Pharmaceutical Products

Pharmaceutical Products

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!

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Clean-Rooms – Modular

We offer a complete range of clean-room solutions to fit your existing clean-room.

Ante Chambers

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.

Portable Clean-rooms

Portable Clean-rooms – 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.

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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.

UV Disinfecting

Proprietary UV disinfection systems provide a safer processing environment and can help extend filter life.  Call, email or chat to get more details.

Clean Benches.

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.

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Venting Equipment.

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

Certified by CSA to meet the ANSI Z358.1 Standard for Emergency Eyewash and Shower Equipment.

CALL FOR COMPLETE SPECIFICATIONS ON THIS IMPORTANT OPTION 1-800-418-9289.

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 conceptual designs in Solid Works 3D to enable our clients to better conceptualize 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.

 

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AEPC 311, Particle counter —

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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

Type: Sterile Products
Aeec525

AEEC525, Ergonomic stool

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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.

Type: Sterile Products
Sharpes Yellow

AESH562, Chemotherapy Sharps Collector

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Chemotherapy Sharps collectors, yellow, 5 gal. For incineration. Biohazardous.

Dimensions: 18 in. x 10.5 in. x 7.5 in.8 collectors/unit. Sold by the unit only.

Type: Sterile Products
Sharps Red

AESH561, Sharps Collector

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Sharps Collector, red, 5 gallons, vented, large funnel entry, latex free. Dimensions: 18 in.

x 10.5 in. x 7.5 in. 8 collectors/unit. Sold by the unit only.

Type: Sterile Products
AENE531

AENE531, Building Exhaust Alarm,

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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

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AEPF532, Prefilters

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Prefilters – ASHRE high efficiency Merv 11 Filter 20” x 20” x 2”

Type: Sterile Products
2compartment

AEMD514, 2-compartment dispenser

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2-compartment dispenser, 1/4″ acrylic, 12″ long x 20″ wide x 18″ high

Type: Sterile Products
3compartment

AEMD513, 3-compartment dispenser

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3-compartment dispenser, 1/4″ acrylic, 12″ long x 20″ wide x 18″ high

Custom boxes available

Type: Sterile Products
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AEIH568, IV hooks

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IV hooks, stainless steel (set of 4)

Custom Made hooks are available

Type: Sterile Products
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AEFL524, replacement bulb

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Low-profile miniature fluorescent strip lights/replacement bulbs, 13 watts. Used on

outside of isolator. $19.00/each.Two bulbs/unit.

Type: Sterile Products
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AEUV512, UV lamp replacement — $94.72/each

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Germicidal Replacement Lamp for Units equipped with our UV sanitization system.

Lamp will actually sterilize all non shadowed areas.

Type: Sterile Products
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AEUV Custom, UV disinfecting technology:

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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

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Sampling Sterile Media Contact Plates–

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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.

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AEVA596 Viable Air Sampling Sterile Media Plates

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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.

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AEGF595, Gloved Fingertip Sampling Contact Plates

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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.

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AEVA597, Viable Air Sampling Sterile MEA Media Plates–

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(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.

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AEVP101, Calibration Device(calibration device for above AEVP100)

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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.

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AEVP100, Viable Particle sampler

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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.

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AEHR593, High Risk Media Fill Test Kit

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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

Type: Sterile Products
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AEMR592, Medium Risk Media Fill Test Kit

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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.

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AESC586, Chemo/Sterile sleeve liners

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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.

Aesc564

AESC546, Sleeve liners

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Standard Sleeve liners. For Hygiene and comfort while wearing short sleeves in an

isolator. Made of LiquidGuard material, lint free anti-static treated, white, 200 sleeves/unit

(100 pairs).

Type: Sterile Products
12 Inch Shoulder O Rings

AEOR563, 12” dia. O-Rings

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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 [1] pair per

package. Used for attaching glove sleeve to glove port. Call us to match to other Brands

Type: Sterile Products
Aesl5421

AESL542, Non-Latex Isolator Sleeve

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 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

AELN578, Full hand glove liners

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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.

Wristorings

AEOR564, 3-1/2” dia. Wrist/Glove/Cuff O-Rings

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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.

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AEGL543, Extra thick gloves.

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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.

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AEGL580, Chemo gloves, ASTM D6978-05 tested for 4 hours.–

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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.

Type:Sterile Products
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AEGL508, CAI, Nitrile gloves 11mil

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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.

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AEGL585, CAI, Nitrile gloves 9mil–

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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.

Anti Fatigue Mats

AEAF 582 ISO 5 certified AntiFatigue Mats 22×36.

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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.

Type:Sterile Products
Tacky Mats Copy

AETM 583 Peel-Off Clean Room Sticky Floor Mats 24″ x 36″ (4 Pads, 30 Sheets per Pad)

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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.

Aesk575zz

AESK575, Sterile, 9×9, Dry, ISO 5, Blended Wipes

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Sterile, 9” x 9” nominal 55/45 Cellulose blend, clean room rated wipes. 300 wipes double

bagged in a perforated package.

Type: Sterile Products
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AESK559, Head Swab

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Rectangular head swab. Perfect for the hard to reach spots. Closed-cell polyurethane

foam head, large polypropylene handle 20 bags of 50 per unit of 1,000.

Type: Sterile Products
Aesk575

AESK575, Sterile, 9×9, Dry, ISO 5, Blended Wipes .

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Sterile, 9” x 9” nominal 55/45 Cellulose blend, clean room rated wipes. 300 wipes double

bagged in a perforated package.

Type: Sterile Products
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AESK558, Sterile, 9×9, Dry, ISO 4, 100% Polyester Wipes.

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Sterile Wipe LP, 9” x 9” nominal polyester knit wipers. 100 wipes/outer bag (10 inner

bags of 10).

Aesk674

AESK574, Sterile, 9×9, Pre-wetted, ISO 5, Blended Wipes.

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Sterile, 9” x 9” nominal 55/45 Cellulose blend, clean room rated wipes, pre-wetted w/70%

isopropyl alcohol. 30 wipes in a resealable package.

Type: Sterile Products
Sterile AlphaSat Wipes Photo 300x141 200x94 1

AESK557, Sterile, 9×9, Pre-wetted, ISO 4, 100%Polyester Wipes– $444.64/case or 400 total wipes.

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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.

Type: Sterile Products
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AESK555, Mini Mop Replacement Covers

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Mini Mop Covers, replacements; 25/bag, 150/case. $450.00/case of 6

Type: Sterile Products
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AESK566, Mini Mop Replacement Pads and clips

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Mop pads that go under mop covers and 4 clips.

Type: Sterile Products
Mini Alpha Mop Photo 300x145 200x97 1

AESK552, Isolator Mini Mop

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Isolator Cleaning Tool w/two handles (18″ and 24″). One mop head and 6 polyester mop

covers.

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).

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AESK549, Mini Environment Cleaning & Maintenance Starter Kit.

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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).

Type: Sterile Products
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AEDC579, Isolator Grade Disinfectant Cleaner,

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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.

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AESA505, Sterile 70% Isopropyl Alcohol

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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.

Type: Sterile Products
Request A Quote 3d

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.

Aseptic Enclosures

St. Louis, MO

800-418-9289

© 2012 Aseptic Enclosures. ALL RIGHTS RESERVED. Confidential – Property of Aseptic Enclosures
Any use of materials including reproduction, modification, distribution or republication, without the prior written consent of Aseptic Enclosures, is strictly prohibited.