Media Fill Test Kits. Manufactured by. Making USP <797> compliance easy!

Transcription

1 Media Fill Test Kits Manufactured by Making USP <797> compliance easy!

2 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 self-contained ready-to-use kit A results log sheet is included in each kit Detailed instructions and diagrams are included with each kit Kits are designed to help you follow USP s<797> guidelines. Surface Sampling Air Sampling Sterility Tests

3 Sterility Testing by Direct Inoculation of Pharmaceuticals using Hardy Diagnostics Media <USP 7> Drug solutions can be tested for sterility by direct inoculation into Tryptic Soy Broth (TSB) and Fluid Thioglycollate according to procedures found in <USP 7>. By incubating for days, a lack of fungal, aerobic, and anaerobic bacterial contamination can be proven. Please consult <USP 7> (Table II) to verify proper inoculum size and media volume. The USP recommended media for direct inoculation. Fluid Thioglycollate Broth Medium with Indicator, USP For the cultivation of microorganisms and USP sterility procedures. 0ml glass bottle, 0ml fill, 50/pk...CA glass bottle, fill, /pk...ca 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. 0ml glass bottle, 0ml fill, 50/pk...CA glass bottle, fill, 0/pk...CA

4 Cat. no. CA Low-Risk Level Media Fill Test Kit Kit Contents x Sterile Tryptic Soy Broth Vial x 0ml Empty Sterile Vials x Write-on Whirl-Pak Bag x Results Log Sheet Procedure Summary from USP <797> Aseptically transfer Tryptic Soy Broth to empty sterile vials using a sterile syringe. Attach sterile adhesive seals. Incubate at 5ºC to 5ºC. Examine for turbidity at the end of days. *Syringe(s), needle(s), and adhesive seals not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. transfers of each Sterile Tryptic Soy Broth Vial 0ml vial 0ml vial 0ml vial

5 Cat. no. CA Procedure Summary from USP <797> Medium-Risk Level Media Fill Test Kit - Comprehensive Kit Contents x 700ml Sterile Tryptic Soy Broth Bag 6 x Empty Sterile Bags 6 x 0ml Empty Sterile Vials x Write-on Whirl-Pak Bag x Results Log Sheet Aseptically transfer Sterile Tryptic Soy Broth to empty sterile bags using gravity tubing. Transfer Tryptic Soy Broth between bags using a sterile syringe. Aseptically transfer Tryptic Soy Broth to small empty sterile vials. 5 6 Attach sterile adhesive seals. Incubate at 5ºC to 5ºC. Examine for turbidity at the end of days. 700ml Sterile Tryptic Soy Broth Bag *Syringe(s), needle(s), gravity tubing, and adhesive seals not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. Three transfers using syringe Three transfers using syringe Three transfers using syringe 5

6 Cat. no. CA Medium-Risk Level Media Fill Test Kit - Basic Kit Contents x 50ml Serum Vials Sterile Tryptic Soy Broth 6 x 50ml Serum Vials (empty), sterile x 0ml Serum Vials (empty), sterile x Write-on Whirl-Pak Bag x Results Log Sheet Economically priced Medium-Risk Test Kit Procedure Summary from USP <797> Aseptically transfer two aliquots of approximately of sterile Tryptic Soy Broth into each of the empty sterile 50ml vials using gravity tubing. Repeat this process with fresh tubing two more times so that there will be six 50ml vials containing of test medium. Transfer Tryptic Soy Broth between empty vials using a sterile syringe and 8-gauge needle. Aseptically transfer Tryptic Soy Broth to small empty sterile vials using a sterile syringe and vented needle Apply sterile adhesive seals aseptically to the rubber closures once the vials have been filled. Incubate the vials at 0ºC to 5ºC and/or 0ºC to 5ºC for days. Examine for turbidity. Record results on the Results Log Sheet. *Syringe(s), needle(s), and adhesive seals not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. 50ml 50ml 50ml 6

7 Cat. no. CA High-Risk Level Media Fill Test Kit Kit Contents x gm Tryptic Soy Broth Powder (non-sterile) 9 x 0ml Empty Sterile Vials x Write-on Whirl-Pak Bag x Results Log Sheet Procedure Summary from USP <797> Unscrew cap and add of water (non-bacteriostatic) to Tryptic Soy Broth powder. Screw on cap and mix. 5 6 Attach sterile adhesive seals. Incubate at 5ºC to 5ºC. Examine for turbidity at the end of days. Transfer the appropriate amounts of Tryptic Soy Broth to empty sterile vials using a sterile 0ml syringe with and without a 0. micron filter. *Syringe(s), needle(s), adhesive seals, non-bacteriostatic water, and filters not included. Whirl-Pak is a registered trademark of Nasco Industries, Inc. Add non-bacteriostatic water* to grams Tryptic Soy Broth Powder Screw on cap and mix needle positive control needle positive control needle positive control filter filter filter 7

8 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 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 ( ) Remove lid. Gently press plate to surface without twisting or sliding. Replace lid and incubate at 0-5 º C. After 8-7 hours, count the number of colonies. Record your results. Fingertip Sampling Personnel monitoring (glove fingertips) is required to be done at initial competency evaluation and no fewer than three times before being allowed to compound sterile preparations. Remove lid. Gently press glove tips to plate surface. Replace lid and incubate at 0-5 º C. After 8-7 hours, count the number of colonies. Record your results. Culture Media for Surface and Finger Tip Sampling Malt Extract Agar* with Lecithin and Tween Selective for yeast and mold. 5x00mm contact plate (0 plates)... CA Tween is a registered trademark of ICI Americas, Inc. *MEA is recommended only for High Risk Level compounding environments. Tryptic Soy Agar with Lecithin and Tween 5x60mm contact plate (0 plates)...ca Lit. No WCN.CA