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HAR DY DIAGNOSTIC S Media Fill Test Kits USP 797 COMPLIANT Low Risk Medium Risk High Risk Validate the proficiency of your technicians and pharmacists per USP 797 Test for sterility per USP 71 www.HardyValKits.com 011013ss
Compliance was never so easy! Microbial Contamination Testing for CSPs Hardy 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 . 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 selfcontained 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 2 A Culture of Service www.HardyValKits.com
Media Fill Test Kits Low-Risk Level 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 Procedure Summary from USP 797 1 Aseptically transfer Tryptic Soy Broth to empty sterile vials using a sterile 10ml syringe. 2 Attach sterile adhesive seals. 3 Incubate at 25 º C to 35 º C. 4 Examine for turbidity at end of 14 days. 4 transfers of 5ml each 100ml Sterile Tryptic Soy Broth Vial 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. Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 3
Media Fill Test Kits Medium-Risk Level Comprehensive Kit Contents 1 x 700ml Sterile Tryptic Soy Broth Bag 6 x 125ml Empty Sterile Bags 6 x 20ml Empty Sterile Vials 1 x Write-on Whirl-Pak Bag 1 x Results Log Sheet Cat. no. HVM1 Utilizes procedures that closely represent typical complex manipulations used to compound medium-risk level preparations as described in USP 797 . Procedure Summary from USP 797 1 Aseptically transfer 100ml Sterile Tryptic Soy Broth to empty sterile bags using gravity tubing. 2 Transfer Tryptic Soy Broth between bags, using a sterile 10ml syringe. 3 Aseptically transfer 5ml Tryptic Soy Broth to small empty sterile vials. 4 Attach sterile adhesive seals. 5 Incubate at 25 º C to 35 º C. 6 Examine for turbidity at end of 14 days. 700ml Sterile Tryptic Soy Broth Bag 100ml 100ml 5ml 5ml 5ml 5ml Three 5ml transfers using syringe 5ml 100ml 100ml 5ml 5ml 5ml 5ml 100ml Three 5ml transfers using syringe 5ml 5ml 5ml 5ml 5ml 100ml Three 5ml transfers using syringe 5ml *Syringe(s), needle(s), and adhesive seals not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. 4 A Culture of Service www.HardyValKits.com
Media Fill Test Kits Medium-Risk Level-Basic Low Cost Medium-Risk Kit, fulfills minimum requirements Kit Contents 3 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 Bag 1 x Results Log Sheet Cat. no. HVM2 Meets basic requirements for medium-risk challenge testing. Procedure Summary 1 2 3 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. 4 5 Transfer Tryptic Soy Broth between empty vials, using a sterile 10ml syringe and 18-gauge needle. Apply sterile adhesive seals aseptically to the rubber closures once the vials have been filled. Incubate the vials at 20 º C to 25 º C and/ or 30 º C to 35 º C for 14 days. 6 Examine for turbidity. 7 Record results on the “Results Log Sheet”. Aseptically transfer 5ml Tryptic Soy Broth to small empty sterile vials using a sterile 10ml syringe and vented needle. 25ml 50ml 25ml 25ml 50ml 5ml 25ml 25ml 50ml 5ml 5ml 5ml 5ml 25ml 5ml 5ml 5ml 5ml 5ml 5ml 5ml 5ml 5ml 5ml *Syringe(s), needle(s), and adhesive seals not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 5
Media Fill Test Kits High-Risk Level 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 Cat. no. HVH1 Procedure Summary from USP 797 1 Unscrew cap and add 100ml of water (non-bacteriostatic) to Tryptic Soy Broth powder. 2 Screw on cap and mix. 3 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. 4 Attach sterile adhesive seals. 5 Incubate at 25 º C to 35 º C. 6 Examine for turbidity at end of 14 days. Add 100ml non-bacteriostatic water* to 3 grams Tryptic Soy Broth Powder Screw on cap and mix 25ml 25ml 5ml needle 5ml positive control needle 10ml filter 25ml 10ml 5ml positive control needle 10ml filter positive control 10ml filter 10ml 10ml *Syringe(s), needle(s), adhesive seals, non-bacteriostatic water, and filters not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. 6 A Culture of Service www.HardyValKits.com
Environmental Monitoring Air Monitoring Impact Air Sampler 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. Impact Air Sampler for Active Air Sampling Cat. no. 5500 1 Remove cover from sampler. 2 Install plate in its holder and remove lid from plate. 3 Select settings on Spin Air sampler and press start. 4 Once the cycle is complete, replace lid and incubate TSA 33 - 35 ºC for 38 - 72 hours. 5 After 48 hours, count the number of colonies. Incubate *Malt Extract Agar 26 - 30 C for 5 - 7 days. 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 Culture Media for Air Sampling Tryptic Soy Agar (TSA) 15x100mm, 10 plates. G60 Malt Extract Agar (MEA)* Selective for yeast and mold. 15x100mm, 10 plates. W28 *MEA Agar is recommended only for High Risk Level compounding environments. Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 7
Environmental Monitoring Surface & Finger Tip Sampling Hardy 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. Surface Sampling Surface sampling is required on a periodic basis for each laminar air flow workbench or barrier isolator. Tryptic Soy Agar (P34) 1 Remove lid. 2 Gently press plate to surface without twisting or sliding. 3 Replace lid and incubate at 30 - 35 º C. After 48 - 72 hours, count the number of colonies. Fingertip Sampling 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. 1 Remove lid. 2 Gently press glove tips to plate surface. Culture Media for Surface and Finger Tip Sampling Tryptic Soy Agar with Lecithin and Tween 15x60mm, 10 contact plates.P34 Malt 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. 8 A Culture of Service www.HardyValKits.com 3 Replace lid and incubate at 30 - 35 º C. After 48 - 72 hours, count the number of colonies. Record your results.
Biological Indicators 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-tointerpret 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 ºC 100/pk. BST100 20/pk. BST20 1 A 2 3 B 4 C 5 D 13 MM Dry Block Incubator.112001 Heat Block Insert. 110013 Surface Monitoring Solar-Cult Flex-Paddle Surface Monitoring Slide The surface monitoring slide is simply a two sidded 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. Holding 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 Kit Neutralizing 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 Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 9
CSP Kits Test to be performed on returned I.V. solutions Random Testing Kit Contents 5 x 5ml Double Strength Tryptic Soy Broth Syringes 5 x Write-on Whirl-Pak Bags 1 x Results Log Sheet Cat. no. HVR1 Use on expired or returned drugs to check sterility, for quality assurance purposes only. 1 2 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. 3 Incubate at 25 ºC to 35 ºC. 4 Examine for turbidity at end of 14 days. 5 Does not fulfill requirements for USP 71 Sterility Testing. 5ml Sterile Double Strength Tryptic Soy Broth Syringe Dra into w 5m the ls of syr dru ing g e *Sterile needles not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. 10 A Culture of Service www.HardyValKits.com
Sterility Testing Direct Inoculation of 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. Below are some some types of media that can be used for direct inoculation. Tryptic Soy Broth, USP Recommended 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 Tryptic Soy Broth, USP Recommended 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 Fluid Thioglycollate Broth Medium with Indicator, USP For the cultivation of anaerobic microorganisms. 100ml glass bottle with needle port septum, 100ml fill, 12/pk.U47 Fluid Thioglycollate Broth Medium with Indicator, USP For the cultivation of anaerobic microorganisms. 20ml glass bottle with needle port septum, 20ml fill 50/pk.U68 Custom containers and fill volumes are available upon request. Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 11
Sterility Testing - Filtering Sterisart Universal Pump Sterility Testing System 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 peristaltic pump made of stainless steel, and is equipped with appropriate features for attaching a Sterisart sterility test canister. After the Sterisart canisters have been positioned 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, 12 distributing 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. A Culture of Service www.HardyValKits.com
Sterisart Universal Pump The Sterisart Universal pump can be used in clean rooms, integrated into clean benches, or installed in the work area of isolators. Each.16420 Support rod Features and Benefits 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. Spring loaded fastening arm for media containers Control unit Optional ampoule breaker Sterisart disposable canisters Bottle holding ring Spike/ Needle Pump head Speed selection knob Pump Clamping lever Carrying handle Draining container Draining tube Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 13
Sterisart NF Canisters for Sterility Testing Disposable Sample Canisters and Adapters for use with Sterisart Universal Pump Transfer tubing Vent filter For sterility testing in isolators and clean benches. Individually sterile, double-packaged, gamma irradiated, needles made of stainless steel. Septum Easy-to-read graduated marks Sterisart Canisters can be ordered with or without a needle port septum for sub-culturing of positive results. Pre-installed color-coded tube clamps. Reliable membrane for high retention of microbes VHP resistant packaging. Stainless steel septum needle. Multiple styles available for different applications. Call for product recommendation for your application. 14 A Culture of Service www.HardyValKits.com
Growth Promotion Testing USP 71 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 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 strain Each.8172 Equipment 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 True-Tempe Incubator Thermometers These 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. Teflon is a registered trademark of DuPont Corp. Sales@HardyDiagnostics.com Fax: 805-928-2950 Ph: 800-266-2222 15
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as described in USP 797 . Kit Contents 1 x 700ml Sterile Tryptic Soy Broth Bag 6 x 125ml Empty Sterile Bags 6 x 20ml Empty Sterile Vials 1 x Write-on Whirl-Pak Bag 1 x Results Log Sheet Cat. no. HVM1 5ml 5ml Three 5ml transfers using syringe 5ml 5ml 100ml 100ml 700ml Sterile Tryptic Soy Broth Bag 5ml 5ml 5ml Three 5ml transfers using syringe .
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