CERTIFICATION. Certificate No. The AOAC Research Institute hereby certifies that the performance of the test kit known as: MC Media Pad YM

Transcription

1 CERTIFICATION AOAC Perormance Tested SM Certiicate No The AOAC Research Institute hereby certiies that the perormance o the test kit known as: MC Media Pad YM manuactured by JNC Corporation 2 1, Otemachi 2 chrome Chiyoda ku Tokyo Japan This method has been evaluated in the AOAC Perormance Tested Methods SM Proram, and ound to perorm as stated by the manuacturer continent to the comments contained in the manuscript. This certiicate means that an AOAC Certiication Mark License Areement has been executed which authorizes the manuacturer to display the AOAC Perormance Tested SM certiication mark alon with the statement "THIS METHOD'S PERFORMANCE WAS REVIEWED BY AOAC RESEARCH INSTITUTE AND WAS FOUND TO PERFORM TO THE MANUFACTURER'S SPECIFICATIONS" on the above mentioned method or a period o one calendar year rom the date o this certiicate (January 15, 218 December 31, 218). Renewal may be ranted at the end o one year under the rules stated in the licensin areement. Deborah McKenzie Deborah McKenzie, Senior Director Sinature or AOAC Research Institute January 15, 218 Date 2275 Research Blvd., Ste. 3, Rockville, Maryland, USA Telephone: Fax: Internet e mail: aoacri@aoac.or * World Wide Web Site:

2 METHOD AUTHORS Oscar Caballero, Susan Alles, Quynh Nhi Le, Mark Mozola, and Jennier Rice SUBMITTING COMPANY Neoen Corporation 62 Lesher Place Lansin, MI USA CURRENT COMPANY JNC Corporation 2 1, Otemachi 2 chrome Chiyoda ku Tokyo Japan KIT NAME(S) MC Media Pad YM Formerly Sanita kun Yeasts and Molds CATALOG NUMBERS SK5A25 SK5B25, SK5A1, SK5B1 INDEPENDENT LABORATORY Q Laboratories, Inc 14 Harrison Avenue Cincinnati, OH USA AOAC EXPERTS AND PEER REVIEWERS Yi Chen 1, Dorn Clark 2, Wayne Ziemer 3 1 FDA CFSAN, Collee Park, MD, USA 2 Marshield Food Saety, Marshield, WI Consultant, Loanville, GA, USA APPLICABILITY OF METHOD Taret oranism Yeast and Mold Matrices Breaded chicken nuets, dry pet ood, orane juice concentrate, yourt, and cake mix REFERENCE METHOD US FDA (21) Bacterioloical Analytical Manual, chapter 18, Yeasts, Molds, and Mycotoxins (3) Perormance claims Perormance equivalent to that o the reerence method. ORIGINAL CERTIFICATION DATE November 1, 214 METHOD MODIFICATION RECORD 1. June 217 Under this AOAC Perormance Tested SM License Number, this method is distributed by: 1. Merck KGaA CERTIFICATION RENEWAL RECORD Renewed Annually throuh December 218 SUMMARY OF MODIFICATION 1. Name chane rom Sanita kun to MC Media Pad YM Under this AOAC Perormance Tested SM License Number, this method is distributed as: 1. MC Media Pad Yeast and Mold PRINCIPLE OF THE METHOD (1) MC Media Pad YM, ormerly known as Sanita kun Yeasts and Molds, is a simple, eective device to be used or the enumeration o yeasts and molds. It consists o a nonwoven abric on which a layer o microbial nutrients is deposited in a ilm (5). The basic device (abric, nutrient, and base ilm) is inserted between an adhesive backin or stability and a transparent ilm. These serve to deter evaporation and acilitate inspection o the inoculated device. Sample solutions potentially containin yeasts and/or molds are deposited on the abric portion o the device. The sample solution then diuses throuhout the entire pad to dissolve and release the nutrient compound ilm, ormin a hihly viscous solution. Durin the assimilation process o the dissolved nutrient ilm and the nonwoven abric, microoranisms mirate to or near the surace o the abric, where they metabolize nutrients and a unique dye to produce a visible red color ater incubation. DISCUSSION OF THE VALIDATION STUDY (1) Results o the internal and independent laboratory studies demonstrate that MC Media Pad YM is an eective platorm or the enumeration o yeasts and molds in breaded chicken nuets, dry pet ood, orane juice concentrate, yourt, and cake mix. With the exception o dry pet ood (.1% peptone water) at the low level and orane juice concentrate (PBS) at the medium level, there were no instances in which MC Media Pad Yeast and Mold produced siniicantly lower counts than the FDA/BAM reerence method. On the other hand, the cake mix medium (PBS) and low and medium (.1% peptone) level counts were siniicantly hiher or MC Media Pad Yeast and Mold than or the FDA/BAM reerence method. The results presented here prescribe a minimum incubation time o 48 h or.1% peptone water as diluent and 72 h or PBS as diluent.

3 JNC Corporation MC Media Pad YM AOAC Certiication Number Table 1. Test matrixes and inoculum oranisms. (1) Food Breaded chicken Dry pet ood Orane juice concentrate Yourt Cake mix Inoculum Strain Penicillium citrinum Asperillus umiatus Naturally contaminated yeast Candida amata Fusarium raminearum

4 JNC Corporation MC Media Pad YM AOAC Certiication Number Table 2. Comparison o yeast and mold recovery levels ater 72 h incubation time between MC Media Pad Yeasts and Molds and FDA/BAM reerence methods usin PBS as diluent. (1) Taret Level Reerence Reerence MC Media MC Media MC Media p 95% 95% Commodity Reerence Mean a Mean Dierence d b (CFU/) S r RSD c r Pad Mean e Pad S r Pad RSD r value h LCL i UCL j Breaded Chicken Cake Mix Pet Food Orane Juice Orane Juice l Yourt a Mean lo transormed counts in CFU/ (Lo 1 [CFU/ + (.1)]) o ive test portions plated by the reerence method. b Repeatability standard deviation o counts by the reerence method. c Relative standard deviation or repeatability by the reerence method. d Mean dierence between MC Media Pad Yeasts and Molds and the reerence method. e Mean lo transormed counts in CFU/ (Lo 1 [CFU/ + (.1)]) o ive test portions tested by the MC Media Pad Yeasts and Molds method. Repeatability standard deviation o counts by the MC Media Pad Yeasts and Molds method. Relative standard deviation or repeatability by the MC Media Pad Yeasts and Molds method. h p value or a 2 tail unpaired t test, P <.5 indicates siniicance at the 95% conidence interval. i 95% lower conidence limit or dierence o means. j 95% upper conidence limit or dierence o means. k Square o correlation coeicient. l Independent lab study. R 2k

5 Table 3. Comparison o yeast and mold recovery levels ater 48 h incubation time between MC Media Pad Yeasts and Molds and FDA/BAM reerence methods usin.1% peptone water as diluent. (1) Taret Level (CFU/) Commodity Reerence Mean a Reerence S r b Reerence c RSD r Mean Dierence d MC Media Pad Mean e MC Media Pad S r MC Media Pad RSD r p 95% 95% value h LCL i UCL j 1 Breaded Chicken Cake Mix Pet Food Orane Juice Orane Juice l Yourt a Mean lo transormed counts in CFU/ (Lo 1 [CFU/ + (.1)]) o ive test portions plated by the reerence method. b Repeatability standard deviation o counts by the reerence method. c Relative standard deviation or repeatability by the reerence method. d Mean dierence between MC Media Pad Yeasts and Molds and the reerence method. e Mean lo transormed counts in CFU/ (Lo 1 [CFU/ + (.1)]) o ive test portions tested by the MC Media Pad Yeasts and Molds method. Repeatability standard deviation o counts by the MC Media Pad Yeasts and Molds method. Relative standard deviation or repeatability by the MC Media Pad Yeasts and Molds method. h p value or a 2 tail unpaired t test, P <.5 indicates siniicance at the 95% conidence interval. i 95% lower conidence limit or dierence o means. j 95% upper conidence limit or dierence o means. k Square o correlation coeicient. l Independent lab study. R 2k

6 JNC Corporation MC Media Pad YM AOAC Certiication Number REFERENCES CITED 1. Caballero, Oscar, Alles, Susan, Le, Quynh Nhi, Mozola, and Rice, Jennier., Validation o the NeoFilm or Yeast and Mold Method or Enumeration o Yeasts and Molds in Select Foods, AOAC Perormance Tested SM certiication number AOAC Research Institute Validation Outline or NeoFilm or Yeast and Mold Method or Enumeration o Yeasts and Molds, Approved November US FDA (21) Bacterioloical Analytical Manual, chapter 18, Yeasts, Molds, and Mycotoxins 4. AOAC INTERNATIONAL Methods Committee Guidelines or Validation o Microbioloical Methods or Food and Environmental Suraces (212) Oicial Methods o Analysis o AOAC INTERNATIONAL, 19th Ed., Appendix J, AOAC INTERNATIONAL, Rockville, MD, 5. Morita H, Ushiyama M, Aoyama S, and Iwasaki M. (23) J AOAC Intl. 86,