Germfree CSE Series User manual
Germfree - CSE User Manual - v1.1 - 10AUG2023 - RMH
Compounding Safety Enclosure (CSE Series)
User Manual
CSE Series
Compounding Safety Enclosure
User Manual
2
Contents
Introduction ........................................................... 3
Installation ............................................................ 4
Unpacking ...................................................... 4
Crate Contents................................................... 4
Set-Up .......................................................... 4
Operation ............................................................. 5
Geing Started .................................................. 5
Advance Planning and Good Technique ............................ 5
Maintenance .......................................................... 6
Lighting ......................................................... 6
Cleaning and Decontamination ................................... 6
Tests and Results ....................................................... 7
Airflow Velocity .................................................. 7
Airflow Paerens................................................. 7
HEPA Filter Integrity Tests ......................................... 7
Equipment Drawings ................................................... 8
CSES-4SS ....................................................... 8
CSES-6SS ....................................................... 9
Electrical Schematic .................................................... 10
Parts List .............................................................. 11
Quality Statement ..................................................... 12
Our Company ......................................................... 12
Germfree’s Mission .................................................... 12
CSE Series
Compounding Safety Enclosure
User Manual
3
Introduction
Your Compounding Safety Enclosure is designed to provide the operator with maximum protection from
particulate or aerosol contamination. The unit consists of a main work area with one (CSES) or two (CSED)
large hinged doors for the ingress and egress of large pieces of equipment before the unit has been put into
operation. Above the work area are pre-filters that swing down into the work area for changing. The pre-
filters remove large particles from the air prior to entering the HEPA Filter, thus extending the HEPA filter’s life.
The Compounding Safety Enclosure is designed to circulate 100% of the air volume drawn through the front
window(s) back into the ambient environment. The Compounding Safety Enclosure draws the air in through the
sash opening, then up through the filters, providing a wash of particulate laden air away from the user.
The Compounding Safety Enclosure is made from the highest quality materials including 14 and 16 ga. stainless
steel and ¼” Acrylic. The stainless steel surfaces inside the hood are impervious to most chemicals and are
easily cleaned. With minimal maintenance, your Compounding Safety Enclosure will add to the beauty and
utility of your Pharmacy for many years.
Contact Germfree Customer Service
+1 386.265.4300
CSE Series
Compounding Safety Enclosure
User Manual
4
Installation
Unpacking
The unit is shipped in a single crate to be fully assembled, ready to be moved to its final location, with an
additional crate for the stand (optional) . 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 aer 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 the factory immediately at +1
386.265.4300. Without this inspection of the equipment and packing materials, the Freight Company may not
accept a claim for damage or loss.
Crate Contents
The crates should contain the following components:
• Complete Compounding Safety Enclosure
• Stand for Compounding Safety Enclosure (OPTIONAL)
• Box of stainless steel and acrylic cleaning supplies
Set-Up
To set up the unit, simply place the unit on the table or stand where it is to be used and connect to an
appropriate power supply. Prior to operation it is recommended that a complete wipe down of the entire unit be
performed to remove any gross particulate contamination. It is also recommended the unit be tested by a third
party certification company prior to use.
CSE Series
Compounding Safety Enclosure
User Manual
5
Operation
Getting Started
You will need one standard 15-ampere outlet to operate this system. Aer the unit has been installed and
connected to the electrical power supply, it can be turned on. The two lighted switches on the control panel
indicate the operation of the fan and fluorescent lights. The unit includes a variable speed motor control located
behind a plug on the control panel (casual adjustment is not recommended).
Advance Planning and Good Technique
The successful use of the Compounding Safety Enclosure as a safety tool depends on two factors: advance
planning, and good operating technique. Even the most sophisticated and elaborate systems would be
unsatisfactory if proper technique were not employed. It is therefore the responsibility of the pharmacy
Supervisor or head of the particular project to train the personnel who will use the unit and to see that good
technique is maintained. If this is not done, a false sense of security may prevail.
To achieve maximum safety during the use of your Compounding Safety Enclosure, you should take into
account the equipment and materials necessary for the proposed operation and outline the procedural details
for your particular operations. The best way to accomplish this is the use of a checklist and/or protocol that
would include the equipment, apparatus, tools and supplies necessary for the anticipated procedure. The list
should include the order of events and other details necessary for the successful completion of the proposed
operation. Particular detail should be given to the sequence in which materials must be passed into or out of
the Compounding Safety Enclosure through the front window opening.
CSE Series
Compounding Safety Enclosure
User Manual
6
Maintenance
Lighting
The unit is equipped with fluorescent lights, which are aached to the front access panel. These bulbs can
be changed by removing the light housing and twisting the bulb. If it is necessary to change the ballast, it is
located in the motor housing below the removable perforated screen. Both the fluorescent tubes and ballast
should be available from a local lighting supply or hardware store.
Cleaning and Decontamination
The acrylic surfaces of the CSE series can be periodically cleaned with a so dry cloth to remove dust or
particulate accumulation. If desired, a solution of 50% IPA, or 5% bleach, or commercially available detergent
may be used to decontaminate the acrylic surfaces. The following cleaners are INCOMPATIBLE with the acrylic
surfaces – acetone and abrasive cleaners. For aesthetic purposes, an anti-static cleaner may be applied to the
acrylic to prevent accumulation of particulates on the exterior. UV radiation will adversely affect the acrylic
surfaces and should not be used as a germicide in the CSE series. Additionally, the unit should be placed in a
location that is not exposed to direct sun light.
The stainless steel is impervious to most chemicals, and can be cleaned with any solvent or stainless steel
cleaner. However, if your floor is routinely cleaned with strong solutions of sodium hypochlorite, care should be
taken to avoid repeated exposure of the stainless steel legs on the stand.
Additionally, care should be taken when cleaning around the optional HEPA filter to not spray any liquid directly
on the filter. If the filter is accidentally weed, it does not necessarily mean the filter is damaged. However, the
unit should be turned off until the filter is dry. If the amount of liquid is excessive, a recertification might be
warranted.
CSE Series
Compounding Safety Enclosure
User Manual
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Tests and Results
Airflow Velocity
The inward air velocity is measured across the plain of the sash opening. The velocities are set to be
approximately 50-70 fpm average. This velocity range is chosen to minimize the turbulence in the air. Velocities
outside of this range are not desirable. To assure the air velocity does not increase to a point where containment
may be lost due to turbulence, the motor speed should not be adjusted without assistance from a certifier or
industrial hygienist.
Airflow Patterens
The airflow paerns can be viewed by passing a smoke source around and through the sash opening and
observing the smoke as it enters the fumehood and is drawn through the unit. The smoke should pass directly
through the unit with a constant wash of air across the work deck. The air should flow into the hood with no
reflux out of the front window opening.
HEPA Filter Integrity Tests
The velocities are set to the specified range and the unit is allowed time to flush all ambient particles from the
work area. A poly-dispersed, aerosolized DOP is introduced into the upstream filter plenum. A concentration
of at least 10 micrograms per liter is introduced. The downstream filter face is then scanned for aerosol
penetration. The penetration shall not exceed .01% at any point. The HEPA filters in the Laminar flow hood are
rated to be 99.99% efficient.
CSE Series
Compounding Safety Enclosure
User Manual
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Equipment Drawings
CSES-4SS
CSE Series
Compounding Safety Enclosure
User Manual
9
CSES-6SS
CSE Series
Compounding Safety Enclosure
User Manual
10
Electrical Schematic
CSE Series
Compounding Safety Enclosure
User Manual
11
Parts List
ITEM DESCRIPTION MFG PART NO.
HEPA Filter 99.99 % eff. HEPA Corp. 22”x42”x3” 4 foot units
“ “ “ 22”x66”x3” 6 foot units
Pre Filter Pleated Varies 20”x22”x1” 4 foot units
“ “ “ 32”x22”x1” 6 foot units
Motor / Blower Motorized Impeller Continental 2250 XR 2B38
Inlet Ring For Impeller Continental # 225 IR
Speed Control Motor Speed KB electronics KBMC 15 NS
Pressure Gauge Magnehelic Dwyer 2002
Switches Light and Motor Carlingswitch LRGSEK-611-C-G-B-E-125N
Gas Shock Window Li GSI 66u140315bb0111-6-foot unit
“ “ “ 66u140315bb0067-4-foot unit
CSE Series
Compounding Safety Enclosure
User Manual
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Our Company
Germfree has been a leading innovator in aseptic
control and isolation systems since 1962.
We design and manufacture a diverse range
of equipment and facilities for life science
applications.
Our systems are integral to critical processes across
many sectors. We specialize in complex projects and
custom applications that serve the rigorous demands
of our clients. Our high-specification bioGO
Modular Facilities operate across the world, and are
sustainable 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
quality materials and are designed to operate reliably
for decades. We stand behind our work and take
pride in our superior crasmanship.
Germfree’s Mission
Creating Environments that Serve Life Science Innovation and Advance Global Health
Germfree
4 Sunshine Blvd.
Ormond Beach, Florida, USA 32174
+1 386.265.4300
www.germfree.com
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