compliant - pharma choice · 2016. 5. 11. · fingertip sampling surface sampling is required on a...

Media FillTest Kits

USP <797>COMPLIANT

011013ss

HARDY DIAGNOSTICS

Low Risk

Medium Risk

High Risk

•Validatetheproficiencyofyourtechnicians andpharmacistsperUSP<797>•TestforsterilityperUSP<71>

www.HardyValKits.com

Compliancewasnever soeasy!

One kit supplies what is needed to test the proficiency of one technician or pharmacist.

Kits are available for low, medium, and high risk procedures.

Components are in a self-contained ready-to-use kit.

A results log sheet is included in each kit.

Detailed instructions and diagrams are included with each kit.

Expert technical support is available from our staff of microbiologists.

Kits are designed to help you follow USP <797> guidelines.

Surface Sampling

Air Sampling

Sterility Tests

Microbial Contamination Testing for CSPsHardy Diagnostics offers all the products you need to easily assess the risk of microbial contamination of your CSPs (Compounded Sterile Preparations) according to the USP, Chapter <797>.

2 A Culture of Service™ | www.HardyValKits.com

[email protected] | Fax: 805-928-2950 | Ph: 800-266-2222 3

Aseptically transfer Tryptic Soy Broth to empty sterile vials using a sterile 10ml syringe.

Attach sterile adhesive seals.

Incubate at 25 ºC to 35 ºC.

Examine for turbidity at end of 14 days.

Procedure Summary from USP <797>

*Syringe(s), needle(s), and adhesive seals not included.Whirl-Pak is a registered trademark of Nasco Industries, Inc.

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Low-RiskLevel

Kit Contents1 x 100ml Sterile Tryptic Soy Broth Vial3 x 20ml Empty Sterile Vials1 x Write-on Whirl-Pak® Bag1 x Results Log Sheet

Media Fill Test Kits

Cat.no.HVL1

100ml Sterile Tryptic Soy Broth Vial

4 transfers of 5ml each

20ml vial 20ml vial 20ml vial



*Syringe(s), needle(s), and adhesive seals not included.

Whirl-Pak is a registered trademark of Nasco Industries, Inc.

Medium-RiskLevel

Aseptically transfer 100ml Sterile Tryptic Soy Broth to empty sterile bags using gravity tubing.

Transfer Tryptic Soy Broth between bags, using a sterile 10ml syringe.

Aseptically transfer 5ml Tryptic Soy Broth to small empty sterile vials.

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Comprehensive

Utilizes procedures that closely represent typical complex manipulations used to compound medium-risk level preparations as described in USP <797>.

Kit Contents1 x 700ml Sterile Tryptic Soy Broth Bag6 x 125ml Empty Sterile Bags6 x 20ml Empty Sterile Vials1 x Write-on Whirl-Pak® Bag1 x Results Log Sheet

Cat.no.HVM1

5ml5ml

Three 5ml transfers using syringe

5ml

5ml

100ml100ml

700ml Sterile Tryptic Soy Broth Bag

5ml

5ml5ml


5ml

5ml

100ml100ml

5ml

5ml5ml


5ml

5ml

100ml100ml

5ml



Kit Contents3 x 50ml Serum Vial Sterile Tryptic Soy Broth (TSB)6 x 50ml Serum Vial (empty), sterile 3 x 20ml Serum Vials (empty), sterile 1 x Write-on Whirl-Pak® Bag1 x Results Log Sheet

Procedure Summary

*Syringe(s), needle(s), and adhesive seals not included.


Medium-RiskLevel-Basic

Aseptically transfer two aliquots of approximately 25ml of sterile Tryptic Soy Broth into each of the empty sterile 50ml vials using tubing. Repeat this process with fresh tubing two more times so that there will be six 50ml vials containing 25ml of test medium.

Transfer Tryptic Soy Broth between empty vials, using a sterile 10ml syringe and 18-gauge needle.

Aseptically transfer 5ml Tryptic Soy Broth to small empty sterile vials using a sterile 10ml syringe and vented needle.

Apply sterile adhesive seals aseptically to the rubber closures once the vials have been filled.

Incubate the vials at 20 ºC to 25 ºC and/or 30 ºC to 35 ºC for 14 days.

Examine for turbidity.

Record results on the “Results Log Sheet”.

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LowCostMedium-RiskKit,fulfillsminimumrequirements

Meets basic requirements for medium-risk challenge testing.

5ml5ml

5ml5ml5ml

5ml5ml5ml

5ml5ml5ml

5ml5ml 5ml5ml

50ml

25ml 25ml

50ml

25ml 25ml

50ml

25ml 25ml

Cat.no.HVM2



25ml 25ml 25ml

Add 100ml non-bacteriostatic water*to 3 grams Tryptic Soy Broth Powder

Screw on cap and mix

10ml�lter

10ml

5ml

needle positive control

10ml�lter

10ml

5ml


10ml�lter

10ml

5ml


Unscrew cap and add 100ml of water (non-bacteriostatic) to Tryptic Soy Broth powder.

Screw on cap and mix.


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


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High-RiskLevel




Transfer the appropriate amounts of Tryptic Soy Broth to empty sterile vials using a sterile 30ml syringe with and without a 0.2 micron filter.

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Kit Contents1 x 3gm Tryptic Soy Broth Powder (non-sterile)9 x 20ml Empty Sterile Vials1 x Write-on Whirl-Pak® Bag1 x Results Log Sheet Cat.no.HVH1

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Spin Air Microbial Sampler This innovative microbiological impact air sampler pulls air in a controlled fashion against the agar plate. The plate rotates during the process to ensure maximum distribution of the microorganism throughout the plate surface. Holds 100mm Petri dishes. The time, airflow, and rotation speed are variable. Carrying case and battery charger included. This unit is computer connectable and bar code compatible.

Features•Easy to operate•Durable•Cost effective•Holds standard 100mm Petri dish•Adjustable-time, air volume, and rotation speeds•The unit comes fully calibrated •Carrying case and charger included•This unit is computer connectable and bar code

compatible

Each ......................................................................................5500

AirMonitoringEnvironmental Monitoring

Impact Air Sampler for Active Air Sampling

Remove cover from sampler.

Select settings on Spin Air sampler and press start.

After 48 hours, count the number of colonies. Incubate *Malt Extract Agar 26 - 30°C for 5 - 7 days.

Once the cycle is complete, replace lid and incubate TSA 33 - 35 ºC for 38 - 72 hours.

Install plate in its holder and remove lid from plate.

Tryptic Soy Agar (TSA)15x100mm, 10 plates .......................................G60

Malt Extract Agar (MEA)* Selective for yeast and mold.15x100mm, 10 plates .......................................W28

Culture Media forAir Sampling

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USP <797> requires that the number of viable microorganisms in the air environment of the compounding area be evaluated. This test is to be performed at least semi-annually for all risk levels. More frequent sampling will provide earlier detection of loss of environmental control failures. Hardy Diagnostics offers an easy way of accomplishing this using an impact air sampler. Cat.no.5500

ImpactAirSampler

*MEA Agar is recommended only for High Risk Level compounding environments.


Surface Sampling

Remove lid.1 Gently press plate to surface without twisting or sliding.

2 Replace lid and incubate at 30 - 35 ºC. After 48 - 72 hours, count the number of colonies.

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Tryptic Soy Agar with Lecithin and Tween®15x60mm, 10 contact plates................................................P34Malt Extract Agar (MEA)*15x60mm, 10 contact plates .................................................... P93

Tween is a registered trademark of ICI Americas, Inc.*MEA Agar is recommended only for High Risk Level

compounding environments.

Remove lid.1 Gently press glove tips to plate surface.

2 Replace lid and incubate at 30 - 35 ºC. After 48 - 72 hours, count the number of colonies. Record your results.

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Fingertip Sampling

Surface sampling is required on a periodic basis for each laminar air flow workbench or barrier isolator.

Personnel monitoring (glove fingertips) is required to be done at initial competency evaluation and no less than three times before being allowed to compound sterile preparations. Re-evaluation is required at each media fill challenge test.

Surface&FingerTipSamplingHardy Diagnostics offers a fast and convenient way to monitor the microbial bioburden of the work surface of your laminar air flow workbench. Contact agar plates are simply pressed onto the surface or glove fingertips, incubated, and colonies are counted.

Environmental Monitoring

Culture Media for Surface and Finger Tip Sampling

Tryptic Soy Agar (P34)


BiologicalIndicators

SurfaceMonitoring

SporAmpule®A Biological Indicator (BI) system ideal for monitoring liquid cycles as well as standard steam sterilization cycles containing Geobacillus stearothermophilus spores. Gives clear, easy-to-interpret results. Purple to yellow color change or visible turbidity of processed ampule indicates sterilizer failure.Final results after 48 hours incubation in any dry block incubator operating at 55-60 ºC100/pk ........................................................................ BST10020/pk ............................................................................ BST20

Dry Block Incubator ..............................................112001 Heat Block Insert ....................................................110013

Solar-Cult® Flex-Paddle Surface Monitoring SlideThe surface monitoring slide is simply a two sid-ded agar coated plastic paddle which is attached to the cap of a shatter-proof, optically clear, colorless plastic vial. To sample a surface, remove the cap/paddle assembly from the vial. Hold-ing cap in hand, press the surface of the paddle gently onto the surface to be tested (paddle will flex to right angles with a gentle pushing motion). Incubate at 30 -35 ºC. After 48 - 72 hours, count the number of colonies.Tryptic Soy Agar w/Lecithin and Tween® 80 on both sides of the paddle,10/pk .............................................................................FP400

EnviroTrans™ Swab KitNeutralizing Saline(Pre-moistened, ready-to-use)A ready-to-use swab and tube pre-filled with 5 mls of neutralizing saline. Simply remove the cap, which is attached to the Dacron® swab. Collect your sample by swabbing the surface, recap, and send to the lab. The solution can be inoculated onto a Tryptic Soy Agar petri plate (Cat. no. G60). Incubate at 30 -35 ºC. After 48 - 72 hours, count the number of colonies. Excellent for detection or enumeration of microorganisms from environmental surfaces.5ml, 20/box ............................................................... SRK55

TSA, Cat. no. G60

13MM

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*Sterile needles not included.


RandomTesting

Attach sterile needle to 5ml of sterile double strength Tryptic Soy Broth syringe.

Draw 5ml of compounded preparation into the Double Strength Tryptic Soy Broth Syringe.

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Does not fulfill requirements for USP <71> Sterility Testing.

Test to be performed on returned I.V. solutions

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Kit Contents5 x 5ml Double Strength Tryptic Soy Broth Syringes5 x Write-on Whirl-Pak® Bags1 x Results Log Sheet

CSP Kits

Cat.no.HVR1

Use on expired or returned drugs to check sterility, for quality assurance purposes only.

Draw 5mls of drug

into the syringe

5ml Sterile Double StrengthTryptic Soy Broth Syringe


TrypticSoyBroth,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 ...................U46

TrypticSoyBroth,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 ......................U38

FluidThioglycollateBrothMediumwithIndicator,USPFor the cultivation of anaerobic microorganisms.20ml glass bottle with needle port septum, 20ml fill 50/pk .......................U68

FluidThioglycollateBrothMedium withIndicator,USPFor the cultivation of anaerobic microorganisms.100ml glass bottle with needle port septum,100ml fill, 12/pk ...................U47

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.

Below are some some types of media that can be used for direct inoculation.

Custom containers and fill volumes are available upon request.

Sterility TestingDirect InoculationofPharmaceuticalsusingHardyDiagnosticsMedia<USP71>


The preferred method for sterility testing is the membrane filter method using a closed sterility test system, such as the new disposable sterility test system Sterisart®. The Sterisart® Universal pump is a peri-staltic pump made of stainless steel, and is equipped with appropriate features for attaching a Sterisart® sterility test canister.

After the Sterisart® canisters have been po-sitioned and the sterility test system spike/needle has been inserted into the sample container, the pump is started. The pump draws liquid from the sample container into the specially designed double tubing,

Sterisart®UniversalPumpSterilityTestingSystemdistributing the liquid equally to both Sterisart® canisters. Similarly, the pump then flushes the Sterisart® canisters with rinse liquid such as Fluid A, (Cat. no. U109). Finally, the pump fills the two Sterisart® canisters with culture media, such as Tryptic Soy Broth 100ml, (Cat. no. U46), or Fluid Thioglycollate Medium 100ml, (Cat. no. U47). The Sterisart® canisters are then incubated for 14 days.

SterilityTesting-Filtering

A Culture of Service™ | www.HardyValKits.com


Sterisart® Universal PumpThe Sterisart® Universal pump can be used in clean rooms, integrated into clean benches, or installed in the work area of isolators.Each ...............................................................................16420

Control unit

Speed selection knob

Optional ampoule breaker

PumpClamping lever

Support rod

Bottle holding ring

Spike/Needle

Spring loaded fastening arm for media containers

Carrying handle Draining tube

Draining container

Pump head

Sterisart® disposable canisters

FeaturesandBenefits•Closed system – decrease the chance

of technician contamination.•Rugged and maintenance-free.•Compact and ergonomic construction.•Modular design.•Pump available with special software

(menu-driven prompts for operator guidance; all process sequences can be logged; barcode recognition).

•Convenient foot switch activator.


Transfer tubing

Easy-to-read graduated marks

Reliable membrane for high retention of microbes

Vent filter

Pre-installed color-coded tube clamps.

Sterisart Canisters can be ordered with or without a needle port septum for sub-cultur-ing of positive results.

VHP resistant packaging. Stainless steel septum needle.

Septum

Sterisart®NFCanistersforSterilityTestingDisposable Sample Canisters and Adapters for use with Sterisart® Universal Pump

For sterility testing in isolators and clean benches. Individually sterile, double-packaged, gamma irradiated, needles made of stainless steel.

Multiple styles available for different applications. Call for product recommendation for your application.


Incubator (Low cost, small foot print)This compact incubator fits easily on most counter tops. The incubator holds a constant temperature to plus or minus one degree. It is made of powder coated steel and has an acrylic see-through door. It comes with two adjustable shelves. Capable of temperatures up to 60 °C. Capacity is 0.8 cubic feet. The inside dimensions of the chamber are 13” W x 14” H x 16.25” D. Each...............................................132000

Kit includes:• 1 vial of each microorganism (1 lyophilized pellet

per vial)• 5 vials of hydrating fluid (1.2 mL in each vial)• 5 peel-off labels, one for each strainEach...............................................8172

EZ-Accu Shot™ Select is packaged as a kit containing five Quality Control strains required by the Pharmacopeias for Growth Promotion Testing, all of which are derived from the American Type Culture Collection (ATCC®).

Licensed, traceable strains:Aspergillus brasiliensis ATCC® 16404™Bacillus subtilis subsp. spizizenii ATCC® 6633™Candida albicans ATCC® 10231™Pseudomonas aeruginosa ATCC® 9027™Staphylococcus aureus subsp. aureus ATCC® 6538™

True-Tempe™ Incubator ThermometersThese environmentally safe thermometers contain no dangerous mercury; instead they are filled with red spirit alcohol. For additional safety, they are encased in a Teflon® coating to prevent breakage. Range is 18 °C to 50 °C, with 0.5 °C divisions. 135mm in height. The thermometer is sealed within a fluid-filled unbreakable bottle to prevent temperature reading fluctuations, due to the opening and closing of the incubator door. Attached magnet allows for adherence to the inside wall of the incubator. Each...............................................I0301S.

Equipment

GrowthPromotionTestingUSP<71>

Teflon is a registered trademark of DuPont Corp.

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compliant - pharma choice · 2016. 5. 11. · fingertip sampling surface sampling is required on a...

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