Germfree VersaFlow User manual

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

VersaFlowTM
Compounding Aseptic Isolator
User Manual
2
Contents
Receiving Instructions .................................................. 4
Packaged VersaFlow.............................................. 4
Unpacking the VersaFlow ......................................... 4
Contents Packed in Interchange Chamber .......................... 5
Electrical Requirements................................................. 6
Certification ........................................................... 7
Safety, Operation and Additional Professional Training .................... 8
Product 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 Preparations (Light) ..................... 20
Cleaning Agents ....................................................... 21
Cleaning Terms ........................................................ 22
Light Bulb Replacement ................................................ 23

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Filters ................................................................. 24
Gloves ................................................................ 25
Changing Gloves 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

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Receiving Instructions
The Compounding Aseptic Isolator is shipped fully assembled in a single crate. All equipment must be inspected
immediately upon receipt. If there is visible damage to the container or unit it must be noted on the receiving
documents by the driver. The carrier must then be notified to arrange for an immediate inspection to verify the
damage to the equipment. If damage to the unit is found aer it is uncrated (concealed damage), the receiver
should notify the delivering carrier at once. Do not move the equipment or discard any of the shipping materials
until a concealed damage inspection is performed. 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 aer delivery.
Contact Germfree Customer Service
+1 386.265.4300
[email protected]
Packaged VersaFlow
• The VersaFlow is on a skid with a riser to prevent
movement during shipment.
• The unit is stretch wrapped and strapped to the
skid.
• Protected by corrugated cardboard.
• The skid is accessible for a pallet jack.
Unpacking the VersaFlow
• Remove the corrugated cardboard.
• Remove the metal strapping.
• Remove stretch wrap.
• 3-4 people may be needed to li the VersaFlow off
the skid.
**Caution: The VersaFlow is top heavy**
• Unlock the casters and roll the VersaFlow to its final
destination.

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Contents Packed 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

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Electrical Requirements
VersaFlow-4USP 115V, 60 Hz, 15 amp, 10’ hospital grade power cord for standard wall outlet
VersaFlow-6USP 115V, 60 Hz, 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.

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Certification
The Compounding Aseptic Isolator is a complete and self-contained unit whose performance was tested and
documented before shipping. It requires certification aer the unit has been installed and prior to operation.
This is especially important aer transportation of the VersaFlow from our factory to your facility. The purpose of
this retesting is to verify that the HEPA filter, airflows and pressures are within 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 needs to be performed
every 6 months or as regulations dictate.
For a certifier listing in your area if you do not already have service, go to www.Germfree.com and visit our
Hospital Pharmacy Resource Center. For any additional information please contact Germfree at +1 386.265.4300.

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Safety, Operation and Additional Professional
Training
The VersaFlow provides a contained environment that allows for greater protection for both personnel and
product than traditional open front laminar flow equipment. However, this protection can only be achieved
through proper technique. The following is a list of topics that may apply to your operation. Many of these items
may require additional professional study and practice beyond the information found in this manual.
1. Operation of the VersaFlow
2. Understanding HEPA particulate filtration
3. Proper 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 proper maintenance and initial and periodic certification
10. Understanding Federal, State and Local applicable professional regulations.
To obtain this information and understanding may require additional professional training. If you need
assistance in finding Professional Pharmacy Organizations offering additional training for any of the above items
please call Pharmacy Equipment Sales at Germfree, +1 386.265.4300.

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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Product Protection
The Compounding Aseptic Isolator offers the highest level of product protection by providing vertical
unidirectional (laminar) flow HEPA filtered air to the complete work environment. The unit utilizes a full width
and depth supply HEPA filter above the work surface. This provides a beer than ISO Class 5 particulate-free
environment. Particulates generated by manipulations are continuously removed, maintaining ISO Class 5 or
beer conditions when operational. All air entering the VersaFlow is twice filtered, once by the pre-filter then by
the supply HEPA filter.

VersaFlowTM
Compounding Aseptic Isolator
User Manual
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HEPA Filtration Theory
The Compounding Aseptic Isolator uses HEPA (High Efficiency Particulate Air) filters to provide the highest
level of product protection. These filters are the laminar flow supply HEPA filter, which filters all air passing over
the entire work area. All filters are rated to remove particulates and aerosols 0.3 micron in size with a minimum
efficiency of 99.99%. These filters are even more effective at removing particulates both larger and smaller than
0.3 microns as the graph below depicts. Personnel and product protection from gas and fumes are not provided
by HEPA filtration.
HEPA filters are recognized as 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 air stream around filter fibers and become captured (physical
interference between particles and fibers).
3. Diffusion - Very small “particles” are bombarded by gas molecules causing them to move erratically
(Brownian motion) and contact the filter fibers.
4. Straining - Occurs when the smallest dimension of the particulate is greater than the distance between
adjoining filter media fibers.
5. Electrostatic attraction - Enhances mechanical capture through attraction of oppositely charged
particles.