ACI, CAI, CACI, Isolators
Infection control is a global issue … At Aseptic Enclosures, we have a strong commitment to helping you improve your aseptic processing and containment.
Compounding Aseptic Isolator (CAI)
Is an isolator specifically designed for Aseptic preparations, and USP 797 compliant Hospital Pharmacy compounding pharmaceutical ingredients or preparations. It will maintain an aseptic environment within the isolator throughout the compounding and material transfer processes. Typically our isolators run at ISO CLASS 4/ASTM CLASS10 during working conditions. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter.Please note: This equipment provides product protection only. Call, email or chat to get more details.
Compounding Aseptic Containment Isolator (CACI)
USP 797 compliant, hospital pharmacist protection from exposure to undesirable levels of airborne drugs throughout the compounding and material transfer processes. They provide an superior aseptic environment for compounding sterile preparations. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation. Call, email or chat to get more details.
ACI Aseptic Containment Isolator
– Designed specifically for Research and Development. Just like our CACI’s that are used for cytotoxic chemotherapy compounding, our ACI’s provide a superior solution to class II BSC’s. They provide comprehensive containment that protects both the product and person. They run at exceptionally low particulate levels!
Clean-Rooms – Modular
We offer a complete range of clean-room solutions to fit your existing clean-room.
A clean room is a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface and personnel gear are not exceeded for a specified cleanliness class. Call, email or chat to get more details.
– Built on casters for mobility. Portable clean-rooms can be produced in a variety of sizes to accommodate your work.
Class 100 – 100,000 ISO 5-8. This 8x8x8 unit pictured is used in a parenteral (inject-able) production facility for raw materials testing. Products are brought into the warehouse and then transported via forklift into this class 100,000 room where drums are open and material is removed for QC testing. Product is then quarantined until QC testing is completed.
Although 512 cu ft, our clean-room can easily be moved around the warehouse. Recovery times are quite quick. Going from ambient particulate levels to clean-room quality just a few minutes. Construction can be from a variety of materials. This unit is enamel coated mild steel. It has 3 wall of polycarbonate and one vinyl curtain strip-wall that allows heavy equipment entry and exit. Combination wall of strip and/or solid are available. Anti chambers can be added. Air Changes Per Hour can be specified. Lighting is totally external to the clean-room. Pre-filter is easily changed.
Portable HEPA Fan Filter Units
Portable fan filter units can be used for a variety of applications to add additional air-changes per hour to existing clean-rooms that need upgrading. For areas where traditional fan filter units can not be installed. To supplement and clean up air for existing HVAC systems. This particular model was built for a patient diagnosed with COPD. It was located near the intake of the existing HVAC intake to supply clean air to the system. It has a capacity of 1500 cfm which is sufficient to provide class 100,000 air to approximately 1,100 square feet (10 acph @ 8ft ceilings).Ceiling units, remote ducted, wall mounted with low wall return are all available at a variety of output rating.
Proprietary UV disinfection systems provide a safer processing environment and can help extend filter life. Call, email or chat to get more details.
Sometimes the total containment solution is overkill. For less important “pretty clean” applications our cleanbench can be an economical and effective solution. They provide an ISO class 5 /ASTM class 100 environment, but, please note, that condition is only guaranteed under steady state conditions. In normal operation, user error and procedural breaches are pretty common. With that in mind, we can build any type of clean bench that your job requires. Custom heights, widths, depths, materials, lifting systems. We also have all the standard sizes 2-8ft. Picture here is a 6ft slimline clean bench with Lexan sides and a stainless work-surface.
If you need help getting your equipment vented, call us for details on equipment and supplies we offer to vent your hazardous effluent out of the building. Show to the right is an installation without the cover of a 1000 cfm downdraft exhaust fan.
Portable Eyewash Station
Ideal for remote locations. Using gravity to supply a continuous flow of clean water to injured personnel for a full 15 minutes at .4 gpm (1.5 L), this model is a reliable source for safety. Recognizing the 7501’s full patterned flushing feature, those working in remote areas can’t help but feel confident with this piece of emergency equipment day after day.
- Featuring a FDA approved high-density green polyethylene tank easily activated by pulling the yellow activation arm down to the open position
- A wide-fill opening with threaded cap permits easy inspection, cleaning and filling
- Relocation is simple due to the easily mounted bracket (included) and light design
Custom Enclosures, Booths, Hoods and Isolators
Much of the work we do at Aseptic Enclosures is of standard design, but there are many builds we have done for clients that are custom. Typically, customers expect custom designs to be price prohibitive. However, we have a very efficient system of redesigning from our standard products base. We can provide approval drawings as part of the design review process. Typically, we will provide detailed 3D models for the conceptual designs to enable our clients to better visualize our solution to their requirement.
Additional airflow modeling can also be provided to assure desired characteristics are built into the product. Typical airflow modeling includes computational fluid dynamics. In this process air-flows are evaluated in conjunction with design features of our equipment to analyze the laminar airflow of our designs. Unidirectional airflow is quite important in aseptic applications due to the cleaning effect of a sterile air shower vs. that of a turbulent flow design.
AEPC 311, Particle counter —
Kit includes everything you need: 3 channel laser diode particle counter w/internal pump.
0.3um- 5.0um Good to ISO 4. NIST traceable. Computer download software and USB
cable Isokinetic Probe. Calibration Filters Rechargeable batteries (4.5 hour constant use
AEEC525, Ergonomic stool
Puncture proof ergonomic stool. 5-Way Adjustable. Chemical resistant Polyurethane. Ideal for extended sitting periods, this adjustable stool helps fight fatigue with 5 ergonomic adjustments and a contoured seat and back. The upholstery of this swivel stool is made with puncture and wear resistant self skinned polyurethane that is easy to clean. The seat features a plate reinforcement that helps this shop chair withstand heavy duty use in tough working environments. The seat also has a waterfall edge to help blood circulation to the legs. Ergonomic adjustments of this work stool include independent seat and back tilt adjustment, 38″ to 48-1/2″ back height adjustment, 22″ to 32-1/2″ pneumatic seat height adjustment and 2″ back depth range adjustment. This shop stool includes a 360 degree chrome foot ring that is height adjustable. Seat measures 18-1/2″W x 18″D. Back measures 16-1/2″W x 13″H. Stable 5 blade base includes both casters for mobility and glides for stationary use. Easy Assembly. 1 Year Limited Warranty.
AENE531, Building Exhaust Alarm,
Aseptic Enclosures’ Building Exhaust
Alarm System is designed to monitor your vent line to assure adequate vacuum is
maintained at all times. It has 2 alarm set points to notify personnel if there is not
enough, or conversely too much vacuum in the exhaust line. While not enough vacuum
AEUV Custom, UV disinfecting technology:
We can provide a self contained UV disinfection system for additional security in aseptic
processing to act as a supplement to the decontamination process. This system is
pharmaceutical grade surface sterilization technology that will sterilize the non-shadowed
Sampling Sterile Media Contact Plates–
At least semiannual testing required for each PEC (Primary Engineering Control. i.e.
Hood, Isolator, BSC, Cleanbench, Glovebox, CAI, CACI, etc.). In higher usage facilities,
more frequent testing may be prudent. Kit contains 10 gel coated contact plates.
AEVA596 Viable Air Sampling Sterile Media Plates
AEVA596 Viable Air Sampling Sterile TSA Media Plates. Tryptic Soy Agar (TSA) with
Lecithin and Polysorbate 80. This test is for bacteria and has to be done in conjunction
with AEVA597. At least semiannual testing required for each PEC (Primary Engineering.
AEGF595, Gloved Fingertip Sampling Contact Plates
Gloved Fingertip Sampling Contact Plates. Contact plates can be used for the
determination of viable counts on smooth, dry surfaces as well as for personnel hygiene
monitoring (clothing, gloves, or hands). Contains 10 plates in each sleeve plus a drying.
AEVA597, Viable Air Sampling Sterile MEA Media Plates–
(Malt Extract Agar) with Lecithin and Polysorbate 80. This test is for Fungus (yeast and
molds) and has to be done in conjunction with AEVA596, at least semiannual testing
required for each PEC (Primary Engineering Control, i.e. Hood, Isolator, BSC.
AEVP101, Calibration Device(calibration device for above AEVP100)
This device monitors AEVP100 pressure and allows for the calibration of its air flow rate.
The calibrated flow rate will be maintained at a constant flow throughout the collection
period. Four timing routines are selectable from the keypad and continuous Flow.
AEVP100, Viable Particle sampler
Viable Particle sampler. For use with our viable air plates. This unit is ideal for
continuous operation in your primary engineering control to detect viable particulate. It Is
a good indicator of problems with either the equipment or process. w/120V charger.
AEHR593, High Risk Media Fill Test Kit
AEMR593 High Risk Sterile Media Test Kit. Semiannual test required for each
compounding pharmacist or technician. In higher usage facilities, more frequent testing
may be necessary. Kit consists of 3g Tryptic Soy Powder Media, 9-sterile empty 30ml
AEMR592, Medium Risk Media Fill Test Kit
Annual test required for each compounding pharmacist or technician. Kit consists of
three 100ml vial of Sterile Tryptic Soy Broth (TSB) liquid growth media, six sterile empty
100ml vials, nine sterile empty 30ml vials, test log and test instructions. Other required.
AESC586, Chemo/Sterile sleeve liners
Chemo Sleeve liners Provide added protection from possible chemical permeation
through the isolator sleeve. Elasticized arms and cuffs. Gamma irradiated. Lot number is
shown on each individual bag to provide product trace-ability. Blue. One pair per sealed.
AEOR563, 12” dia. O-Rings
For attaching Sleeves to the Isolator Shoulder Ring Flanges. Much longer lasting than
the common black type. Our 12” dia. Shoulder O-Rings. Silicone. One  pair per
package. Used for attaching glove sleeve to glove port. Call us to match to other Brands
AESL542, Non-Latex Isolator Sleeve
Replacements Available FOR ANY ISOLATOR BRAND
Glove Under Sleeve Design. 15-17 mil thickness. Polished interior finish for superior
cleanibility. Non-latex. Our CAI and CACI glovebox sleeves have been proven to be
resistant to nine different cyto toxic chemicals under ASTM 6978; Dacarbazine.
AELN578, Full hand glove liners
Our Standard style. Size is Large with a Blue cuff. Stretchable. Our glove liners keep
your “shared” reusable gloves clean on the inside by keeping perspiration down. They
make it easier to don your isolator gloves. Ambidextrous. Liners are washable.
AEOR564, 3-1/2” dia. Wrist/Glove/Cuff O-Rings
For attaching any of our gloves to isolator sleeves. 3-1/2” dia. Cuff
O-Rings. Long lasting Silicone has a much better life than the black style rings used by
others. Replacements are available for uses with other brands of Isolators just specify.
AEGL543, Extra thick gloves.
Thicker and extra Durable for longevity. Yes they will last a long time, but these gloves
do not have a good feel. But if you don’t need much touch sensitivity they are your best
bet. Green, 16 mil, non-flocked, 13” L. Comes in sizes: 7, 8, 9, 10, 11. Please specify.
AEGL580, Chemo gloves, ASTM D6978-05 tested for 4 hours.–
Chemo gloves, ASTM D6978-05 permeation tested for 4 hours without decontamination.
Gamma irradiated, individually packaged 10 pairs/sealed outer package. 30 pairs/unit.
Sizes: 6, 6.5, 7, 7.5, 8, 8.5, 9. Please specify size.
AEGL508, CAI, Nitrile gloves 11mil
General replacement Nitrile gloves, for our CAI with GUS configuration. Compatible with
other Isolators as well. Good for reuse until evidence of wear. Compatible with most
cleaning agents. Dark Blue, 11 mil, diamond grip. Comes in sizes: 6, 7, 8, 9, 10, 11.
AEGL585, CAI, Nitrile gloves 9mil–
Our new Standard glove for all CAI’s. They are a little thinner for better “touch” but still
provide good durability. Individual hand fitted for better comfort. They are also less
expensive! For our CAI with GUS configuration. Compatible with other Isolators as well.
AEAF 582 ISO 5 certified AntiFatigue Mats 22×36.
Perfect for long stands at the hood. Developed to prevent fatigue in controlled
environments, our mats are certified for use in ISO Class 5 Clean Rooms. This unique
and incredibly comfortable anti-fatigue mat is a 100%premium molded urethane.
AETM 583 Peel-Off Clean Room Sticky Floor Mats 24″ x 36″ (4 Pads, 30 Sheets per Pad)
A simple method to help keep your area clean with these tacky mat shoe cleaners. Once
a sheet is dirty, peel off to get the next clean sheet. Sheets are numbered so you know
when they are getting low. Other sizes are available. White.
AESK557, Sterile, 9×9, Pre-wetted, ISO 4, 100%Polyester Wipes– $444.64/case or 400 total wipes.
Sterile AlphaSat Wipes, Iso class 4 approved, 9” x 9” nominal polyester sealed-border
wipes, pre-wetted w/70% isopropyl alcohol. 20/flexpack, 20 flexpacks or 400 wipes total.
AESK552, Isolator Mini Mop
Isolator Cleaning Tool w/two handles (18″ and 24″). One mop head and 6 polyester mop
Contrary to popular belief, we feel it is not good practice to routinely open your isolator
doors to clean the interior. If running properly, the Isolator stays as clean (probably).
AESK549, Mini Environment Cleaning & Maintenance Starter Kit.
Mini Environment Cleaning & Maintenance Starter Kit: ISO Class 3-5; 1-Mini Mop isolator
cleaning tool and 2 handles, 1 bag sterile pre-wetted w/70% IPA (20 wipers/bag), 1 bag
SterileLP Dry Wiper (100 wipers/bag).
AEDC579, Isolator Grade Disinfectant Cleaner,
Ready to use, hospital-grade, disinfectant against Staphylocidal, Pseudomonacidal,
Virucidal and Fungicidal. Complies with OSHA’s bloodborne pathogens standard. For
use in controlling the risk of nosocomial infection. Is effective in hard water up to 400
ppm (calculated as CaCO3) in the presence of 5% organic serum. Compatible w/Aseptic.
AESA505, Sterile 70% Isopropyl Alcohol
Sterile 70% Isopropyl Alcohol;. Double bagged, lot numbers & expiration dates. 16 oz.
Trigger Spray, 12 bottles/unit. Why Use Sterile IPA? The USP mentions sterile IPA 36 times. Non-sterile alcohol is
actually a superior habitat for infection causing spores. Sterilization Kills Spores.
How to Choose a Glovebox?
So, you’re trying to pick a glovebox, but you aren’t sure which one to choose. Many manufacturers will tell you that their equipment is the best, but why take their word for it when you can find out for yourself? Here are some of the most important aspects of a glovebox to consider when making your decision to ensure that you purchase what’s best for your pharmacy.
Warranty. Of course the longer the warranty is the more peace of mind it brings to your purchase. It’s also good to know what is included in the warranty, so there are no surprises if you do have a problem.
Unidirectional airflow. As required by USP on page 21, all gloveboxes must maintain unidirectional (laminar) airflow in the main and transfer chambers.
Pressure differentials are a very important consideration in how clean the equipment stays during working conditions.
Certification. Does the glovebox manufacturer guarantee to certify to USP regulations? Can you obtain documentation from the manufacturer that the glovebox will meet ISO Class 5 air quality requirements, as described on page 23 under Placement of Primary Engineering Controls?
Price. Make sure that you are getting the most bang for your buck. Get pricing from each manufacturer for comparison.
Differential Pressure Monitor. As required by USP on page 24, the glovebox must monitor pressure between the main chamber, transfer chamber, and outside environment.
Ergonomics. What features does the glovebox have to make it more comfortable to work in and easier to maintain? Pay close attention to the gloveport design. Does it accommodate a variety of body styles? Does the front panel allow for maximum visibility of the workspace?
Chemo Compounding Considerations. According to USP on page 14, a negative pressure glovebox (CACI) “optimally should be 100% vented to the outside air through HEPA filtration.” When negative pressure units use recirculated, or even partially recirculated air, there is a risk of carry over contamination. During hazardous compounding, fine particles, such as aerosol, can seep through the HEPA filter. If the air is recirculating then the particles can be recirculated back into the main working chamber which would cross contaminate the next CSPs.
Optimally, you would want a chemo glovebox that has total exhaust to protect patients and personnel.
Under no circumstance should personnel ever prepare hazardous and nonhazardous CSPs in the same glovebox.
Setup and Training. Sometimes having one-on-one interaction with a certified glovebox technician is needed to teach your staff how to properly use the glovebox.
Sales Representatives. How knowledgeable and helpful are the people representing the company? It will likely be a good representation of how helpful and available the company will be after the purchase as well.
Technical Support. If there is a problem with your glovebox, it’s good to know there is someone nearby that can fix the problem quickly.
Options. Look at what comes standard with your glovebox purchase, and make sure that you will need everything. Otherwise, you’re paying for unnecessary devices which could possibly obstruct airflow and add to the decontamination process.
Customizing. If you have a special need, or request how easily can your glovebox manufacturer implement that change for you?
Ambient Lighting. Where is the light mounted on the glovebox? What features does the glovebox have to allow for maximum visibility of the work-surface?
Ultimately, we, at Aseptic Enclosures, want you to choose the glovebox that is best for you and your pharmacy staff. Knowing how to compare glovebox manufacturers will make it much easier for you to choose the one that best fits your needs.
St. Louis, MO
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