Eurofins ams Laboratories Pty Ltd

Site

Sydney Laboratory

Accreditation No.

15773

Site No.

16983

Date of Accreditation

09 Oct 2008

Address

179 Magowar Road
Girraween, NSW 2145
Australia

eurofins.com.au/biopharma-services

Contact

Mr Fergus O'Connell P: +61 0402364620

Availability

Services available to external clients

Scope of Accreditation

Sydney Laboratory

ISO/IEC 17025 (2017)

Environment

Service Product Determinant Technique Procedure
Analysis for microorganisms Air - Ambient; Air - Confined spaces; Air - Indoor Escherichia coli​​​​; Staphylococcus aureus; Coliforms; Mesophilic aerobic spore formers; Plate count; Pseudomonads; Yeasts and moulds Contact plates; Settle plate

in-house method ME-124

Bacterial isolates; Mould isolates; Yeast isolates Identification MALDI-TOF in-house methods TMI-004
Identification Microscopy in-house method TMI-005
Identification Molecular in-house method TMI-006
Estuarine waters; Fresh waters; Industrial waters - Treated, recirculating; Marine waters; Potable waters; Purified and processed waters; Swimming pool and spa waters Escherichia coli​​​​; Coliforms - Thermotolerant Membrane filter

AS 4276.7 (in-house method TMW-141)

Pseudomonas aeruginosa Membrane filter

AS 4276.13 (in-house method TMW-220)

Heterotrophic colony count Pour plate

AS 4276.3 (in-house method TMW-140)

Coliforms Membrane filter

AS 4276.5 (in-house method TMW-142)

Estuarine waters; Fresh waters; Industrial waters - Treated, recirculating; Marine waters; Potable waters; Purified and processed waters; Swimming pool and spa waters; Waters containing biocides Legionella pneumophila; Legionella spp. Spread plate

AS 3896 (in-house method TMW-114)

Estuarine waters; Fresh waters; Industrial waters - Treated, recirculating; Marine waters; Purified and processed waters; Swimming pool and spa waters Pseudomonads Membrane filter in-house method TMW-112
Estuarine waters; Fresh waters; Industrial waters - Treated, recirculating; Marine waters; Purified and processed waters; Swimming pool and spa waters; Waters containing biocides Heterotrophic colony count Spread plate

AS 4276.3 (in-house method TMW-114)

Surfaces Escherichia coli​​​​; Staphylococcus aureus; Coliforms; Mesophilic aerobic spore formers; Plate count; Pseudomonads; Yeasts and moulds Pour plate

in-house method TME-113

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Analysis for physical and chemical characteristics of human and veterinary medicines including vaccines Filterable solutions and soluble preparations; Ointments; Pharmaceuticals; Surgical devices; Surgical dressings and related products Sub-visible particles Microscopy; Visual examination

in-house method TMS-002

Sub-visible particles Particle counter

in-house method TMS-001

Medical devices Bioburden Filtration

ISO 11737-1 (in-house method TMPC-120)

Biological analysis of cosmetics, perfumes and essentials oils Cosmetic products; Cosmetic raw materials; Cosmetic waters; Essential oils; Perfumes Clostridia - Anaerobic spore formers Enrichment broths; Selective agar; Streak plate

BP Appendix XVIB (in-house method TMPC-150)

Yeasts and moulds Membrane filter; Pour plate; Selective agar; Streak plate

BP Appendix XVIB (in-house method TMPC-102)

Plate count Membrane filter; Pour plate; Spread plate - Aerobic and anaerobic

BP Appendix XVIB (in-house method TMPC-101)

Bile tolerant gram negative bacteria Enrichment broths; Selective agar; Streak plate

BP Appendix XVIB (in-house method TMPC-225)

Escherichia coli​​​​ Enrichment broths

BP Appendix XVIB (in-house method TMPC-105)

Salmonella spp. Enrichment broths; Selective agar; Streak plate

BP Appendix XVIB (in-house method TMPC-106)

Indicator organisms Enrichment broths; Membrane filter

BP Appendix XVIB (in-house method TMPC-103)

Biological analysis of human and veterinary medicines including vaccines Antibiotics Minimum inhibitory concentration (MIC) Large plate antibiotic assay - Punch hole

BP Appendix XVIA (in-house method TMA-001)

Biological products; Pharmaceuticals Plate count Membrane filter; Pour plate; Spread plate

BP Appendix XVIB (in-house method TMPC-101)


Bile tolerant gram negative bacteria Enrichment broths; Streak plate BP Appendix XVIB (in-house method TMPC -225)
Indicator organisms Enrichment broths; Membrane filter BP Appendix XVIB (in-house method TMPC-103)
Endotoxin Limulus amoebocyte lysate (LAL)

BP Appendix XIVC (in-house method TML-125)

Clostridia - Anaerobic spore formers Enrichment broths; Selective agar; Streak plate BP Appendix XVIB (in-house method TMPC-150)
Salmonella spp. Enrichment broths; Selective agar; Streak plate BP Appendix XVIB (in-house method TMPC-106)
Escherichia coli​​​​ Enrichment broths BP Appendix XVIB (in-house method TMPC-105)
Preservative efficacy Pour plate

BP Appendix XVIC (in-house method TMPC-107)

USP 51 (in-house method TMPC-108)

in-house method TMPC-109

Yeasts and moulds Membrane filter; Pour plate; Selective agar; Streak plate BP Appendix XVIB (in-house method TMPC-102)
Filterable solutions and soluble preparations; Ointments; Pharmaceuticals; Surgical devices; Surgical dressings and related products Test for sterility; Test of sterility Suspension

BP Appendix XVIA, ISO 11737-2 (in-house method TMS-115)

Probiotics Bacterial spores; Yeasts and moulds Pour plate; Spread plate

in-house method TMF-131

Lactobacillus spp. Pour plate; Spread plate in-house method TMF-130
Biological analysis of other healthcare or pharmaceutical products and accessories Biological indicators Indicator organisms Direct inoculation

USP 55 (in-house method TME-157)

Disinfectants Efficacy In-vivo skin disinfectant EN1499/EN1500 (in-house methods TMD 258/TMD 259)
Pharmaceutical waters Aerobes - Total viable Membrane filter BP Part III General Notices (in-house method TMW-111)
Staphylococcus aureus; Coliforms; Pseudomonads; Yeasts and moulds Membrane filter in-house method TMW-112
Spore strips Bacillus atrophaeus​​​​; Bacillus subtilis; Geobacillus stearothermophilus; Indicator organisms; Spores Direct inoculation USP 55 (in-house method TME-155)
Virucides Efficacy Antimicrobial suspension in-house method TMD 256

ISO/IEC 17025 (2017)

Manufactured Goods

Service Product Determinant Technique Procedure Limitations
Products and appliances connected to the water supply - Physical evaluation Plumbing products and materials in contact with water Flavour profile Not applicable AS/NZS 4020 Appendix C
BS 6920-2.2.1, BS 6920-2.2.2, BS 6920-2.2.3, 
Growth of aquatic microorganisms Not applicable AS/NZS 4020 Appendix E
BS 6920 - 2.4
Appearance Not applicable AS/NZS 4020 Appendix D
BS 6920 - 2.3
Extraction only
Products and appliances connected to the water supply - Sample preparation Plumbing products and materials in contact with water Not applicable Immersion - High temperature AS/NZS 4020 Appendix J
Not applicable Immersion exposure; In-the-product exposure AS/NZS 4020 Appendix I
Not applicable Extraction - Functional test units AS/NZS 4020 Appendix K
Not applicable Immersion exposure; In-the-product exposure AS/NZS 4020 Appendix A (in-house methods TMP 19100 and TMP 1919101)
Products and appliances connected to the water supply - Toxicity evaluation Plumbing products and materials in contact with water Cytotoxicity Ames test AS/NZS 4020 Appendix F
BS 6920-2.5
Potential metal leaching Not applicable AS/NZS 4020 Appendix H
BS 6920-2.6
Extraction only
Mutagenicity Ames test AS/NZS 4020 Appendix G

ISO/IEC 17025 (2017)

Materials

Service Product Determinant Technique Procedure Limitations
Analysis of biofuels, hydrocarbon fuels and related fuel products Crude oil; Fuel oil Cytotoxicity Ames test ASTM Designation: E 1687
Analysis of lubricants, oils and related products Base oils Cytotoxicity Ames test
ASTM Designation: E 1687

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