCUMENTATION FOR PROPER APPLICATION AND SAFETY PRECAUTIONS. Remember to document all cleaning activities per Standard Operating Procedures (SOP’s) of your facility. 24 . • Forearm/armrest support . An evaluation of normal work practices should be performed with each user when working in an Isolator. Vision or sightlines For each of the above evaluation criterion. ) c. • Effective work zone layout .The Isolator is provided with glove ports that provide forearm support. Use soft lint free wipes for wiping process Recommended cleaners for polycarbonates are: • • • Formula 409 (for external surfaces only) Windex D w/Ammonia D (for external surfaces only) 70% Isopropyl Alcohol The use of polycarbonate has some important don’ts: • • Do Not use abrasive or high alkaline cleaners Do Not scrape with squeegees.5 Cleaning Procedures Cleaning the Isolator is an important function in terms of sterility.A six-way articulating seat and back control for personalized adjustment to assure proper user posture. Either raise the hinged window to a full-open position or leave closed cleaning through the gloves. several aids may be supplied to accommodate the user. chair foot support or foot rest. High use could be as frequent as monthly with low usage extended out to quarterly. or accommodation of work practices is extremely important for proper Isolator usage and user health and safety. Please visit our on-line store website at www. Apply appropriate disinfecting solution to Isolator surfaces. the study. RE-WIPE ALL SURFACES WITH 70% ISOPROPYL ALCOHOL OR SIMILAR NON-CORROSIVE ANTI-MICROBIAL AGENT TO REMOVE CHLORIDES OR HALOGENS PREVENING DAMAGE TO STAINLESS STEEL SURFACES. Keep your window clean and sightlines clear to your effect work zone. Effective work zone layout for work practice c. 6. razor blades. be sure back is fully supported with proper chair adjustments.0 for Polycarbonate material compatibility. • Ergonomic chair . a. After the specified contact time. or other sharp instruments. b. is not prone to induce allergic reactions. OM0141 25 . see insert. The NuAire selection of gloves provided on the Isolator was based on general usage. Reference ASHP and NIOSH for additional guidance documents. Nitrile. dissipates electrostatic charge as well. sleeve/glove replacement is largely dependent upon usage and wear. resists puncture and offers excellent abrasion protection. oils. offers strong resistance to most aromatic hydrocarbons. sterile. Other glove types may be used if desired or found to perform better for CAI users. gasoline. hexane. so more frequent replacement may be necessary. (See BCD-10484 for sleeve/glove replacement procedure. The NU-PR797 utilizes a smooth sleeve configuration for cleanability. and xylene.) Depending upon Isolator usage. either ambidextrous or form fit being at least 12 inches long. the glove can be removed from the sleeve. power-free. is made as a synthetic polymer.6. NuAire typically recommends sleeve/glove replacement on the following schedule: • Sleeves – Once every six months • Gloves . type. Nitrile offers great properties for both sleeve and glove application. isopropanol. In addition. is recommended for ethanol.6 Sleeve/Glove Usage The pharmagard Isolator utilizes Nitrile sleeves and gloves. fats. Nitrile: is flexible and shows outstanding tensile and compression stress qualities. and greases. acids. petroleum solvents. which is known as Butadiene Acrylonitrile. At a minimum. cost and availability. as well as the sleeve can be removed from the glove port. the gloves should be at least 6 mils thick. For NuAire NU-797 Isolator replacement gloves/sleeves.Once per week Of course. turpentine. This includes both certification as well as repair.27 x 1. Use duct tape and plastic to seal the exhaust area. The life rating of the bulb is 9000 hours based on three-hour burning cycles. (1.m) Note. Unplug the Isolator before decontamination equipment is plugged into these outlets or run the decontamination power cords under the front seal area.2 CAUTION: BE SURE ISOLATOR IS TOTALLY SEALED TO PREVENT ANY LABORATORY EXPOSURE TO DECONTAMINATION GAS. 7.m) -600 74 x 48 x 25 ¾ in. (1.ft. per NSF Standard 49. 5. ! 3. OM0141 26 . 3. Simply remove the acorn retaining nuts and washers and pull the lamp assembly off in a horizontal direction. 2.22 x .ft.22 x .7 cu. If fumigation decontamination is necessary. Fluorescent Lamp.1 POTENTIAL ELECTRICAL HAZARD ONLY QUALIFIED PERSON TO ACCESS 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.65m) 52. Annex G.0 General Maintenance ! ATTENTION ACCOMPANY'S INFORMATION OR IMPORTANT SYMBOL 188 191 CAUTION: 7. use the following procedure: 1. The lamp bulb is removed by displacing the bulb to one side against the compressible bulb holder. (1. 2. switch Isolator light switch off. it is necessary to remove the lamp assembly.65m) 35. 1. Annex G. To replace a bulb. using the following chart to calculate chemical requirements. (1. Place decontamination equipment inside the work area.50 cu. Decontamination No maintenance should be performed on the interior of the Isolator (area behind access panels) unless the Isolator is known to be chemically inert.7. Perform decontamination procedure per NSF Standard 49.88 x 1. The entire lamp assembly is held fixed to the front viewing by two stainless steel acorn nuts.01 cu. Surface disinfection is performed as specified in the cleaning procedures. rapid start and placed external to the Isolator to aid maintenance and minimize heat build-up within the Isolator. First. Reverse the procedure to reinstall the lamp assembly. Isolator Size Isolator Dimensions Isolator Volume -400 50 x 48 x 25 ¾ in. the outlets in the work area are energized as long as the Isolator is plugged in and switched on the front panel.9 cu. Reference decontamination procedure. Bulb Replacement The one (T8) fluorescent bulb is cool white. Remove the two filter clamp bolts by turning counter clockwise 2. Lift the permanent plenum and hold up with wire strap or clip. etc.18 m/s). b.7. To remove the intake or exhaust filter from top of Isolator: 1. OM0141 Pull up the frame free and remove the filter. To remove the supply filter: 1.3. Step 3: Filter Removal a. Remove nuts. 3. resting on the safety straps. 27 . The screws have O-rings and should be replaced if damaged or badly deformed. Relax the intake filter seal loading mechanism by turning the two nuts counter clockwise until one can see a definite release of the loading springs. Carefully remove the supply filter. The interior of the Isolator is now fully exposed for replacement of the filters and/or motor/blower. springs. Step 2: Remove front filter panel. 2. Step 1: Remove screws at each upper side of the control center and allow the control center to rotate down. The HEPA Filters should not be replaced until the entire Isolator is known to be chemically "clean". and lockwashers. This may permit the average downflow velocity to be as low as 35 LFPM (.3 HEPA Filter Replacement (Drawing BCD-10398) The HEPA Filter under normal usage and barring an accident (a puncture) do not need replacement until the downflow velocity cannot be maintained. which is held into position by Phillip pan head screws.1 Procedure CAUTION: Disconnect electrical power from the unit before attempting any maintenance action. CAUTION: Screws are used in lieu of acorn nuts. washers. 7. g. drop the front of the diffuser several inches and pull forward gently. Motor/blower voltages should also be monitored and recorded upon final calibration. Isolator pressure: OM0141 Work zone: 0. NuAire provides one adjustment to calibrate the airflow within the Isolator.7. Now the motor/blower is accessible through the top of the work zone. The motor/blower is secured to a mounting plate. The two test points to measure supply motor voltage is located on the main control module (see sketch below). After removing the fasteners. which can be accessed by removing the exhaust filter on top of the Isolator. 2. The Isolator is considered to be certifiable if the following airflow measurements are present: a.it is secured to the back wall of the Isolator with projecting studs. it is necessary to tilt the screen past the Isolators work zone edge. The motor voltage may be monitored using a digital voltmeter. When removing or installing. Airflow Calibration The NU-PR797 airflow calibration consists of adjustments to balance the airflow within the Isolator. which is secured by (4) fasteners. c. The diffuser is secured to the Isolator shell by #1/4-20 acorn nuts located immediately behind the front. The blower speed adjustment for supply airflow via motor voltage regulator located on the main control module.g. First. Rotate up control center and fasten in normal position b. remove the mounting plate.g. minimum Interchange: 0. THIS WORK SHOULD BE DONE ONLY BY A QUALIFIED TECHNICIAN WHO CAN MEASURE THE AIRFLOW FROM THE FILTERS WITH A SUITABLE VELOMETER. NOTE. 1. and then remove the motor/blower from the mounting plate. b.15" w.4 Motor/Blower Replacement ) NOTE: Supply filter must be removed to access both motor/blowers. and at least .18 m/s) minimum.05” w. Recirculating air inside the Isolator can impact the pressure and temperature of the Isolator. hinged window. Supply Blower Speed Adjustment/Motor Voltage Test Points b. 28 . Open hinged window and remove work zone supply diffuser. lower than workzone pressure. Downflow average: 35 fpm (. This can be adjusted by the flow control plate. minimum. Disconnect electrical connections as necessary to free motor/blower. 7. the diffuser is purposely a tight fit .5 Installation Re-install motor/blower by reversing the above steps.10" w. Supply Motor/Blower a. This is: a. Step 2: • If necessary.6 Downflow Calibration Step 1: • Raise hinged window to access workzone and place a velometer in the Isolator work zone on the horizontal plane 6 inches (152mm) from the supply diffuser. the HEPA filter media and seals must be directly accessible. PAO) should be supplied in the rear center of the workzone over the intake slots. Filter Integrity Check In order to check filter and filter seal integrity. The exhaust filter does not require testing on the positive pressure Isolator either. If a smaller differential pressure is needed than slide the baffle out from the worktray.BEFORE STARTING AIRFLOW CALIBRATION PROCEDURE.0. lower than the pressure in the main workzone chamber. since the airflow will be taken directly into the supply HEPA filter. drop the front of the diffuser plate several inches and pull forward gently.05”w. OM0141 29 . After removing the fasteners.2 7.5. LET THE ISOLATOR RUN FOR AT LEAST 10 MINUTES.it is secured to the back wall of the Isolator interior by a light push fit with projecting studs. If a greater differential pressure is needed. Step 3: • Proceed to pressure calibration Adjustment of Differential Pressure between Main Workzone Chamber and Interchange Chamber The pressure in the interchange chamber should be maintained at . adjust airflow control potentiometer.5. The diffuser plate placed below the HEPA to protect the filter during normal usage may be removed as follows: The diffuser is secured to the Isolator shell by #1/4-20 acorn nuts located immediately behind the front viewing window. then loosen the fasteners and slide the baffle beneath the worktray.g. by the measuring instrument. Spot check several points on the recommended downflow velocity test grid found in table 7.e. located on the main control module in the control center to the above stated airflow requirements.1 7. The intake filter does not require testing. Be sure to tighten the fasteners before returning to operation of the unit. Note that the diffuser is purposely a tight fit . The challenge material (i. 7. This pressure differential can be adjusted by changing the position of the slide baffle beneath the interchange worktray. 5 micron or larger particles at the appropriate measuring rate.64 (753) 35. Turn on Isolator and let warm up for several minutes.25 (743) 29. 7. Cleanliness Classification Test The Isolator cleanliness classification test is performed to assure compliance to ISO 14644-1.Table 7. No readings should be taken closer than 6 inches (152mm) from the inside perimeter. The particle count process would be to connect the input tubing to the test port provided on the Isolator both inside with several feet of tubing/sampling cone and outside. Downflow Measurement a.81 (300) 11.0 Recommended Measurement Methods for Isolator Downflow A. However. The grid location is designated as the workzone centerpoint and each corner measured 6-inches (152mm) from the inside perimeter. Procedure: Downflow velocities are measured on a grid. Downflow velocities are typically taken with the hinged window open. Recommended Instruments: Alnor 8500 or TSI 8355 Thermoanemometer b. Test Data .18 m/s) minimum. 2. OM0141 30 . Average downflow velocity > 35 fpm (. downflow velocities can be also taken with the hinged window closed. Record the 5 particle count values for each of the test points over the 1-minute sample time. downflow average velocities readings will be approximately 10% less than in the open position due to laminar airflow restriction of the Thermoanemometer reading. Turn on particle counter and flush out sample tubing line to remove latent particles.43 (595) 23. In the closed position. but still well above the minimum average downflow requirement./min. Cleanrooms and Associated Controlled Environments.91 (303) 17. Individual readings must be within +20 percent (factory) + 25% (field) or + 16 fpm of the average downflow velocity whichever is greater. in a horizontal plane 6 inches (152mm) below the supply filter diffuser. Take 5 test points in 1-minute intervals on a grid in a horizontal plane as measured by the centerpoint of the glove ports.55 (903) 41. Set the particle counter to measure 0.73 (663) 29. c.37 (1203) 53.25 (1353) 6 (152) 10 (254) 14 (356) Number of Readings: d. (m/s) Acceptance Criteria: 1.82 (453) 23.7 Average Velocity ft. The cleanliness classification test is performed using a particle counter to measure particle counts within the Isolator workzone.62 (448) 17.Inches (mm): 400 600 6 (152) 6 (152) 11. All final count values shall be less than 100 particles per cubic feet (ppcf) or 3520 particles per cubic meter (ppcm).46 (1053) 47. Part 1: Classification of Air Cleanliness. CAUTION: Disconnect electrical power from the unit before attempting any maintenance action. lockwashers and nuts.7. Turn on Isolator and let warm up for several minutes. sleeves and gloves. relay logic and an independent motor speed control.8 Enclosure Integrity Test The Isolator enclosure integrity test is performed to verify that no contamination entry points exist within the Isolator workzone. Set the particle counter to measure 0. The particle count process would be to connect the input tubing to the test port provided on the Isolator both inside with several feet of tubing/sampling cone and outside. sleeves and gloves. All final count values shall be less than 100 ppcf or 3520 ppcm. Record particle count values for each of the areas over the 1-minute sample time. 1 inch from internal interchange door perimeter seal. Turn on particle counter and flush out sample tubing line to remove latent particles. OM0141 31 . Scan all areas as described below in 1-minutes intervals.9 Main Control Board Description & Replacement The main control board consists of one Printed Circuit Board (PCB) assembly. The enclosure integrity test is performed using a particle counter to measure particle counts within the Isolator workzone in specific locations.e. All AC circuits are fuse protected and when replacement is necessary. USE ONLY FUSES OF SAME TYPE AND RATING FOR PROTECTION AGAINST RISK OF FIRE. glove port. a momentary surge or spike of particle counts may be an indication of particle intrusion and must be investigated and corrected. During the scanning process. window seal. The assembly consists of a power supply. 1 inch from perimeter of glove ports. All electrical connections are made with removable terminals and/or Faston connectors. i.5 micron or larger particles at the appropriate measuring rate. 1 inch from entire perimeter of hinged window gasket area. The main control board is fastened to the control center with (6) 6-32 studs. 7. Check voltage to blower on main control board in the control center and at bulkhead connector. If re-occurrence of the error indicator is immediate or daily. Let blower motor cool off for a minimum of 30 minutes to assure thermal protector is not open. use guide below to correct the situation.) Isolator outlets will not turn on. Check blower fuse on main control board in control center. Error Indicator Troubleshooting Guide Error Indicator OM0141 Indicator Correction Isolator fluorescent lights will not turn on. Check ballast. Check for short on main control board. Error indicators can be verified by turning the errored function on/off. motor voltage regulator. the audible alarm and error indicator will be presented and stay on until the error is cleared. Check light fuse on main control board in control center. Isolator blower will not turn on. Isolate output of circuit by disconnecting control center connectors. Blower/lights/outlet fuses continue to blow. Check voltage to light ballasts. Check blower capacitor. any or all red indicators display an error. (Note: blower motor has internal thermal protector. Step 2: VERIFY ERROR INDICATORS. please perform the following: Step 1: NOTE ALL ERROR INDICATORS. Check blower motor. Check voltage to outlets.0 Error Indicators & Troubleshooting Audible alarms and error indicators occur for a variety of reasons. 32 .8. When the cabinet is running. to isolate the short. When presented with an error indicator. Check outlet fuse on main control board in control center. etc. Check fluorescent lamps. Check wiring to blower. Whenever an alarm condition is present. light circuit. Step 3: MONITOR RE-OCCURRENCE OF ERROR INDICATORS. Contact ratings are 250 VAC maximum at 2 amps. NC. The contact points are located on main control module. 9. The contact points are located on the monitor within the control center. which are activated whenever the blower key is turned on.9. OM0141 33 .2 Pharmagard Digital Monitor Alarm Contacts (Optional) The optional Pharmagard Digital Monitor has alarm relay contact (COM.0 Remote Contacts 9.1 Fan Relay Contacts The fan relay contacts are single pole normally open or closed contact closure outputs. Contact ratings are 250 VAC maximum at 2 Amps. NO) whenever a pressure alarm occurs. Upon start up. The monitor also has alarm contacts.10. It is recommended that the monitor be calibrated during the certification process. This is accomplished through an offset calibration procedure. If the [RESET] key is pressed. Press [RESET] key to enter the alarm setpoint value. COM. it must stay on the alarm limit foe 5 seconds consistently or it will not recognize it as an alarm. • • • Press and hold [Ï] and [Ð] arrow key simultaneously for 3 seconds until the red LED blinks and the display alternates “In” and a pressure value. Use [Ï] and [Ð] arrow keys to adjust the display value desired.1. all segments displays. the audible alarm will sound. If the monitor is not functioning properly. the alarm should be silenced for 5 minutes. The monitor starts when the Isolator blower is turned on. then ring back 1 second every 10 seconds. However. The LED’s indicate acceptable pressure (green). NO.4 Audible alarm The audible alarm should be activated whenever the pressure reaches the high or low alarm setpoint. yellow and red LED’s will blink to indicate an error.1 Pharmagard Digital Monitor 10.1. 10. If the Isolator pressure remains low for more than 60 seconds. and LED’s will light and a short audible alarm will sound to indicate a properly functioning monitor. Once the 4-minute warm-up period is complete. the green. Use [Ï] and [Ð] arrow keys to adjust the display value to match the main workzone chamber pressure minihelic gauge. During the next 4 minutes. To verify or to change the alarm setpoints. (yellow) or alarm condition (red). low and 0. This will initiate a 60 second audible alarm delay for material movement purposes. To accomplish. the monitor will measure and display the current main workzone chamber pressure.1 General The pharmagard digital monitor uses an integrated digital pressure transducer to monitor positive pressure. The segment display is green and operates to + 0. The monitor is powered by 24 VAC supplied from the main control board.0 Optional Equipment 10. the alarm would be reset and silenced.3 High/Low Alarm Setpoint Calibration The pharmagard digital monitor is factory calibrated to 0. the Isolator’s pressure will decrease. sensitivity. Once the 5 second period of constant alarm is present. perform the following procedure.1. NC for external monitoring. OM0141 34 . the pressure returns to acceptable limits. perform the following once the Isolator has been certified to its proper airflow and the monitor is through the warm-up period.005” w. The monitor indicates through both a segment display and LED’s.g.g. then continue to ring back for 1 second every 10. If at any time. the audible should sound for 30 seconds. Press [RESET] key to enter the nominal pressure value (red LED will stop blinking and display will indicate pressure value). caution or near alarm points to within 0. once the alarm pressure is reached.1. The monitor will display the low setpoint and indicate a pending alarm.50” w.g.10” w. During external door openings.01” w. 10.2 Nominal Pressure Calibration The pharmagard digital monitor is factory calibrated to match the main workzone chamber minihelic gauge pressure value. the segment display will indicate dashes and green LED will blink during the warm-up period.g. high. All user interaction is accomplished through the arrow and reset keys. • • • Press and hold either [Ï] key for high alarm or [Ð] key for low alarm for 3 seconds until the red LED blinks and the display alternates either “Hi” or “Lo” and a pressure value. 10. OM0141 Description Sharps (small) Container BD# 305460 NuAire# X-980955-01 Waste Container 305465 X-980955-02 Sharps (Large) Container 305477 X-980955-04 35 . Upon removing a full Sharps container. or any BD medical system distributor.10. The SST tube is covered within the workzone with a machined plastic stopper with a post to push wrapper materials down into the waste container. www. Plastic bags maybe used with the waste container allowing the containers lid to close over the plastic bag for a tight seal. The waste container can be emptied by opening the semi-fastened lid. The waste container is located directly under the SST tube and held in place with a hinged platform.scientificvisions.2 Sharps/Garbage Disposal System for Non-Hazardous Drugs 10. NuAire utilizes BD medical system waste and Sharps containers and may be reordered through the NuAire online store. The waste container is locked into position with a handle tightner located on the side of the hinged platform. The waste containers top opening is inserted into the SST tube and sealed with a ring gasket as it is pushed up tight against the bottom of the Isolator.2. The waste chute is designed with a large sealed stainless steel (SST) tube that extends from the worksurface to just under the bottom of the Isolator.1 General (BCD-10481) The Sharps/garbage disposal system for non-hazardous drugs provides a unique method to dispose of Sharps and waste material within the Isolator during the Compounding Sterile Product (CSP) preparation process. the transport lid should be placed over the top opening and disposed of through the proper procedures of the facility. The Sharps container functions identically to the waste container except the contents cannot be emptied once full.com. The enclosure will be all metal grounded to earth. vapor phased Hydrogen Peroxide or Ethylene Oxide without degradation of Isolator materials. Pollution degree 2 assumes that normally only non-conductive pollution such as dust occurs with the exception of occasional conductivity caused by condensation. It depends on the nature of the electricity supply and its overvoltage protection means. which the instrument is designed to withstand safely.11. 1 Phase. 6 Amps 115V. 11. 60Hz.7 EMC Performance (classified for light industrial) Emissions: EN61326 Immunity: EN61326 (Note: The EMC performance requirements are generated within the product enclosure. the membrane front panel will also include a ground plane for maximum protection and an electrostatic shield. For example. In addition. CHLORINATED AND HALOGEN MATERIALS ARE NOT RECOMMENDED FOR USE ON STAINLESS STEEL SURFACES.1 Electrical (Supply Voltage Fluctuation Not to Exceed +/. the expected transient overvoltage is 2500 V for a 230 V supply and 1500 V for a 120 V supply.4 Installation Category: 2.5 Pollution Degree: 2. 60Hz.3 Light Exposure Standard Fluorescent Lighting @ 150 ft. 11.0 Electrical/Environmental Requirements 11. 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.60% Relative Humidity Environment Altitude: 6562 Feet (2000 meters) maximum 11.10%) *NU-PR797-400 *NU-PR797-600 115V.30°C) Environment Humidity: 20% . Chamber decontamination can be accomplished by paraformaldehyde.0 Pollution degree describes the amount of conductive pollution present in the operating environment.0 Installation category (overvoltage category) defines the level of transient overvoltage.2 Operational Performance (for indoor use only) Environment Temperature Range: 60°F-85°F (15°C . 11. OM0141 36 . 8 Amps *UL/UL-C Listed 11. 11.6 Chemical Exposure Chemical exposure should be limited to antibacterial materials used for cleaning and disinfecting. 1 Phase. candles (1614 LUX) maximum intensity. ) Acetone Acrylonitrile Ammonia Ammonium fluoride Ammonium hydroxide Ammonium sulfide Benzene Benzoic acid Benzyl alcohol Brake fluid Bromobenzene Butylic acid OM0141 Carbon tetrachloride Carbon disulfide Carbolic acid Caustic potash solution (5%) Caustic soda solution (5%) 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 Methylene chloride Nitrobezene Nurocellulose lacquer Ozone 37 Phenol Phosphorous hydroxy chloride Phosphorous trichloride Proplonic acid Pyridine Sodium sulfide Sodium hydroxide Sodium nitrate Sylfuric acid (1%) Tetrahydronaphthalene Thiophene Toluene Turpentine Xylene .1 Polycarbonate sheet is resistant at 70° to these chemicals.0 Polycarbonate Material Compatibility 12. Acetaldehyde Acetic acid (conc.2 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 Polycarbonate sheet is not resistant to these chemicals.12. 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 12. RECYCLE Component Base Cabinet Front Grill Worksurface Window Window Frame Front Service Panel Control Center Supply Diffuser Supply HEPA Filter Inlet/Exhaust Filter HEPA Filter Frames Impeller Motor Printed Wiring Assembly Wire Ballasts Connectors Hardware Interchange Wall Interchange Door Glove Port ) OM0141 LEAD FREE Material Stainless Steel Stainless Steel Stainless Steel Polycarbonate Stainless Steel Painted Steel Painted Steel Aluminum Aluminum / Glass Media Galvanized or Aluminum Painted Steel Aluminum Various Steel/Copper Lead Free Electronic PVC Coated Copper Various Steel.0 Disposal and Recycle Cabinets that are no longer in use and are ready for disposal contain reusable materials. state and federal guidelines for disposal of HEPA filter solid waste. ALL components with the exception of the HEPA filters may be disposed and/or recycled after they are known to be properly disinfected. CAUTION Prior to any disassembly for disposal. the cabinet must be decontaminated. 38 .13. ) NOTE: ! Follow all local. Electronic Nylon Stainless Steel and Steel Stainless Steel w/PVC Polycarbonate PVC NOTE: Material type can be verified with use of a magnet with stainless and aluminum being non-magnetic. OM0141 39 . OM0141 40 . OM0141 41 . OM0141 42 . OM0141 43 . OM0141 44 . OM0141 45 . OM0141 46 .