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© 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, and ESSENTIAL TO CARE are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners.
CONTENTHardyVAL™ Introduction 01
HardyVAL™ and USP <797> 02HardyVAL™ Test Kits 03
Media Bags 08HardyVAL™ á la carte 10
Air Sampling - TRIO.BAS™ 11Media for Environmental Monitoring 18
Sterility Testing 20 HardyVAL™ Random Test 21
Compliance was never so easy!
01
Verify The Efficacy Of Your Aseptic Technique
Quality culture media tested for performance, pH and sterility
Kits are designed to help you follow USP <797> guidelines
Kits supply what is needed to test the proficiency and aseptic technique of technicians or pharmacists in a self-contained ready-to-use format
Kits are available for low, medium, and high complexity procedures
Á la carte components enhance kits or allow for customized tests based on your compounding processes
Surface Sampling
Air Sampling
Sterility Tests
Results log sheet is included in each kit
Hardy Diagnostics offers all the products you need to easily assess the risk of microbial contamination of your CSPs (Compounded Sterile Preparations) according to USP Chapter <797>.
© 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, and ESSENTIAL TO CARE are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners.
MTK
Recommended for verification of personal aseptic technique for low and medium complexity levels within a sterile compounding facility or other cleanroom application. Each kit contains enough media to perform aseptic technique verification for up to five technicians.Culture media is quality control tested for growth promotion, pH, and sterility.
Each kit contains: ` Tryptic Soy Broth (TSB), USP, Media Bags, 100ml, 5/kit ` Tryptic Soy Broth (TSB), USP, 20ml serum vial with needle-port septum,
15ml fill, 5/kit ` Tryptic Soy Broth (TSB), 3 ml Ampoules, (non-toxic red dye is added to
the TSB to easily visualize the sample being transferred), 5/kit 5 tests per kit HVMTK
03
Choose from five pre-assembled kits for ease-of-use OR create your own aseptic technique challenge with our á la carte line of HardyVAL™ media and
containers.
How do I determine which kit or products are right for me?
ASEPTIC TECHNIQUE VALIDATION
MULTIPLE TECHNICIAN VERIFICATION KIT
02
USP <797> states, in part:"All compounding personnel must perform
media-fill testing to assess their sterile technique and related practices initially and every 6 months thereafter. When performing a media-fill test, simulate the most difficult and challenging compounding procedures
and processing conditions encountered by the person, replacing all the components used in the CSPs with soybean-casein digest media."
MEDIUM-COMPLEXITY MEDIA FILL TEST KIT BASIC
*Syringe(s), needle(s), and adhesive seals not included.
Whirl-Pak® is a registered trademark of Nasco Industries, Inc.
Kit Contents`` 3 x 50ml Serum Vials Sterile
Tryptic Soy Broth`` 6 x 50ml Serum Vials
(empty), sterile
`` 3 x 20ml Serum Vials (empty), sterile
`` 1 x Write-on Whirl-Pak® Bag`` 1 x Results Log Sheet
05
LOW-COMPLEXITY MEDIA FILL TEST KIT
*Syringe(s), needle(s), and adhesive seals not included.
Whirl-Pak® is a registered trademark of Nasco Industries, Inc.
Kit Contents`` 1 x 100ml Sterile Tryptic Soy Broth Vial`` 3 x 20ml Empty Sterile Vials`` 1 x Write-on Whirl-Pak® Bag`` 1 x Results Log Sheet
Cat. no. HVL1
Cat. no. HVM2
50ml
25ml 25ml
50ml
25ml 25ml
50ml
25ml 25ml
5ml
5ml
5ml
5ml5ml
5ml
5ml
5ml
5ml5ml
5ml
5ml
5ml
5ml5ml
100ml Sterile Tryptic Soy Broth Vial
4 transfers of 5ml each
20ml vial 20ml vial 20ml vial
Culture Media is quality control testedfor growth promotion, pH and sterility
04
25ml 25ml 25ml
Add 100ml non-bacteriostatic water*to 3 grams Tryptic Soy Broth Powder
Screw on cap and mix
10ml
needle
10ml
5ml
needle positive control
filter 10ml
needle
10ml
5ml
needle positive control
filter 10ml
needle
10ml
5ml
needle positive control
filter
*Syringe(s), needle(s), adhesive seals, non-bacteriostatic water, and filters not included.
Whirl-Pak® is a registered trademark of Nasco Industries, Inc.
06
HIGH-COMPLEXITY MEDIA FILL TEST KIT
Kit Contents`` 1 x 3gm Tryptic Soy Broth
Powder (non-sterile)`` 9 x 20ml Empty Sterile Vials`` 1 x Write-on Whirl-Pak® Bag`` 1 x Results Log Sheet
07
HVM2MEDIUM-COMPLEXITY MEDIA FILL TEST KIT - COMPREHENSIVE
5ml5ml Three 5ml
transfers using syringe
5ml
5ml
100ml100ml
700ml Sterile Tryptic Soy Broth Bag
5ml
5ml5ml Three 5ml
transfers using syringe
5ml
5ml
100ml100ml
5ml
5ml5ml Three 5ml
transfers using syringe
5ml
5ml
100ml100ml
5ml
Kit Contents`` 1 x 700ml Sterile Tryptic Soy Broth Bag`` 6 x 100ml Empty Sterile Bags`` 6 x 20ml Empty Sterile Vials`` 1 x Write-on Whirl-Pak® Bag`` 1 x Results Log Sheet
Cat. no. HVM1
Cat. no. HVH1
Culture Media is quality control testedfor growth promotion, pH and sterility
*Syringe(s), needle(s), adhesive seals, non-bacteriostatic water, and filters not included.
Whirl-Pak® is a registered trademark of Nasco Industries, Inc.
09
Ideal for verifying aseptic technique of pharmacists, nurses, or pharmaceutical
manufacturing technicians.
TRYPTIC SOY BROTH
MEDIA BAGS
`Two ports: needle-port and spike-port`Terminally autoclaved for high sterility assurance
`Quality tested to USP <71> Standards Tryptic Soy Broth (TSB) is manufactured in an
ISO 13485 Facility`Growth promotion testing performed on each lot of media
`Hang Notch on the top of the Media Bag™ allows the technician to hang the bag
`Media Bags Cat. no. HDU100 are packaged in double 2ml zippered bags
Available in: Media Bag TSB 100ml fill, 10pk HDU100Media Bag TSB700ml fill, 5pk HDHVB5
Hang Notch
Spike PortNeedle Port
HDU100
HDHVB5Culture Media is quality control testedfor growth promotion, pH and sterility
08
HDHVB5
Spike Port
Needle Port
Tryptic Soy Broth
Tryptic Soy Broth, 15ml, USP10/pk HDU382
Tryptic Soy Broth (Powder), USP
For High Complexity Compounding Simulations. 3gm of non-sterile TSB powder, 10/pk U130H
Tryptic Soy Broth, USP
100ml bottle with needle-port septum, 100ml fill, 10/pk HDU101
Serum VialEmpty vial, 20ml capacity, terminally autoclaved,10/pk HDSV20
Empty vial, 100ml capacity, terminally autoclaved,10/pk HDSV100
HDSV20 11
Media Bag
Terminally sterilized, empty, 100ml media bag, 10/pk HDHVB10
Tryptic Soy BrothAmpoules3ml glass ampoules of media designed to complement personal aseptic technique proficiency tests as described in USP procedures. 20/pk HDR35
Culture Media is quality control tested for growth promotion, pH
and sterility
SCORE MARK
MEDIA IS TINTED RED TO ASSIST IN MEDIA TRANSFER VISUALIZATION
10
Design custom media fill manipulations to best simulate
your most challenging compounding processes with
our á la carte line of media
USP <797> environmental monitoring compliance with active microbial air samplers
Easy to clean surface with antimicrobial coating and IP65 dust and waterproof
certification
No plugs or external connections
Programmable time, volume, place, and person
options
Aspirating chambers designed for standard agar plates: contact or
mono Petri dishes Aspirating head with quick bayonet fixing system for
easy manipulation
Cat. no.
MONO Kit, 100 liters/min., contact plate BAS200KMONO Kit, 100 liters/min., Petri plate BAS201KMONO Kit, 200 liters/min., contact plate BAS205KMONO Kit, 200 liters/min., Petri plate BAS206K
Each kit includes: • TRIO.BAS MONO air sampler• Induction battery charger and cable• Aspirating head• Cover head• ROBUSTUS carrying case• Calibration certificate• IQ, OQ, PQ fillable document
Ideal for cleanroom use
Features:• No plugs or external connections• Delayed interval sampling and remote start capabilities• Data transfer capability via Bluetooth
(Separate purchase required. See page 15)
• See HardyDiagnostics.com/air-sampler-calibration for calibration information
Each kit includes: • TRIO.BAS DUO air sampler• Induction battery charger and cable• Aspirating heads
Cat. no.
DUO Kit, 100 liters/min., contact plate BAS220KDUO Kit, 100 liters/min., Petri plate BAS221KDUO Kit, 200 liters/min., contact plate BAS225KDUO Kit, 200 liters/min., Petri plate BAS226K
Ideal forcleanroom use
Features:• No plugs or external connections• Two aspirating heads for sampling on separate plates to determine
bacterial and yeast/mold counts• Programmable for simultaneous or interval aspirating times• Data transfer capability via Bluetooth. (Separate purchase required. See page 15)
• See HardyDiagnostics.com/air-sampler-calibration for calibration information
Achieve faster sampling times and better statistical results with the DUO!
• Cover heads• ROBUSTUS carrying case• Calibration certificate• IQ, OQ, PQ fillable document
DUOMONO
1312
DAILY SHIFT HEADS
Cat. no.
DAILY SHIFT HEAD, contact plate, 30/bx BAS340DAILY SHIFT HEAD, Petri plate, 30/bx BAS341
Benefits of Daily Shift Heads:
Individually packaged, sterile by irradiation, and includes a certificate of sterility assurance. Technopolymer aspirating heads are ready for immediate cleanroom use.
• A daily certificate of sterilization assurance is requested by regulatory authorities as part of the usual auditing process. Use of DAILY SHIFT aspirating heads eliminates the cost of sterilization after each sample cycle and the consequent task of preparing the certificate of sterility
• DAILY SHIFT heads offer convenience and time savings during periods of unusually heavy workloads
• DAILY SHIFT heads offer peace of mind in case of autoclave breakage or unavailability
• DAILY SHIFT heads can be used on the same day, on the same shift, inside the same cleanroom
• Semi-transparent to confirm agar plate has been properly inserted• Six year shelf life from date of sterilization
DAILY SHIFT HEADSTrio.Bas™ air samplers have data transfer capability via bluetooth. Choose the preferred data download method. A separate purchase is required.
Tablet Device* (for data transfer)Portable tablet for remote control of instrument(s), data download storage and transfer capabilities. *Requires CD software BAS296
Each ...........................................................................BAS301
CD Software*Enables data transfer capability from instrument or smart phone/tablet to PC by Bluetooth.*For Bluetooth capable Windows systems
Each ...........................................................................BAS296
Bluetooth PrinterSmall footprint. Pair with instrument for immediate printout of sampling data, or choose to store data and print out sampling history at a later date.
Bluetooth printer, 11 x 8 x 5 ..............................BAS520Paper rolls (57mm, 10/bx) ................................BAS421
Bluetooth Key*For transferring sampling data to a PC that does not include built-in Bluetooth feature. *Requires CD software BAS296
Each ...........................................................................BAS420
DATA TRANSFERDATA INTEGRITY VERIFIED
1514
17
ACCESSORIESTechnopolymer standup holder for optimal use on tripods or carts
for MONO, DUO Each .......................BAS376
Stainless Steel Wall Holderfor wall mount or table
Each ........................BAS530
Stainless SteelVertical Hook and KnobEach ........................BAS521
Aluminum Tripod56cm to 153cm. Device and standup holder (optional) not included.Each .......................BAS380
Stainless Steel AISI 316 Tripod150cm to 200cm. Ideal for cleanroom use. Device not included.Each .......................BAS523
BAS376
16
MULTI HOLDER CARTS
Maxi Multi Holder CartStainless steel AISI 316 cart on wheels with fixed vertical hook holder and adjustable vertical extension post. Ideal inside cleanroom.
• Dimensions: 25x35x70cm• Extension post adjustable height:
100cm to 210cm
Each ..................................................BAS372
Mini Multi Holder CartStainless steel AISI 316 cart on wheels equipped with three shelves.
Ideal inside cleanroom.• Dimensions: 25x35x70cm Each.........................................BAS371
(Pictured with DUO, MONOand stand, not included)
(Pictured with DUO, MONOand stand, not included)
MULTI HOLDER CARTS
1. Twist and remove lid.
2. Gently press plate to surface without twisting or sliding.
3. Twist clockwise until frosted bands line up and lock lids into place.
TM
Friction lid design keeps lids in place. Locking feature assures lids stay secured.
TSA (Tryptic Soy Agar) with Lecithin and Tween® 80 For the cultivation and enumeration of microorganisms. 15x65mm contact plate, 10/pk P34
SabDex (Sabouraud Dextrose) AgarFor the cultivation of fungi. 15x65mm contact plate, 10/pk P36
MEA (Malt Extract Agar) with Lecithin and TweenFor the cultivation and enumeration of fungi. 15x65mm contact plate, 10/pk P93
18
Culture Media is quality control testedfor growth promotion, pH and sterility
SabDex Agar with Lecithin and Tween® 80For the detection and enumeration of yeasts and fungi.SterEM, 15x100mm plate, triple bagged, 34ml fill10/pk W595
SabDex AgarFor the detection and enumeration of yeasts and fungi.SterEM, 15x100mm plate, triple bagged10/pk W565
SabDex Agar, USPFor the detection and enumeration of yeasts and fungi.15x100mm plate,10/pk W70
Malt Extract AgarFor the cultivation and enumeration of yeasts and molds.15x100mm plate, 34ml deep fill10/pk HDW28
Tryptic Soy Agar with Lecithin and Tween® 80General growth medium for the isolation and cultivation of microorganisms. SterEM, 15x100mm plate, triple bagged10/pk W520
Tryptic Soy Agar (TSA)General growth medium for the isolation and cultivation of microorganisms. SterEM, 15x100mm Red Tinted plate, triple bagged, 34ml fill10/pk W540R
Tryptic Soy Agar (TSA) Deep FillGeneral growth medium for the isolation and cultivation of microorganisms.SterEM, 15x100mm plate, triple bagged, 34ml fill10/pk W540
Tryptic Soy Agar (TSA), USPGeneral growth medium for the isolation and cultivation of microorganisms.15x100mm plate,10/pk W64
Tryptic Soy Agar (TSA)General growth medium for the isolation and cultivation of microorganisms.SterEM, 15x100mm plate, triple bagged,10/pk W570
Irradiated Plates
Irradiated Plates
Non Irradiated Plates
Non Irradiated Plates
19
TSA (Tryptic Soy Agar) with Lecithin and Tween® 80, USP For the cultivation and enumeration of microorganisms. 15x65mm contact plate, triple bagged, 10/pk P520
TSA (Tryptic Soy Agar) with Lecithin and Tween® 80, USP, Red Tinted Plate For the cultivation and enumeration of microorganisms. 15x65mm contact plate, triple bagged, 10/pk P520R
SabDex (Sabouraud Dextrose) Agar with Lecithin and Tween® 80 For the detection and enumeration of yeasts and fungi. 15x65mm contact plate, triple bagged, 10/pk P595
D/E Neutralizing Agar, USP For use in the cultivation of microorganisms from environ-mental surfaces. 15x65mm contact plate, triple bagged, 10/pk P580
Prepared culture media for personnel, garb, surface and air sampling.
ENVIRONMENTAL MONITORING
USP recommended media for direct inoculation
STERILITY TESTING by Direct Inoculationof Pharmaceuticals using Hardy Diagnostics Media <USP 71>
Drug solutions can be tested for sterility by direct inoculation into Tryptic Soy Broth (TSB) and Fluid Thioglycollate according to procedures found in <USP 71>. By incubating for 14 days, a lack of fungal, aerobic, and anaerobic bacterial contamination can be proven. Please consult <USP 71> (Table II) to verify proper inoculum size and media volume.
Culture Media is quality control tested for growth promotion, pH and sterility
Tryptic Soy Broth, USPRecommended for use as a general purpose medium for the isolation and cultivation of a wide variety of bacteria and fungi.
100ml glass bottle with needle port septum, 100ml fill,
20/pk U46H
Tryptic Soy Broth, USPRecommended for use as a general purpose medium for the isolation and cultivation of a wide variety of bacteria and fungi.
20ml glass bottle with needle port septum, 20ml fill,
50/pk U38H
Fluid Thioglycollate Broth Medium with Indicator, USPFor the cultivation of anaerobic microorganisms.
100ml glass bottle with needle port septum, 100ml fill,
20/pk U84H
20ml glass bottle with needle port septum, 20ml fill, 50/pk U68H
20
Draw 5ml of druginto the syringe
5ml Sterile DoubleStrength Tryptic Soy Broth Syringe
1. Attach sterile needle to 5ml of sterile double strength Tryptic Soy Broth syringe.
2. Draw 5ml of compounded preparation into the Double Strength Tryptic Soy Broth Syringe.
3. Incubate syringe 4. Examine for turbidity at the
end of 14 days.5. Does not fulfill requirements
for USP <71> Sterility Testing.
Use on expired or returned drugs to check sterility (for quality assurance purposes only).
Kit Contents 5 x 5ml Double Strength
Tryptic Soy Broth Syringes 5 x Write-on Whirl-Pak® Bags 1 x Results Log Sheet
Procedure Summary
RANDOM TESTINGCat. no. HVR1
21
090619sg
© 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, and ESSENTIAL TO CARE are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners.
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