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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>.


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.


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


filter 10ml

needle

10ml

5ml


filter

*Syringe(s), needle(s), adhesive seals, non-bacteriostatic water, and filters not included.


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


5ml

5ml

100ml100ml

5ml

5ml5ml Three 5ml


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


*Syringe(s), needle(s), adhesive seals, non-bacteriostatic water, and filters not included.


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


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.


50/pk U38H

Fluid Thioglycollate Broth Medium with Indicator, USPFor the cultivation of anaerobic microorganisms.


20/pk U84H

20ml glass bottle with needle port septum, 20ml fill, 50/pk U68H

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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 ...€¦ · personal aseptic technique for...

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Transcript of © 2018 Cardinal Health. All Rights Reserved. CARDINAL ...€¦ · personal aseptic technique for...