Germfree VersaFlow User Manual Download

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Germfree - VersaFlow

Compounding Aseptic Isolator User Manual - v1.0 - 15SEP2021 - RMH

VersaFlow

Compounding Aseptic Isolator

User Manual

Summary of Contents for VersaFlow

Page 1: ...Germfree VersaFlowTM Compounding Aseptic Isolator User Manual v1 0 15SEP2021 RMH VersaFlow TM Compounding Aseptic Isolator User Manual ...

Page 2: ...ct Protection 9 HEPA Filtration Theory 10 Unidirectional Laminar Air Flow 11 Components Identifier 12 Front of VersaFlow 12 Inside the Work Area 12 Control Panel 14 Side View 14 Initial Cleaning 15 Exterior 15 Interior 15 Operation 16 Proper Aseptic Technique 17 Cleaning the VersaFlow Heavy Duty Rigorous 18 Exterior 18 Interior 18 Inside the Interchange Chamber 19 Cleaning the VersaFlow Between Pr...

Page 3: ...oves While Maintaining Containment 29 Alarm 30 Troubleshooting for Alarm Sounding 30 Available Options 31 Electronic Height Adjusting Stand 31 Sealed Data Port 31 Additional Options 31 Parts List 32 Quality Statement 33 Our Company 33 Germfree s Mission 33 Appendix A Sensocon User Manual ...

Page 4: ...ed If the carrier will not perform this service please contact our factory immediately at 1 386 265 4300 ask for the shipping department Without this inspection of the equipment and packing materials the freight company may not accept a claim for damage or loss and take the position that the damage occurred after delivery Contact Germfree Customer Service 1 386 265 4300 cs Germfree com Packaged Ve...

Page 5: ...cked in Interchange Chamber 1 Pre assembled Sleeves and Gloves 2 Maintenance kit the white box User Manual Stoppers for Waste Sharps Tubes Keys for Front Lock Complimentary set of Gloves Yellow Electrical Outlet Cord 3 Alcohol Wipes 4 Any additional purchased sleeves ...

Page 6: ... 15 amp 10 hospital grade power cord for standard wall outlet It is essential that the equipment be properly grounded it is a violation of your warranty to operate without For service to the unit it is essential that the power cord outlet be easily accessible If the Electrical Height Adjustment option was purchased it requires its own power receptacle and a 15 amp circuit on all sized units ...

Page 7: ...thin limits and the unit is performing properly It is always a good idea to review basic operation of your new VersaFlow with the certification company personnel due to their knowledge of this type of equipment The VersaFlow certification needs to be performed by a company that has the proper equipment and training needed to test and measure HEPA filter performance Recertification of the VersaFlow...

Page 8: ...r operator technique 4 Understanding chemical compatibilities for proper glove selection 5 Understanding chemical compatibilities for proper cleaning and sterilization 6 Understanding chemical compatibilities for proper decontamination 7 Understanding sterile product preparation and aseptic technique 8 Understanding hazards associated with the products handled in the VersaFlow 9 Understanding prop...

Page 9: ... air to the complete work environment The unit utilizes a full width and depth supply HEPA filter above the work surface This provides a better than ISO Class 5 particulate free environment Particulates generated by manipulations are continuously removed maintaining ISO Class 5 or better conditions when operational All air entering the VersaFlow is twice filtered once by the pre filter then by the...

Page 10: ... one of the finest forms of mechanical air filtration available for this application HEPA filters improve or become more efficient as they load under use There are a number of mechanisms involved in HEPA filtration which is briefly presented below 1 Impingement Large particulates e g dust are captured by the filter fibers as the air stream flows around the fibers 2 Interception Particulates follow...

Page 11: ...ions and Biological Safety Cabinets The Compounding Aseptic Isolator utilizes a full width and depth supply HEPA filter above the work surface Any particle laden air is swept from the work area with a wash of HEPA filtered air Filtered air washes over the work area into the front and rear grilles Particles that are generated by the work are immediately washed into the returns and out of the work z...

Page 12: ...fier Front of VersaFlow 1 Prefilter Housing 2 Control Panel 3 Light Housing 4 Gloveports 5 Viewing Panel 6 Interchange Chamber 7 Door Latch 8 Optional Electric Lift Height Adjustment Switch 9 Casters Inside the Work Area 1 IV Bar 2 Inner Interchange Chamber Door 3 Work Tray ...

Page 13: ...VersaFlowTM Compounding Aseptic Isolator User Manual 13 1 Diffuser Screen 2 Electrical Outlet 3 Optional Sealed Data Port ...

Page 14: ... Breaker Switch 6 Light Switch 7 Light Cable 8 Speed Control for certifier use only 9 Audible Alarm On Off Switch 10 Interchange Chamber Purge Timer Audible Alarm should remain on at all times during operation Side View 1 Supply HEPA Filter and Motor Housing 2 Main Power Cord 3 Junction Box for Work Area Electrical Outlet 4 Gas Shock Window Lift 5 Optional Sealed Data Port ...

Page 15: ...t or a solution specifically designated for the cleaning of acrylic surfaces Do not use ammonia based cleaner on the acrylic It is important to never use abrasive cleaners or organic solvents on the acrylic components Additionally the acrylic should not be cleaned with any solution stronger than 50 ethyl or 70 isopropyl alcohol Interior Open the front access window and allow the VersaFlow to conti...

Page 16: ...ne interchange chamber door before opening the other 13 Place compounding elements into the interchange chamber wipe down 14 Remove hands from the interchange chamber and close 15 Wait at least 10 seconds before bringing compounding elements into work area 16 Begin preparation 17 Dispose of waste through the sliding interchange chamber door using the sealed bag method 18 Remove completed preparati...

Page 17: ...the environment is not cleaned well or the operator s technique is poor an aseptic media fill test will usually reveal the inadequacies Never block air grills do not operate without gloves or sleeves or place anything other than compounding elements in the work area or this will compromise the workability of the unit During operation be sure to disinfect and sanitize the work area at the beginning...

Page 18: ...n front of the work area to the rear 1 Open the front access window 2 Spray disinfectant cleaner on a lint free cleaning wipe Wipe the filter diffuser in the top of the work area wiping from side to side overlapping strokes Work outward from back to front 3 Do not spray cleaners directly toward the Supply HEPA filter always spray the cleaner onto the cleaning wipe then clean the filter protector s...

Page 19: ...e the front access window 14 Spray 70 IPA directly on all surfaces of the rest of the work area under sliding work trays the inside of the front access window gloves and sleeves 15 Allow the VersaFlow to run for 10 minutes before use Inside the Interchange Chamber 1 Follow the same steps as cleaning the inside of the VersaFlow ...

Page 20: ...s 3 Leave the spray bottle in the interchange chamber and close the outer interchange chamber door 4 Open the inner interchange chamber door and remove the spray bottle 5 Spray all vertical surfaces in the work area with alcohol and wipe from top to bottom with clean wipes Use overlapping strokes moving left to right 6 Spray the air grills and work surface with alcohol and wipe from left to right ...

Page 21: ...each Solutions Sodium Hypochlorite Clorox Cyosan Purex Quaternary Ammonium Compounds QUATS Ordinary housekeeping of floors furniture walls bactericide fungicide viricide not as effective as phenols Quatsyl Coverage 258 End Bac Hi Tor Decon QUAT 100 By Veltek Lysol IC Alpha Lemon QUAT by Alphasource Cleaning Agents This list is by no means comprehensive nor does it constitute endorsement by Germfre...

Page 22: ...ng so as to destroy or prevent the growth of disease carrying microorganisms 3 To free from infection especially by destroying harmful microorganisms Sanitization 1 That part of decontamination that reduces viable microorganisms to a defined acceptance level normally achieved by using a chemical agent or heat 2 To make sanitary as by cleaning or sterilizing if the apparatus is not properly sanitiz...

Page 23: ...d and rotate it one quarter turn clockwise This should put the end prongs in line with the loading slot 5 Slide the bulb free 6 Lower the end of the bulb carefully out of the socket When one end is free pull slightly and the other end should come out also 7 Set the old bulb aside and lift a new bulb into the fixture 8 Hold the bulb horizontally and rotate the new bulb until the prongs on each end ...

Page 24: ...the supply HEPA filter Regular replacement of the prefilter will lengthen the life of your supply HEPA filter One digital pressure gauge is an indicator of differential pressure between the blower inlet and the Supply HEPA filter It is a qualitative indicator of the HEPA filter condition Your certifier should note the starting pressure and monitor it periodically A large change in readings in a sh...

Page 25: ...eeve O ring clamp rubber ring that can stretch to fit around the 10 gloveport 1 Pull the Glove and Sleeve out of the work area so that the sleeve is inside out and pull the existing glove and securing O rings off 2 Fold the sleeve back over the GOS so that the end of the sleeve is even with the end of the GOS 3 Stretch the O ring clamp over the sleeve and secure in the last groove of the GOS the o...

Page 26: ...VersaFlowTM Compounding Aseptic Isolator User Manual 26 ...

Page 27: ...7 TIP Stretching the new glove cuff with both hands before trying to stretch it over the GOS will sometimes make the task easier as well as identify weaknesses in the glove before you get it into the work environment The thumb of the glove should point up ...

Page 28: ...VersaFlowTM Compounding Aseptic Isolator User Manual 28 ...

Page 29: ...pointed up 5 Stretch the new glove s cuff over the old one up to the middle groove of the GOS 6 Secure the new glove with the glove O ring at the middle groove of the GOS 7 Push the glove and sleeve back into the work area 8 Reach into the work area through another glove and grab the new glove assembly At this point the glove exposed to the work area is the old glove with the new glove trapped beh...

Page 30: ...ve or negative overall pressures Troubleshooting for Alarm Sounding Possible Cause Corrective Action Glove Rip Tear Removal Replace Glove Sleeve Rip Tear Removal Replace Sleeve Inner Interchange Chamber Door open Close Inner Interchange Chamber Door View Panel not Sealed Ensure latches are fastened on view panel Pressure Hose Disconnected Reconnect small tube between control panel and work area Af...

Page 31: ...gram up to four height settings When using the height adjustment it requires a five minute rest period between adjustment cycles Sealed Data Port The next page gives instructions on how to use the sealed cable pass through if your unit is so equipped You will find the vial of lubricant that is mentioned in the instructions in your maintenance kit Use caution when setting the pass through up as it ...

Page 32: ...0 A Speed Control 170 0030 00 A Green Lighted Switch Motor 001 1000 06 Supply Motor Sleeves SLV ADD 10 Additional Pair of Butadyl Hypalon Sleeves for VF 4 VF 6 VF 64 SLV ADD 8 Additional Pair of Butadyl Hypalon Sleeves for VF CT 001 1000 03 A 3 Groove GOS for Two Part Glove Sleeve with 4 O Rings 396 0005 00 A Black O Rings for Gloveport qty 1 001 1000 13 A Orange O Rings for GOS Trashport qty 1 Ac...

Page 33: ...ble as permanent facilities in remote regions with harsh conditions Quality Statement Accountability We will deliver our products on time as promised and free from defects Ownership We will strive to exceed expectations at every level and we will work to make sure that each customer is satisfied with the service that they receive Longevity All of our products are constructed from the highest quali...

Page 34: ...VersaFlowTM Compounding Aseptic Isolator User Manual Appendix A Sensocon User Manual ...

Page 35: ...Bulletin 102 0 Installation and Operation Manual Series A3 and A4 Differential Pressure Controller Sensocon Inc Phone 863 248 2800 Fax 863 248 2798 www sensocon com ...

Page 36: ... Specifications 1 3 Dimensional Drawings 2 Installation 2 1 Mounting 2 2 Pressure Connections 2 3 Electrical Connections 3 Operation 3 1 Display 3 2 Key Function 4 Programming 4 1 Menu Structure 4 2 Security Level 4 3 Main Menu 4 4 Set Up Menu 4 5 Secure Menu 5 Other Features 5 1 Moving Program Variables 5 2 Opti Link 5 3 Limited Warranty ...

Page 37: ...utput and improved accuracies There is also a low cost weatherproof cover available for outdoor applications Example A3110 06 Description Model A Round Panel Mount Housing 3 LED display process arch LCD Display 4 LED display process arch OLED Control 1 Control 2 SPDT relays 0 None Transmitter 1 4 20 mA 0 1 Accuracy 1 0 50 01 0 0 50 02 0 1 03 0 2 04 0 3 05 0 4 06 0 5 07 0 8 08 0 10 09 0 15 10 0 20 ...

Page 38: ...ce with optional cover the entire product is weatherproof Relays 2 SPDT 8 Amps 250 VAC 5A 30 VDC Electrical Connections screw terminals Response Time 100 ms Display 4 Digit red LED digits LCD or OLED programming display Process Connection Push on connection for 3 16 tubing Agency Approvals Pending UL C UL CE Patents Pending Custom calibrations including improved accuracy and improved thermal effec...

Page 39: ...control with the provided gasket through the hole and secure it to the panel with the provided mounting tabs and screws Retrofitting old technology is also easy with the Series A3 and A4 They have been designed to fit in industry standard holes ranging from 4 9 16 to 4 13 16 so simply remove the old device and insert the new control into the existing cut out 2 INSTALLATION 2 1 Mounting ...

Page 40: ...he weather proof cover has been attached the control can be mounted to any flat surface with the four mounting screws provided with the cover Flush Mounting with Weather Proof cover The Series A3 and A4 can also be flush mounted with a weather proof cover The procedure is the same as above but utilizes two extra long mounting screws provided with the weather proof cover for the bottom two panel co...

Page 41: ...the front display will give a positive value If the HI connection has a lower absolute value than the LO connection the front display will give a negative value NOTES 1 Supply Voltage is universal from 16 265VAC or VDC 2 For internally sourced 4 20 mA loop maximum loop resistance is 750 Ω for externally sourced loop at 36 VDC maximum loop resistance is 1800 Ω 3 Isolation Relays 1000 VAC to all oth...

Page 42: ...show either 3 or 4 digits based on the users preference The LCD or OLED display is used for programming and displaying the unit of measure and up to 4 other user selected program parameters The LED indicators for SP1 SP2 and Alarm give indication when the parameter is in the actuated state The A3 and A4 have four buttons located on the face of the control used for programming There is an up arrow ...

Page 43: ...he accept button for three seconds this will accept the change and take you back to the menu you were currently in At any point while in a parameter change screen you can hold the cancel button for one second to return to the previous menu without accepting a change to that parameter To manually reset the alarm after an alarm condition has occurred if this feature is used hold the right and left a...

Page 44: ...p value Screen Saver Saver Off On Contrast Contr N lo N med N hi I lo I med I hi K Factor Kfact value Duct Shape Xsect circ rect Duct Diameter diam value Duct Width X dim value Duct Height Y dim value Zero Zero Reset Span Span value Reset Access Access Main Set up Secure none Factory Default Reset No Yes Process Output Lo pol value Process Output Hi poh value Secure Menu Current Power source P S O...

Page 45: ... Set Point is selected there will be no parameters for Set Point 2 or Alarm in the programming 1 Set Point 1SP For control with one SPDT relay 2 Set Point 2SP For control with two independent SPDT relays Set Point Alarm SPAL For control with one SPDT relay and one alarm relay Alarm AL For alarm operation only Set Point Settings Set 1 Set 2 Each set point can be entered as a high and low value for ...

Page 46: ...OFF OFF ON ON ON Relay Action Direct Acting Reverse Acting DB direct acting DB reverse acting Actuation 1 act 2 act The actuation parameter determines whether the relays will react to increasing or decreasing pressure This parameter also affects the status of the LED indicators on the front of the gauge The above graphs illustrate the differences Direct The relays turn on with increasing pressure ...

Page 47: ...e the relay when the process is below the low alarm set point The high and low alarm can be used together so the alarm relay is actuated when the process is above or below the high alarm and low alarm set points respectively The selection will dictate which alarm parameters are shown in the Main Menu The below figure shows the three alarm types High Alarm hi High alarm Low Alarm lo Low alarm High ...

Page 48: ...ed since the last time it was reset value Allows the user to manually reset the value Mode Mode The control is capable of measuring and displaying pressure velocity or flow For velocity and flow a flow sensing device such as a pitot tube or orifice plate with a know flow coefficient is required For flow it is also necessary to know the dimensions of the duct that the flow is being measured in so t...

Page 49: ...40 0 036 0 074 1 868 2 491 249 1 0 249 0 578 2 000 0 167 50 80 5 080 0 072 0 147 3 737 4 982 498 2 0 498 1 156 3 000 0 250 76 20 7 620 0 108 0 221 5 605 7 473 747 3 0 747 1 734 4 000 0 333 101 6 10 16 0 145 0 294 7 473 9 964 996 4 0 996 2 312 5 000 0 417 127 0 12 70 0 181 0 368 9 342 12 45 1245 1 245 2 890 8 000 0 667 203 2 20 32 0 289 0 588 14 95 19 93 1993 1 993 4 624 10 00 0 833 254 0 25 40 0 3...

Page 50: ...ntrast Contr This allows the image and contrast of the programming display to be adjusted Normal low N lo Normal image low contrast Normal medium N med Normal image medium contrast Normal high N hi Normal image high contrast Inverted low I lo Inverted image low contrast Inverted medium I med Inverted image medium contrast Inverted high I hi Inverted image high contrast K Factor Kfact For flow and ...

Page 51: ...revent tampering Once this parameter is set a security code must be entered to regain access to the locked menus as shown in the below table This feature can be used in conjunction with moving program variables section 5 1 to grant or restrict access to specific variables Secure menu Secure Selecting Secure will give the user access to all menus Set up menu Set up Selecting Set Up will give the us...

Page 52: ...current loop The programming menu can be fully customized by the user Parameters can be moved from one menu to another This allows the user to reorganize the menu structure to better fit their needs or to put unused or unwanted parameters in one menu and then lock that menu so that those variables can not be accessed To move a program parameter to another menu highlight the parameter to be moved a...

Page 53: ...te the program has been successfully uploaded to the control LIMITED WARRANTY SENSOCON warrants its products to be free from defects in materials and workmanship for a period of one 1 year from the date of shipment subject to the following terms and conditions Without charge SENSOCON will repair replace or refund the purchase price at SENSOCON s option products found to be defective in materials o...

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