FM0030-S02-RM1642-20140414exp20140730 15/04/2014 page 1 of 3 REFERENCE MATERIAL CERTIFICATE This certificate supersedes all previous issues. A2LA Accredited Product Name FM0030-S02 Batch Number 1642 Hazard Information This reference material contains micro-organisms. Please take suitable precautions at all times when handling this material. Please download MSDS via below link: http://www.ifmqs.com.au/referencematerials/qmt022-02%20msds%20microbiological%20reference%20culture.pdf Description of the Certified Quantity per pack Presentation white powder 50g plastic screw capped jar Organism Content (For traceability, refer to individual RM certificates.) REF Organism Name (IFM Number) RM1302 Aspergillus niger (0019) RM1361 Enterobacter aerogenes (2201) RM1477 Escherichia coli (2005) RM1485 Candida utilis (0016) Unit 4/58 Stennett Road, Ingleburn NSW 2565, Australia Telephone: +61 (0)2 9618 3311 Facsimile: + 61 (0)2 9618 3355 Email: ContactIFM@ifmqs.com.au Web: www.ifmqs.com.au QPF137-04
FM0030-S02-RM1642-20140414exp20140730 15/04/2014 page 2 of 3 Intended Use Microbiological reference material for routine quality control purposes Instructions for Use Shake container well before opening. Use aseptic technique at all times. Follow directions below for relevant applications. Reseal container after use and store at 3 C - 5 C protected from light. Quantitative applications Semi-quantitative applications Weigh 10 g reference material and accurately prepare a 1:10 dilution with 0.1% microbiological peptone water. Mix well to dissolve powder. Store protected from light at 3 C - 5 C when not in use. Shake well before each use. Use within 6 hours. Calculate the result obtained per gram of original powder. When removed without compressing the powder, 1 level scoop delivers approximately 3 g of reference material. This enables a convenient method of obtaining semi-quantitative levels of micro-organisms for parallel tests, checking media recovery and similar applications where the required number of organisms is not critical. The number of scoops used and volume of diluent in which the material is dissolved may be varied to suit the number of target organisms required. The example in the below table for semi-quantitative applications applies to 1 scoop dissolved in 50 ml of diluent. (5% error is allowed.) We recommend using 0.1% microbiological peptone water, but other non-selective diluent solutions may also be used. The semi-quantitative solution may be stored protected from light at 3 C - 5 C for 30 hours. Internal validation checks should be conducted before extending this time. Shake well before each use. Values quoted in this certificate do not apply when the reference material is used in a manner contrary to the instructions. Values quoted have been statistically verified using the instructions described above. The weight specified in the instructions is the minimum sample size required to yield the results stated in the table of certified values. Unit 4/58 Stennett Road, Ingleburn NSW 2565, Australia Telephone: +61 (0)2 9618 3311 Facsimile: + 61 (0)2 9618 3355 Email: ContactIFM@ifmqs.com.au Web: www.ifmqs.com.au QPF137-04
FM0030-S02-RM1642-20140414exp20140730 15/04/2014 page 3 of 3 Date of Certification April 14, 2014 Certificate Expiry July 30, 2014 (Certificate will be extended after this date.) Functional Expiry Use within 4 months of purchase. Certified Values & their uncertainties* Not included in scope of accreditation. Data was log transformed prior to applying statistical processes. The expeccted value is the average of results on the declared day of test. The upper and lower limits reflect the ranges of results determined by application of uncertainties due to sample inhomogeneity, laboratory measurement uncertainty, transit and natural product shelf life, in accordance with ISO G34. Tests were conducted on: April 1, 2014 Quantitative Applications Test Name (Method Reference) As the coliforms present are also the only Enterobacteriaceae present, the total coliform count and quoted limits apply for Enterobacteriaceae counts. All results reflect per gram of original powder. Coliforms (IFM0705) E_coli (IFM0705) Mould (IFM0703_1) SPC (IFM0701_3) Yeast (IFM0703_1) Current expected value 2.4E+03 1.6E+02 3.3E+03 1.0E+04 8.4E+02 High limit 4.9E+03 5.8E+02 5.9E+03 1.6E+04 1.6E+03 Low limit 5.3E+02 2.3E+01 2.9E+02 4.0E+03 2.7E+02 Semi quantitative Applications (Approximation provided for guidance only, not included in certification. Results are expressed per 1 ml of prepared solution. "Scoop" refers to the instrument supplied by IFM Quality Services for this purpose.) Test Name (Method Reference) Coliforms (IFM0705) E_coli (IFM0705) Mould (IFM0703_1) SPC (IFM0701_3) Yeast (IFM0703_1) Approximate Value 1.4E+02 9.5E+00 2.0E+02 6.0E+02 5.1E+01 High limit 3.2E+02 3.7E+01 3.8E+02 1.0E+03 1.0E+02 Low limit 3.0E+01 1.3E+00 1.6E+01 2.2E+02 1.1E+01 Authorised By, Technical Manager Unit 4/58 Stennett Road, Ingleburn NSW 2565, Australia Telephone: +61 (0)2 9618 3311 Facsimile: + 61 (0)2 9618 3355 Email: ContactIFM@ifmqs.com.au Web: www.ifmqs.com.au QPF137-04
Aspergillus niger Certificate of Identity of Culture Please note that this organism has the following classification: (Suitable precautions should be taken at all times.) Batch Number: RM1302 RM Number: 1302 risk group II IFM No: 0019 Date of preparation: 09 Jan 2013 Format of Culture: inoculum Organism_Source: UNSW 809900 This batch sourced from: : UNSW 809900 NCTC reference: ATCC reference: DateObtained: may2012 Gram stain and microscopy: Intended use: standard organism for use as control in testing catalase: not tested oxidase: not tested motility by culture: not tested growth in anaerobic conditions: (Please refer to the traceability report for more information.) Information Supporting the Identification of this Organism Mould (Spores present ) no growth motility by microscopy: not tested growth in oxygen: growth growth in CO2: growth indole test: unkwown additional information: Organism appears consitent with mould. Black yellow edge and yellow underside. Identification performed by animal health laboratory perth = Aspergillus niger Certification date: 29 Apr 2013 Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contactifm@ifmqs.com.au web: www.ifmqs.com.au Printed 15/04/2014 3:51:01 PM
Traceability Report for: IFM 0019 Aspergillus niger Batch Number RM Id Date Prepared Type Source RM1302 1302 9/01/2013 inoculum UNSW 809900 This report has been checked for accuracy. Printed: 15/04/2014 3:51:04 PM Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contact_ifm@ifmqs.com.au Page 1 of 1
Enterobacter aerogenes Certificate of Identity of Culture Please note that this organism has the following classification: (Suitable precautions should be taken at all times.) Batch Number: RM1361 RM Number: 1361 risk group II IFM No: 2201 Date of preparation: 27 Feb 2013 Format of Culture: inoculum Organism_Source: NCTC 10006 This batch sourced from: : 2201-20100406/FD NCTC reference: ATCC reference: DateObtained: 10006 13048 30/3/04 (Please refer to the traceability report for more information.) Intended use: standard organism for use as control in testing Information Supporting the Identification of this Organism Gram stain and microscopy: gram negative rods catalase: positive motility by microscopy: motile oxidase: negative growth in oxygen: growth motility by culture: motile growth in CO2: growth growth in anaerobic conditions: growth indole test: negative additional information: negative in EC broth at 44.5C. Identified with 91.4% certainty using Microbact 24E. Certification date: 01 Nov 2013 Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contactifm@ifmqs.com.au web: www.ifmqs.com.au Printed 15/04/2014 3:51:35 PM
Traceability Report for: IFM 2201 Enterobacter aerogenes Batch Number RM Id Date Prepared Type Source RM1361 1361 27/02/2013 inoculum 2201-20100406/FD 2201-20100406/FD 0078 6/04/2010 freeze dried 2201-20060511/FD 2201-20060511/FD 0077 11/05/2006 freeze dried 2201-20040622/FZ 2201-20040622/FZ 0223 22/06/2004 frozen NCTC 10006 This report has been checked for accuracy. Printed: 15/04/2014 3:51:39 PM Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contact_ifm@ifmqs.com.au Page 1 of 1
Escherichia coli Certificate of Identity of Culture Please note that this organism has the following classification: (Suitable precautions should be taken at all times.) Batch Number: RM1477 RM Number: 1477 risk group II IFM No: 2005 Date of preparation: 12 Jun 2013 Format of Culture: inoculum Organism_Source: NCTC 9001 This batch sourced from: : 2005-20100414/FD NCTC reference: ATCC reference: DateObtained: 9001 11775 30/3/04 Gram stain and microscopy: Intended use: standard organism for use as control in testing catalase: positive oxidase: negative motility by culture: motile growth in anaerobic conditions: (Please refer to the traceability report for more information.) Information Supporting the Identification of this Organism gram negative rods growth motility by microscopy: motile growth in oxygen: growth growth in CO2: growth indole test: positive additional information: ferments lactose at 44.5C EC broth positive, LTB positive, metallic green colonies on EMB. Id by microbact e.coli 96.7% on 7/8/2006. API 20 e performed 30/11/12 Excellent ID E. coli, profile = 5144552 Certification date: 04 Sep 2013 Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contactifm@ifmqs.com.au web: www.ifmqs.com.au Printed 15/04/2014 3:52:08 PM
Traceability Report for: IFM 2005 Escherichia coli Batch Number RM Id Date Prepared Type Source RM1477 1477 12/06/2013 inoculum 2005-20100414/FD 2005-20100414/FD 0075 14/04/2010 freeze dried 2005-20060724/FD 2005-20060724/FD 0074 24/07/2006 freeze dried 2005-20040511/FD 2005-20040511/FD 0187 11/05/2004 freeze dried NCTC 9001 This report has been checked for accuracy. Printed: 15/04/2014 3:52:11 PM Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contact_ifm@ifmqs.com.au Page 1 of 1
Candida utilis Certificate of Identity of Culture Please note that this organism has the following classification: (Suitable precautions should be taken at all times.) Batch Number: RM1485 RM Number: 1485 risk group I IFM No: 0016 Date of preparation: 20 Jun 2013 Format of Culture: inoculum Organism_Source: UNSW 709400 This batch sourced from: : 0016-20120823/FD NCTC reference: ATCC reference: DateObtained: 19/6/12 (Please refer to the traceability report for more information.) Intended use: standard organism for use as control in testing Information Supporting the Identification of this Organism Gram stain and microscopy: Large oval budding cells catalase: positive motility by microscopy: motile oxidase: negative growth in oxygen: growth motility by culture: not tested growth in CO2: not tested growth in anaerobic conditions: growth indole test: unknown additional information: Identified by Animal Health Laboratories Perth as Candida utilis. Certification date: 01 Oct 2013 Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contactifm@ifmqs.com.au web: www.ifmqs.com.au Printed 15/04/2014 3:52:32 PM
Traceability Report for: IFM 0016 Candida utilis Batch Number RM Id Date Prepared Type Source RM1485 1485 20/06/2013 inoculum 0016-20120823/FD 0016-20120823/FD 1202 23/08/2012 freeze dried 0016-20120630/FZ 0016-20120630/FZ 1186 30/06/2012 frozen UNSW 709400 This report has been checked for accuracy. Printed: 15/04/2014 3:52:36 PM Tel: +61 2 9618 3311 Fax: +61 2 9618 3355 Email: contact_ifm@ifmqs.com.au Page 1 of 1