Download Cleanroom Consumables Product Showcase

Product Showcase
Cleanroom Consumables
Product Showcase
ACHIEVING AND MAINTAINING COMPLIANCE WITH USP CHAPTER <797> DOES NOT BEGIN AND END
with building a cleanroom or acquiring a compounding aseptic isolator (CAI). Rather, it is essential to establish policies and procedures – and to procure the products that support them – in order to ensure the sterility of your compounded preparations and the safety of your patients. From personnel protective equipment
to sterility testing kits, many consumable products contribute to effective compounding operations.
On the pages that follow, PP&P highlights a variety of products that can be used in your <797>-compliant sterile compounding operations and ultimately improve patient safety in your facility.
Reconstitution Device
EPS, Inc., has developed the Dispensing-Spike II Reconstitution Device for reconstituting medication from multiple dose IV vials while providing sterile air filtration. The
Dispensing-Spike II device has a
large, 0.2-micron hydrophobic air
filter to trap aerosol meds and to
minimize blowback. Its construction creates short venting and
fluid pathways, and the thin
spike minimizes coring and permits easy penetration of rubber
stopper vials. The luer lock port
design maintains a secure closure between the device and
the syringe. The hinged cap and
easy-gripping spike sheath help
to maintain sterilization before use, minimize touch contamination, and ensure a
closed system for disposal.
Cleanroom Accessories
As part of its Compliance Solutions
Program, Attentus Medical provides a full
line of cleanroom products, from tacky
mats to wipers to face masks. The company also provides sample cleanroom
policies, as well as phone support to help
organization keep abreast of regulation
news and accrediting interpretations.
Attentus Medical
Circle reader service number 22
or visit www.attentusmedical.com
EPS, Inc.
Circle reader service number 21 or visit www.medi-dose.com
Alert Bands for IV Medications
Baxa’s ShrinkSafe Paralytic Identification Bands can help hospitals eliminate medication errors associated with paralytic agents or neuromuscular blocking agents. ShrinkSafe ID bands are plastic sleeves specific to
high-alert medications. They add a forcing function to routine administration by requiring users to remove an additional cover at the point of care.
Simply slide the band over the vials and pass them through a heat tunnel.
To access the vial septum, you have to break the seal. With ShrinkSafe,
users have both a visual and a tactile alert for paralytic agents. Red
“warning” labels and a differentiated feel from traditional injectable drug
vials promote safe administration.
Baxa Corporation
Circle reader service number 26 or visit www.baxa.com
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Disposable
Nitrile Gloves
Ansell launches
100% nitrile, latexand powder-free
nitra-Touch gloves.
The ambidextrous
nitra-Touch gloves
are puncture resistant and have a
beaded cuff for easy donning.
Ansell Healthcare Products LLC
Circle reader service number 25
or visit www.ansellhealthcare.com
NOVEMBER 2006
Product Showcase
Dry, Pre-Saturated, and Sterile Wipers
Kimberly-Clark Professional introduces a complete line of dry, pre-saturated, and sterile
Kimtech Pure* Wipers for cleanroom environments. The new product line includes both dry
and sterile Kimtech Pure* CL3 Wipers, which can
be used for the most critical surface wiping tasks
in ISO Class 3 or higher cleanroom environments.
The dry Kimtech Pure* CL3 Wipers are 100%
continuous filament double-knit polyester. The dry
Kimtech Pure* CL3 Sterile Wipers are 100% polyester and solvent- and abrasion-resistant.
They are also gamma irradiated to a 10-6 sterility assurance level (SAL) and cleanroom laundered, with laser-sealed edges.
Kimberly-Clark Professional
Circle reader service number 24 or visit www.kcprofessional.com
Filter Integrity Tests
Q.I. Medical introduces the Bubble Point
Tester to help pharmacists comply with
USP Chapter <797>. The tester validates
the integrity of sterilizing grade filters used
to prepare high-risk-level compounded
sterile preparations. Every tester kit comes
with directions for use, a pressure gage,
stainless steel connectors, a 20-cc syringe,
and silicon tubing. The pressure gage is
accurate to +/- 1% over the entire range.
The Bubble Point Tester is available
through Q.I. Medical for less than $75.
Q.I. Medical
Circle reader service number 23 or www.qimedical.com
Sterile and Non-Sterile Cleanroom Wipers
ITW Texwipe offers a selection of disposable sterile
and non-sterile wipers for use in compounding sterile
preparations. SterileWipes clean cleanrooms, isolators, and biosafety cabinets quickly and easily. Sterile
CleanPaks are an alternative to wipers and spray
bottles of alcohol. ITW Texwipe also provides sterile
alcohols for the one-step cleaning of surfaces and
for use in the final rinse and residue removal step of
many critical cleaning protocols. ITW Texwipe’s product line for contamination control includes an array
of sterile products, wipers, swabs, mops, cleaning
solutions, and stationery for use in controlled and cleanroom environments. ITW Texwipe
also offers technical resources and support, contamination control audits, hands-on seminars, training posters, and application-specific training for achieving contamination control in your clean area.
ITW Texwipe
Circle reader service number 27 or visit www.texwipe.com
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Cold Filterable Media
for Media Fill Trials
Oxoid Cold Filterable Media for media
fill trials are now available from Remel.
Oxoid Cold Filterable Tryptone Soya
Broth and Cold Filterable Vegetable
Peptone Broth readily dissolve in cold
water and are highly filterable at room
temperature. Oxoid Cold Filterable
Media are designed to flow freely
through a 2-μm filter.
By allowing faster filtering (without the
need to heat the media or change
blocked filters), these products can
save valuable time in completing media
fill trials and more accurately mimic the
aseptic production process. Oxoid Cold
Filterable Media are gamma-irradiated
with a dosage validated as lethal to
Mycoplasma, yeast, mold, and bacteria (including bacterial spores). Cold
Filterable Vegetable Peptone Broth
offers an alternative that is completely
free of animal-derived materials. Cold
Filterable Media are tested according
to specifications for growth of microorganisms established by the United
States.
Remel
Circle reader service number 28
or visit www.remel.com
NOVEMBER 2006