Therapeutic Goods Administration

Site

Laboratories Branch Microbiology – Microbiology

Accreditation No.

2432

Site No.

2664

Date of Accreditation

30 Jun 1989

Address

136 Narrabundah Lane
Symonston, ACT 2609
Australia

tga.gov.au

Contact

Mrs Annette Carmichael P: +61 (02) 62328416

Availability

Services conditionally available to external clients

Scope of Accreditation

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Analysis for microorganisms Bacterial isolates; Yeast isolates Identification MALDI-TOF in-house method M4 (Bruker Library number 9607 MSP Version 10.0)
Biological analysis of human and veterinary medicines including vaccines Antibiotics Potency Microbioassay

BP Appendix XVI A (in-house method M8)

Medical devices Pyronema domesticum Qualitative selective enrichment

in-house method M2 Section 4.5

Medical devices; Medicinal preparations; Pharmaceuticals Test for sterility Direct inoculation

BP Appendix XVI A (in-house method S2 Section 8.6.2)

Preservative efficacy Spread plate

BP Appendix XVI C (in-house method M2 Section 8.1), USP-NF 51 (in-house method M2 Section 8.3), ISO 14730 (in-house method M2 Section 8.2)

Staphylococcus aureus; Staphylococcus spp. Qualitative

in-house method M2 Section 4.2.6 and 4.3.6

Aerobes - Total viable Spread plate

in-house method M2 Section 4.3.2

Anaerobes Qualitative

in-house method M2 Section 4.2.7 and 4.3.7

Escherichia coli​​​​ Qualitative

in-house method M2 Section 4.2.3 and 4.3.3

Aerobes - Total viable Membrane filter

in-house method M2 Section 4.2.2

Aerobes - Total viable Qualitative

in-house method M2 Section 4.2.3 and 4.3.3

Pseudomonads Qualitative

in-house method M2 Section 4.2.5 and 4.3.5

Medical devices; Pharmaceuticals Test for sterility Membrane filter

BP Appendix XVI A (in-house method S2 Section 8.6.2)

Medicinal preparations; Pharmaceuticals Salmonella spp. Qualitative

in-house method M2 Section 4.2.4 and 4.3.4

Lactobacillus spp. Spread plate

in-house method M2 Section 6.3

Osmophilic yeasts Qualitative

in-house method M2 Section 4.4.2

Probiotics Pour plate; Spread plate in-house method M9 Sections 18.01, 18.02, 18.03, 19.04, 19.05, 19.06 and 20.07
Candida albicans; Clostridium spp.​​​​; Escherichia coli​​​​; Pseudomonas aeruginosa; Staphylococcus aureus; Bile tolerant gram negative bacteria Qualitative

BP Appendix XVI B, EP, USP-NF 61, USP-NF 62

Aerobes; Yeasts and moulds Membrane filter

BP Appendix XVI B, EP, USP-NF 61, USP-NF 62

Aerobes; Yeasts and moulds Spread plate

BP Appendix XVI B, EP, USP-NF 61 and USP-NF 62

Biological analysis of other healthcare or pharmaceutical products and accessories Bactericides Efficacy Mycobacteria carrier

ASTM E2111-00 (in-house method M6.3)

Disinfectants Efficacy Antimicrobial suspension TGA Disinfectant Test
Sporicides Efficacy Carrier test

ASTM E2111-00 (in-house method M6.4)

Tampons Aerobes Pour plate AS/NZS 2869 Appendix D
Identification of bacterial contaminants; Yeasts and moulds Direct inoculation; Pour plate

AS/NZS 2869 appendix D

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.